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Incidental Asymptomatic Fibular Stress Fractures Presenting as Varus Knee Osteoarthritis: A Case Report
ABSTRACT
Stress fractures are often missed, especially in unusual clinical settings. We report on 2 patients who presented to our orthopedic surgery clinic with incidental findings of asymptomatic proximal fibular tension side stress fractures in severe longstanding varus osteoarthritic knees. Initial plain films demonstrated an expansile deformity of the proximal fibular shaft, and differential diagnosis included a healed or healing fracture versus possible neoplasm. Magnetic resonance imaging with and without gadolinium was utilized to rule out the latter prior to planned total knee arthroplasty.
Continue to: The proximal fibula...
The proximal fibula is a rare site for stress fractures, with most of these fractures occurring in military recruits.1 To the authors’ knowledge, there has been only 1 documented case of a proximal fibular stress fracture in patients with severe osteoarthritis (OA) and fixed varus deformity, which mimicked L5 radiculopathy.2 We are not aware of any reports of asymptomatic tension-side fibular stress fractures in varus knees. In our 2 cases, the patients were indicated for total knee arthroplasty (TKA) for varus degenerative joint disease after failing nonoperative treatment; however, further work-up was justified to rule out neoplasm after plain films revealed expansile deformities of the proximal fibular shaft. Each patient subsequently underwent magnetic resonance imaging (MRI) with and without gadolinium contrast, which demonstrated a healed and healing proximal fibular stress fracture. Magnetic resonance imaging is rarely indicated in the evaluation of degenerative joint disease, and stress fractures about a varus knee generally occur on the compression side of the tibia and are symptomatic.3-7 The patients provided informed written consent for print and electronic publication of this case report.
CASE REPORT
The first patient was a 77-year-old male who presented with longstanding knee pain, left greater than right, exacerbated by weight-bearing activities. The patient had no improvement with physical therapy or anti-inflammatory medication. He denied any history of trauma, weakness, paresthesias, or a recent increase in activity. The patient also denied any fevers, chills, night sweats, or other constitutional symptoms. On physical examination, the patient had an antalgic gait and limited range of motion bilaterally. Examination of his right lower extremity demonstrated a fixed 5° varus deformity. No distinct point tenderness was noted.
Radiographs of the right knee demonstrated varus deformity and tricompartmental degenerative changes with severe medial joint space narrowing. An expansile deformity of the proximal right fibular shaft was also noted (Figure 1), which was not present on the films 2 years earlier (Figure 2). The absence of this deformity on previous imaging raised the suspicion of a tumor. An MRI with and without gadolinium, which was obtained to rule out a neoplastic process, showed an old, healed proximal fibular shaft fracture with chronic periosteal reaction (Figure 3). There was no marrow edema to suggest acute injury and no neoplastic lesion. He was reassured regarding the benign findings and was scheduled for a left TKA, as his pain was more severe on the left knee. The patient’s stress fracture healed without complications, and he underwent a successful left TKA. He returned approximately 6 months after his procedure with worsening right knee pain and underwent a successful TKA on the right knee as well.
The second patient was a 67-year-old male with longstanding bilateral knee pain, right greater than left, with no antecedent trauma. He denied a history of increased activity, or weakness or paresthesias. He denied any fevers, chills, night sweats, or other constitutional symptoms. One year prior to presentation at our clinic, he had received corticosteroid injections and hyaluronic acid, without relief. The patient also had a history with another surgeon of arthroscopy 1 year earlier and subchondroplasty 3 years before presentation to our clinic. On physical examination, the patient’s right knee displayed a fixed 7° varus deformity with decreased range of motion, effusion, and diffuse crepitus. Further examination revealed tenderness to palpation of the proximal fibula.
Radiographs of the right knee showed degenerative joint disease with varus deformity and medial compartment joint space narrowing. They also demonstrated an expansile deformity of mixed lucency and sclerosis involving the proximal right fibular shaft (Figure 4). Although these findings appeared to be consistent with a stress fracture, their appearance was also suspicious for a neoplasm. To rule out malignancy, an MRI with and without gadolinium was obtained that revealed a healing stress fracture of the proximal fibula (Figure 5). The patient was reassured, and plans were made to proceed with a TKA. The patient’s stress fracture healed without complications, and he underwent successful right TKA. Radiographs from the patient’s 8-week follow-up showed a healed fibular stress fracture (Figure 6).
Continue to: DISCUSSION
DISCUSSION
To our knowledge, this is the first report of incidental tension-side stress fractures in varus osteoarthritic knees. Stress fractures have been classified into 2 groups, fatigue fractures and insufficiency fractures. Fatigue fractures occur when abnormal stress is applied to normal bones, and insufficiency fractures result when normal stress is applied to abnormal bones.8 Stress fractures can also be classified into risk categories based on which bone is involved and the loading of the bone.9 Sites loaded in tension have increased risk of nonunion, progression to complete fracture, and reoccurrence compared with sites loaded in compression.9 Stress fractures of the fibula occur rarely, and when present, they are more commonly observed in the distal fibula in athletes and military recruits.1 Stress fractures occur rarely in patients with primary OA, and when present in this setting, obesity and malalignment are the contributing factors.3 Neither patient was obese in our case (body mass index of 27 and 28, respectively), but significant varus deformity was present in both patients. Stress fractures occurring near the knee in the setting of a varus deformity generally occur on the compression side of the tibia and are symptomatic.3-7
Regarding malalignment, Cheung and colleagues10 reported about a case of an elderly female with OA of the knee with valgus deformity that initially developed a proximal fibular stress fracture followed by a proximal tibial stress fracture. However, both of our patients had varus deformities. Mullaji and Shetty3 documented stress fractures in 34 patients with OA, a majority with varus deformities, but did not report any isolated proximal fibular stress fractures. Manish and colleagues2 reported the only documented case of an isolated proximal fibular stress fracture in a patient with osteoarthritic varus deformity. The patient presented initially with pain and paresthesias of the lower thigh and leg consistent with an L5 radiculopathy. They believed that the varus deformity and the repetitive contraction of the lateral knee muscles put increased shear forces on the fibula leading to the stress fracture. Our patients did not present with any radicular symptoms, a history of acute worsening pain, or an increased activity concerning for a stress fracture. Instead, our patients presented with progressively worsening knee pain typical of severe OA and incidental findings on imaging of tension-side fibular stress fractures. An MRI with and without gadolinium confirmed the diagnosis of a healed fracture in our first patient and a healing fracture in our second patient.
CONCLUSION
Although exceedingly rare in osteoarthritic varus knees, we presented 2 cases of MRI-confirmed proximal fibular stress fractures in this report. As demonstrated, patients may present with symptoms of OA or radicular symptoms as described by Manish and colleagues.2 Presentation may also include an expansile lesion on imaging, prompting a differential diagnosis that includes a neoplasm. If present in the setting of an osteoarthritic varus knee, stress fractures of the proximal fibula should heal with conservative treatment and not affect the plan or outcome of TKA.
- Devas MB, Sweetnam R. Stress fractures of the fibula; a review of fifty cases in athletes. J Bone Joint Surg Br. 1956;38-B(4):818-829.
- Manish KK, Agnivesh T, Pramod PS, Samir SD. Isolated proximal fibular stress fracture in osteoarthritis knee presenting as L5 radiculopathy. J Orthop Case Reports. 2015;5(3):75-77. doi:10.13107/jocr.2250-0685.315.
- Mullaji A, Shetty G. Total knee arthroplasty for arthritic knees with tibiofibular stress fractures: classification and treatment guidelines. J Arthroplasty. 2010;25(2):295-301. doi:10.1016/j.arth.2008.11.012.
- Sourlas I, Papachristou G, Pilichou A, Giannoudis PV, Efstathopoulos N, Nikolaou VS. Proximal tibial stress fractures associated with primary degenerative knee osteoarthritis. Am J Orthop (Belle Mead NJ). 2009;38(3):120-124
- Demir B, Gursu S, Oke R, Ozturk K, Sahin V. Proximal tibia stress fracture caused by severe arthrosis of the knee with varus deformity. Am J Orthop (Belle Mead NJ). 2009;38(9):457-459.
- Satku K, Kumar VP, Pho RW. Stress fractures of the tibia in osteoarthritis of the knee. J Bone Joint Surg Br. 1987;69(2):309-311. doi:10.1302/0301-620X.69B2.3818767.
- Martin LM, Bourne RB, Rorabeck CH. Stress fractures associated with osteoarthritis of the knee. A report of three cases. J Bone Joint Surg Am. 1988;70(5):771-774.
- Hong SH, Chu IT. Stress fracture of the proximal fibula in military recruits. Clin Orthop Surg. 2009;1(3):161-164. doi:10.4055/cios.2009.1.3.161
- Knapik JJ, Reynolds K, Hoedebecke KL. Stress fractures: Etiology, epidemiology, diagnosis, treatment, and prevention. J Spec Oper Med. 17(2):120-130.
- Cheung MHS, Lee M-F, Lui TH. Insufficiency fracture of the proximal fibula and then tibia: A case report. J Orthop Surg. 2013;21(1):103-105. doi:10.1177/230949901302100126
ABSTRACT
Stress fractures are often missed, especially in unusual clinical settings. We report on 2 patients who presented to our orthopedic surgery clinic with incidental findings of asymptomatic proximal fibular tension side stress fractures in severe longstanding varus osteoarthritic knees. Initial plain films demonstrated an expansile deformity of the proximal fibular shaft, and differential diagnosis included a healed or healing fracture versus possible neoplasm. Magnetic resonance imaging with and without gadolinium was utilized to rule out the latter prior to planned total knee arthroplasty.
Continue to: The proximal fibula...
The proximal fibula is a rare site for stress fractures, with most of these fractures occurring in military recruits.1 To the authors’ knowledge, there has been only 1 documented case of a proximal fibular stress fracture in patients with severe osteoarthritis (OA) and fixed varus deformity, which mimicked L5 radiculopathy.2 We are not aware of any reports of asymptomatic tension-side fibular stress fractures in varus knees. In our 2 cases, the patients were indicated for total knee arthroplasty (TKA) for varus degenerative joint disease after failing nonoperative treatment; however, further work-up was justified to rule out neoplasm after plain films revealed expansile deformities of the proximal fibular shaft. Each patient subsequently underwent magnetic resonance imaging (MRI) with and without gadolinium contrast, which demonstrated a healed and healing proximal fibular stress fracture. Magnetic resonance imaging is rarely indicated in the evaluation of degenerative joint disease, and stress fractures about a varus knee generally occur on the compression side of the tibia and are symptomatic.3-7 The patients provided informed written consent for print and electronic publication of this case report.
CASE REPORT
The first patient was a 77-year-old male who presented with longstanding knee pain, left greater than right, exacerbated by weight-bearing activities. The patient had no improvement with physical therapy or anti-inflammatory medication. He denied any history of trauma, weakness, paresthesias, or a recent increase in activity. The patient also denied any fevers, chills, night sweats, or other constitutional symptoms. On physical examination, the patient had an antalgic gait and limited range of motion bilaterally. Examination of his right lower extremity demonstrated a fixed 5° varus deformity. No distinct point tenderness was noted.
Radiographs of the right knee demonstrated varus deformity and tricompartmental degenerative changes with severe medial joint space narrowing. An expansile deformity of the proximal right fibular shaft was also noted (Figure 1), which was not present on the films 2 years earlier (Figure 2). The absence of this deformity on previous imaging raised the suspicion of a tumor. An MRI with and without gadolinium, which was obtained to rule out a neoplastic process, showed an old, healed proximal fibular shaft fracture with chronic periosteal reaction (Figure 3). There was no marrow edema to suggest acute injury and no neoplastic lesion. He was reassured regarding the benign findings and was scheduled for a left TKA, as his pain was more severe on the left knee. The patient’s stress fracture healed without complications, and he underwent a successful left TKA. He returned approximately 6 months after his procedure with worsening right knee pain and underwent a successful TKA on the right knee as well.
The second patient was a 67-year-old male with longstanding bilateral knee pain, right greater than left, with no antecedent trauma. He denied a history of increased activity, or weakness or paresthesias. He denied any fevers, chills, night sweats, or other constitutional symptoms. One year prior to presentation at our clinic, he had received corticosteroid injections and hyaluronic acid, without relief. The patient also had a history with another surgeon of arthroscopy 1 year earlier and subchondroplasty 3 years before presentation to our clinic. On physical examination, the patient’s right knee displayed a fixed 7° varus deformity with decreased range of motion, effusion, and diffuse crepitus. Further examination revealed tenderness to palpation of the proximal fibula.
Radiographs of the right knee showed degenerative joint disease with varus deformity and medial compartment joint space narrowing. They also demonstrated an expansile deformity of mixed lucency and sclerosis involving the proximal right fibular shaft (Figure 4). Although these findings appeared to be consistent with a stress fracture, their appearance was also suspicious for a neoplasm. To rule out malignancy, an MRI with and without gadolinium was obtained that revealed a healing stress fracture of the proximal fibula (Figure 5). The patient was reassured, and plans were made to proceed with a TKA. The patient’s stress fracture healed without complications, and he underwent successful right TKA. Radiographs from the patient’s 8-week follow-up showed a healed fibular stress fracture (Figure 6).
Continue to: DISCUSSION
DISCUSSION
To our knowledge, this is the first report of incidental tension-side stress fractures in varus osteoarthritic knees. Stress fractures have been classified into 2 groups, fatigue fractures and insufficiency fractures. Fatigue fractures occur when abnormal stress is applied to normal bones, and insufficiency fractures result when normal stress is applied to abnormal bones.8 Stress fractures can also be classified into risk categories based on which bone is involved and the loading of the bone.9 Sites loaded in tension have increased risk of nonunion, progression to complete fracture, and reoccurrence compared with sites loaded in compression.9 Stress fractures of the fibula occur rarely, and when present, they are more commonly observed in the distal fibula in athletes and military recruits.1 Stress fractures occur rarely in patients with primary OA, and when present in this setting, obesity and malalignment are the contributing factors.3 Neither patient was obese in our case (body mass index of 27 and 28, respectively), but significant varus deformity was present in both patients. Stress fractures occurring near the knee in the setting of a varus deformity generally occur on the compression side of the tibia and are symptomatic.3-7
Regarding malalignment, Cheung and colleagues10 reported about a case of an elderly female with OA of the knee with valgus deformity that initially developed a proximal fibular stress fracture followed by a proximal tibial stress fracture. However, both of our patients had varus deformities. Mullaji and Shetty3 documented stress fractures in 34 patients with OA, a majority with varus deformities, but did not report any isolated proximal fibular stress fractures. Manish and colleagues2 reported the only documented case of an isolated proximal fibular stress fracture in a patient with osteoarthritic varus deformity. The patient presented initially with pain and paresthesias of the lower thigh and leg consistent with an L5 radiculopathy. They believed that the varus deformity and the repetitive contraction of the lateral knee muscles put increased shear forces on the fibula leading to the stress fracture. Our patients did not present with any radicular symptoms, a history of acute worsening pain, or an increased activity concerning for a stress fracture. Instead, our patients presented with progressively worsening knee pain typical of severe OA and incidental findings on imaging of tension-side fibular stress fractures. An MRI with and without gadolinium confirmed the diagnosis of a healed fracture in our first patient and a healing fracture in our second patient.
CONCLUSION
Although exceedingly rare in osteoarthritic varus knees, we presented 2 cases of MRI-confirmed proximal fibular stress fractures in this report. As demonstrated, patients may present with symptoms of OA or radicular symptoms as described by Manish and colleagues.2 Presentation may also include an expansile lesion on imaging, prompting a differential diagnosis that includes a neoplasm. If present in the setting of an osteoarthritic varus knee, stress fractures of the proximal fibula should heal with conservative treatment and not affect the plan or outcome of TKA.
ABSTRACT
Stress fractures are often missed, especially in unusual clinical settings. We report on 2 patients who presented to our orthopedic surgery clinic with incidental findings of asymptomatic proximal fibular tension side stress fractures in severe longstanding varus osteoarthritic knees. Initial plain films demonstrated an expansile deformity of the proximal fibular shaft, and differential diagnosis included a healed or healing fracture versus possible neoplasm. Magnetic resonance imaging with and without gadolinium was utilized to rule out the latter prior to planned total knee arthroplasty.
Continue to: The proximal fibula...
The proximal fibula is a rare site for stress fractures, with most of these fractures occurring in military recruits.1 To the authors’ knowledge, there has been only 1 documented case of a proximal fibular stress fracture in patients with severe osteoarthritis (OA) and fixed varus deformity, which mimicked L5 radiculopathy.2 We are not aware of any reports of asymptomatic tension-side fibular stress fractures in varus knees. In our 2 cases, the patients were indicated for total knee arthroplasty (TKA) for varus degenerative joint disease after failing nonoperative treatment; however, further work-up was justified to rule out neoplasm after plain films revealed expansile deformities of the proximal fibular shaft. Each patient subsequently underwent magnetic resonance imaging (MRI) with and without gadolinium contrast, which demonstrated a healed and healing proximal fibular stress fracture. Magnetic resonance imaging is rarely indicated in the evaluation of degenerative joint disease, and stress fractures about a varus knee generally occur on the compression side of the tibia and are symptomatic.3-7 The patients provided informed written consent for print and electronic publication of this case report.
CASE REPORT
The first patient was a 77-year-old male who presented with longstanding knee pain, left greater than right, exacerbated by weight-bearing activities. The patient had no improvement with physical therapy or anti-inflammatory medication. He denied any history of trauma, weakness, paresthesias, or a recent increase in activity. The patient also denied any fevers, chills, night sweats, or other constitutional symptoms. On physical examination, the patient had an antalgic gait and limited range of motion bilaterally. Examination of his right lower extremity demonstrated a fixed 5° varus deformity. No distinct point tenderness was noted.
Radiographs of the right knee demonstrated varus deformity and tricompartmental degenerative changes with severe medial joint space narrowing. An expansile deformity of the proximal right fibular shaft was also noted (Figure 1), which was not present on the films 2 years earlier (Figure 2). The absence of this deformity on previous imaging raised the suspicion of a tumor. An MRI with and without gadolinium, which was obtained to rule out a neoplastic process, showed an old, healed proximal fibular shaft fracture with chronic periosteal reaction (Figure 3). There was no marrow edema to suggest acute injury and no neoplastic lesion. He was reassured regarding the benign findings and was scheduled for a left TKA, as his pain was more severe on the left knee. The patient’s stress fracture healed without complications, and he underwent a successful left TKA. He returned approximately 6 months after his procedure with worsening right knee pain and underwent a successful TKA on the right knee as well.
The second patient was a 67-year-old male with longstanding bilateral knee pain, right greater than left, with no antecedent trauma. He denied a history of increased activity, or weakness or paresthesias. He denied any fevers, chills, night sweats, or other constitutional symptoms. One year prior to presentation at our clinic, he had received corticosteroid injections and hyaluronic acid, without relief. The patient also had a history with another surgeon of arthroscopy 1 year earlier and subchondroplasty 3 years before presentation to our clinic. On physical examination, the patient’s right knee displayed a fixed 7° varus deformity with decreased range of motion, effusion, and diffuse crepitus. Further examination revealed tenderness to palpation of the proximal fibula.
Radiographs of the right knee showed degenerative joint disease with varus deformity and medial compartment joint space narrowing. They also demonstrated an expansile deformity of mixed lucency and sclerosis involving the proximal right fibular shaft (Figure 4). Although these findings appeared to be consistent with a stress fracture, their appearance was also suspicious for a neoplasm. To rule out malignancy, an MRI with and without gadolinium was obtained that revealed a healing stress fracture of the proximal fibula (Figure 5). The patient was reassured, and plans were made to proceed with a TKA. The patient’s stress fracture healed without complications, and he underwent successful right TKA. Radiographs from the patient’s 8-week follow-up showed a healed fibular stress fracture (Figure 6).
Continue to: DISCUSSION
DISCUSSION
To our knowledge, this is the first report of incidental tension-side stress fractures in varus osteoarthritic knees. Stress fractures have been classified into 2 groups, fatigue fractures and insufficiency fractures. Fatigue fractures occur when abnormal stress is applied to normal bones, and insufficiency fractures result when normal stress is applied to abnormal bones.8 Stress fractures can also be classified into risk categories based on which bone is involved and the loading of the bone.9 Sites loaded in tension have increased risk of nonunion, progression to complete fracture, and reoccurrence compared with sites loaded in compression.9 Stress fractures of the fibula occur rarely, and when present, they are more commonly observed in the distal fibula in athletes and military recruits.1 Stress fractures occur rarely in patients with primary OA, and when present in this setting, obesity and malalignment are the contributing factors.3 Neither patient was obese in our case (body mass index of 27 and 28, respectively), but significant varus deformity was present in both patients. Stress fractures occurring near the knee in the setting of a varus deformity generally occur on the compression side of the tibia and are symptomatic.3-7
Regarding malalignment, Cheung and colleagues10 reported about a case of an elderly female with OA of the knee with valgus deformity that initially developed a proximal fibular stress fracture followed by a proximal tibial stress fracture. However, both of our patients had varus deformities. Mullaji and Shetty3 documented stress fractures in 34 patients with OA, a majority with varus deformities, but did not report any isolated proximal fibular stress fractures. Manish and colleagues2 reported the only documented case of an isolated proximal fibular stress fracture in a patient with osteoarthritic varus deformity. The patient presented initially with pain and paresthesias of the lower thigh and leg consistent with an L5 radiculopathy. They believed that the varus deformity and the repetitive contraction of the lateral knee muscles put increased shear forces on the fibula leading to the stress fracture. Our patients did not present with any radicular symptoms, a history of acute worsening pain, or an increased activity concerning for a stress fracture. Instead, our patients presented with progressively worsening knee pain typical of severe OA and incidental findings on imaging of tension-side fibular stress fractures. An MRI with and without gadolinium confirmed the diagnosis of a healed fracture in our first patient and a healing fracture in our second patient.
CONCLUSION
Although exceedingly rare in osteoarthritic varus knees, we presented 2 cases of MRI-confirmed proximal fibular stress fractures in this report. As demonstrated, patients may present with symptoms of OA or radicular symptoms as described by Manish and colleagues.2 Presentation may also include an expansile lesion on imaging, prompting a differential diagnosis that includes a neoplasm. If present in the setting of an osteoarthritic varus knee, stress fractures of the proximal fibula should heal with conservative treatment and not affect the plan or outcome of TKA.
- Devas MB, Sweetnam R. Stress fractures of the fibula; a review of fifty cases in athletes. J Bone Joint Surg Br. 1956;38-B(4):818-829.
- Manish KK, Agnivesh T, Pramod PS, Samir SD. Isolated proximal fibular stress fracture in osteoarthritis knee presenting as L5 radiculopathy. J Orthop Case Reports. 2015;5(3):75-77. doi:10.13107/jocr.2250-0685.315.
- Mullaji A, Shetty G. Total knee arthroplasty for arthritic knees with tibiofibular stress fractures: classification and treatment guidelines. J Arthroplasty. 2010;25(2):295-301. doi:10.1016/j.arth.2008.11.012.
- Sourlas I, Papachristou G, Pilichou A, Giannoudis PV, Efstathopoulos N, Nikolaou VS. Proximal tibial stress fractures associated with primary degenerative knee osteoarthritis. Am J Orthop (Belle Mead NJ). 2009;38(3):120-124
- Demir B, Gursu S, Oke R, Ozturk K, Sahin V. Proximal tibia stress fracture caused by severe arthrosis of the knee with varus deformity. Am J Orthop (Belle Mead NJ). 2009;38(9):457-459.
- Satku K, Kumar VP, Pho RW. Stress fractures of the tibia in osteoarthritis of the knee. J Bone Joint Surg Br. 1987;69(2):309-311. doi:10.1302/0301-620X.69B2.3818767.
- Martin LM, Bourne RB, Rorabeck CH. Stress fractures associated with osteoarthritis of the knee. A report of three cases. J Bone Joint Surg Am. 1988;70(5):771-774.
- Hong SH, Chu IT. Stress fracture of the proximal fibula in military recruits. Clin Orthop Surg. 2009;1(3):161-164. doi:10.4055/cios.2009.1.3.161
- Knapik JJ, Reynolds K, Hoedebecke KL. Stress fractures: Etiology, epidemiology, diagnosis, treatment, and prevention. J Spec Oper Med. 17(2):120-130.
- Cheung MHS, Lee M-F, Lui TH. Insufficiency fracture of the proximal fibula and then tibia: A case report. J Orthop Surg. 2013;21(1):103-105. doi:10.1177/230949901302100126
- Devas MB, Sweetnam R. Stress fractures of the fibula; a review of fifty cases in athletes. J Bone Joint Surg Br. 1956;38-B(4):818-829.
- Manish KK, Agnivesh T, Pramod PS, Samir SD. Isolated proximal fibular stress fracture in osteoarthritis knee presenting as L5 radiculopathy. J Orthop Case Reports. 2015;5(3):75-77. doi:10.13107/jocr.2250-0685.315.
- Mullaji A, Shetty G. Total knee arthroplasty for arthritic knees with tibiofibular stress fractures: classification and treatment guidelines. J Arthroplasty. 2010;25(2):295-301. doi:10.1016/j.arth.2008.11.012.
- Sourlas I, Papachristou G, Pilichou A, Giannoudis PV, Efstathopoulos N, Nikolaou VS. Proximal tibial stress fractures associated with primary degenerative knee osteoarthritis. Am J Orthop (Belle Mead NJ). 2009;38(3):120-124
- Demir B, Gursu S, Oke R, Ozturk K, Sahin V. Proximal tibia stress fracture caused by severe arthrosis of the knee with varus deformity. Am J Orthop (Belle Mead NJ). 2009;38(9):457-459.
- Satku K, Kumar VP, Pho RW. Stress fractures of the tibia in osteoarthritis of the knee. J Bone Joint Surg Br. 1987;69(2):309-311. doi:10.1302/0301-620X.69B2.3818767.
- Martin LM, Bourne RB, Rorabeck CH. Stress fractures associated with osteoarthritis of the knee. A report of three cases. J Bone Joint Surg Am. 1988;70(5):771-774.
- Hong SH, Chu IT. Stress fracture of the proximal fibula in military recruits. Clin Orthop Surg. 2009;1(3):161-164. doi:10.4055/cios.2009.1.3.161
- Knapik JJ, Reynolds K, Hoedebecke KL. Stress fractures: Etiology, epidemiology, diagnosis, treatment, and prevention. J Spec Oper Med. 17(2):120-130.
- Cheung MHS, Lee M-F, Lui TH. Insufficiency fracture of the proximal fibula and then tibia: A case report. J Orthop Surg. 2013;21(1):103-105. doi:10.1177/230949901302100126
TAKE-HOME POINTS
- Proximal fibular stress fractures in patients with primary osteoarthritis and fixed varus deformity have rarely been reported.
- Stress fractures occurring near the knee in the setting of a varus deformity generally occur on the compression side of the tibia and are symptomatic.
- Proximal fibular stress fractures may present as an incidental finding of an expansile deformity on plain films in patients with varus osteoarthritic knees.
- Magnetic resonance imaging is rarely indicated in the evaluation of degenerative joint disease; however, it was justified in our case to rule out neoplasm.
- When present in the setting of an osteoarthritic varus knee, stress fractures of the proximal fibula should heal with conservative treatment and should not affect the plan or outcome of TKA.
Medical Complications and Outcomes After Total Shoulder Arthroplasty: A Nationwide Analysis
ABSTRACT
There is a paucity of evidence describing the types and rates of postoperative complications following total shoulder arthroplasty (TSA). We sought to analyze the complications following TSA and determine their effects on described outcome measures.
Using discharge data from the weighted Nationwide Inpatient Sample from 2006 to 2010, patients who underwent primary TSA were identified. The prevalence of specific complications was identified using the International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes. The data from this database represent events occurring during admission, prior to discharge. The associations between patient characteristics, complications, and outcomes of TSA were evaluated. The specific outcomes analyzed in this study were mortality and length of stay (LOS).
A total of 125,766 patients were identified. The rate of complication after TSA was 6.7% (8457 patients). The most frequent complications were respiratory, renal, and cardiac, occurring in 2.9%, 0.8%, and 0.8% of cases, respectively. Increasing age and total number of preoperative comorbidities significantly increased the likelihood of having a complication. The prevalence of postoperative shock and central nervous system, cardiac, vascular, and respiratory complications was significantly higher in patients who suffered postoperative mortality (88 patients; 0.07% mortality rate) than in those who survived surgery (P < 0.0001). In terms of LOS, shock and infectious and vascular complications most significantly increased the length of hospitalization.
Postoperative complications following TSA are not uncommon and occur in >6% of patients. Older patients and certain comorbidities are associated with complications after surgery. These complications are associated with postoperative mortality and increased LOS.
Continue to: Total shoulder arthroplasty...
Total shoulder arthroplasty (TSA) provides a predictably high level of satisfaction with survival as high as 92% at 15 years.1 As implant instrumentation and surgical technique and understanding have improved, the frequency of TSAs being performed has also increased.2 Although there are enough data on long-term surgical complications following TSA,1,3-6 there is a paucity of evidence delineating the incidence and types of postoperative complications during hospitalization. Several current issues motivate the improved understanding of TSA, including the increasing number of TSAs being performed, the desire to improve quality of care, and the desire to create financially efficient healthcare.
The purpose of this study is to detail the postoperative complications that occur following TSA using a large national database. Specifically, our goals are to determine the incidence and types of complications after shoulder arthroplasty, determine the patient factors that are associated with these complications, and evaluate the effects of these complications on postoperative in-hospital mortality and length of stay (LOS). Our hypothesis is that there would be a correlation between specific patient factors and complications and that these complications would adversely correlate to patient postoperative outcomes.
METHODS
DESIGN
We conducted a retrospective analysis of TSAs captured by the Nationwide Inpatient Sample (NIS) database between 2006 and 2010. The NIS is the largest all-payer inpatient database that is currently available to the public in the United States.7
The NIS is a part of the Healthcare Cost and Utilization Project funded by the Agency for Healthcare Research and Quality (AHRQ) and the US Department of Health and Human Services. The NIS database is designed to approximate a 20% sample of US hospitals and the patients they serve, including community, academic, general, and specialty-specific hospitals such as orthopedic hospitals.7 The 2010 update of the NIS database contains discharge data from 1051 hospitals across 45 states, with a representative sample of >39 million inpatient hospital stays.7 The NIS database and its data sources have been independently validated and assessed for quality each year since 1988.8Furthermore, comparative analysis of multiple database elements and distributions has been validated against standard norms, including the National Hospital Discharge Survey.9 The NIS database has been used in numerous published studies.2,10,11
PATIENT SELECTION
The yearly NIS databases from 2006 to 2010 were compiled. Patients aged ≥40 years who underwent a TSA were identified using the International Classification of Diseases, 9th Revision (ICD-9), procedural code 81.80. Exclusion criteria were patients with a primary or a secondary diagnosis of humeral or scapular fracture, chronic osteomyelitis, rheumatologic diseases, or evidence of concurrent malignancy (Figure 1).
Native to NIS are patient demographics, including age, sex, and race. Patient comorbidities as described by Elixhauser and colleagues12 are also included in the database.
Continue to: OUTCOMES...
OUTCOMES
The primary outcome of this study was a description of the type and frequency of postoperative complications of TSA. To conduct this analysis, we queried the TSA cohort for specific ICD-9 codes representing acute cardiac, central nervous system, infectious, gastrointestinal, genitourinary, postoperative shock, renal, respiratory, surgical, vascular, and wound complications. The ICD-9 codes used to identify complications were modeled according to previous literature on various surgical applications and were further parsed to reflect only acute postoperative diagnoses13-15(see the Appendix for the comprehensive list of ICD-9 codes).
Two additional outcomes were analyzed, including postoperative mortality and LOS. Postoperative mortality was defined as death occurring prior to discharge. We calculated the average LOS among the complication and the noncomplication cohort.
STATISTICAL ANALYSIS
Patient demographics and target outcomes of the study were analyzed by frequency distribution. Where applicable, the chi-square and the Student’s t tests were used to confirm the statistical difference for dichotomous and continuous variables, respectively. Multivariate regressions were performed after controlling for possible clustering of the data using a generalized estimating equation following a previous analytical methodology.16-20 The results are reported with odds ratios and 95% confidence intervals where applicable, all statistical tests with P ≤ 0.05 were considered to be significant, and all statistical tests were two-sided. We conducted all analyses using SAS, version 9.2 (SAS Institute).
RESULTS
From 2006 to 2010, a weighted sample of 141,973 patients was found to undergo a TSA. After applying our inclusion and exclusion criteria, our study cohort consisted of 125,766 patients (Figure 1).
Continue to: OVERALL TSA COHORT DEMOGRAPHICS...
OVERALL TSA COHORT DEMOGRAPHICS
The average age of the TSA cohort was 69.4 years (standard deviation [SD], 21.20), and 54.1% were females. The cohort had significant comorbidities, with 83.3% of them having at least 1 comorbidity at the time of surgery. Specifically, 31.3% of the patients had 1 comorbidity, 26.5% had 2 comorbidities, and 25.4% had ≥3 comorbidities. Hypertension was the most common comorbidity present in 66.2% of patients, and diabetes was the second most common comorbidity with a prevalence of 16.8%.
COMPLICATION COHORT DEMOGRAPHICS
An overall postoperative complication rate of 6.7% (weighted sample of 8457 patients) was noted in the overall TSA cohort. The TSA cohort was dichotomized into patients who suffered at least 1 complication (weighted, n = 8457) and patients undergoing routine TSAs (weighted, n = 117,308). The average age was significantly higher in the complication vs routine cohort (71.38 vs 69.27 years, P < 0.0001). Similarly, there were significantly more comorbidities (2.51 vs 1.71, P < 0.0001) in the complication cohort.
COMPLICATIONS
We noted a complication rate of 6.7% (weighted sample of 8457 patients). A single complication was noted in 5% of these patients, whereas 1.3% and 0.4% of the patients had 2 and ≥3 complications, respectively. Respiratory abnormalities (2.9%), acute renal failure (0.8%), and cardiac complications (0.8%) were the most prevalent complications after TSA. The list of complications is detailed in Figure 2. Logistic regression analysis of patient characteristics predicting complications showed that advanced age (odds ratio [OR], 2.1 in those aged ≥85 years) and increasing number of comorbidities (≥3; OR, 3.5) were most significant in predicting complications (all P < 0.0001) (Figure 3). Despite the ubiquity of hypertension in this patient population, it was not a significant predictor of complication (OR, 0.9); in contrast, pulmonary disorders (OR, 5.1) and fluid and electrolyte disorders (4.0) were most strongly associated with the development of a postoperative complication after surgery (Figure 4).
EFFECT OF COMPLICATIONS ON LOS
The average length of hospitalization was 2.3 days (95% confidence interval, 2.22-2.25) among the entire cohort. The average LOS was longer in the complication cohort (3.9 days) than in patients who did not have a complication (2.1 days, P < 0.0001). Of the specific complications noted, hemodynamic shock (11.8 days); infectious, most commonly pneumonia (7.6 days); and vascular complications (6.9 days) were associated with the longest hospitalizations. This result is summarized in Figure 5.
MORTALITY
An overall postoperative (in-house) mortality rate of 0.07% was noted (weighted, n = 88). Comparison between the patient cohort that died vs those who survived TSA resulted in significant differences in the rates of complications. Complications that were most significantly different between the cohorts included cardiac (60.47% vs 0.75%, P < 0.0001), postoperative shock (26.61% vs 0.04%, P < 0.0001), and respiratory complications (43.1% vs 2.8%, P < 0.0001). It is important to note that the overall rate of postoperative shock was exceedingly low in the TSA cohort, but it was highly prevalent in the mortality cohort, occurring in 26.61% of patients. A summary of the mortality statistics is presented in Figure 6.
Continue to: DISCUSSION...
DISCUSSION
TSA continues to be associated with high levels of satisfaction;1 as a result, its incidence is increasing.2 As our understanding and efficiency improves nationally, it is imperative that we determine the short-term and longer-term outcomes and complications. In addition, the factors that may affect prognosis must be elucidated to provide a more individualized and effective standard of care. To date, most of the outcome studies of TSA have evaluated long-term outcomes and specific implant-related complications.1,5,6,21,22 Our intent was to evaluate the complications that occur in the postoperative period and their effect on unique “patient care” outcomes. With knowledge of these complications and the predisposing factors, we can better assess patients, risk-stratify, and provide appropriate guidelines.
We noted that complications occurring after TSA are not uncommon, with >6% of patients suffering a postoperative complication. In this study, the number of complications noted was associated with worse patient outcomes. In addition, we noted that patients undergoing a TSA have a significant burden of comorbidities; however, hematologic and fluid disorders (eg, iron deficiency anemia, pulmonary circulatory disorders, and fluid imbalances) were most important in predicting postoperative complications.
Increased LOS in the hospital after TSA was associated with the occurrence of complications. Of all noted complications, shock and infectious and vascular complications led to the longest hospitalizations. Hospital-acquired pneumonia was the most common infectious etiology, while pulmonary embolism and deep vein thrombosis were the most consistent vascular complications. Although seldom studied in the TSA population, a similar finding has been noted in patients after THA. O’Malley and colleagues,23 using the American College of Surgeon’s National Surgical Quality Improvement Program database, identified independent factors that were associated with complications and average prolonged LOS. They noted that the occurrence of major complications was associated with a prolonged LOS. Some, but not all the major complications, included organ space infection, cardiac events, pneumonia, and venous thromboembolic events.23 Therefore, attempts to limit the amount of time spent in hospitals and control the associated costs must focus on managing the incidence of complications.
Postoperative mortality after TSA was uncommon, occurring in 0.07% of the patients in this study. The low incidence of mortality noted in this study is probably related to the fact that our data represent mortality, whereas in the hospital and, unlike most mortality studies, it does not account for patient demise that may occur in the months after surgery. Other reports have noted that mortality occurs in <1.5% of these patients.24-28 Singh and colleagues25 observed in their evaluation of perioperative mortality after TSA a mortality rate of 0.8% with 90 days after 4380 shoulder replacements performed at their institution. Using multivariate analysis, they were able to identify associations between mortality and increasing American Society of Anesthesiology (ASA) class and Charlson Comorbidity Index. These results in relation to ours would indicate that the majority of patients who die after shoulder arthroplasty do so after initial discharge. Although we could not determine a causal relationship between mortality and patient comorbidities, we noted that certain complications strongly correlated with mortality. In patients who died, there was a relatively high incidence of cardiac (60.5%) and respiratory (43.1%) complications. Similarly, although postoperative shock was almost nonexistent in the patients who survived surgery (0.04%), it was much more common in the patients who suffered mortality (26.6%).
This study is not without limitations. Data were extracted from a national database, therefore precluding the inclusion of specific details of surgery and functional assessment. Inherent to ICD-9 coding, we were unable to assess the exact detail and severity of complications. For instance, we cannot be certain what criteria were used to define “acute renal failure” for each patient. This study is retrospective in nature and therefore adequate randomization and standardization of patients is not possible. Similarly, the nature of the database may not allow for exacting our inclusion and exclusion criteria. However, the large sample size of the patient population lessens the chance of potential biases and type 2 errors. Prior to October 2010, reverse shoulder arthroplasty was coded under the ICD-9procedural code 81.80 as TSA. Therefore, there is some overlap between TSA and reverse shoulder arthroplasty in our data. Reverse shoulder arthroplasty is now coded under ICD-9 procedural code 81.88. It is possible that results may differ if reverse shoulder arthroplasty were excluded from our patient cohort. This can be an area of future research.
CONCLUSION
Although much is known about the long-term hardware and functional complications after TSA, in this study, we have attempted to broaden the understanding of perioperative complications and the associated sequelae. Complications are common after TSA surgery and are related to adverse outcomes. In the setting of healthcare changes, the surgeon and the patient must understand the cause, types, incidence, and outcomes of medical and surgical complications after surgery. This allows for more accurate “standard of care” metrics. Further large-volume multicenter studies are needed to gain further insight into the short- and long-term outcomes of TSA.
1. Fox TJ, Cil A, Sperling JW, Sanchez-Sotelo J, Schleck CD, Cofield RH. Survival of the glenoid component in shoulder arthroplasty. J Shoulder Elbow Surg. 2009;18(6):859-863. doi:10.1016/j.jse.2008.11.020.
2. Kim SH, Wise BL, Zhang Y, Szabo RM. Increasing incidence of shoulder arthroplasty in the United States. J Bone Joint Surg Am. 2011;93(24):2249-2254. doi:10.2106/JBJS.J.01994.
3. Ahmadi S, Lawrence TM, Sahota S, et al. The incidence and risk factors for blood transfusion in revision shoulder arthroplasty: our institution's experience and review of the literature. J Shoulder Elbow Surg. 2014;23(1):43–48. doi:10.1016/j.jse.2013.03.010.
4. Boyd AD Jr, Aliabadi P, Thornhill TS. Postoperative proximal migration in total shoulder arthroplasty. Incidence and significance. J Arthroplasty. 1991;6(1):31-37. doi:10.1016/S0883-5403(06)80154-3.
5. Choi T, Horodyski M, Struk AM, Sahajpal DT, Wright TW. Incidence of early radiolucent lines after glenoid component insertion for total shoulder arthroplasty: a radiographic study comparing pressurized and unpressurized cementing techniques. J Shoulder Elbow Surg. 2013;22(3):403-408. doi:10.1016/j.jse.2012.05.041.
6. Favard L, Katz D, Colmar M, Benkalfate T, Thomazeau H, Emily S. Total shoulder arthroplasty - arthroplasty for glenohumeral arthropathies: results and complications after a minimum follow-up of 8 years according to the type of arthroplasty and etiology. Orthop Traumatol Surg Res. 2012;98(4 Suppl):S41-S47. doi:10.1016/j.otsr.2012.04.003.
7. Agency for Healthcare Research and Quality. Introduction to the HCUP national inpatient sample (NIS) 2012. https://hcup-us.ahrq.gov/db/nation/nis/NISIntroduction2012.pdf 2012. Accessed June 9, 2013.
8. Agency for Healthcare Research and Quality. HCUP quality control procedures. https://hcup-us.ahrq.gov/db/quality.pdf. Accessed June 15, 2013.
9. Agency for Healthcare Research and Quality. Comparative analysis of HCUP and NHDS inpatient discharge data: technical supplement 13. https://archive.ahrq.gov/research/data/hcup/nhds/niscomp.html. Accessed June 15, 2013.
10. Rajaee SS, Trofa D, Matzkin E, Smith E. National trends in primary total hip arthroplasty in extremely young patients: a focus on bearing surface usage. J Arthroplasty. 2012;27(10):1870-1878. doi:10.1016/j.arth.2012.04.006.
11. Bozic KJ, Kurtz S, Lau E, et al. The epidemiology of bearing surface usage in total hip arthroplasty in the United States. J Bone Joint Surg Am. 2009;91(7):1614-1620. doi:10.2106/JBJS.H.01220.
12. Elixhauser A, Steiner C, Harris DR, Coffey RM. Comorbidity measures for use with administrative data. Med Care. 1998;36(1):8-27. doi:10.1097/00005650-199801000-00004.
13. Cahill KS, Chi JH, Day A, Claus EB. Prevalence, complications, and hospital charges associated with use of bone-morphogenetic proteins in spinal fusion procedures. JAMA. 2009;302(1):58-66. doi:10.1001/jama.2009.956.
14. Lin CA, Kuo AC, Takemoto S. Comorbidities and perioperative complications in HIV-positive patients undergoing primary total hip and knee arthroplasty. J Bone Joint Surg Am. 2013;95(11):1028-1036. doi:10.2106/JBJS.L.00269.
15. Rasouli MR, Maltenfort MG, Ross D, Hozack WJ, Memtsoudis SG, Parvizi J. Perioperative morbidity and mortality following bilateral total hip arthroplasty. J Arthroplasty. 2014;29(1):142-148. doi:10.1016/j.arth.2013.04.001.
16. Begg CB, Riedel ER, Bach PB, et al. Variations in morbidity after radical prostatectomy. N Engl J Med. 2002;346(15):1138-1144. doi:10.1056/NEJMsa011788.
17. Hu JC, Gold KF, Pashos CL, Mehta SS, Litwin MS. Temporal trends in radical prostatectomy complications from 1991 to 1998. J Urol. 2003;169(4):1443-1448. doi:10.1097/01.ju.0000056046.16588.e4.
18. Abdollah F, Sun M, Schmitges J, et al. Surgical caseload is an important determinant of continent urinary diversion rate at radical cystectomy: a population-based study. Ann Surg Oncol. 2011;18(9):2680-2687. doi:10.1245/s10434-011-1618-2.
19. Panageas KS, Schrag D, Riedel E, Bach PB, Begg CB. The effect of clustering of outcomes on the association of procedure volume and surgical outcomes. Ann Intern Med. 2003;139(8):658-665. doi:10.7326/0003-4819-139-8-200310210-00009.
20. Joice GA, Deibert CM, Kates M, Spencer BA, McKiernan JM. "Never events”: centers for Medicare and Medicaid Services complications after radical cystectomy. Urology. 2013;81(3):527-532. doi:10.1016/j.urology.2012.09.050.
21. Taunton MJ, McIntosh AL, Sperling JW, Cofield RH. Total shoulder arthroplasty with a metal-backed, bone-ingrowth glenoid component. Medium to long-term results. J Bone Joint Surg Am. 2008;90(10):2180-2188. doi:10.2106/JBJS.G.00966.
22. Raiss P, Schmitt M, Bruckner T, et al. Results of cemented total shoulder replacement with a minimum follow-up of ten years. J Bone Joint Surg Am. 2012;94(23):e1711-e1710. doi:10.2106/JBJS.K.00580.
23. O'Malley NT, Fleming FJ, Gunzler DD, Messing SP, Kates SL. Factors independently associated with complications and length of stay after hip arthroplasty: analysis of the National Surgical Quality Improvement Program. J Arthroplasty. 2012;27(10):1832-1837. doi:10.1016/j.arth.2012.04.025.
24. White CB, Sperling JW, Cofield RH, Rowland CM. Ninety-day mortality after shoulder arthroplasty. J Arthroplasty. 2003;18(7):886-888. doi:10.1016/S0883-5403(03)00269-9.
25. Singh JA, Sperling JW, Cofield RH. Ninety day mortality and its predictors after primary shoulder arthroplasty: an analysis of 4,019 patients from 1976-2008. BMC Musculoskelet Disord. 2011;12:231. doi:10.1186/1471-2474-12-231.
26. Fehringer EV, Mikuls TR, Michaud KD, Henderson WG, O'Dell JR. Shoulder arthroplasties have fewer complications than hip or knee arthroplasties in US veterans. Clin Orthop Relat Res. 2010;468(3):717-722. doi:10.1007/s11999-009-0996-2.
27. Farmer KW, Hammond JW, Queale WS, Keyurapan E, McFarland EG. Shoulder arthroplasty versus hip and knee arthroplasties: a comparison of outcomes. Clin Orthop Relat Res. 2007;455:183-189. doi:10.1097/01.blo.0000238839.26423.8d.
28. Farng E, Zingmond D, Krenek L, Soohoo NF. Factors predicting complication rates after primary shoulder arthroplasty. J Shoulder Elbow Surg. 2011;20(4):557-563. doi:10.1016/j.jse.2010.11.005.
ABSTRACT
There is a paucity of evidence describing the types and rates of postoperative complications following total shoulder arthroplasty (TSA). We sought to analyze the complications following TSA and determine their effects on described outcome measures.
Using discharge data from the weighted Nationwide Inpatient Sample from 2006 to 2010, patients who underwent primary TSA were identified. The prevalence of specific complications was identified using the International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes. The data from this database represent events occurring during admission, prior to discharge. The associations between patient characteristics, complications, and outcomes of TSA were evaluated. The specific outcomes analyzed in this study were mortality and length of stay (LOS).
A total of 125,766 patients were identified. The rate of complication after TSA was 6.7% (8457 patients). The most frequent complications were respiratory, renal, and cardiac, occurring in 2.9%, 0.8%, and 0.8% of cases, respectively. Increasing age and total number of preoperative comorbidities significantly increased the likelihood of having a complication. The prevalence of postoperative shock and central nervous system, cardiac, vascular, and respiratory complications was significantly higher in patients who suffered postoperative mortality (88 patients; 0.07% mortality rate) than in those who survived surgery (P < 0.0001). In terms of LOS, shock and infectious and vascular complications most significantly increased the length of hospitalization.
Postoperative complications following TSA are not uncommon and occur in >6% of patients. Older patients and certain comorbidities are associated with complications after surgery. These complications are associated with postoperative mortality and increased LOS.
Continue to: Total shoulder arthroplasty...
Total shoulder arthroplasty (TSA) provides a predictably high level of satisfaction with survival as high as 92% at 15 years.1 As implant instrumentation and surgical technique and understanding have improved, the frequency of TSAs being performed has also increased.2 Although there are enough data on long-term surgical complications following TSA,1,3-6 there is a paucity of evidence delineating the incidence and types of postoperative complications during hospitalization. Several current issues motivate the improved understanding of TSA, including the increasing number of TSAs being performed, the desire to improve quality of care, and the desire to create financially efficient healthcare.
The purpose of this study is to detail the postoperative complications that occur following TSA using a large national database. Specifically, our goals are to determine the incidence and types of complications after shoulder arthroplasty, determine the patient factors that are associated with these complications, and evaluate the effects of these complications on postoperative in-hospital mortality and length of stay (LOS). Our hypothesis is that there would be a correlation between specific patient factors and complications and that these complications would adversely correlate to patient postoperative outcomes.
METHODS
DESIGN
We conducted a retrospective analysis of TSAs captured by the Nationwide Inpatient Sample (NIS) database between 2006 and 2010. The NIS is the largest all-payer inpatient database that is currently available to the public in the United States.7
The NIS is a part of the Healthcare Cost and Utilization Project funded by the Agency for Healthcare Research and Quality (AHRQ) and the US Department of Health and Human Services. The NIS database is designed to approximate a 20% sample of US hospitals and the patients they serve, including community, academic, general, and specialty-specific hospitals such as orthopedic hospitals.7 The 2010 update of the NIS database contains discharge data from 1051 hospitals across 45 states, with a representative sample of >39 million inpatient hospital stays.7 The NIS database and its data sources have been independently validated and assessed for quality each year since 1988.8Furthermore, comparative analysis of multiple database elements and distributions has been validated against standard norms, including the National Hospital Discharge Survey.9 The NIS database has been used in numerous published studies.2,10,11
PATIENT SELECTION
The yearly NIS databases from 2006 to 2010 were compiled. Patients aged ≥40 years who underwent a TSA were identified using the International Classification of Diseases, 9th Revision (ICD-9), procedural code 81.80. Exclusion criteria were patients with a primary or a secondary diagnosis of humeral or scapular fracture, chronic osteomyelitis, rheumatologic diseases, or evidence of concurrent malignancy (Figure 1).
Native to NIS are patient demographics, including age, sex, and race. Patient comorbidities as described by Elixhauser and colleagues12 are also included in the database.
Continue to: OUTCOMES...
OUTCOMES
The primary outcome of this study was a description of the type and frequency of postoperative complications of TSA. To conduct this analysis, we queried the TSA cohort for specific ICD-9 codes representing acute cardiac, central nervous system, infectious, gastrointestinal, genitourinary, postoperative shock, renal, respiratory, surgical, vascular, and wound complications. The ICD-9 codes used to identify complications were modeled according to previous literature on various surgical applications and were further parsed to reflect only acute postoperative diagnoses13-15(see the Appendix for the comprehensive list of ICD-9 codes).
Two additional outcomes were analyzed, including postoperative mortality and LOS. Postoperative mortality was defined as death occurring prior to discharge. We calculated the average LOS among the complication and the noncomplication cohort.
STATISTICAL ANALYSIS
Patient demographics and target outcomes of the study were analyzed by frequency distribution. Where applicable, the chi-square and the Student’s t tests were used to confirm the statistical difference for dichotomous and continuous variables, respectively. Multivariate regressions were performed after controlling for possible clustering of the data using a generalized estimating equation following a previous analytical methodology.16-20 The results are reported with odds ratios and 95% confidence intervals where applicable, all statistical tests with P ≤ 0.05 were considered to be significant, and all statistical tests were two-sided. We conducted all analyses using SAS, version 9.2 (SAS Institute).
RESULTS
From 2006 to 2010, a weighted sample of 141,973 patients was found to undergo a TSA. After applying our inclusion and exclusion criteria, our study cohort consisted of 125,766 patients (Figure 1).
Continue to: OVERALL TSA COHORT DEMOGRAPHICS...
OVERALL TSA COHORT DEMOGRAPHICS
The average age of the TSA cohort was 69.4 years (standard deviation [SD], 21.20), and 54.1% were females. The cohort had significant comorbidities, with 83.3% of them having at least 1 comorbidity at the time of surgery. Specifically, 31.3% of the patients had 1 comorbidity, 26.5% had 2 comorbidities, and 25.4% had ≥3 comorbidities. Hypertension was the most common comorbidity present in 66.2% of patients, and diabetes was the second most common comorbidity with a prevalence of 16.8%.
COMPLICATION COHORT DEMOGRAPHICS
An overall postoperative complication rate of 6.7% (weighted sample of 8457 patients) was noted in the overall TSA cohort. The TSA cohort was dichotomized into patients who suffered at least 1 complication (weighted, n = 8457) and patients undergoing routine TSAs (weighted, n = 117,308). The average age was significantly higher in the complication vs routine cohort (71.38 vs 69.27 years, P < 0.0001). Similarly, there were significantly more comorbidities (2.51 vs 1.71, P < 0.0001) in the complication cohort.
COMPLICATIONS
We noted a complication rate of 6.7% (weighted sample of 8457 patients). A single complication was noted in 5% of these patients, whereas 1.3% and 0.4% of the patients had 2 and ≥3 complications, respectively. Respiratory abnormalities (2.9%), acute renal failure (0.8%), and cardiac complications (0.8%) were the most prevalent complications after TSA. The list of complications is detailed in Figure 2. Logistic regression analysis of patient characteristics predicting complications showed that advanced age (odds ratio [OR], 2.1 in those aged ≥85 years) and increasing number of comorbidities (≥3; OR, 3.5) were most significant in predicting complications (all P < 0.0001) (Figure 3). Despite the ubiquity of hypertension in this patient population, it was not a significant predictor of complication (OR, 0.9); in contrast, pulmonary disorders (OR, 5.1) and fluid and electrolyte disorders (4.0) were most strongly associated with the development of a postoperative complication after surgery (Figure 4).
EFFECT OF COMPLICATIONS ON LOS
The average length of hospitalization was 2.3 days (95% confidence interval, 2.22-2.25) among the entire cohort. The average LOS was longer in the complication cohort (3.9 days) than in patients who did not have a complication (2.1 days, P < 0.0001). Of the specific complications noted, hemodynamic shock (11.8 days); infectious, most commonly pneumonia (7.6 days); and vascular complications (6.9 days) were associated with the longest hospitalizations. This result is summarized in Figure 5.
MORTALITY
An overall postoperative (in-house) mortality rate of 0.07% was noted (weighted, n = 88). Comparison between the patient cohort that died vs those who survived TSA resulted in significant differences in the rates of complications. Complications that were most significantly different between the cohorts included cardiac (60.47% vs 0.75%, P < 0.0001), postoperative shock (26.61% vs 0.04%, P < 0.0001), and respiratory complications (43.1% vs 2.8%, P < 0.0001). It is important to note that the overall rate of postoperative shock was exceedingly low in the TSA cohort, but it was highly prevalent in the mortality cohort, occurring in 26.61% of patients. A summary of the mortality statistics is presented in Figure 6.
Continue to: DISCUSSION...
DISCUSSION
TSA continues to be associated with high levels of satisfaction;1 as a result, its incidence is increasing.2 As our understanding and efficiency improves nationally, it is imperative that we determine the short-term and longer-term outcomes and complications. In addition, the factors that may affect prognosis must be elucidated to provide a more individualized and effective standard of care. To date, most of the outcome studies of TSA have evaluated long-term outcomes and specific implant-related complications.1,5,6,21,22 Our intent was to evaluate the complications that occur in the postoperative period and their effect on unique “patient care” outcomes. With knowledge of these complications and the predisposing factors, we can better assess patients, risk-stratify, and provide appropriate guidelines.
We noted that complications occurring after TSA are not uncommon, with >6% of patients suffering a postoperative complication. In this study, the number of complications noted was associated with worse patient outcomes. In addition, we noted that patients undergoing a TSA have a significant burden of comorbidities; however, hematologic and fluid disorders (eg, iron deficiency anemia, pulmonary circulatory disorders, and fluid imbalances) were most important in predicting postoperative complications.
Increased LOS in the hospital after TSA was associated with the occurrence of complications. Of all noted complications, shock and infectious and vascular complications led to the longest hospitalizations. Hospital-acquired pneumonia was the most common infectious etiology, while pulmonary embolism and deep vein thrombosis were the most consistent vascular complications. Although seldom studied in the TSA population, a similar finding has been noted in patients after THA. O’Malley and colleagues,23 using the American College of Surgeon’s National Surgical Quality Improvement Program database, identified independent factors that were associated with complications and average prolonged LOS. They noted that the occurrence of major complications was associated with a prolonged LOS. Some, but not all the major complications, included organ space infection, cardiac events, pneumonia, and venous thromboembolic events.23 Therefore, attempts to limit the amount of time spent in hospitals and control the associated costs must focus on managing the incidence of complications.
Postoperative mortality after TSA was uncommon, occurring in 0.07% of the patients in this study. The low incidence of mortality noted in this study is probably related to the fact that our data represent mortality, whereas in the hospital and, unlike most mortality studies, it does not account for patient demise that may occur in the months after surgery. Other reports have noted that mortality occurs in <1.5% of these patients.24-28 Singh and colleagues25 observed in their evaluation of perioperative mortality after TSA a mortality rate of 0.8% with 90 days after 4380 shoulder replacements performed at their institution. Using multivariate analysis, they were able to identify associations between mortality and increasing American Society of Anesthesiology (ASA) class and Charlson Comorbidity Index. These results in relation to ours would indicate that the majority of patients who die after shoulder arthroplasty do so after initial discharge. Although we could not determine a causal relationship between mortality and patient comorbidities, we noted that certain complications strongly correlated with mortality. In patients who died, there was a relatively high incidence of cardiac (60.5%) and respiratory (43.1%) complications. Similarly, although postoperative shock was almost nonexistent in the patients who survived surgery (0.04%), it was much more common in the patients who suffered mortality (26.6%).
This study is not without limitations. Data were extracted from a national database, therefore precluding the inclusion of specific details of surgery and functional assessment. Inherent to ICD-9 coding, we were unable to assess the exact detail and severity of complications. For instance, we cannot be certain what criteria were used to define “acute renal failure” for each patient. This study is retrospective in nature and therefore adequate randomization and standardization of patients is not possible. Similarly, the nature of the database may not allow for exacting our inclusion and exclusion criteria. However, the large sample size of the patient population lessens the chance of potential biases and type 2 errors. Prior to October 2010, reverse shoulder arthroplasty was coded under the ICD-9procedural code 81.80 as TSA. Therefore, there is some overlap between TSA and reverse shoulder arthroplasty in our data. Reverse shoulder arthroplasty is now coded under ICD-9 procedural code 81.88. It is possible that results may differ if reverse shoulder arthroplasty were excluded from our patient cohort. This can be an area of future research.
CONCLUSION
Although much is known about the long-term hardware and functional complications after TSA, in this study, we have attempted to broaden the understanding of perioperative complications and the associated sequelae. Complications are common after TSA surgery and are related to adverse outcomes. In the setting of healthcare changes, the surgeon and the patient must understand the cause, types, incidence, and outcomes of medical and surgical complications after surgery. This allows for more accurate “standard of care” metrics. Further large-volume multicenter studies are needed to gain further insight into the short- and long-term outcomes of TSA.
ABSTRACT
There is a paucity of evidence describing the types and rates of postoperative complications following total shoulder arthroplasty (TSA). We sought to analyze the complications following TSA and determine their effects on described outcome measures.
Using discharge data from the weighted Nationwide Inpatient Sample from 2006 to 2010, patients who underwent primary TSA were identified. The prevalence of specific complications was identified using the International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes. The data from this database represent events occurring during admission, prior to discharge. The associations between patient characteristics, complications, and outcomes of TSA were evaluated. The specific outcomes analyzed in this study were mortality and length of stay (LOS).
A total of 125,766 patients were identified. The rate of complication after TSA was 6.7% (8457 patients). The most frequent complications were respiratory, renal, and cardiac, occurring in 2.9%, 0.8%, and 0.8% of cases, respectively. Increasing age and total number of preoperative comorbidities significantly increased the likelihood of having a complication. The prevalence of postoperative shock and central nervous system, cardiac, vascular, and respiratory complications was significantly higher in patients who suffered postoperative mortality (88 patients; 0.07% mortality rate) than in those who survived surgery (P < 0.0001). In terms of LOS, shock and infectious and vascular complications most significantly increased the length of hospitalization.
Postoperative complications following TSA are not uncommon and occur in >6% of patients. Older patients and certain comorbidities are associated with complications after surgery. These complications are associated with postoperative mortality and increased LOS.
Continue to: Total shoulder arthroplasty...
Total shoulder arthroplasty (TSA) provides a predictably high level of satisfaction with survival as high as 92% at 15 years.1 As implant instrumentation and surgical technique and understanding have improved, the frequency of TSAs being performed has also increased.2 Although there are enough data on long-term surgical complications following TSA,1,3-6 there is a paucity of evidence delineating the incidence and types of postoperative complications during hospitalization. Several current issues motivate the improved understanding of TSA, including the increasing number of TSAs being performed, the desire to improve quality of care, and the desire to create financially efficient healthcare.
The purpose of this study is to detail the postoperative complications that occur following TSA using a large national database. Specifically, our goals are to determine the incidence and types of complications after shoulder arthroplasty, determine the patient factors that are associated with these complications, and evaluate the effects of these complications on postoperative in-hospital mortality and length of stay (LOS). Our hypothesis is that there would be a correlation between specific patient factors and complications and that these complications would adversely correlate to patient postoperative outcomes.
METHODS
DESIGN
We conducted a retrospective analysis of TSAs captured by the Nationwide Inpatient Sample (NIS) database between 2006 and 2010. The NIS is the largest all-payer inpatient database that is currently available to the public in the United States.7
The NIS is a part of the Healthcare Cost and Utilization Project funded by the Agency for Healthcare Research and Quality (AHRQ) and the US Department of Health and Human Services. The NIS database is designed to approximate a 20% sample of US hospitals and the patients they serve, including community, academic, general, and specialty-specific hospitals such as orthopedic hospitals.7 The 2010 update of the NIS database contains discharge data from 1051 hospitals across 45 states, with a representative sample of >39 million inpatient hospital stays.7 The NIS database and its data sources have been independently validated and assessed for quality each year since 1988.8Furthermore, comparative analysis of multiple database elements and distributions has been validated against standard norms, including the National Hospital Discharge Survey.9 The NIS database has been used in numerous published studies.2,10,11
PATIENT SELECTION
The yearly NIS databases from 2006 to 2010 were compiled. Patients aged ≥40 years who underwent a TSA were identified using the International Classification of Diseases, 9th Revision (ICD-9), procedural code 81.80. Exclusion criteria were patients with a primary or a secondary diagnosis of humeral or scapular fracture, chronic osteomyelitis, rheumatologic diseases, or evidence of concurrent malignancy (Figure 1).
Native to NIS are patient demographics, including age, sex, and race. Patient comorbidities as described by Elixhauser and colleagues12 are also included in the database.
Continue to: OUTCOMES...
OUTCOMES
The primary outcome of this study was a description of the type and frequency of postoperative complications of TSA. To conduct this analysis, we queried the TSA cohort for specific ICD-9 codes representing acute cardiac, central nervous system, infectious, gastrointestinal, genitourinary, postoperative shock, renal, respiratory, surgical, vascular, and wound complications. The ICD-9 codes used to identify complications were modeled according to previous literature on various surgical applications and were further parsed to reflect only acute postoperative diagnoses13-15(see the Appendix for the comprehensive list of ICD-9 codes).
Two additional outcomes were analyzed, including postoperative mortality and LOS. Postoperative mortality was defined as death occurring prior to discharge. We calculated the average LOS among the complication and the noncomplication cohort.
STATISTICAL ANALYSIS
Patient demographics and target outcomes of the study were analyzed by frequency distribution. Where applicable, the chi-square and the Student’s t tests were used to confirm the statistical difference for dichotomous and continuous variables, respectively. Multivariate regressions were performed after controlling for possible clustering of the data using a generalized estimating equation following a previous analytical methodology.16-20 The results are reported with odds ratios and 95% confidence intervals where applicable, all statistical tests with P ≤ 0.05 were considered to be significant, and all statistical tests were two-sided. We conducted all analyses using SAS, version 9.2 (SAS Institute).
RESULTS
From 2006 to 2010, a weighted sample of 141,973 patients was found to undergo a TSA. After applying our inclusion and exclusion criteria, our study cohort consisted of 125,766 patients (Figure 1).
Continue to: OVERALL TSA COHORT DEMOGRAPHICS...
OVERALL TSA COHORT DEMOGRAPHICS
The average age of the TSA cohort was 69.4 years (standard deviation [SD], 21.20), and 54.1% were females. The cohort had significant comorbidities, with 83.3% of them having at least 1 comorbidity at the time of surgery. Specifically, 31.3% of the patients had 1 comorbidity, 26.5% had 2 comorbidities, and 25.4% had ≥3 comorbidities. Hypertension was the most common comorbidity present in 66.2% of patients, and diabetes was the second most common comorbidity with a prevalence of 16.8%.
COMPLICATION COHORT DEMOGRAPHICS
An overall postoperative complication rate of 6.7% (weighted sample of 8457 patients) was noted in the overall TSA cohort. The TSA cohort was dichotomized into patients who suffered at least 1 complication (weighted, n = 8457) and patients undergoing routine TSAs (weighted, n = 117,308). The average age was significantly higher in the complication vs routine cohort (71.38 vs 69.27 years, P < 0.0001). Similarly, there were significantly more comorbidities (2.51 vs 1.71, P < 0.0001) in the complication cohort.
COMPLICATIONS
We noted a complication rate of 6.7% (weighted sample of 8457 patients). A single complication was noted in 5% of these patients, whereas 1.3% and 0.4% of the patients had 2 and ≥3 complications, respectively. Respiratory abnormalities (2.9%), acute renal failure (0.8%), and cardiac complications (0.8%) were the most prevalent complications after TSA. The list of complications is detailed in Figure 2. Logistic regression analysis of patient characteristics predicting complications showed that advanced age (odds ratio [OR], 2.1 in those aged ≥85 years) and increasing number of comorbidities (≥3; OR, 3.5) were most significant in predicting complications (all P < 0.0001) (Figure 3). Despite the ubiquity of hypertension in this patient population, it was not a significant predictor of complication (OR, 0.9); in contrast, pulmonary disorders (OR, 5.1) and fluid and electrolyte disorders (4.0) were most strongly associated with the development of a postoperative complication after surgery (Figure 4).
EFFECT OF COMPLICATIONS ON LOS
The average length of hospitalization was 2.3 days (95% confidence interval, 2.22-2.25) among the entire cohort. The average LOS was longer in the complication cohort (3.9 days) than in patients who did not have a complication (2.1 days, P < 0.0001). Of the specific complications noted, hemodynamic shock (11.8 days); infectious, most commonly pneumonia (7.6 days); and vascular complications (6.9 days) were associated with the longest hospitalizations. This result is summarized in Figure 5.
MORTALITY
An overall postoperative (in-house) mortality rate of 0.07% was noted (weighted, n = 88). Comparison between the patient cohort that died vs those who survived TSA resulted in significant differences in the rates of complications. Complications that were most significantly different between the cohorts included cardiac (60.47% vs 0.75%, P < 0.0001), postoperative shock (26.61% vs 0.04%, P < 0.0001), and respiratory complications (43.1% vs 2.8%, P < 0.0001). It is important to note that the overall rate of postoperative shock was exceedingly low in the TSA cohort, but it was highly prevalent in the mortality cohort, occurring in 26.61% of patients. A summary of the mortality statistics is presented in Figure 6.
Continue to: DISCUSSION...
DISCUSSION
TSA continues to be associated with high levels of satisfaction;1 as a result, its incidence is increasing.2 As our understanding and efficiency improves nationally, it is imperative that we determine the short-term and longer-term outcomes and complications. In addition, the factors that may affect prognosis must be elucidated to provide a more individualized and effective standard of care. To date, most of the outcome studies of TSA have evaluated long-term outcomes and specific implant-related complications.1,5,6,21,22 Our intent was to evaluate the complications that occur in the postoperative period and their effect on unique “patient care” outcomes. With knowledge of these complications and the predisposing factors, we can better assess patients, risk-stratify, and provide appropriate guidelines.
We noted that complications occurring after TSA are not uncommon, with >6% of patients suffering a postoperative complication. In this study, the number of complications noted was associated with worse patient outcomes. In addition, we noted that patients undergoing a TSA have a significant burden of comorbidities; however, hematologic and fluid disorders (eg, iron deficiency anemia, pulmonary circulatory disorders, and fluid imbalances) were most important in predicting postoperative complications.
Increased LOS in the hospital after TSA was associated with the occurrence of complications. Of all noted complications, shock and infectious and vascular complications led to the longest hospitalizations. Hospital-acquired pneumonia was the most common infectious etiology, while pulmonary embolism and deep vein thrombosis were the most consistent vascular complications. Although seldom studied in the TSA population, a similar finding has been noted in patients after THA. O’Malley and colleagues,23 using the American College of Surgeon’s National Surgical Quality Improvement Program database, identified independent factors that were associated with complications and average prolonged LOS. They noted that the occurrence of major complications was associated with a prolonged LOS. Some, but not all the major complications, included organ space infection, cardiac events, pneumonia, and venous thromboembolic events.23 Therefore, attempts to limit the amount of time spent in hospitals and control the associated costs must focus on managing the incidence of complications.
Postoperative mortality after TSA was uncommon, occurring in 0.07% of the patients in this study. The low incidence of mortality noted in this study is probably related to the fact that our data represent mortality, whereas in the hospital and, unlike most mortality studies, it does not account for patient demise that may occur in the months after surgery. Other reports have noted that mortality occurs in <1.5% of these patients.24-28 Singh and colleagues25 observed in their evaluation of perioperative mortality after TSA a mortality rate of 0.8% with 90 days after 4380 shoulder replacements performed at their institution. Using multivariate analysis, they were able to identify associations between mortality and increasing American Society of Anesthesiology (ASA) class and Charlson Comorbidity Index. These results in relation to ours would indicate that the majority of patients who die after shoulder arthroplasty do so after initial discharge. Although we could not determine a causal relationship between mortality and patient comorbidities, we noted that certain complications strongly correlated with mortality. In patients who died, there was a relatively high incidence of cardiac (60.5%) and respiratory (43.1%) complications. Similarly, although postoperative shock was almost nonexistent in the patients who survived surgery (0.04%), it was much more common in the patients who suffered mortality (26.6%).
This study is not without limitations. Data were extracted from a national database, therefore precluding the inclusion of specific details of surgery and functional assessment. Inherent to ICD-9 coding, we were unable to assess the exact detail and severity of complications. For instance, we cannot be certain what criteria were used to define “acute renal failure” for each patient. This study is retrospective in nature and therefore adequate randomization and standardization of patients is not possible. Similarly, the nature of the database may not allow for exacting our inclusion and exclusion criteria. However, the large sample size of the patient population lessens the chance of potential biases and type 2 errors. Prior to October 2010, reverse shoulder arthroplasty was coded under the ICD-9procedural code 81.80 as TSA. Therefore, there is some overlap between TSA and reverse shoulder arthroplasty in our data. Reverse shoulder arthroplasty is now coded under ICD-9 procedural code 81.88. It is possible that results may differ if reverse shoulder arthroplasty were excluded from our patient cohort. This can be an area of future research.
CONCLUSION
Although much is known about the long-term hardware and functional complications after TSA, in this study, we have attempted to broaden the understanding of perioperative complications and the associated sequelae. Complications are common after TSA surgery and are related to adverse outcomes. In the setting of healthcare changes, the surgeon and the patient must understand the cause, types, incidence, and outcomes of medical and surgical complications after surgery. This allows for more accurate “standard of care” metrics. Further large-volume multicenter studies are needed to gain further insight into the short- and long-term outcomes of TSA.
1. Fox TJ, Cil A, Sperling JW, Sanchez-Sotelo J, Schleck CD, Cofield RH. Survival of the glenoid component in shoulder arthroplasty. J Shoulder Elbow Surg. 2009;18(6):859-863. doi:10.1016/j.jse.2008.11.020.
2. Kim SH, Wise BL, Zhang Y, Szabo RM. Increasing incidence of shoulder arthroplasty in the United States. J Bone Joint Surg Am. 2011;93(24):2249-2254. doi:10.2106/JBJS.J.01994.
3. Ahmadi S, Lawrence TM, Sahota S, et al. The incidence and risk factors for blood transfusion in revision shoulder arthroplasty: our institution's experience and review of the literature. J Shoulder Elbow Surg. 2014;23(1):43–48. doi:10.1016/j.jse.2013.03.010.
4. Boyd AD Jr, Aliabadi P, Thornhill TS. Postoperative proximal migration in total shoulder arthroplasty. Incidence and significance. J Arthroplasty. 1991;6(1):31-37. doi:10.1016/S0883-5403(06)80154-3.
5. Choi T, Horodyski M, Struk AM, Sahajpal DT, Wright TW. Incidence of early radiolucent lines after glenoid component insertion for total shoulder arthroplasty: a radiographic study comparing pressurized and unpressurized cementing techniques. J Shoulder Elbow Surg. 2013;22(3):403-408. doi:10.1016/j.jse.2012.05.041.
6. Favard L, Katz D, Colmar M, Benkalfate T, Thomazeau H, Emily S. Total shoulder arthroplasty - arthroplasty for glenohumeral arthropathies: results and complications after a minimum follow-up of 8 years according to the type of arthroplasty and etiology. Orthop Traumatol Surg Res. 2012;98(4 Suppl):S41-S47. doi:10.1016/j.otsr.2012.04.003.
7. Agency for Healthcare Research and Quality. Introduction to the HCUP national inpatient sample (NIS) 2012. https://hcup-us.ahrq.gov/db/nation/nis/NISIntroduction2012.pdf 2012. Accessed June 9, 2013.
8. Agency for Healthcare Research and Quality. HCUP quality control procedures. https://hcup-us.ahrq.gov/db/quality.pdf. Accessed June 15, 2013.
9. Agency for Healthcare Research and Quality. Comparative analysis of HCUP and NHDS inpatient discharge data: technical supplement 13. https://archive.ahrq.gov/research/data/hcup/nhds/niscomp.html. Accessed June 15, 2013.
10. Rajaee SS, Trofa D, Matzkin E, Smith E. National trends in primary total hip arthroplasty in extremely young patients: a focus on bearing surface usage. J Arthroplasty. 2012;27(10):1870-1878. doi:10.1016/j.arth.2012.04.006.
11. Bozic KJ, Kurtz S, Lau E, et al. The epidemiology of bearing surface usage in total hip arthroplasty in the United States. J Bone Joint Surg Am. 2009;91(7):1614-1620. doi:10.2106/JBJS.H.01220.
12. Elixhauser A, Steiner C, Harris DR, Coffey RM. Comorbidity measures for use with administrative data. Med Care. 1998;36(1):8-27. doi:10.1097/00005650-199801000-00004.
13. Cahill KS, Chi JH, Day A, Claus EB. Prevalence, complications, and hospital charges associated with use of bone-morphogenetic proteins in spinal fusion procedures. JAMA. 2009;302(1):58-66. doi:10.1001/jama.2009.956.
14. Lin CA, Kuo AC, Takemoto S. Comorbidities and perioperative complications in HIV-positive patients undergoing primary total hip and knee arthroplasty. J Bone Joint Surg Am. 2013;95(11):1028-1036. doi:10.2106/JBJS.L.00269.
15. Rasouli MR, Maltenfort MG, Ross D, Hozack WJ, Memtsoudis SG, Parvizi J. Perioperative morbidity and mortality following bilateral total hip arthroplasty. J Arthroplasty. 2014;29(1):142-148. doi:10.1016/j.arth.2013.04.001.
16. Begg CB, Riedel ER, Bach PB, et al. Variations in morbidity after radical prostatectomy. N Engl J Med. 2002;346(15):1138-1144. doi:10.1056/NEJMsa011788.
17. Hu JC, Gold KF, Pashos CL, Mehta SS, Litwin MS. Temporal trends in radical prostatectomy complications from 1991 to 1998. J Urol. 2003;169(4):1443-1448. doi:10.1097/01.ju.0000056046.16588.e4.
18. Abdollah F, Sun M, Schmitges J, et al. Surgical caseload is an important determinant of continent urinary diversion rate at radical cystectomy: a population-based study. Ann Surg Oncol. 2011;18(9):2680-2687. doi:10.1245/s10434-011-1618-2.
19. Panageas KS, Schrag D, Riedel E, Bach PB, Begg CB. The effect of clustering of outcomes on the association of procedure volume and surgical outcomes. Ann Intern Med. 2003;139(8):658-665. doi:10.7326/0003-4819-139-8-200310210-00009.
20. Joice GA, Deibert CM, Kates M, Spencer BA, McKiernan JM. "Never events”: centers for Medicare and Medicaid Services complications after radical cystectomy. Urology. 2013;81(3):527-532. doi:10.1016/j.urology.2012.09.050.
21. Taunton MJ, McIntosh AL, Sperling JW, Cofield RH. Total shoulder arthroplasty with a metal-backed, bone-ingrowth glenoid component. Medium to long-term results. J Bone Joint Surg Am. 2008;90(10):2180-2188. doi:10.2106/JBJS.G.00966.
22. Raiss P, Schmitt M, Bruckner T, et al. Results of cemented total shoulder replacement with a minimum follow-up of ten years. J Bone Joint Surg Am. 2012;94(23):e1711-e1710. doi:10.2106/JBJS.K.00580.
23. O'Malley NT, Fleming FJ, Gunzler DD, Messing SP, Kates SL. Factors independently associated with complications and length of stay after hip arthroplasty: analysis of the National Surgical Quality Improvement Program. J Arthroplasty. 2012;27(10):1832-1837. doi:10.1016/j.arth.2012.04.025.
24. White CB, Sperling JW, Cofield RH, Rowland CM. Ninety-day mortality after shoulder arthroplasty. J Arthroplasty. 2003;18(7):886-888. doi:10.1016/S0883-5403(03)00269-9.
25. Singh JA, Sperling JW, Cofield RH. Ninety day mortality and its predictors after primary shoulder arthroplasty: an analysis of 4,019 patients from 1976-2008. BMC Musculoskelet Disord. 2011;12:231. doi:10.1186/1471-2474-12-231.
26. Fehringer EV, Mikuls TR, Michaud KD, Henderson WG, O'Dell JR. Shoulder arthroplasties have fewer complications than hip or knee arthroplasties in US veterans. Clin Orthop Relat Res. 2010;468(3):717-722. doi:10.1007/s11999-009-0996-2.
27. Farmer KW, Hammond JW, Queale WS, Keyurapan E, McFarland EG. Shoulder arthroplasty versus hip and knee arthroplasties: a comparison of outcomes. Clin Orthop Relat Res. 2007;455:183-189. doi:10.1097/01.blo.0000238839.26423.8d.
28. Farng E, Zingmond D, Krenek L, Soohoo NF. Factors predicting complication rates after primary shoulder arthroplasty. J Shoulder Elbow Surg. 2011;20(4):557-563. doi:10.1016/j.jse.2010.11.005.
1. Fox TJ, Cil A, Sperling JW, Sanchez-Sotelo J, Schleck CD, Cofield RH. Survival of the glenoid component in shoulder arthroplasty. J Shoulder Elbow Surg. 2009;18(6):859-863. doi:10.1016/j.jse.2008.11.020.
2. Kim SH, Wise BL, Zhang Y, Szabo RM. Increasing incidence of shoulder arthroplasty in the United States. J Bone Joint Surg Am. 2011;93(24):2249-2254. doi:10.2106/JBJS.J.01994.
3. Ahmadi S, Lawrence TM, Sahota S, et al. The incidence and risk factors for blood transfusion in revision shoulder arthroplasty: our institution's experience and review of the literature. J Shoulder Elbow Surg. 2014;23(1):43–48. doi:10.1016/j.jse.2013.03.010.
4. Boyd AD Jr, Aliabadi P, Thornhill TS. Postoperative proximal migration in total shoulder arthroplasty. Incidence and significance. J Arthroplasty. 1991;6(1):31-37. doi:10.1016/S0883-5403(06)80154-3.
5. Choi T, Horodyski M, Struk AM, Sahajpal DT, Wright TW. Incidence of early radiolucent lines after glenoid component insertion for total shoulder arthroplasty: a radiographic study comparing pressurized and unpressurized cementing techniques. J Shoulder Elbow Surg. 2013;22(3):403-408. doi:10.1016/j.jse.2012.05.041.
6. Favard L, Katz D, Colmar M, Benkalfate T, Thomazeau H, Emily S. Total shoulder arthroplasty - arthroplasty for glenohumeral arthropathies: results and complications after a minimum follow-up of 8 years according to the type of arthroplasty and etiology. Orthop Traumatol Surg Res. 2012;98(4 Suppl):S41-S47. doi:10.1016/j.otsr.2012.04.003.
7. Agency for Healthcare Research and Quality. Introduction to the HCUP national inpatient sample (NIS) 2012. https://hcup-us.ahrq.gov/db/nation/nis/NISIntroduction2012.pdf 2012. Accessed June 9, 2013.
8. Agency for Healthcare Research and Quality. HCUP quality control procedures. https://hcup-us.ahrq.gov/db/quality.pdf. Accessed June 15, 2013.
9. Agency for Healthcare Research and Quality. Comparative analysis of HCUP and NHDS inpatient discharge data: technical supplement 13. https://archive.ahrq.gov/research/data/hcup/nhds/niscomp.html. Accessed June 15, 2013.
10. Rajaee SS, Trofa D, Matzkin E, Smith E. National trends in primary total hip arthroplasty in extremely young patients: a focus on bearing surface usage. J Arthroplasty. 2012;27(10):1870-1878. doi:10.1016/j.arth.2012.04.006.
11. Bozic KJ, Kurtz S, Lau E, et al. The epidemiology of bearing surface usage in total hip arthroplasty in the United States. J Bone Joint Surg Am. 2009;91(7):1614-1620. doi:10.2106/JBJS.H.01220.
12. Elixhauser A, Steiner C, Harris DR, Coffey RM. Comorbidity measures for use with administrative data. Med Care. 1998;36(1):8-27. doi:10.1097/00005650-199801000-00004.
13. Cahill KS, Chi JH, Day A, Claus EB. Prevalence, complications, and hospital charges associated with use of bone-morphogenetic proteins in spinal fusion procedures. JAMA. 2009;302(1):58-66. doi:10.1001/jama.2009.956.
14. Lin CA, Kuo AC, Takemoto S. Comorbidities and perioperative complications in HIV-positive patients undergoing primary total hip and knee arthroplasty. J Bone Joint Surg Am. 2013;95(11):1028-1036. doi:10.2106/JBJS.L.00269.
15. Rasouli MR, Maltenfort MG, Ross D, Hozack WJ, Memtsoudis SG, Parvizi J. Perioperative morbidity and mortality following bilateral total hip arthroplasty. J Arthroplasty. 2014;29(1):142-148. doi:10.1016/j.arth.2013.04.001.
16. Begg CB, Riedel ER, Bach PB, et al. Variations in morbidity after radical prostatectomy. N Engl J Med. 2002;346(15):1138-1144. doi:10.1056/NEJMsa011788.
17. Hu JC, Gold KF, Pashos CL, Mehta SS, Litwin MS. Temporal trends in radical prostatectomy complications from 1991 to 1998. J Urol. 2003;169(4):1443-1448. doi:10.1097/01.ju.0000056046.16588.e4.
18. Abdollah F, Sun M, Schmitges J, et al. Surgical caseload is an important determinant of continent urinary diversion rate at radical cystectomy: a population-based study. Ann Surg Oncol. 2011;18(9):2680-2687. doi:10.1245/s10434-011-1618-2.
19. Panageas KS, Schrag D, Riedel E, Bach PB, Begg CB. The effect of clustering of outcomes on the association of procedure volume and surgical outcomes. Ann Intern Med. 2003;139(8):658-665. doi:10.7326/0003-4819-139-8-200310210-00009.
20. Joice GA, Deibert CM, Kates M, Spencer BA, McKiernan JM. "Never events”: centers for Medicare and Medicaid Services complications after radical cystectomy. Urology. 2013;81(3):527-532. doi:10.1016/j.urology.2012.09.050.
21. Taunton MJ, McIntosh AL, Sperling JW, Cofield RH. Total shoulder arthroplasty with a metal-backed, bone-ingrowth glenoid component. Medium to long-term results. J Bone Joint Surg Am. 2008;90(10):2180-2188. doi:10.2106/JBJS.G.00966.
22. Raiss P, Schmitt M, Bruckner T, et al. Results of cemented total shoulder replacement with a minimum follow-up of ten years. J Bone Joint Surg Am. 2012;94(23):e1711-e1710. doi:10.2106/JBJS.K.00580.
23. O'Malley NT, Fleming FJ, Gunzler DD, Messing SP, Kates SL. Factors independently associated with complications and length of stay after hip arthroplasty: analysis of the National Surgical Quality Improvement Program. J Arthroplasty. 2012;27(10):1832-1837. doi:10.1016/j.arth.2012.04.025.
24. White CB, Sperling JW, Cofield RH, Rowland CM. Ninety-day mortality after shoulder arthroplasty. J Arthroplasty. 2003;18(7):886-888. doi:10.1016/S0883-5403(03)00269-9.
25. Singh JA, Sperling JW, Cofield RH. Ninety day mortality and its predictors after primary shoulder arthroplasty: an analysis of 4,019 patients from 1976-2008. BMC Musculoskelet Disord. 2011;12:231. doi:10.1186/1471-2474-12-231.
26. Fehringer EV, Mikuls TR, Michaud KD, Henderson WG, O'Dell JR. Shoulder arthroplasties have fewer complications than hip or knee arthroplasties in US veterans. Clin Orthop Relat Res. 2010;468(3):717-722. doi:10.1007/s11999-009-0996-2.
27. Farmer KW, Hammond JW, Queale WS, Keyurapan E, McFarland EG. Shoulder arthroplasty versus hip and knee arthroplasties: a comparison of outcomes. Clin Orthop Relat Res. 2007;455:183-189. doi:10.1097/01.blo.0000238839.26423.8d.
28. Farng E, Zingmond D, Krenek L, Soohoo NF. Factors predicting complication rates after primary shoulder arthroplasty. J Shoulder Elbow Surg. 2011;20(4):557-563. doi:10.1016/j.jse.2010.11.005.
TAKE HOME POINTS
- Medical complications are common (6.7%) after total shoulder arthroplasty.
- Age and preoperative medical comorbidities increased the risk of a postoperative complication.
- The most frequent medical complications are respiratory, renal, and cardiac.
- Length of stay was effected most by shock, infections, and vascular complications.
- Mortality was associated with major complications such as, shock, central nervous system, cardiac, vascular, and respiratory complications.
Mycobacterium abscessus: A Rare Cause of Periprosthetic Knee Joint Infection
ABSTRACT
A 61-year-old woman with a periprosthetic knee joint infection caused by Mycobacterium abscessus was successfully treated with surgical débridement, multidrug antimicrobial therapy, and staged reimplantation. To the authors’ knowledge, this represents the first report of successfully treating this organism after knee arthroplasty.
M. abscessus knee infections are rare, and there are no specific guidelines to inform treatment or successful treatment regimens for periprosthetic knee infections. Medical management alone was not successful in this case and hence cannot be recommended. Using a collaborative multidisciplinary approach, including surgical débridement, staged reimplantation, and multidrug antimicrobials, successful eradication of the periprosthetic joint infection caused by M. abscessus was achieved.
Continue to: Total knee arthroplasty...
Total knee arthroplasty (TKA) procedures are projected to increase by more than 6-fold by 2030, with concurrent increases in revision TKA for infection projected.1 Infection after TKA remains one of the most serious complications of the procedure, occurring in <2% of primary TKAs.2 The majority of prosthetic joint infections (PJIs) are caused by staphylococci and streptococci.3 Although infection and treatment of PJIs by mycobacterial species have been described, there are presently no established treatment guidelines for mycobacterial PJIs.4,5
Given the scarcity of clinical experience in dealing with these organisms, and the predicted increasing incidence of revision knee arthroplasty due to infection, we describe an unusual case of a PJI caused by Mycobacterium abscessus (M. abscessus), which was successfully treated using a combination of antimicrobial therapy and staged reconstruction. The patient provided written informed consent for print and electronic publication of this case report.
BACKGROUND
Mycobacteria are common environmental organisms that can survive harsh conditions, including low pH and extreme temperatures. They form biofilms and may be difficult to eradicate in cases of infection.6M. abscessus has proven to be difficult to eradicate due to limited antimicrobial susceptibility, lack of bactericidal options, and the variable presence of the erm gene, which yields inducible resistance to macrolides.7 Post-procedural outbreaks due to mycobacteria have been reported, often attributed to contaminated multiuse instruments, inadequate sterilization of tap water, multiuse vials, or improper skin preparation.6,8-13
CASE REPORT
A 61-year-old woman was referred with a 3-year history of progressive left knee pain and swelling. Before 8 months, she had undergone knee arthroscopy and had been treated with multiple steroid and hyaluronic acid injections, as well as ultrasound-guided aspiration of a Baker’s cyst (Figures 1A, 1B).
She elected to proceed with TKA 1 month after her last steroid injection. There was no preoperative concern for native joint infection. At the time of arthroplasty, clear joint fluid was encountered, and a deep tissue culture was taken (Figures 2A-2C).
Routine screening cultures for acid-fast bacilli (AFB) returned positive 9 days after the index arthroplasty, with subsequent identification of a nontuberculous mycobacterium (NTM), M. abscessus, subspecies massiliense. Sensitivity tests revealed susceptibility to amikacin, cefoxitin, and tigecycline (Table 1). The isolate was found to have inducible macrolide resistance by erm gene testing.
Table 1. Initial Mycobacterium abscessus massiliense Susceptibilities
Medication | Minimum Inhibitory Concentration |
Amikacin | 16 (S) |
Cefoxitin | 16 (S) |
Imipenem | 8 (I) |
Linezolid | 16 (I) |
Clarithromycin | 2 (S)a |
Tigecycline | 1 (S) |
aAt 3 days; erm gene detected at 7 days.
Given no prior surgical suspicion for infection and the uncertain significance of the culture result, treatment options were debated. Medical management was selected based on the presumption that if infection was present, it was a native joint infection in which surgical débridement had already been undertaken at the time of primary arthroplasty. Similar reports for the treatment of M. tuberculosis infection in the knee have been reported with some success.14,15 Short-interval reassessment was planned. Antimicrobial therapy was selected based on susceptibility data and clinical experience and consisted of intravenous (IV) cefoxitin, oral clarithromycin, and thrice-weekly intravenous amikacin. Over the ensuing weeks, she developed fevers, knee swelling, and persistent elevation of erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). With known potential of this organism for biofilm formation in other areas of the body and positive repeat cultures of the knee joint fluid, confirming the offending organism, a deep and resistant infection of the implant could not be excluded. Therefore, in an attempt to give the patient the best opportunity for clinical cure, the patient subsequently underwent a 2-stage antibiotic spacer explantation and exchange (Figures 3A, 3B). Moderate caseous material was present throughout the knee joint and the subcutaneous tissues. All bone was débrided, and complete synovectomy was undertaken, along with the removal of all implants. The antibiotic concentrations within the spacer were selected by guidance from the Infectious Disease and Pharmacy based on minimal inhibitory concentrations, with 3 packages of cement (40 g each) utilized and a total of 10 g of amikacin and 24 g of cefoxitin contained within the spacer. The patient continued systemic administration of amikacin, cefoxitin, and clarithromycin.
Continue to: One month postoperatively...
One month postoperatively, her constitutional symptoms, including fevers and night sweats, abated and inflammatory markers (ESR and CRP) had normalized. There were no clinical signs of infection. Amikacin was discontinued due to a 10-dB change on audiologic screening (4-6 kHz range), and tigecycline was substituted. Ultimately, she underwent 15 weeks of antimycobacterial therapy, 10 of which were after the explantation.
Eight weeks after cessation of her antibiotics, she underwent open biopsy. Multiple operative tissue samples showed negative results in pathology and culture tests.
Replantation was performed 14 weeks after stopping antimicrobials and 24 weeks after her explantation. The bone appeared healthy without evidence of osteomyelitis. A constrained reconstruction was secured with tobramycin-impregnated cement. One small island of necrotizing granuloma was observed within the bony cortex on histologic review; the granulomata appeared active with scattered neutrophils along with histiocytes and lymphocytes. AFB stains were negative. Intraoperative cultures, including mycobacterial cultures, were negative.
Based on the histologic evidence that infection may have persisted, and given the high stakes, antimicrobial treatment was reinitiated. Amikacin was again stopped after 3 weeks due to the development of tinnitus; tigecycline was substituted to complete the fourth and final week, at which point all antibiotics were discontinued. The patient was followed up uneventfully for 4 years (Figures 4A-4D and 5A-5C) with normal ESR and CRP. She continues to be ambulatory without assistive devices and walks an average of 30 miles per week without pain or constitutional symptoms.
Continue to: DISCUSSION...
DISCUSSION
Diagnosis of acute infection after TKA remains challenging, as some degree of pain, swelling, and even postoperative fevers may be common in noninfected TKA patients. Synovial white blood cell count and differential as well as alpha-defensin levels have been cited as predictive factors of infection.16,17 Deep tissue and synovial fluid cultures offer the advantage of both identification and antimicrobial sensitivity testing of the offending organism. In this case, culture of the knee joint fluid at the time of TKA led to the unexpected finding of M. abscessus infection.
Preventable outbreaks due to M. abscessus have been reported and attributed to contaminated multiuse instruments, inadequate sterilization of tap water, multiuse vials, and improper skin preparation.11-13 Rarely, M. abscessus has been reported as the cause of PJI. When an unusual organism is encountered after native joint instrumentation, an investigation should be undertaken to identify the source of contamination, with the assistance of infection control practitioners and/or the US Food and Drug Administration reporting. Reporting and investigation was undertaken in this case, though no suspect source could be identified.
Although there were no signs of infection prior to the TKA, there is an ongoing debate as to whether intra-articular corticosteroid injections increase the risk of PJIs, and if so, what the optimal amount of time to wait between procedures is. Although several earlier studies have been underpowered to answer these questions,18 this patient underwent TKA 1 month following the corticosteroid injection. Recent meta-analyses have shown no definitive evidence to indicate that this increased her risk of PJI.19,20
Continue to: Treatments for mycobacterial infections...
Treatments for mycobacterial infections have been described with variable efficacy,21,22 and only 2 cases of successfully treated PJIs have been reported after infection with M. abscessus. Both these cases were described in total hip arthroplasties,23,24 and to the authors’ knowledge, this report represents the first described successfully treated case after TKA. Staged reconstruction remains a standard treatment for invasive organisms chronically infecting prosthetic joint implants, with reimplantation pending joint sterility and improvement in inflammatory markers.3 Previous successful reports of treating M. abscessus describe either resection arthroplasty21 or staged reconstruction.23,24 The authors reported variable multidrug antimicrobial regimens, as summarized in Table 2, as guidelines for the treatment of mycobacterial PJI are currently not available.
CONCLUSION
This case report represents an episode of iatrogenic septic arthritis caused by Mycobacteria of the native knee after previous history of instrumentation, corticosteroid, and hyaluronic acid injections, with an overall indolent clinical course until subsequent arthroplasty. There were several important lessons learned, which are as follows: 1) Multidrug combination with antimicrobial therapy combined with aggressive surgical débridement and staged reimplantation permitted successful eradication of TKA PJI caused by M. abscessus in this patient. 2) Initial medical management alone was not successful and cannot be recommended for the treatment of M. abscessus in the setting of PJI. 3) Delaying the surgical débridement and the reconstructive course for a trial of medical management contributed to the ultimate requirement of a tibial tubercle osteotomy for an ankylosed knee at replantation. In this case, we initially had a low index of suspicion for deep infection, contributing to delayed surgical débridement. Ideally, a high degree of clinical suspicion should be maintained for joint infection in the presence of positive culture isolates of M. abscessus, as it may have a delayed clinical presentation of the typical features of PJI (fevers, swelling, erythema, etc). In such cases, the authors recommend consideration of early surgical débridement. 4) Medical management of TKA PJI is not without risks. Careful monitoring of patient side effects during antimicrobial administration remains paramount, as this patient did sustain a degree of hearing loss associated with prolonged medical therapy. 5) In complicated PJIs involving rare and intrinsically resistant organisms, a collaborative multidisciplinary approach, including specialists in orthopedic surgery, infectious disease, microbiology, pharmacy, and pathology, may be the preferred path to clinical cure.
1. Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007;89(4):780-785. doi:10.2106/JBJS.F.00222.
2. Cobo J, Del Pozo JL. Prosthetic joint infection: diagnosis and management. Expert Rev Anti Infect Ther. 2011;9(9):787-802. doi:10.1586/eri.11.95.
3. Toms AD, Davidson D, Masri BA, Duncan CP. The management of peri-prosthetic infection in total joint arthroplasty. J Bone Joint Surg Br. 2006;88(2):149-155. doi:10.1302/0301-620X.88B2.17058.
4. Osmon DR, Berbari EF, Berendt AR, et al. Diagnosis and management of prosthetic joint infection: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2013;56(1):e1-e25. doi:10.1093/cid/cis803.
5. Restrepo C, Schmitt S, Backstein D, et al. Antibiotic treatment and timing of reimplantation. J Orthop Res. 2014;32 Suppl 1:S136-S140. doi:10.1002/jor.22557.
6. De Groote MA, Huitt G. Infections due to rapidly growing mycobacteria. Clin Infect Dis. 2006;42(12):1756-1763. doi:10.1086/504381.
7. Nash KA, Brown-Elliott BA, Wallace RJ Jr. A novel gene, erm(41), Confers inducible macrolide resistance to clinical isolates of Mycobacterium abscessus but is absent from Mycobacterium chelonae. Antimicrob Agents Chemother. 2009;53(4):1367-1376. doi:10.1128/AAC.01275-08.
8. Furuya EY, Paez A, Srinivasan A, et al. Outbreak of Mycobacterium abscessus wound infections among "lipotourists" from the United States who underwent abdominoplasty in the Dominican Republic. Clin Infect Dis. 2008;46(8):1181-1188. doi:10.1086/529191.
9. Jarand J, Levin A, Zhang L, Huitt G, Mitchell JD, Daley CL. Clinical and microbiologic outcomes in patients receiving treatment for Mycobacterium abscessus pulmonary disease. Clin Infect Dis. 2011;52(5):565-571. doi:10.1093/cid/ciq237.
10. Mueller PS, Edson RS. Disseminated Mycobacterium abscessus infection manifesting as fever of unknown origin and intra-abdominal lymphadenitis: case report and literature review. Diagn Microbiol Infect Dis. 2001;39(1):33-37. doi:10.1016/S0732-8893(00)00211-X.
11. Mushatt DM, Witzig RS. Successful treatment of Mycobacterium abscessus infections with multidrug regimens containing clarithromycin. Clin Infect Dis. 1995;20(5):1441-1442. doi:10.1093/clinids/20.5.1441.
12. Tiwari TS, Ray B, Jost KC Jr, et al. Forty years of disinfectant failure: outbreak of postinjection Mycobacterium abscessus infection caused by contamination of benzalkonium chloride. Clin Infect Dis. 2003;36(8):954-962. doi:10.1086/368192.
13. Villanueva A, Calderon RV, Vargas BA, et al. Report on an outbreak of postinjection abscesses due to Mycobacterium abscessus, including management with surgery and clarithromycin therapy and comparison of strains by random amplified polymorphic DNA polymerase chain reaction. Clin Infect Dis. 1997;24(6):1147-1153. doi:10.1086/513656.
14. Gale DW, Harding ML. Total knee arthroplasty in the presence of active tuberculosis. J Bone Joint Surg Br. 1991;73(6):1006-1007. doi:10.1302/0301-620X.73B6.1955424.
15. Kim YH. Total knee arthroplasty for tuberculous arthritis. J Bone Joint Surg Am. 1988;70(9):1322-1330. doi:10.2106/00004623-198870090-00008.
16. Bedair H, Ting N, Jacovides C, et al. The Mark Coventry Award: diagnosis of early postoperative TKA infection using synovial fluid analysis. Clin Orthop Relat Res. 2011;469(1):34-40. doi:10.1007/s11999-010-1433-2.
17. Bingham J, Clarke H, Spangehl M, Schwartz A, Beauchamp C, Goldberg B. The alpha defensin-1 biomarker assay can be used to evaluate the potentially infected total joint arthroplasty. Clin Orthop Relat Res. 2014;472(12):4006-4009. doi:10.1007/s11999-014-3900-7.
18. Marsland D, Mumith A, Barlow IW. Systematic review: the safety of intra-articular corticosteroid injection prior to total knee arthroplasty. Knee. 2014;21(1):6-11. doi:10.1016/j.knee.2013.07.003.
19. Charalambous CP, Prodromidis AD, Kwaees TA. Do intra-articular steroid injections increase infection rates in subsequent arthroplasty? A systematic review and meta-analysis of comparative studies. J Arthroplast. 2014;29(11):2175-2180. doi:10.1016/j.arth.2014.07.013.
20. Xing D, Yang Y, Ma X, Ma J, Ma B, Chen Y. Dose intraarticular steroid injection increase the rate of infection in subsequent arthroplasty: grading the evidence through a meta-analysis. J Orthop Surg Res. 2014;9:107. doi:10.1186/s13018-014-0107-2.
21. Eid AJ, Berbari EF, Sia IG, Wengenack NL, Osmon DR, Razonable RR. Prosthetic joint infection due to rapidly growing mycobacteria: report of 8 cases and review of the literature. Clin Infect Dis. 2007;45(6):687-694. doi:10.1086/520982.
22. Herold RC, Lotke PA, MacGregor RR. Prosthetic joint infections secondary to rapidly growing Mycobacterium fortuitum. Clin Orthop Relat Res. 1987;216(216):183-186. doi:10.1097/00003086-198703000-00029.
23. Petrosoniak A, Kim P, Desjardins M, Lee BC. Successful treatment of a prosthetic joint infection due to Mycobacterium abscessus. Can J Infect Dis Med Microbiol. 2009;20(3):e94-e96.
24. Yinkey LM, Halsey ES, Lloyd BA. Successful tigecycline combination therapy for Mycobacterium abscessus infection of a total hip arthroplasty. Infect Dis Clin Practice. 2010;18(4):269-270. doi:10.1097/IPC.0b013e3181d04a09.
25. AAOS Guidelines: the diagnosis of periprosthetic joint infections of the hip and knee guideline and evidence report. Adopted by the American Academy of Orthopaedic Surgeons Board of Directors; June 18th, 2010. AAOS Publication: 2010.
26. Griffith DE, Aksamit T, Brown-Elliott BA, et al; ATS Mycobacterial Diseases Subcomittee; American Thoracic Society; Infectious Disease Society of America. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med. 2007;175(4):367-416.
ABSTRACT
A 61-year-old woman with a periprosthetic knee joint infection caused by Mycobacterium abscessus was successfully treated with surgical débridement, multidrug antimicrobial therapy, and staged reimplantation. To the authors’ knowledge, this represents the first report of successfully treating this organism after knee arthroplasty.
M. abscessus knee infections are rare, and there are no specific guidelines to inform treatment or successful treatment regimens for periprosthetic knee infections. Medical management alone was not successful in this case and hence cannot be recommended. Using a collaborative multidisciplinary approach, including surgical débridement, staged reimplantation, and multidrug antimicrobials, successful eradication of the periprosthetic joint infection caused by M. abscessus was achieved.
Continue to: Total knee arthroplasty...
Total knee arthroplasty (TKA) procedures are projected to increase by more than 6-fold by 2030, with concurrent increases in revision TKA for infection projected.1 Infection after TKA remains one of the most serious complications of the procedure, occurring in <2% of primary TKAs.2 The majority of prosthetic joint infections (PJIs) are caused by staphylococci and streptococci.3 Although infection and treatment of PJIs by mycobacterial species have been described, there are presently no established treatment guidelines for mycobacterial PJIs.4,5
Given the scarcity of clinical experience in dealing with these organisms, and the predicted increasing incidence of revision knee arthroplasty due to infection, we describe an unusual case of a PJI caused by Mycobacterium abscessus (M. abscessus), which was successfully treated using a combination of antimicrobial therapy and staged reconstruction. The patient provided written informed consent for print and electronic publication of this case report.
BACKGROUND
Mycobacteria are common environmental organisms that can survive harsh conditions, including low pH and extreme temperatures. They form biofilms and may be difficult to eradicate in cases of infection.6M. abscessus has proven to be difficult to eradicate due to limited antimicrobial susceptibility, lack of bactericidal options, and the variable presence of the erm gene, which yields inducible resistance to macrolides.7 Post-procedural outbreaks due to mycobacteria have been reported, often attributed to contaminated multiuse instruments, inadequate sterilization of tap water, multiuse vials, or improper skin preparation.6,8-13
CASE REPORT
A 61-year-old woman was referred with a 3-year history of progressive left knee pain and swelling. Before 8 months, she had undergone knee arthroscopy and had been treated with multiple steroid and hyaluronic acid injections, as well as ultrasound-guided aspiration of a Baker’s cyst (Figures 1A, 1B).
She elected to proceed with TKA 1 month after her last steroid injection. There was no preoperative concern for native joint infection. At the time of arthroplasty, clear joint fluid was encountered, and a deep tissue culture was taken (Figures 2A-2C).
Routine screening cultures for acid-fast bacilli (AFB) returned positive 9 days after the index arthroplasty, with subsequent identification of a nontuberculous mycobacterium (NTM), M. abscessus, subspecies massiliense. Sensitivity tests revealed susceptibility to amikacin, cefoxitin, and tigecycline (Table 1). The isolate was found to have inducible macrolide resistance by erm gene testing.
Table 1. Initial Mycobacterium abscessus massiliense Susceptibilities
Medication | Minimum Inhibitory Concentration |
Amikacin | 16 (S) |
Cefoxitin | 16 (S) |
Imipenem | 8 (I) |
Linezolid | 16 (I) |
Clarithromycin | 2 (S)a |
Tigecycline | 1 (S) |
aAt 3 days; erm gene detected at 7 days.
Given no prior surgical suspicion for infection and the uncertain significance of the culture result, treatment options were debated. Medical management was selected based on the presumption that if infection was present, it was a native joint infection in which surgical débridement had already been undertaken at the time of primary arthroplasty. Similar reports for the treatment of M. tuberculosis infection in the knee have been reported with some success.14,15 Short-interval reassessment was planned. Antimicrobial therapy was selected based on susceptibility data and clinical experience and consisted of intravenous (IV) cefoxitin, oral clarithromycin, and thrice-weekly intravenous amikacin. Over the ensuing weeks, she developed fevers, knee swelling, and persistent elevation of erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). With known potential of this organism for biofilm formation in other areas of the body and positive repeat cultures of the knee joint fluid, confirming the offending organism, a deep and resistant infection of the implant could not be excluded. Therefore, in an attempt to give the patient the best opportunity for clinical cure, the patient subsequently underwent a 2-stage antibiotic spacer explantation and exchange (Figures 3A, 3B). Moderate caseous material was present throughout the knee joint and the subcutaneous tissues. All bone was débrided, and complete synovectomy was undertaken, along with the removal of all implants. The antibiotic concentrations within the spacer were selected by guidance from the Infectious Disease and Pharmacy based on minimal inhibitory concentrations, with 3 packages of cement (40 g each) utilized and a total of 10 g of amikacin and 24 g of cefoxitin contained within the spacer. The patient continued systemic administration of amikacin, cefoxitin, and clarithromycin.
Continue to: One month postoperatively...
One month postoperatively, her constitutional symptoms, including fevers and night sweats, abated and inflammatory markers (ESR and CRP) had normalized. There were no clinical signs of infection. Amikacin was discontinued due to a 10-dB change on audiologic screening (4-6 kHz range), and tigecycline was substituted. Ultimately, she underwent 15 weeks of antimycobacterial therapy, 10 of which were after the explantation.
Eight weeks after cessation of her antibiotics, she underwent open biopsy. Multiple operative tissue samples showed negative results in pathology and culture tests.
Replantation was performed 14 weeks after stopping antimicrobials and 24 weeks after her explantation. The bone appeared healthy without evidence of osteomyelitis. A constrained reconstruction was secured with tobramycin-impregnated cement. One small island of necrotizing granuloma was observed within the bony cortex on histologic review; the granulomata appeared active with scattered neutrophils along with histiocytes and lymphocytes. AFB stains were negative. Intraoperative cultures, including mycobacterial cultures, were negative.
Based on the histologic evidence that infection may have persisted, and given the high stakes, antimicrobial treatment was reinitiated. Amikacin was again stopped after 3 weeks due to the development of tinnitus; tigecycline was substituted to complete the fourth and final week, at which point all antibiotics were discontinued. The patient was followed up uneventfully for 4 years (Figures 4A-4D and 5A-5C) with normal ESR and CRP. She continues to be ambulatory without assistive devices and walks an average of 30 miles per week without pain or constitutional symptoms.
Continue to: DISCUSSION...
DISCUSSION
Diagnosis of acute infection after TKA remains challenging, as some degree of pain, swelling, and even postoperative fevers may be common in noninfected TKA patients. Synovial white blood cell count and differential as well as alpha-defensin levels have been cited as predictive factors of infection.16,17 Deep tissue and synovial fluid cultures offer the advantage of both identification and antimicrobial sensitivity testing of the offending organism. In this case, culture of the knee joint fluid at the time of TKA led to the unexpected finding of M. abscessus infection.
Preventable outbreaks due to M. abscessus have been reported and attributed to contaminated multiuse instruments, inadequate sterilization of tap water, multiuse vials, and improper skin preparation.11-13 Rarely, M. abscessus has been reported as the cause of PJI. When an unusual organism is encountered after native joint instrumentation, an investigation should be undertaken to identify the source of contamination, with the assistance of infection control practitioners and/or the US Food and Drug Administration reporting. Reporting and investigation was undertaken in this case, though no suspect source could be identified.
Although there were no signs of infection prior to the TKA, there is an ongoing debate as to whether intra-articular corticosteroid injections increase the risk of PJIs, and if so, what the optimal amount of time to wait between procedures is. Although several earlier studies have been underpowered to answer these questions,18 this patient underwent TKA 1 month following the corticosteroid injection. Recent meta-analyses have shown no definitive evidence to indicate that this increased her risk of PJI.19,20
Continue to: Treatments for mycobacterial infections...
Treatments for mycobacterial infections have been described with variable efficacy,21,22 and only 2 cases of successfully treated PJIs have been reported after infection with M. abscessus. Both these cases were described in total hip arthroplasties,23,24 and to the authors’ knowledge, this report represents the first described successfully treated case after TKA. Staged reconstruction remains a standard treatment for invasive organisms chronically infecting prosthetic joint implants, with reimplantation pending joint sterility and improvement in inflammatory markers.3 Previous successful reports of treating M. abscessus describe either resection arthroplasty21 or staged reconstruction.23,24 The authors reported variable multidrug antimicrobial regimens, as summarized in Table 2, as guidelines for the treatment of mycobacterial PJI are currently not available.
CONCLUSION
This case report represents an episode of iatrogenic septic arthritis caused by Mycobacteria of the native knee after previous history of instrumentation, corticosteroid, and hyaluronic acid injections, with an overall indolent clinical course until subsequent arthroplasty. There were several important lessons learned, which are as follows: 1) Multidrug combination with antimicrobial therapy combined with aggressive surgical débridement and staged reimplantation permitted successful eradication of TKA PJI caused by M. abscessus in this patient. 2) Initial medical management alone was not successful and cannot be recommended for the treatment of M. abscessus in the setting of PJI. 3) Delaying the surgical débridement and the reconstructive course for a trial of medical management contributed to the ultimate requirement of a tibial tubercle osteotomy for an ankylosed knee at replantation. In this case, we initially had a low index of suspicion for deep infection, contributing to delayed surgical débridement. Ideally, a high degree of clinical suspicion should be maintained for joint infection in the presence of positive culture isolates of M. abscessus, as it may have a delayed clinical presentation of the typical features of PJI (fevers, swelling, erythema, etc). In such cases, the authors recommend consideration of early surgical débridement. 4) Medical management of TKA PJI is not without risks. Careful monitoring of patient side effects during antimicrobial administration remains paramount, as this patient did sustain a degree of hearing loss associated with prolonged medical therapy. 5) In complicated PJIs involving rare and intrinsically resistant organisms, a collaborative multidisciplinary approach, including specialists in orthopedic surgery, infectious disease, microbiology, pharmacy, and pathology, may be the preferred path to clinical cure.
ABSTRACT
A 61-year-old woman with a periprosthetic knee joint infection caused by Mycobacterium abscessus was successfully treated with surgical débridement, multidrug antimicrobial therapy, and staged reimplantation. To the authors’ knowledge, this represents the first report of successfully treating this organism after knee arthroplasty.
M. abscessus knee infections are rare, and there are no specific guidelines to inform treatment or successful treatment regimens for periprosthetic knee infections. Medical management alone was not successful in this case and hence cannot be recommended. Using a collaborative multidisciplinary approach, including surgical débridement, staged reimplantation, and multidrug antimicrobials, successful eradication of the periprosthetic joint infection caused by M. abscessus was achieved.
Continue to: Total knee arthroplasty...
Total knee arthroplasty (TKA) procedures are projected to increase by more than 6-fold by 2030, with concurrent increases in revision TKA for infection projected.1 Infection after TKA remains one of the most serious complications of the procedure, occurring in <2% of primary TKAs.2 The majority of prosthetic joint infections (PJIs) are caused by staphylococci and streptococci.3 Although infection and treatment of PJIs by mycobacterial species have been described, there are presently no established treatment guidelines for mycobacterial PJIs.4,5
Given the scarcity of clinical experience in dealing with these organisms, and the predicted increasing incidence of revision knee arthroplasty due to infection, we describe an unusual case of a PJI caused by Mycobacterium abscessus (M. abscessus), which was successfully treated using a combination of antimicrobial therapy and staged reconstruction. The patient provided written informed consent for print and electronic publication of this case report.
BACKGROUND
Mycobacteria are common environmental organisms that can survive harsh conditions, including low pH and extreme temperatures. They form biofilms and may be difficult to eradicate in cases of infection.6M. abscessus has proven to be difficult to eradicate due to limited antimicrobial susceptibility, lack of bactericidal options, and the variable presence of the erm gene, which yields inducible resistance to macrolides.7 Post-procedural outbreaks due to mycobacteria have been reported, often attributed to contaminated multiuse instruments, inadequate sterilization of tap water, multiuse vials, or improper skin preparation.6,8-13
CASE REPORT
A 61-year-old woman was referred with a 3-year history of progressive left knee pain and swelling. Before 8 months, she had undergone knee arthroscopy and had been treated with multiple steroid and hyaluronic acid injections, as well as ultrasound-guided aspiration of a Baker’s cyst (Figures 1A, 1B).
She elected to proceed with TKA 1 month after her last steroid injection. There was no preoperative concern for native joint infection. At the time of arthroplasty, clear joint fluid was encountered, and a deep tissue culture was taken (Figures 2A-2C).
Routine screening cultures for acid-fast bacilli (AFB) returned positive 9 days after the index arthroplasty, with subsequent identification of a nontuberculous mycobacterium (NTM), M. abscessus, subspecies massiliense. Sensitivity tests revealed susceptibility to amikacin, cefoxitin, and tigecycline (Table 1). The isolate was found to have inducible macrolide resistance by erm gene testing.
Table 1. Initial Mycobacterium abscessus massiliense Susceptibilities
Medication | Minimum Inhibitory Concentration |
Amikacin | 16 (S) |
Cefoxitin | 16 (S) |
Imipenem | 8 (I) |
Linezolid | 16 (I) |
Clarithromycin | 2 (S)a |
Tigecycline | 1 (S) |
aAt 3 days; erm gene detected at 7 days.
Given no prior surgical suspicion for infection and the uncertain significance of the culture result, treatment options were debated. Medical management was selected based on the presumption that if infection was present, it was a native joint infection in which surgical débridement had already been undertaken at the time of primary arthroplasty. Similar reports for the treatment of M. tuberculosis infection in the knee have been reported with some success.14,15 Short-interval reassessment was planned. Antimicrobial therapy was selected based on susceptibility data and clinical experience and consisted of intravenous (IV) cefoxitin, oral clarithromycin, and thrice-weekly intravenous amikacin. Over the ensuing weeks, she developed fevers, knee swelling, and persistent elevation of erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). With known potential of this organism for biofilm formation in other areas of the body and positive repeat cultures of the knee joint fluid, confirming the offending organism, a deep and resistant infection of the implant could not be excluded. Therefore, in an attempt to give the patient the best opportunity for clinical cure, the patient subsequently underwent a 2-stage antibiotic spacer explantation and exchange (Figures 3A, 3B). Moderate caseous material was present throughout the knee joint and the subcutaneous tissues. All bone was débrided, and complete synovectomy was undertaken, along with the removal of all implants. The antibiotic concentrations within the spacer were selected by guidance from the Infectious Disease and Pharmacy based on minimal inhibitory concentrations, with 3 packages of cement (40 g each) utilized and a total of 10 g of amikacin and 24 g of cefoxitin contained within the spacer. The patient continued systemic administration of amikacin, cefoxitin, and clarithromycin.
Continue to: One month postoperatively...
One month postoperatively, her constitutional symptoms, including fevers and night sweats, abated and inflammatory markers (ESR and CRP) had normalized. There were no clinical signs of infection. Amikacin was discontinued due to a 10-dB change on audiologic screening (4-6 kHz range), and tigecycline was substituted. Ultimately, she underwent 15 weeks of antimycobacterial therapy, 10 of which were after the explantation.
Eight weeks after cessation of her antibiotics, she underwent open biopsy. Multiple operative tissue samples showed negative results in pathology and culture tests.
Replantation was performed 14 weeks after stopping antimicrobials and 24 weeks after her explantation. The bone appeared healthy without evidence of osteomyelitis. A constrained reconstruction was secured with tobramycin-impregnated cement. One small island of necrotizing granuloma was observed within the bony cortex on histologic review; the granulomata appeared active with scattered neutrophils along with histiocytes and lymphocytes. AFB stains were negative. Intraoperative cultures, including mycobacterial cultures, were negative.
Based on the histologic evidence that infection may have persisted, and given the high stakes, antimicrobial treatment was reinitiated. Amikacin was again stopped after 3 weeks due to the development of tinnitus; tigecycline was substituted to complete the fourth and final week, at which point all antibiotics were discontinued. The patient was followed up uneventfully for 4 years (Figures 4A-4D and 5A-5C) with normal ESR and CRP. She continues to be ambulatory without assistive devices and walks an average of 30 miles per week without pain or constitutional symptoms.
Continue to: DISCUSSION...
DISCUSSION
Diagnosis of acute infection after TKA remains challenging, as some degree of pain, swelling, and even postoperative fevers may be common in noninfected TKA patients. Synovial white blood cell count and differential as well as alpha-defensin levels have been cited as predictive factors of infection.16,17 Deep tissue and synovial fluid cultures offer the advantage of both identification and antimicrobial sensitivity testing of the offending organism. In this case, culture of the knee joint fluid at the time of TKA led to the unexpected finding of M. abscessus infection.
Preventable outbreaks due to M. abscessus have been reported and attributed to contaminated multiuse instruments, inadequate sterilization of tap water, multiuse vials, and improper skin preparation.11-13 Rarely, M. abscessus has been reported as the cause of PJI. When an unusual organism is encountered after native joint instrumentation, an investigation should be undertaken to identify the source of contamination, with the assistance of infection control practitioners and/or the US Food and Drug Administration reporting. Reporting and investigation was undertaken in this case, though no suspect source could be identified.
Although there were no signs of infection prior to the TKA, there is an ongoing debate as to whether intra-articular corticosteroid injections increase the risk of PJIs, and if so, what the optimal amount of time to wait between procedures is. Although several earlier studies have been underpowered to answer these questions,18 this patient underwent TKA 1 month following the corticosteroid injection. Recent meta-analyses have shown no definitive evidence to indicate that this increased her risk of PJI.19,20
Continue to: Treatments for mycobacterial infections...
Treatments for mycobacterial infections have been described with variable efficacy,21,22 and only 2 cases of successfully treated PJIs have been reported after infection with M. abscessus. Both these cases were described in total hip arthroplasties,23,24 and to the authors’ knowledge, this report represents the first described successfully treated case after TKA. Staged reconstruction remains a standard treatment for invasive organisms chronically infecting prosthetic joint implants, with reimplantation pending joint sterility and improvement in inflammatory markers.3 Previous successful reports of treating M. abscessus describe either resection arthroplasty21 or staged reconstruction.23,24 The authors reported variable multidrug antimicrobial regimens, as summarized in Table 2, as guidelines for the treatment of mycobacterial PJI are currently not available.
CONCLUSION
This case report represents an episode of iatrogenic septic arthritis caused by Mycobacteria of the native knee after previous history of instrumentation, corticosteroid, and hyaluronic acid injections, with an overall indolent clinical course until subsequent arthroplasty. There were several important lessons learned, which are as follows: 1) Multidrug combination with antimicrobial therapy combined with aggressive surgical débridement and staged reimplantation permitted successful eradication of TKA PJI caused by M. abscessus in this patient. 2) Initial medical management alone was not successful and cannot be recommended for the treatment of M. abscessus in the setting of PJI. 3) Delaying the surgical débridement and the reconstructive course for a trial of medical management contributed to the ultimate requirement of a tibial tubercle osteotomy for an ankylosed knee at replantation. In this case, we initially had a low index of suspicion for deep infection, contributing to delayed surgical débridement. Ideally, a high degree of clinical suspicion should be maintained for joint infection in the presence of positive culture isolates of M. abscessus, as it may have a delayed clinical presentation of the typical features of PJI (fevers, swelling, erythema, etc). In such cases, the authors recommend consideration of early surgical débridement. 4) Medical management of TKA PJI is not without risks. Careful monitoring of patient side effects during antimicrobial administration remains paramount, as this patient did sustain a degree of hearing loss associated with prolonged medical therapy. 5) In complicated PJIs involving rare and intrinsically resistant organisms, a collaborative multidisciplinary approach, including specialists in orthopedic surgery, infectious disease, microbiology, pharmacy, and pathology, may be the preferred path to clinical cure.
1. Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007;89(4):780-785. doi:10.2106/JBJS.F.00222.
2. Cobo J, Del Pozo JL. Prosthetic joint infection: diagnosis and management. Expert Rev Anti Infect Ther. 2011;9(9):787-802. doi:10.1586/eri.11.95.
3. Toms AD, Davidson D, Masri BA, Duncan CP. The management of peri-prosthetic infection in total joint arthroplasty. J Bone Joint Surg Br. 2006;88(2):149-155. doi:10.1302/0301-620X.88B2.17058.
4. Osmon DR, Berbari EF, Berendt AR, et al. Diagnosis and management of prosthetic joint infection: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2013;56(1):e1-e25. doi:10.1093/cid/cis803.
5. Restrepo C, Schmitt S, Backstein D, et al. Antibiotic treatment and timing of reimplantation. J Orthop Res. 2014;32 Suppl 1:S136-S140. doi:10.1002/jor.22557.
6. De Groote MA, Huitt G. Infections due to rapidly growing mycobacteria. Clin Infect Dis. 2006;42(12):1756-1763. doi:10.1086/504381.
7. Nash KA, Brown-Elliott BA, Wallace RJ Jr. A novel gene, erm(41), Confers inducible macrolide resistance to clinical isolates of Mycobacterium abscessus but is absent from Mycobacterium chelonae. Antimicrob Agents Chemother. 2009;53(4):1367-1376. doi:10.1128/AAC.01275-08.
8. Furuya EY, Paez A, Srinivasan A, et al. Outbreak of Mycobacterium abscessus wound infections among "lipotourists" from the United States who underwent abdominoplasty in the Dominican Republic. Clin Infect Dis. 2008;46(8):1181-1188. doi:10.1086/529191.
9. Jarand J, Levin A, Zhang L, Huitt G, Mitchell JD, Daley CL. Clinical and microbiologic outcomes in patients receiving treatment for Mycobacterium abscessus pulmonary disease. Clin Infect Dis. 2011;52(5):565-571. doi:10.1093/cid/ciq237.
10. Mueller PS, Edson RS. Disseminated Mycobacterium abscessus infection manifesting as fever of unknown origin and intra-abdominal lymphadenitis: case report and literature review. Diagn Microbiol Infect Dis. 2001;39(1):33-37. doi:10.1016/S0732-8893(00)00211-X.
11. Mushatt DM, Witzig RS. Successful treatment of Mycobacterium abscessus infections with multidrug regimens containing clarithromycin. Clin Infect Dis. 1995;20(5):1441-1442. doi:10.1093/clinids/20.5.1441.
12. Tiwari TS, Ray B, Jost KC Jr, et al. Forty years of disinfectant failure: outbreak of postinjection Mycobacterium abscessus infection caused by contamination of benzalkonium chloride. Clin Infect Dis. 2003;36(8):954-962. doi:10.1086/368192.
13. Villanueva A, Calderon RV, Vargas BA, et al. Report on an outbreak of postinjection abscesses due to Mycobacterium abscessus, including management with surgery and clarithromycin therapy and comparison of strains by random amplified polymorphic DNA polymerase chain reaction. Clin Infect Dis. 1997;24(6):1147-1153. doi:10.1086/513656.
14. Gale DW, Harding ML. Total knee arthroplasty in the presence of active tuberculosis. J Bone Joint Surg Br. 1991;73(6):1006-1007. doi:10.1302/0301-620X.73B6.1955424.
15. Kim YH. Total knee arthroplasty for tuberculous arthritis. J Bone Joint Surg Am. 1988;70(9):1322-1330. doi:10.2106/00004623-198870090-00008.
16. Bedair H, Ting N, Jacovides C, et al. The Mark Coventry Award: diagnosis of early postoperative TKA infection using synovial fluid analysis. Clin Orthop Relat Res. 2011;469(1):34-40. doi:10.1007/s11999-010-1433-2.
17. Bingham J, Clarke H, Spangehl M, Schwartz A, Beauchamp C, Goldberg B. The alpha defensin-1 biomarker assay can be used to evaluate the potentially infected total joint arthroplasty. Clin Orthop Relat Res. 2014;472(12):4006-4009. doi:10.1007/s11999-014-3900-7.
18. Marsland D, Mumith A, Barlow IW. Systematic review: the safety of intra-articular corticosteroid injection prior to total knee arthroplasty. Knee. 2014;21(1):6-11. doi:10.1016/j.knee.2013.07.003.
19. Charalambous CP, Prodromidis AD, Kwaees TA. Do intra-articular steroid injections increase infection rates in subsequent arthroplasty? A systematic review and meta-analysis of comparative studies. J Arthroplast. 2014;29(11):2175-2180. doi:10.1016/j.arth.2014.07.013.
20. Xing D, Yang Y, Ma X, Ma J, Ma B, Chen Y. Dose intraarticular steroid injection increase the rate of infection in subsequent arthroplasty: grading the evidence through a meta-analysis. J Orthop Surg Res. 2014;9:107. doi:10.1186/s13018-014-0107-2.
21. Eid AJ, Berbari EF, Sia IG, Wengenack NL, Osmon DR, Razonable RR. Prosthetic joint infection due to rapidly growing mycobacteria: report of 8 cases and review of the literature. Clin Infect Dis. 2007;45(6):687-694. doi:10.1086/520982.
22. Herold RC, Lotke PA, MacGregor RR. Prosthetic joint infections secondary to rapidly growing Mycobacterium fortuitum. Clin Orthop Relat Res. 1987;216(216):183-186. doi:10.1097/00003086-198703000-00029.
23. Petrosoniak A, Kim P, Desjardins M, Lee BC. Successful treatment of a prosthetic joint infection due to Mycobacterium abscessus. Can J Infect Dis Med Microbiol. 2009;20(3):e94-e96.
24. Yinkey LM, Halsey ES, Lloyd BA. Successful tigecycline combination therapy for Mycobacterium abscessus infection of a total hip arthroplasty. Infect Dis Clin Practice. 2010;18(4):269-270. doi:10.1097/IPC.0b013e3181d04a09.
25. AAOS Guidelines: the diagnosis of periprosthetic joint infections of the hip and knee guideline and evidence report. Adopted by the American Academy of Orthopaedic Surgeons Board of Directors; June 18th, 2010. AAOS Publication: 2010.
26. Griffith DE, Aksamit T, Brown-Elliott BA, et al; ATS Mycobacterial Diseases Subcomittee; American Thoracic Society; Infectious Disease Society of America. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med. 2007;175(4):367-416.
1. Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007;89(4):780-785. doi:10.2106/JBJS.F.00222.
2. Cobo J, Del Pozo JL. Prosthetic joint infection: diagnosis and management. Expert Rev Anti Infect Ther. 2011;9(9):787-802. doi:10.1586/eri.11.95.
3. Toms AD, Davidson D, Masri BA, Duncan CP. The management of peri-prosthetic infection in total joint arthroplasty. J Bone Joint Surg Br. 2006;88(2):149-155. doi:10.1302/0301-620X.88B2.17058.
4. Osmon DR, Berbari EF, Berendt AR, et al. Diagnosis and management of prosthetic joint infection: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2013;56(1):e1-e25. doi:10.1093/cid/cis803.
5. Restrepo C, Schmitt S, Backstein D, et al. Antibiotic treatment and timing of reimplantation. J Orthop Res. 2014;32 Suppl 1:S136-S140. doi:10.1002/jor.22557.
6. De Groote MA, Huitt G. Infections due to rapidly growing mycobacteria. Clin Infect Dis. 2006;42(12):1756-1763. doi:10.1086/504381.
7. Nash KA, Brown-Elliott BA, Wallace RJ Jr. A novel gene, erm(41), Confers inducible macrolide resistance to clinical isolates of Mycobacterium abscessus but is absent from Mycobacterium chelonae. Antimicrob Agents Chemother. 2009;53(4):1367-1376. doi:10.1128/AAC.01275-08.
8. Furuya EY, Paez A, Srinivasan A, et al. Outbreak of Mycobacterium abscessus wound infections among "lipotourists" from the United States who underwent abdominoplasty in the Dominican Republic. Clin Infect Dis. 2008;46(8):1181-1188. doi:10.1086/529191.
9. Jarand J, Levin A, Zhang L, Huitt G, Mitchell JD, Daley CL. Clinical and microbiologic outcomes in patients receiving treatment for Mycobacterium abscessus pulmonary disease. Clin Infect Dis. 2011;52(5):565-571. doi:10.1093/cid/ciq237.
10. Mueller PS, Edson RS. Disseminated Mycobacterium abscessus infection manifesting as fever of unknown origin and intra-abdominal lymphadenitis: case report and literature review. Diagn Microbiol Infect Dis. 2001;39(1):33-37. doi:10.1016/S0732-8893(00)00211-X.
11. Mushatt DM, Witzig RS. Successful treatment of Mycobacterium abscessus infections with multidrug regimens containing clarithromycin. Clin Infect Dis. 1995;20(5):1441-1442. doi:10.1093/clinids/20.5.1441.
12. Tiwari TS, Ray B, Jost KC Jr, et al. Forty years of disinfectant failure: outbreak of postinjection Mycobacterium abscessus infection caused by contamination of benzalkonium chloride. Clin Infect Dis. 2003;36(8):954-962. doi:10.1086/368192.
13. Villanueva A, Calderon RV, Vargas BA, et al. Report on an outbreak of postinjection abscesses due to Mycobacterium abscessus, including management with surgery and clarithromycin therapy and comparison of strains by random amplified polymorphic DNA polymerase chain reaction. Clin Infect Dis. 1997;24(6):1147-1153. doi:10.1086/513656.
14. Gale DW, Harding ML. Total knee arthroplasty in the presence of active tuberculosis. J Bone Joint Surg Br. 1991;73(6):1006-1007. doi:10.1302/0301-620X.73B6.1955424.
15. Kim YH. Total knee arthroplasty for tuberculous arthritis. J Bone Joint Surg Am. 1988;70(9):1322-1330. doi:10.2106/00004623-198870090-00008.
16. Bedair H, Ting N, Jacovides C, et al. The Mark Coventry Award: diagnosis of early postoperative TKA infection using synovial fluid analysis. Clin Orthop Relat Res. 2011;469(1):34-40. doi:10.1007/s11999-010-1433-2.
17. Bingham J, Clarke H, Spangehl M, Schwartz A, Beauchamp C, Goldberg B. The alpha defensin-1 biomarker assay can be used to evaluate the potentially infected total joint arthroplasty. Clin Orthop Relat Res. 2014;472(12):4006-4009. doi:10.1007/s11999-014-3900-7.
18. Marsland D, Mumith A, Barlow IW. Systematic review: the safety of intra-articular corticosteroid injection prior to total knee arthroplasty. Knee. 2014;21(1):6-11. doi:10.1016/j.knee.2013.07.003.
19. Charalambous CP, Prodromidis AD, Kwaees TA. Do intra-articular steroid injections increase infection rates in subsequent arthroplasty? A systematic review and meta-analysis of comparative studies. J Arthroplast. 2014;29(11):2175-2180. doi:10.1016/j.arth.2014.07.013.
20. Xing D, Yang Y, Ma X, Ma J, Ma B, Chen Y. Dose intraarticular steroid injection increase the rate of infection in subsequent arthroplasty: grading the evidence through a meta-analysis. J Orthop Surg Res. 2014;9:107. doi:10.1186/s13018-014-0107-2.
21. Eid AJ, Berbari EF, Sia IG, Wengenack NL, Osmon DR, Razonable RR. Prosthetic joint infection due to rapidly growing mycobacteria: report of 8 cases and review of the literature. Clin Infect Dis. 2007;45(6):687-694. doi:10.1086/520982.
22. Herold RC, Lotke PA, MacGregor RR. Prosthetic joint infections secondary to rapidly growing Mycobacterium fortuitum. Clin Orthop Relat Res. 1987;216(216):183-186. doi:10.1097/00003086-198703000-00029.
23. Petrosoniak A, Kim P, Desjardins M, Lee BC. Successful treatment of a prosthetic joint infection due to Mycobacterium abscessus. Can J Infect Dis Med Microbiol. 2009;20(3):e94-e96.
24. Yinkey LM, Halsey ES, Lloyd BA. Successful tigecycline combination therapy for Mycobacterium abscessus infection of a total hip arthroplasty. Infect Dis Clin Practice. 2010;18(4):269-270. doi:10.1097/IPC.0b013e3181d04a09.
25. AAOS Guidelines: the diagnosis of periprosthetic joint infections of the hip and knee guideline and evidence report. Adopted by the American Academy of Orthopaedic Surgeons Board of Directors; June 18th, 2010. AAOS Publication: 2010.
26. Griffith DE, Aksamit T, Brown-Elliott BA, et al; ATS Mycobacterial Diseases Subcomittee; American Thoracic Society; Infectious Disease Society of America. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med. 2007;175(4):367-416.
TAKE-HOME POINTS:
- Periprosthetic joint infections due to Mycobacterium abscess have been rarely reported, and no specific guidlines exist to inform treatment.
- Medical management alone was not successful in our clinical case and cannot be recommended.
- Combination medical and surgical management may provide the best opportunity for clincal cure of periprosthetic infections.
- In complicated periprosthetic joint infections involving rare and intrinsically resistant organisms, a collaborative multidisciplinary approach likley represents the preferred path to clinical cure.
- Successful erradiation of periprosthetic infection with M. abscessus may not preclude acceptable outcomes after revision TKA.
Reverse Total Shoulder Arthroplasty: Indications and Techniques Across the World
ABSTRACT
Reverse total shoulder arthroplasty (RTSA) is a common treatment for rotator cuff tear arthropathy. We performed a systematic review of all the RTSA literature to answer if we are treating the same patients with RTSA, across the world.
A systematic review was registered with PROSPERO, the international prospective register of systematic reviews, and performed with Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines using 3 publicly available free databases. Therapeutic clinical outcome investigations reporting RTSA outcomes with levels of evidence I to IV were eligible for inclusion. All study, subject, and surgical technique demographics were analyzed and compared between continents. Statistical comparisons were conducted using linear regression, analysis of variance (ANOVA), Fisher's exact test, and Pearson's chi-square test.
There were 103 studies included in the analysis (8973 patients; 62% female; mean age, 70.9 ± 6.7 years; mean length of follow-up, 34.3 ± 19.3 months) that had a low Modified Coleman Methodology Score (MCMS) (mean, 36.9 ± 8.7: poor). Most patients (60.8%) underwent RTSA for a diagnosis of rotator cuff arthropathy, whereas 1% underwent RTSA for fracture; indications varied by continent. There were no consistent reports of preopeartive or postoperative scores from studies in any region. Studies from North America reported significantly higher postoperative external rotation (34.1° ± 13.3° vs 19.3° ± 8.9°) (P < .001) and a greater change in flexion (69.0° ± 24.5° vs 56.3° ± 11.3°) (P = .004) compared with studies from Europe. North America had the greatest total number of publications followed by Europe. The total yearly number of publications increased each year (P < .001), whereas the MCMS decreased each year (P = .037).
The quantity, but not the quality of RTSA studies is increasing. Indications for RTSA varied by continent, although most patients underwent RTSA for rotator cuff arthropathy. The majority of patients undergoing RTSA are female over the age of 60 years for a diagnosis of rotator cuff arthropathy with pseudoparalysis.
Continue to: Reverse total shoulder arthroplasty...
Reverse total shoulder arthroplasty (RTSA) is a common procedure with indications including rotator cuff tear arthropathy, proximal humerus fractures, and others.1,2 Studies have shown excellent, reliable, short- and mid-term outcomes in patients treated with RTSA for various indications.3-5 Al-Hadithy and colleagues6 reviewed 41 patients who underwent RTSA for pseudoparalysis secondary to rotator cuff tear arthropathy and, at a mean follow-up of 5 years, found significant improvements in range of motion (ROM) as well as age-adjusted Constant and Oxford Outcome scores. Similarly, Ross and colleagues7 evaluated outcomes of RTSA in 28 patients in whom RTSA was performed for 3- or 4-part proximal humerus fractures, and found both good clinical and radiographic outcomes with no revision surgeries at a mean follow-up of 54.9 months. RTSA is performed across the world, with specific implant designs, specifically humeral head inclination, but is more common in some areas when compared with others.3,8,9
The number of RTSAs performed has steadily increased over the past 20 years, with recent estimates of approximately 20,000 RTSAs performed in the United States in 2011.10,11 However, there is little information about the similarities and differences between those patients undergoing RTSA in various parts of the world regarding surgical indications, patient demographics, and outcomes. The purpose of this study is to perform a systematic review and meta-analysis of the RTSA body of literature to both identify and compare characteristics of studies published (level of evidence, whether a conflict of interest existed), patients analyzed (age, gender), and surgical indications performed across both continents and countries. Essentially, the study aims to answer the question, "Across the world, are we treating the same patients?" The authors hypothesized that there would be no significant differences in RTSA publications, subjects, and indications based on both the continent and country of publication.
METHODS
A systematic review was conducted according to PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) guidelines using a PRISMA checklist.12 A systematic review registration was performed using PROSPERO, the international prospective register of systematic reviews (registration number CRD42014010578).13Two reviewers independently conducted the search on March 25, 2014, using the following databases: Medline, Cochrane Central Register of Controlled Trials, SportDiscus, and CINAHL. The electronic search citation algorithm utilized was: (((((reverse[Title/Abstract]) AND shoulder[Title/Abstract]) AND arthroplasty[Title/Abstract]) NOT arthroscopic[Title/Abstract]) NOT cadaver[Title/Abstract]) NOT biomechanical[Title/Abstract]. English language Level I to IV evidence (2011 update by the Oxford Centre for Evidence-Based Medicine14) clinical studies were eligible. Medical conference abstracts were ineligible for inclusion. All references within included studies were cross-referenced for inclusion if missed by the initial search with any additionally located studies screened for inclusion. Duplicate subject publications within separate unique studies were not reported twice, but rather the study with longer duration follow-up or, if follow-up was equal, the study with the greater number of patients was included. Level V evidence reviews, letters to the editor, basic science, biomechanical and cadaver studies, total shoulder arthroplasty (TSA) papers, arthroscopic shoulder surgery papers, imaging, surgical techniques, and classification studies were excluded.
A total of 255 studies were identified, and, after implementation of the exclusion criteria, 103 studies were included in the final analysis (Figure 1). Subjects of interest in this systematic review underwent RTSA for one of many indications including rotator cuff tear arthropathy, osteoarthritis, rheumatoid arthritis, posttraumatic arthritis, instability, revision from a previous RTSA for instability, infection, acute proximal humerus fracture, revision from a prior proximal humerus fracture, revision from a prior hemiarthroplasty, revision from a prior TSA, osteonecrosis, pseudoparalysis, tumor, and a locked shoulder dislocation. There was no minimum follow-up or rehabilitation requirement. Study and subject demographic parameters analyzed included year of publication, years of subject enrollment, presence of study financial conflict of interest, number of subjects and shoulders, gender, age, body mass index, diagnoses treated, and surgical positioning. Clinical outcome scores sought were the DASH (Disability of the Arm, Shoulder, and Hand), SPADI (Shoulder Pain And Disability Index), Absolute Constant, ASES (American Shoulder and Elbow Score), KSS (Korean Shoulder Score), SST-12 (Simple Shoulder Test), SF-12 (12-item Short Form), SF-36 (36-item Short Form), SSV (Subjective Shoulder Value), EQ-5D (EuroQol-5 Dimension), SANE (Single Assessment Numeric Evaluation), Rowe Score for Instability, Oxford Instability Score, UCLA (University of California, Los Angeles) activity score, Penn Shoulder Score, and VAS (visual analog scale). In addition, ROM (forward elevation, abduction, external rotation, internal rotation) was analyzed. Radiographs and magnetic resonance imaging data were extracted when available. The methodological quality of the study was evaluated using the MCMS (Modified Coleman Methodology Score).15
STATISTICAL ANALYSIS
First, the number of publications per year, level of evidence, and Modified Coleman Methodology Score were tested for association with the calendar year using linear regression. Second, demographic data were tested for association with the continent using Pearson’s chi-square test or ANOVA. Third, indications were tested for association with the continent using Fisher’s exact test. Finally, clinical outcome scores and ROM were tested for association with the continent using ANOVA. Statistical significance was extracted from studies when available. Statistical significance was defined as P < .05.
Continue to: RESULTS...
RESULTS
There were 103 studies included in the analysis (Figure 1). A total of 8973 patients were included, 62% of whom were female with a mean age of 70.9 ± 6.7 years (Table 1). The average follow-up was 34.3 ± 19.3 months. North America had the overall greatest total number of publications on RTSA, followed by Europe (Figure 2). The total yearly number of publications increased by a mean of 1.95 publications each year (P < .001). There was no association between the mean level of evidence with the year of publication (P = .296) (Figure 3). Overall, the rating of studies was poor for the MCMS (mean 36.9 ± 8.7). The MCMS decreased each year by a mean of 0.76 points (P = .037) (Figure 4).
Table 1. Demographic Data by Continent
| North America | Europe | Asia | Australia | Total | P-value |
Number of studies | 52 | 43 | 4 | 4 | 103 | - |
Number of subjects | 6158 | 2609 | 51 | 155 | 8973 | - |
Level of evidence |
|
|
|
|
| 0.693 |
II | 5 (10%) | 3 (7%) | 0 (0%) | 0 (0%) | 8 (8%) |
|
III | 10 (19%) | 4 (9%) | 0 (0%) | 1 (25%) | 15 (15%) |
|
IV | 37 (71%) | 36 (84%) | 4 (100%) | 3 (75%) | 80 (78%) |
|
Mean MCMS | 34.6 ± 8.4 | 40.2 ± 8.0 | 32.5 12.4 | 34.5 ± 6.6 | 36.9 ± 8.7 | 0.010 |
Institutional collaboration |
|
|
|
|
| 1.000 |
Multi-center | 7 (14%) | 6 (14%) | 0 (0%) | 0 (0%) | 13 (13%) |
|
Single-center | 45 (86%) | 37 (86%) | 4 (100%) | 4 (100%) | 90 (87%) |
|
Financial conflict of interest |
|
|
|
|
| 0.005 |
Present | 28 (54%) | 15 (35%) | 0 (0%) | 0 (0%) | 43 (42%) |
|
Not present | 19 (37%) | 16 (37%) | 4 (100%) | 4 (100%) | 43 (42%) |
|
Not reported | 5 (10%) | 12 (28%) | 0 (0%) | 0 (0%) | 17 (17%) |
|
Sex |
|
|
|
|
| N/A |
Male | 2157 (38%) | 1026 (39%) | 13 (25%) | 61 (39%) | 3257 (38%) |
|
Female | 3520 (62%) | 1622 (61%) | 38 (75%) | 94 (61%) | 5274 (62%) |
|
Mean age (years) | 71.3 ± 5.6 | 70.1 ± 7.9 | 68.1 ± 5.3 | 76.9 ± 3.0 | 70.9 ± 6.7 | 0.191 |
Minimum age (mean across studies) | 56.9 ± 12.8 | 52.8 ± 15.7 | 62.8 ± 6.2 | 68.0 ± 12.1 | 55.6 ± 14.3 | 0.160 |
Maximum age (mean across studies) | 82.1 ± 8.6 | 83.0 ± 5.5 | 73.0 ± 9.4 | 85.0 ± 7.9 | 82.2 ± 7.6 | 0.079 |
Mean length of follow-up (months) | 26.5 ± 13.7 | 43.1 ± 21.7 | 29.4 ± 7.9 | 34.2 ± 16.6 | 34.3 ± 19.3 | <0.001 |
Prosthesis type |
|
|
|
|
| N/A |
Cemented | 988 (89%) | 969 (72%) | 0 (0%) | 8 (16%) | 1965 (78%) |
|
Press fit | 120 (11%) | 379 (28%) | 0 (0%) | 41 (84%) | 540 (22%) |
|
Abbreviations: MCMS, Modified Coleman Methodology Score; N/A, not available.
In studies that reported press-fit vs cemented prostheses, the highest percentage of press-fit prostheses compared with cemented prostheses was seen in Australia (84% press-fit), whereas the highest percentage of cemented prostheses was seen in North America (89% cemented). A higher percentage of studies from North America had a financial conflict of interest (COI) than did those from other countries (54% had a COI).
Continue to: Rotator cuff tear arthropathy...
Rotator cuff tear arthropathy was the most common indication for RTSA overall in 5459 patients, followed by pseudoparalysis in 1352 patients (Tables 2 and 3). While studies in North America reported rotator cuff tear arthropathy as the indication for RTSA in 4418 (75.8%) patients, and pseudoparalysis as the next most common indication in 535 (9.2%) patients, studies from Europe reported rotator cuff tear arthropathy as the indication in 895 (33.5%) patients, and pseudoparalysis as the indication in 795 (29.7%) patients. Studies from Asia also had a relatively even split between rotator cuff tear arthropathy and pseudoparalysis (45.3% vs 37.8%), whereas those from Australia were mostly rotator cuff tear arthropathy (77.7%).
Table 2. Number (Percent) of Studies With Each Indication by Continent
| North America | Europe | Asia | Australia | Total | P-value |
Rotator cuff arthropathy | 29 (56%) | 19 (44%) | 3 (75%) | 3 (75%) | 54 (52%) | 0.390 |
Osteoarthritis | 4 (8%) | 10 (23%) | 1 (25%) | 1 (25%) | 16 (16%) | 0.072 |
Rheumatoid arthritis | 9 (17%) | 10 (23%) | 0 (0%) | 2 (50%) | 21 (20%) | 0.278 |
Post-traumatic arthritis | 3 (6%) | 5 (12%) | 0 (0%) | 1 (25%) | 9 (9%) | 0.358 |
Instability | 6 (12%) | 3 (7%) | 0 (0%) | 1 (25%) | 10 (10%) | 0.450 |
Revision of previous RTSA for instability | 5 (10%) | 1 (2%) | 0 (0%) | 1 (25%) | 7 (7%) | 0.192 |
Infection | 4 (8%) | 1 (2%) | 1 (25%) | 0 (0%) | 6 (6%) | 0.207 |
Unclassified acute proximal humerus fracture | 9 (17%) | 5 (12%) | 1 (25%) | 1 (25%) | 16 (16%) | 0.443 |
Acute 2-part proximal humerus fracture | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | N/A |
Acute 3-part proximal humerus fracture | 2 (4%) | 0 (0%) | 0 (0%) | 0 (0%) | 2 (2%) | 0.574 |
Acute 4-part proximal humerus fracture | 5 (10%) | 0 (0%) | 0 (0%) | 0 (0%) | 5 (5%) | 0.183 |
Acute 3- or 4-part proximal humerus fracture | 6 (12%) | 2 (5%) | 0 (0%) | 0 (0%) | 8 (8%) | 0.635 |
Revised from previous nonop proximal humerus fracture | 7 (13%) | 3 (7%) | 0 (0%) | 0 (0%) | 10 (10%) | 0.787 |
Revised from ORIF | 1 (2%) | 1 (2%) | 0 (0%) | 0 (0%) | 2 (2%) | 1.000 |
Revised from CRPP | 0 (0%) | 1 (2%) | 0 (0%) | 0 (0%) | 1 (1%) | 0.495 |
Revised from hemi | 8 (15%) | 4 (9%) | 0 (0%) | 1 (25%) | 13 (13%) | 0.528 |
Revised from TSA | 15 (29%) | 11 (26%) | 0 (0%) | 2 (50%) | 28 (27%) | 0.492 |
Osteonecrosis | 4 (8%) | 2 (5%) | 1 (25%) | 0 (0%) | 7 (7%) | 0.401 |
Pseudoparalysis irreparable tear without arthritis | 20 (38%) | 18 (42%) | 2 (50%) | 1 (25%) | 41 (40%) | 0.919 |
Bone tumors | 0 (0%) | 4 (9.3%) | 0 (0%) | 0 (0%) | 4 (4%) | 0.120 |
Locked shoulder dislocation | 0 (0%) | 0 (0%) | 1 (25%) | 0 (0%) | 1 (1%) | 0.078 |
Abbreviations: CRPP, closed reduction and percutaneous pinning; ORIF, open reduction internal fixation; RTSA, reverse total shoulder arthroplasty; TSA, total shoulder arthroplasty.
Table 3. Number of Patients With Each Indication as Reported by Individual Studies by Continent
| North America | Europe | Asia | Australia | Total |
Rotator cuff arthropathy | 4418 | 895 | 24 | 122 | 5459 |
Osteoarthritis | 90 | 251 | 1 | 14 | 356 |
Rheumatoid arthritis | 59 | 87 | 0 | 2 | 148 |
Post-traumatic arthritis | 62 | 136 | 0 | 1 | 199 |
Instability | 23 | 15 | 0 | 1 | 39 |
Revision of previous RTSA for instability | 29 | 2 | 0 | 1 | 32 |
Infection | 28 | 11 | 2 | 0 | 41 |
Unclassified acute proximal humerus fracture | 42 | 30 | 4 | 8 | 84 |
Acute 3-part proximal humerus fracture | 60 | 0 | 0 | 0 | 6 |
Acute 4-part proximal humerus fracture | 42 | 0 | 0 | 0 | 42 |
Acute 3- or 4-part proximal humerus fracture | 92 | 46 | 0 | 0 | 138 |
Revised from previous nonop proximal humerus fracture | 43 | 53 | 0 | 0 | 96 |
Revised from ORIF | 3 | 9 | 0 | 0 | 12 |
Revised from CRPP | 0 | 3 | 0 | 0 | 3 |
Revised from hemi | 105 | 51 | 0 | 1 | 157 |
Revised from TSA | 192 | 246 | 0 | 5 | 443 |
Osteonecrosis | 9 | 6 | 1 | 0 | 16 |
Pseudoparalysis irreparable tear without arthritis | 535 | 795 | 20 | 2 | 1352 |
Bone tumors | 0 | 38 | 0 | 0 | 38 |
Locked shoulder dislocation | 0 | 0 | 1 | 0 | 1 |
Abbreviations: CRPP, closed reduction and percutaneous pinning; ORIF, open reduction internal fixation; RTSA, reverse total shoulder arthroplasty; TSA, total shoulder arthroplasty.
The ASES, SST-12, and VAS scores were the most frequently reported outcome scores in studies from North America, whereas the Absolute Constant score was the most common score reported in studies from Europe (Table 4). Studies from North America reported significantly higher postoperative external rotation (34.1° ± 13.3° vs 19.3° ± 8.9°) (P < .001) and a greater change in flexion (69.0° ± 24.5° vs 56.3° +/- 11.3°) (P = .004) compared with studies from Europe (Table 5).
Table 4. Outcomes by Continent
Metric (number of studies) | North America | Europe | Asia | Australia | P-value |
DASH | 1 | 2 | 0 | 0 |
|
Preoperative | 54.0 | 62.0 ± 8.5 | - | - | 0.582 |
Postoperative | 24.0 | 32.0 ± 2.8 | - | - | 0.260 |
Change | -30.0 | -30.0 ± 11.3 | - | - | 1.000 |
SPADI | 2 | 0 | 0 | 0 |
|
Preoperative | 80.0 ± 4.2 | - | - | - | N/A |
Postoperative | 34.8 ± 1.1 | - | - | - | N/A |
Change | -45.3 ± 3.2 | - | - | - | N/A |
Absolute constant | 2 | 27 | 0 | 1 |
|
Preopeartive | 33.0 ± 0.0 | 28.2 ± 7.1 | - | 20.0 | 0.329 |
Postoperative | 54.5 ± 7.8 | 62.9 ± 9.0 | - | 65.0 | 0.432 |
Change | +21.5 ± 7.8 | +34.7 ± 8.0 | - | +45.0 | 0.044 |
ASES | 13 | 0 | 2 | 0 |
|
Preoperative | 33.2 ± 5.4 | - | 32.5 ± 3.5 | - | 0.867 |
Postoperative | 73.9 ± 6.8 | - | 75.7 ± 10.8 | - | 0.752 |
Change | +40.7 ± 6.5 | - | +43.2 ± 14.4 | - | 0.670 |
UCLA | 3 | 2 | 1 | 0 |
|
Preoperative | 10.1 ± 3.4 | 11.2 ± 5.7 | 12.0 | - | 0.925 |
Postoperative | 24.5 ± 3.1 | 24.3 ± 3.7 | 24.0 | - | 0.991 |
Change | +14.4 ± 1.6 | +13.1 ± 2.0 | +12.0 | - | 0.524 |
KSS | 0 | 0 | 2 | 0 |
|
Preopeartive | - | - | 38.2 ± 1.1 | - | N/A |
Postoperative | - | - | 72.3 ± 6.0 | - | N/A |
Change | - | - | +34.1 ± 7.1 | - | N/A |
SST-12 | 12 | 1 | 0 | 0 |
|
Preoperative | 1.9 ± 0.8 | 1.2 | - | - | N/A |
Postoperative | 7.1 ± 1.5 | 5.6 | - | - | N/A |
Change | +5.3 ± 1.2 | +4.4 | - | - | N/A |
SF-12 | 1 | 0 | 0 | 0 |
|
Preoperative | 34.5 | - | - | - | N/A |
Postoperative | 38.5 | - | - | - | N/A |
Change | +4.0 | - | - | - | N/A |
SSV | 0 | 5 | 0 | 0 |
|
Preopeartive | - | 22.0 ± 7.4 | - | - | N/A |
Postoperative | - | 63.4 ± 7.9 | - | - | N/A |
Change | - | +41.4 ± 2.1 | - | - | N/A |
EQ-5D | 0 | 2 | 0 | 0 |
|
Preoperative | - | 0.5 ± 0.2 | - | - | N/A |
Postoperative | - | 0.8 ± 0.1 | - | - | N/A |
Change | - | +0.3 ± 0.1 | - | - | N/A |
OOS | 1 | 0 | 0 | 0 |
|
Preoperative | 24.7 | - | - | - | N/A |
Postoperative | 14.9 | - | - | - | N/A |
Change | -9.9 | - | - | - | N/A |
Rowe | 0 | 1 | 0 | 0 |
|
Preoperative | - | 50.2 | - | - | N/A |
Postoperative | - | 82.1 | - | - | N/A |
Change | - | 31.9 | - | - | N/A |
Oxford | 0 | 2 | 0 | 0 |
|
Preoperative | - | 119.9 ± 138.8 | - | - | N/A |
Postoperative | - | 39.9 ± 3.3 | - | - | N/A |
Change | - | -80.6 ± 142.2 | - | - | N/A |
Penn | 1 | 0 | 0 | 0 |
|
Preoperative | 24.9 | - | - | - | N/A |
Postoperative | 66.4 | - | - | - | N/A |
Change | +41.5 | - | - | - | N/A |
VAS | 10 | 1 | 1 | 1 |
|
Preoperative | 6.6 ± 0.8 | 7.0 | 8.4 | 7.0 | N/A |
Postoperative | 2.0 ± 0.7 | 1.0 | 0.8 | 0.8 | N/A |
Change | -4.6 ± 0.8 | -6.0 | -7.6 | -6.2 | N/A |
SF-36 physical | 2 | 0 | 0 | 0 |
|
Preoperative | 32.7 ± 1.2 | - | - | - | N/A |
Postoperative | 39.6 ± 4.0 | - | - | - | N/A |
Change | +7.0 ± 2.8 | - | - | - | N/A |
SF-36 mental | 2 | 0 | 0 | 0 |
|
Preoperative | 43.6 ± 2.8 | - | - | - | N/A |
Postoperative | 48.1 ± 1.0 | - | - | - | N/A |
Change | +4.5 ± 1.8 | - | - | - | N/A |
Abbreviations: ASES, American Shoulder and Elbow Surgeon score; DASH, Disability of the Arm, Shoulder, and Hand; EQ-5D, EuroQol-5 Dimension; KSS, Korean Shoulder Scoring system; N/A, not available; OOS, Orthopaedic Outcome Score; SF, short form; SPADI, Shoulder Pain and Disability Index; SST, Simple Shoulder Test; SSV, Subjective Shoulder Value; UCLA, University of California, Los Angeles; VAS, visual analog scale.
Table 5. Shoulder Range of Motion, by Continent
Metric (number of studies) | North America | Europe | Asia | Australia | P-value |
Flexion | 18 | 22 | 1 | 1 |
|
Preoperative | 57.6 ± 17.9 | 65.5 ± 17.2 | 91.0 | 30.0 | 0.060 |
Postoperative | 126.6 ± 14.4 | 121.8 ± 19.0 | 133.0 | 150.0 | 0.360 |
Change | +69.0 ± 24.5 | +56.3 ± 11.3 | +42.0 | 120.0 | 0.004 |
Abduction | 11 | 12 | 1 | 0 |
|
Preoperative | 53.7 ± 25.0 | 52.0 ± 19.0 | 88.0 | - | 0.311 |
Postoperative | 109.3 ± 15.1 | 105.4 ± 19.8 | 131.0 | - | 0.386 |
Change | 55.5 ± 25.5 | 53.3 ± 8.3 | 43.0 | - | 0.804 |
External rotation | 17 | 19 | 0 | 0 |
|
Preoperative | 19.4 ± 9.9 | 11.2 ± 6.1 | - | - | 0.005 |
Postoperative | 34.1 ± 13.3 | 19.3 ± 8.9 | - | - | <0.001 |
Change | +14.7 ± 13.2 | +8.1 ± 8.5 | - | - | 0.079 |
Continue to: DISCUSSION...
DISCUSSION
RTSA is a common procedure performed in many different areas of the world for a variety of indications. The study hypotheses were partially confirmed, as there were no significant differences seen in the characteristics of the studies published and patients analyzed; although, the majority of studies from North America reported rotator cuff tear arthropathy as the primary indication for RTSA, whereas studies from Europe were split between rotator cuff tear arthropathy and pseudoparalysis as the primary indication. Hence, based on the current literature the study proved that we are treating the same patients. Despite this finding, we may be treating them for different reasons with an RTSA.
RTSA has become a standard procedure in the United States, with >20,000 RTSAs performed in 2011.10 This number will continue to increase as it has over the past 20 years given the aging population in the United States, as well as the expanding indications for RTSA.11 Indications of RTSA have become broad, although the main indication remains as rotator cuff tear arthropathy (>60% of all patients included in this study), and pseudoparalysis (>15% of all patients included in this study). Results for RTSA for rotator cuff tear arthropathy and pseudoparalysis have been encouraging.16,17 Frankle and colleagues16 evaluated 60 patients who underwent RTSA for rotator cuff tear arthropathy at a minimum of 2 years follow-up (average, 33 months). The authors found significant improvements in all measured clinical outcome variables (P < .0001) (ASES, mean function score, mean pain score, and VAS) as well as ROM, specifically forward flexion increased from 55° to 105.1°, and abduction increased from 41.4° to 101.8°. Similarly, Werner and colleagues17 evaluated 58 consecutive patients who underwent RTSA for pseudoparalysis secondary to irreparable rotator cuff dysfunction at a mean follow-up of 38 months. Overall, significant improvements (P < .0001) were seen in the SSV score, relative Constant score, and Constant score for pain, active anterior elevation (42° to 100° following RTSA), and active abduction (43° to 90° following RTSA).
It is essential to understand the similarities and differences between patients undergoing RTSA in different parts of the world so the literature from various countries can be compared between regions, and conclusions extrapolated to the correct patients. For example, an interesting finding in this study is that the majority of patients in North America have their prosthesis cemented whereas the majority of patients in Australia have their prosthesis press-fit. While the patients each continent is treating are not significantly different (mostly older women), the difference in surgical technique could have implications in long- or short-term functional outcomes. Prior studies have shown no difference in axial micromotion between cemented and press-fit humeral components, but the clinical implications surrounding this are not well defined.18 Small series comparing cementless to cemented humeral prosthesis in RTSA have found no significant differences in clinical outcomes or postoperative ROM, but larger series are necessary to validate these outcomes.19 However, studies have shown lower rates of postoperative infections in patients who receive antibiotic-loaded cement compared with those who receive plain bone cement following RTSA.20
Similarly, as the vast majority of patients in North America had an RTSA for rotator cuff arthropathy (75.8%) whereas those from Europe had RTSA almost equally for rotator cuff arthropathy (33.5%) and pseudoparalysis (29.7%), one must ensure similar patient populations before attempting to extrapolate results of a study from a different country to patients in other areas. Fortunately, the clinical results following RTSA for either indication have been good.6,21,22
One final point to consider is the cost effectiveness of the implant. Recent evidence has shown that RTSA is associated with a higher risk for in-hospital death, multiple perioperative complications, prolonged hospital stay, and increased hospital cost when compared with TSA.23 This data may be biased as the patient selection for RTSA varies from that of TSA, but it is a point that must be considered. Other studies have shown that an RTSA is a cost-effective treatment option for treating patients with rotator cuff tear arthropathy, and is a more cost-effective option in treating rotator cuff tear arthropathy than hemiarthroplasty.24,25 Similarly, RTSA offers a more cost-effective treatment option with better outcomes for patients with acute proximal humerus fractures when compared with open reduction internal fixation and hemiarthroplasty.26 However, TSA is a more cost-effective treatment option than RTSA for patients with glenohumeral osteoarthritis.27 With changing reimbursement in healthcare, surgeons must scrutinize not only anticipated outcomes with specific implants but the cost effectiveness of these implants as well. Further cost analysis studies are necessary to determine the ideal candidate for an RTSA.
LIMITATIONS
Despite its extensive review of the literature, this study had several limitations. While 2 independent authors searched for studies, it is possible that some studies were missed during the search process, introducing possible selection bias. No abstracts or unpublished works were included which could have introduced publication bias. Several studies did not report all variables the authors examined, and this could have skewed some of the results since the reporting of additional variables could have altered the data to show significant differences in some measured variables. As outcome measures for various pathologies were not compared, conclusions cannot be drawn on the best treatment option for various indications. As case reports were included, this could have lowered both the MCMS as well as the average in studies reporting outcomes. Furthermore, given the overall poor quality of the underlying data available for this study, the validity/generalizability of the results could be limited as the level of evidence of this systematic review is only as high as the studies it includes. There are subtle differences between rotator cuff arthropathy and pseudoparalysis, and some studies may have classified patients differently than others, causing differences in indications. Finally, as the primary goal of this study was to report on demographics, no evaluation of concomitant pathology at the time of surgery or rehabilitation protocols was performed.
CONCLUSION
The quantity, but not the quality of RTSA studies is increasing. Indications for RTSA varied by continent although most patients underwent RTSA for rotator cuff arthropathy. The majority of patients undergoing RTSA are female over the age of 60 years for a diagnosis of rotator cuff arthropathy with pseudoparalysis.
This paper will be judged for the Resident Writer’s Award.
1. Boileau P, Moineau G, Roussanne Y, O'Shea K. Bony increased-offset reversed shoulder arthroplasty: minimizing scapular impingement while maximizing glenoid fixation. Clin Orthop Relat Res. 2011;469(9):2558-2567. doi:10.1007/s11999-011-1775-4.
2. Gupta AK, Harris JD, Erickson BJ, et al. Surgical management of complex proximal humerus fractures-a systematic review of 92 studies including 4,500 patients. J Orthop Trauma. 2014;29(1):54-59.
3. Cazeneuve JF, Cristofari DJ. Grammont reversed prosthesis for acute complex fracture of the proximal humerus in an elderly population with 5 to 12 years follow-up. Orthop Traumatol Surg Res. 2014;100(1):93-97. doi:10.1016/j.otsr.2013.12.005.
4. Clark JC, Ritchie J, Song FS, et al. Complication rates, dislocation, pain, and postoperative range of motion after reverse shoulder arthroplasty in patients with and without repair of the subscapularis. J Shoulder Elbow Surg. 2012;21(1):36-41. doi:10.1016/j.jse.2011.04.009.
5. De Biase CF, Delcogliano M, Borroni M, Castagna A. Reverse total shoulder arthroplasty: radiological and clinical result using an eccentric glenosphere. Musculoskelet Surg. 2012;96(suppl 1):S27-SS34. doi:10.1007/s12306-012-0193-4.
6. Al-Hadithy N, Domos P, Sewell MD, Pandit R. Reverse shoulder arthroplasty in 41 patients with cuff tear arthropathy with a mean follow-up period of 5 years. J Shoulder Elbow Surg. 2014;23(11):1662-1668. doi:10.1016/j.jse.2014.03.001.
7. Ross M, Hope B, Stokes A, Peters SE, McLeod I, Duke PF. Reverse shoulder arthroplasty for the treatment of three-part and four-part proximal humeral fractures in the elderly. J Shoulder Elbow Surg. 2015;24(2):215-222. doi:10.1016/j.jse.2014.05.022.
8. Mulieri P, Dunning P, Klein S, Pupello D, Frankle M. Reverse shoulder arthroplasty for the treatment of irreparable rotator cuff tear without glenohumeral arthritis. J Bone Joint Surg Am. 2010;92(15):2544-2556. doi:10.2106/JBJS.I.00912.
9. Erickson BJ, Frank RM, Harris JD, Mall N, Romeo AA. The influence of humeral head inclination in reverse total shoulder arthroplasty: a systematic review. J Shoulder Elbow Surg. 2015;24(6):988-993. doi:10.1016/j.jse.2015.01.001.
10. Schairer WW, Nwachukwu BU, Lyman S, Craig EV, Gulotta LV. National utilization of reverse total shoulder arthroplasty in the United States. J Shoulder Elbow Surg. 2015;24(1):91-97. doi:10.1016/j.jse.2014.08.026.
11. Kim SH, Wise BL, Zhang Y, Szabo RM. Increasing incidence of shoulder arthroplasty in the United States. J Bone Joint Surg Am. 2011;93(24):2249-2254. doi:10.2106/JBJS.J.01994.
12. Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. J Clin Epidemiol. 2009;62(10):e1-e34. doi:10.1016/j.jclinepi.2009.06.006.
13. University of York Centre for Reviews and Dissemination, National Institute for Health Research. PROSPERO International prospective register of systematic reviews. University of York Web site. http://www.crd.york.ac.uk/PROSPERO/. Accessed November 1, 2016.
14. Oxford Centre for Evidence-based Medicine – Levels of evidence (March 2009). University of Oxford Web site: https://www.cebm.net/2009/06/oxford-centre-evidence-based-medicine-levels-evidence-march-2009/. Accessed November 1, 2016.
15. Cowan J, Lozano-Calderón S, Ring D. Quality of prospective controlled randomized trials. Analysis of trials of treatment for lateral epicondylitis as an example. J Bone Joint Surg Am. 2007;89(8):1693-1699. doi:10.2106/JBJS.F.00858.
16. Frankle M, Levy JC, Pupello D, et al. The reverse shoulder prosthesis for glenohumeral arthritis associated with severe rotator cuff deficiency. A minimum two-year follow-up study of sixty patients surgical technique. J Bone Joint Surg Am. 2006;88(suppl 1 Pt 2):178-190. doi:10.2106/JBJS.F.00123.
17. Werner CM, Steinmann PA, Gilbart M, Gerber C. Treatment of painful pseudoparesis due to irreparable rotator cuff dysfunction with the Delta III reverse-ball-and-socket total shoulder prosthesis. J Bone Joint Surg Am. 2005;87(7):1476-1486. doi:10.2106/JBJS.D.02342.
18. Peppers TA, Jobe CM, Dai QG, Williams PA, Libanati C. Fixation of humeral prostheses and axial micromotion. J Shoulder Elbow Surg. 1998;7(4):414-418. doi:10.1016/S1058-2746(98)90034-9.
19. Wiater JM, Moravek JE Jr, Budge MD, Koueiter DM, Marcantonio D, Wiater BP. Clinical and radiographic results of cementless reverse total shoulder arthroplasty: a comparative study with 2 to 5 years of follow-up. J Shoulder Elbow Surg. 2014;23(8):1208-1214. doi:10.1016/j.jse.2013.11.032.
20. Nowinski RJ, Gillespie RJ, Shishani Y, Cohen B, Walch G, Gobezie R. Antibiotic-loaded bone cement reduces deep infection rates for primary reverse total shoulder arthroplasty: a retrospective, cohort study of 501 shoulders. J Shoulder Elbow Surg. 2012;21(3):324-328. doi:10.1016/j.jse.2011.08.072.
21. Favard L, Levigne C, Nerot C, Gerber C, De Wilde L, Mole D. Reverse prostheses in arthropathies with cuff tear: are survivorship and function maintained over time? Clin Orthop Relat Res. 2011;469(9):2469-2475. doi:10.1007/s11999-011-1833-y.
22. Naveed MA, Kitson J, Bunker TD. The Delta III reverse shoulder replacement for cuff tear arthropathy: a single-centre study of 50 consecutive procedures. J Bone Joint Surg Br. 2011;93(1):57-61. doi:10.1302/0301-620X.93B1.24218.
23. Ponce BA, Oladeji LO, Rogers ME, Menendez ME. Comparative analysis of anatomic and reverse total shoulder arthroplasty: in-hospital outcomes and costs. J Shoulder Elbow Surg. 2015;24(3):460-467. doi:10.1016/j.jse.2014.08.016.
24. Coe MP, Greiwe RM, Joshi R, et al. The cost-effectiveness of reverse total shoulder arthroplasty compared with hemiarthroplasty for rotator cuff tear arthropathy. J Shoulder Elbow Surg. 2012;21(10):1278-1288. doi:10.1016/j.jse.2011.10.010.
25. Renfree KJ, Hattrup SJ, Chang YH. Cost utility analysis of reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2013;22(12):1656-1661. doi:10.1016/j.jse.2013.08.002.
26. Chalmers PN, Slikker W, 3rd, Mall NA, et al. Reverse total shoulder arthroplasty for acute proximal humeral fracture: comparison to open reduction-internal fixation and hemiarthroplasty. J Shoulder Elbow Surg. 2014;23(2):197-204. doi:10.1016/j.jse.2013.07.044.
27. Steen BM, Cabezas AF, Santoni BG, et al. Outcome and value of reverse shoulder arthroplasty for treatment of glenohumeral osteoarthritis: a matched cohort. J Shoulder Elbow Surg. 2015;24(9):1433-1441. doi:10.1016/j.jse.2015.01.005.
ABSTRACT
Reverse total shoulder arthroplasty (RTSA) is a common treatment for rotator cuff tear arthropathy. We performed a systematic review of all the RTSA literature to answer if we are treating the same patients with RTSA, across the world.
A systematic review was registered with PROSPERO, the international prospective register of systematic reviews, and performed with Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines using 3 publicly available free databases. Therapeutic clinical outcome investigations reporting RTSA outcomes with levels of evidence I to IV were eligible for inclusion. All study, subject, and surgical technique demographics were analyzed and compared between continents. Statistical comparisons were conducted using linear regression, analysis of variance (ANOVA), Fisher's exact test, and Pearson's chi-square test.
There were 103 studies included in the analysis (8973 patients; 62% female; mean age, 70.9 ± 6.7 years; mean length of follow-up, 34.3 ± 19.3 months) that had a low Modified Coleman Methodology Score (MCMS) (mean, 36.9 ± 8.7: poor). Most patients (60.8%) underwent RTSA for a diagnosis of rotator cuff arthropathy, whereas 1% underwent RTSA for fracture; indications varied by continent. There were no consistent reports of preopeartive or postoperative scores from studies in any region. Studies from North America reported significantly higher postoperative external rotation (34.1° ± 13.3° vs 19.3° ± 8.9°) (P < .001) and a greater change in flexion (69.0° ± 24.5° vs 56.3° ± 11.3°) (P = .004) compared with studies from Europe. North America had the greatest total number of publications followed by Europe. The total yearly number of publications increased each year (P < .001), whereas the MCMS decreased each year (P = .037).
The quantity, but not the quality of RTSA studies is increasing. Indications for RTSA varied by continent, although most patients underwent RTSA for rotator cuff arthropathy. The majority of patients undergoing RTSA are female over the age of 60 years for a diagnosis of rotator cuff arthropathy with pseudoparalysis.
Continue to: Reverse total shoulder arthroplasty...
Reverse total shoulder arthroplasty (RTSA) is a common procedure with indications including rotator cuff tear arthropathy, proximal humerus fractures, and others.1,2 Studies have shown excellent, reliable, short- and mid-term outcomes in patients treated with RTSA for various indications.3-5 Al-Hadithy and colleagues6 reviewed 41 patients who underwent RTSA for pseudoparalysis secondary to rotator cuff tear arthropathy and, at a mean follow-up of 5 years, found significant improvements in range of motion (ROM) as well as age-adjusted Constant and Oxford Outcome scores. Similarly, Ross and colleagues7 evaluated outcomes of RTSA in 28 patients in whom RTSA was performed for 3- or 4-part proximal humerus fractures, and found both good clinical and radiographic outcomes with no revision surgeries at a mean follow-up of 54.9 months. RTSA is performed across the world, with specific implant designs, specifically humeral head inclination, but is more common in some areas when compared with others.3,8,9
The number of RTSAs performed has steadily increased over the past 20 years, with recent estimates of approximately 20,000 RTSAs performed in the United States in 2011.10,11 However, there is little information about the similarities and differences between those patients undergoing RTSA in various parts of the world regarding surgical indications, patient demographics, and outcomes. The purpose of this study is to perform a systematic review and meta-analysis of the RTSA body of literature to both identify and compare characteristics of studies published (level of evidence, whether a conflict of interest existed), patients analyzed (age, gender), and surgical indications performed across both continents and countries. Essentially, the study aims to answer the question, "Across the world, are we treating the same patients?" The authors hypothesized that there would be no significant differences in RTSA publications, subjects, and indications based on both the continent and country of publication.
METHODS
A systematic review was conducted according to PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) guidelines using a PRISMA checklist.12 A systematic review registration was performed using PROSPERO, the international prospective register of systematic reviews (registration number CRD42014010578).13Two reviewers independently conducted the search on March 25, 2014, using the following databases: Medline, Cochrane Central Register of Controlled Trials, SportDiscus, and CINAHL. The electronic search citation algorithm utilized was: (((((reverse[Title/Abstract]) AND shoulder[Title/Abstract]) AND arthroplasty[Title/Abstract]) NOT arthroscopic[Title/Abstract]) NOT cadaver[Title/Abstract]) NOT biomechanical[Title/Abstract]. English language Level I to IV evidence (2011 update by the Oxford Centre for Evidence-Based Medicine14) clinical studies were eligible. Medical conference abstracts were ineligible for inclusion. All references within included studies were cross-referenced for inclusion if missed by the initial search with any additionally located studies screened for inclusion. Duplicate subject publications within separate unique studies were not reported twice, but rather the study with longer duration follow-up or, if follow-up was equal, the study with the greater number of patients was included. Level V evidence reviews, letters to the editor, basic science, biomechanical and cadaver studies, total shoulder arthroplasty (TSA) papers, arthroscopic shoulder surgery papers, imaging, surgical techniques, and classification studies were excluded.
A total of 255 studies were identified, and, after implementation of the exclusion criteria, 103 studies were included in the final analysis (Figure 1). Subjects of interest in this systematic review underwent RTSA for one of many indications including rotator cuff tear arthropathy, osteoarthritis, rheumatoid arthritis, posttraumatic arthritis, instability, revision from a previous RTSA for instability, infection, acute proximal humerus fracture, revision from a prior proximal humerus fracture, revision from a prior hemiarthroplasty, revision from a prior TSA, osteonecrosis, pseudoparalysis, tumor, and a locked shoulder dislocation. There was no minimum follow-up or rehabilitation requirement. Study and subject demographic parameters analyzed included year of publication, years of subject enrollment, presence of study financial conflict of interest, number of subjects and shoulders, gender, age, body mass index, diagnoses treated, and surgical positioning. Clinical outcome scores sought were the DASH (Disability of the Arm, Shoulder, and Hand), SPADI (Shoulder Pain And Disability Index), Absolute Constant, ASES (American Shoulder and Elbow Score), KSS (Korean Shoulder Score), SST-12 (Simple Shoulder Test), SF-12 (12-item Short Form), SF-36 (36-item Short Form), SSV (Subjective Shoulder Value), EQ-5D (EuroQol-5 Dimension), SANE (Single Assessment Numeric Evaluation), Rowe Score for Instability, Oxford Instability Score, UCLA (University of California, Los Angeles) activity score, Penn Shoulder Score, and VAS (visual analog scale). In addition, ROM (forward elevation, abduction, external rotation, internal rotation) was analyzed. Radiographs and magnetic resonance imaging data were extracted when available. The methodological quality of the study was evaluated using the MCMS (Modified Coleman Methodology Score).15
STATISTICAL ANALYSIS
First, the number of publications per year, level of evidence, and Modified Coleman Methodology Score were tested for association with the calendar year using linear regression. Second, demographic data were tested for association with the continent using Pearson’s chi-square test or ANOVA. Third, indications were tested for association with the continent using Fisher’s exact test. Finally, clinical outcome scores and ROM were tested for association with the continent using ANOVA. Statistical significance was extracted from studies when available. Statistical significance was defined as P < .05.
Continue to: RESULTS...
RESULTS
There were 103 studies included in the analysis (Figure 1). A total of 8973 patients were included, 62% of whom were female with a mean age of 70.9 ± 6.7 years (Table 1). The average follow-up was 34.3 ± 19.3 months. North America had the overall greatest total number of publications on RTSA, followed by Europe (Figure 2). The total yearly number of publications increased by a mean of 1.95 publications each year (P < .001). There was no association between the mean level of evidence with the year of publication (P = .296) (Figure 3). Overall, the rating of studies was poor for the MCMS (mean 36.9 ± 8.7). The MCMS decreased each year by a mean of 0.76 points (P = .037) (Figure 4).
Table 1. Demographic Data by Continent
| North America | Europe | Asia | Australia | Total | P-value |
Number of studies | 52 | 43 | 4 | 4 | 103 | - |
Number of subjects | 6158 | 2609 | 51 | 155 | 8973 | - |
Level of evidence |
|
|
|
|
| 0.693 |
II | 5 (10%) | 3 (7%) | 0 (0%) | 0 (0%) | 8 (8%) |
|
III | 10 (19%) | 4 (9%) | 0 (0%) | 1 (25%) | 15 (15%) |
|
IV | 37 (71%) | 36 (84%) | 4 (100%) | 3 (75%) | 80 (78%) |
|
Mean MCMS | 34.6 ± 8.4 | 40.2 ± 8.0 | 32.5 12.4 | 34.5 ± 6.6 | 36.9 ± 8.7 | 0.010 |
Institutional collaboration |
|
|
|
|
| 1.000 |
Multi-center | 7 (14%) | 6 (14%) | 0 (0%) | 0 (0%) | 13 (13%) |
|
Single-center | 45 (86%) | 37 (86%) | 4 (100%) | 4 (100%) | 90 (87%) |
|
Financial conflict of interest |
|
|
|
|
| 0.005 |
Present | 28 (54%) | 15 (35%) | 0 (0%) | 0 (0%) | 43 (42%) |
|
Not present | 19 (37%) | 16 (37%) | 4 (100%) | 4 (100%) | 43 (42%) |
|
Not reported | 5 (10%) | 12 (28%) | 0 (0%) | 0 (0%) | 17 (17%) |
|
Sex |
|
|
|
|
| N/A |
Male | 2157 (38%) | 1026 (39%) | 13 (25%) | 61 (39%) | 3257 (38%) |
|
Female | 3520 (62%) | 1622 (61%) | 38 (75%) | 94 (61%) | 5274 (62%) |
|
Mean age (years) | 71.3 ± 5.6 | 70.1 ± 7.9 | 68.1 ± 5.3 | 76.9 ± 3.0 | 70.9 ± 6.7 | 0.191 |
Minimum age (mean across studies) | 56.9 ± 12.8 | 52.8 ± 15.7 | 62.8 ± 6.2 | 68.0 ± 12.1 | 55.6 ± 14.3 | 0.160 |
Maximum age (mean across studies) | 82.1 ± 8.6 | 83.0 ± 5.5 | 73.0 ± 9.4 | 85.0 ± 7.9 | 82.2 ± 7.6 | 0.079 |
Mean length of follow-up (months) | 26.5 ± 13.7 | 43.1 ± 21.7 | 29.4 ± 7.9 | 34.2 ± 16.6 | 34.3 ± 19.3 | <0.001 |
Prosthesis type |
|
|
|
|
| N/A |
Cemented | 988 (89%) | 969 (72%) | 0 (0%) | 8 (16%) | 1965 (78%) |
|
Press fit | 120 (11%) | 379 (28%) | 0 (0%) | 41 (84%) | 540 (22%) |
|
Abbreviations: MCMS, Modified Coleman Methodology Score; N/A, not available.
In studies that reported press-fit vs cemented prostheses, the highest percentage of press-fit prostheses compared with cemented prostheses was seen in Australia (84% press-fit), whereas the highest percentage of cemented prostheses was seen in North America (89% cemented). A higher percentage of studies from North America had a financial conflict of interest (COI) than did those from other countries (54% had a COI).
Continue to: Rotator cuff tear arthropathy...
Rotator cuff tear arthropathy was the most common indication for RTSA overall in 5459 patients, followed by pseudoparalysis in 1352 patients (Tables 2 and 3). While studies in North America reported rotator cuff tear arthropathy as the indication for RTSA in 4418 (75.8%) patients, and pseudoparalysis as the next most common indication in 535 (9.2%) patients, studies from Europe reported rotator cuff tear arthropathy as the indication in 895 (33.5%) patients, and pseudoparalysis as the indication in 795 (29.7%) patients. Studies from Asia also had a relatively even split between rotator cuff tear arthropathy and pseudoparalysis (45.3% vs 37.8%), whereas those from Australia were mostly rotator cuff tear arthropathy (77.7%).
Table 2. Number (Percent) of Studies With Each Indication by Continent
| North America | Europe | Asia | Australia | Total | P-value |
Rotator cuff arthropathy | 29 (56%) | 19 (44%) | 3 (75%) | 3 (75%) | 54 (52%) | 0.390 |
Osteoarthritis | 4 (8%) | 10 (23%) | 1 (25%) | 1 (25%) | 16 (16%) | 0.072 |
Rheumatoid arthritis | 9 (17%) | 10 (23%) | 0 (0%) | 2 (50%) | 21 (20%) | 0.278 |
Post-traumatic arthritis | 3 (6%) | 5 (12%) | 0 (0%) | 1 (25%) | 9 (9%) | 0.358 |
Instability | 6 (12%) | 3 (7%) | 0 (0%) | 1 (25%) | 10 (10%) | 0.450 |
Revision of previous RTSA for instability | 5 (10%) | 1 (2%) | 0 (0%) | 1 (25%) | 7 (7%) | 0.192 |
Infection | 4 (8%) | 1 (2%) | 1 (25%) | 0 (0%) | 6 (6%) | 0.207 |
Unclassified acute proximal humerus fracture | 9 (17%) | 5 (12%) | 1 (25%) | 1 (25%) | 16 (16%) | 0.443 |
Acute 2-part proximal humerus fracture | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | N/A |
Acute 3-part proximal humerus fracture | 2 (4%) | 0 (0%) | 0 (0%) | 0 (0%) | 2 (2%) | 0.574 |
Acute 4-part proximal humerus fracture | 5 (10%) | 0 (0%) | 0 (0%) | 0 (0%) | 5 (5%) | 0.183 |
Acute 3- or 4-part proximal humerus fracture | 6 (12%) | 2 (5%) | 0 (0%) | 0 (0%) | 8 (8%) | 0.635 |
Revised from previous nonop proximal humerus fracture | 7 (13%) | 3 (7%) | 0 (0%) | 0 (0%) | 10 (10%) | 0.787 |
Revised from ORIF | 1 (2%) | 1 (2%) | 0 (0%) | 0 (0%) | 2 (2%) | 1.000 |
Revised from CRPP | 0 (0%) | 1 (2%) | 0 (0%) | 0 (0%) | 1 (1%) | 0.495 |
Revised from hemi | 8 (15%) | 4 (9%) | 0 (0%) | 1 (25%) | 13 (13%) | 0.528 |
Revised from TSA | 15 (29%) | 11 (26%) | 0 (0%) | 2 (50%) | 28 (27%) | 0.492 |
Osteonecrosis | 4 (8%) | 2 (5%) | 1 (25%) | 0 (0%) | 7 (7%) | 0.401 |
Pseudoparalysis irreparable tear without arthritis | 20 (38%) | 18 (42%) | 2 (50%) | 1 (25%) | 41 (40%) | 0.919 |
Bone tumors | 0 (0%) | 4 (9.3%) | 0 (0%) | 0 (0%) | 4 (4%) | 0.120 |
Locked shoulder dislocation | 0 (0%) | 0 (0%) | 1 (25%) | 0 (0%) | 1 (1%) | 0.078 |
Abbreviations: CRPP, closed reduction and percutaneous pinning; ORIF, open reduction internal fixation; RTSA, reverse total shoulder arthroplasty; TSA, total shoulder arthroplasty.
Table 3. Number of Patients With Each Indication as Reported by Individual Studies by Continent
| North America | Europe | Asia | Australia | Total |
Rotator cuff arthropathy | 4418 | 895 | 24 | 122 | 5459 |
Osteoarthritis | 90 | 251 | 1 | 14 | 356 |
Rheumatoid arthritis | 59 | 87 | 0 | 2 | 148 |
Post-traumatic arthritis | 62 | 136 | 0 | 1 | 199 |
Instability | 23 | 15 | 0 | 1 | 39 |
Revision of previous RTSA for instability | 29 | 2 | 0 | 1 | 32 |
Infection | 28 | 11 | 2 | 0 | 41 |
Unclassified acute proximal humerus fracture | 42 | 30 | 4 | 8 | 84 |
Acute 3-part proximal humerus fracture | 60 | 0 | 0 | 0 | 6 |
Acute 4-part proximal humerus fracture | 42 | 0 | 0 | 0 | 42 |
Acute 3- or 4-part proximal humerus fracture | 92 | 46 | 0 | 0 | 138 |
Revised from previous nonop proximal humerus fracture | 43 | 53 | 0 | 0 | 96 |
Revised from ORIF | 3 | 9 | 0 | 0 | 12 |
Revised from CRPP | 0 | 3 | 0 | 0 | 3 |
Revised from hemi | 105 | 51 | 0 | 1 | 157 |
Revised from TSA | 192 | 246 | 0 | 5 | 443 |
Osteonecrosis | 9 | 6 | 1 | 0 | 16 |
Pseudoparalysis irreparable tear without arthritis | 535 | 795 | 20 | 2 | 1352 |
Bone tumors | 0 | 38 | 0 | 0 | 38 |
Locked shoulder dislocation | 0 | 0 | 1 | 0 | 1 |
Abbreviations: CRPP, closed reduction and percutaneous pinning; ORIF, open reduction internal fixation; RTSA, reverse total shoulder arthroplasty; TSA, total shoulder arthroplasty.
The ASES, SST-12, and VAS scores were the most frequently reported outcome scores in studies from North America, whereas the Absolute Constant score was the most common score reported in studies from Europe (Table 4). Studies from North America reported significantly higher postoperative external rotation (34.1° ± 13.3° vs 19.3° ± 8.9°) (P < .001) and a greater change in flexion (69.0° ± 24.5° vs 56.3° +/- 11.3°) (P = .004) compared with studies from Europe (Table 5).
Table 4. Outcomes by Continent
Metric (number of studies) | North America | Europe | Asia | Australia | P-value |
DASH | 1 | 2 | 0 | 0 |
|
Preoperative | 54.0 | 62.0 ± 8.5 | - | - | 0.582 |
Postoperative | 24.0 | 32.0 ± 2.8 | - | - | 0.260 |
Change | -30.0 | -30.0 ± 11.3 | - | - | 1.000 |
SPADI | 2 | 0 | 0 | 0 |
|
Preoperative | 80.0 ± 4.2 | - | - | - | N/A |
Postoperative | 34.8 ± 1.1 | - | - | - | N/A |
Change | -45.3 ± 3.2 | - | - | - | N/A |
Absolute constant | 2 | 27 | 0 | 1 |
|
Preopeartive | 33.0 ± 0.0 | 28.2 ± 7.1 | - | 20.0 | 0.329 |
Postoperative | 54.5 ± 7.8 | 62.9 ± 9.0 | - | 65.0 | 0.432 |
Change | +21.5 ± 7.8 | +34.7 ± 8.0 | - | +45.0 | 0.044 |
ASES | 13 | 0 | 2 | 0 |
|
Preoperative | 33.2 ± 5.4 | - | 32.5 ± 3.5 | - | 0.867 |
Postoperative | 73.9 ± 6.8 | - | 75.7 ± 10.8 | - | 0.752 |
Change | +40.7 ± 6.5 | - | +43.2 ± 14.4 | - | 0.670 |
UCLA | 3 | 2 | 1 | 0 |
|
Preoperative | 10.1 ± 3.4 | 11.2 ± 5.7 | 12.0 | - | 0.925 |
Postoperative | 24.5 ± 3.1 | 24.3 ± 3.7 | 24.0 | - | 0.991 |
Change | +14.4 ± 1.6 | +13.1 ± 2.0 | +12.0 | - | 0.524 |
KSS | 0 | 0 | 2 | 0 |
|
Preopeartive | - | - | 38.2 ± 1.1 | - | N/A |
Postoperative | - | - | 72.3 ± 6.0 | - | N/A |
Change | - | - | +34.1 ± 7.1 | - | N/A |
SST-12 | 12 | 1 | 0 | 0 |
|
Preoperative | 1.9 ± 0.8 | 1.2 | - | - | N/A |
Postoperative | 7.1 ± 1.5 | 5.6 | - | - | N/A |
Change | +5.3 ± 1.2 | +4.4 | - | - | N/A |
SF-12 | 1 | 0 | 0 | 0 |
|
Preoperative | 34.5 | - | - | - | N/A |
Postoperative | 38.5 | - | - | - | N/A |
Change | +4.0 | - | - | - | N/A |
SSV | 0 | 5 | 0 | 0 |
|
Preopeartive | - | 22.0 ± 7.4 | - | - | N/A |
Postoperative | - | 63.4 ± 7.9 | - | - | N/A |
Change | - | +41.4 ± 2.1 | - | - | N/A |
EQ-5D | 0 | 2 | 0 | 0 |
|
Preoperative | - | 0.5 ± 0.2 | - | - | N/A |
Postoperative | - | 0.8 ± 0.1 | - | - | N/A |
Change | - | +0.3 ± 0.1 | - | - | N/A |
OOS | 1 | 0 | 0 | 0 |
|
Preoperative | 24.7 | - | - | - | N/A |
Postoperative | 14.9 | - | - | - | N/A |
Change | -9.9 | - | - | - | N/A |
Rowe | 0 | 1 | 0 | 0 |
|
Preoperative | - | 50.2 | - | - | N/A |
Postoperative | - | 82.1 | - | - | N/A |
Change | - | 31.9 | - | - | N/A |
Oxford | 0 | 2 | 0 | 0 |
|
Preoperative | - | 119.9 ± 138.8 | - | - | N/A |
Postoperative | - | 39.9 ± 3.3 | - | - | N/A |
Change | - | -80.6 ± 142.2 | - | - | N/A |
Penn | 1 | 0 | 0 | 0 |
|
Preoperative | 24.9 | - | - | - | N/A |
Postoperative | 66.4 | - | - | - | N/A |
Change | +41.5 | - | - | - | N/A |
VAS | 10 | 1 | 1 | 1 |
|
Preoperative | 6.6 ± 0.8 | 7.0 | 8.4 | 7.0 | N/A |
Postoperative | 2.0 ± 0.7 | 1.0 | 0.8 | 0.8 | N/A |
Change | -4.6 ± 0.8 | -6.0 | -7.6 | -6.2 | N/A |
SF-36 physical | 2 | 0 | 0 | 0 |
|
Preoperative | 32.7 ± 1.2 | - | - | - | N/A |
Postoperative | 39.6 ± 4.0 | - | - | - | N/A |
Change | +7.0 ± 2.8 | - | - | - | N/A |
SF-36 mental | 2 | 0 | 0 | 0 |
|
Preoperative | 43.6 ± 2.8 | - | - | - | N/A |
Postoperative | 48.1 ± 1.0 | - | - | - | N/A |
Change | +4.5 ± 1.8 | - | - | - | N/A |
Abbreviations: ASES, American Shoulder and Elbow Surgeon score; DASH, Disability of the Arm, Shoulder, and Hand; EQ-5D, EuroQol-5 Dimension; KSS, Korean Shoulder Scoring system; N/A, not available; OOS, Orthopaedic Outcome Score; SF, short form; SPADI, Shoulder Pain and Disability Index; SST, Simple Shoulder Test; SSV, Subjective Shoulder Value; UCLA, University of California, Los Angeles; VAS, visual analog scale.
Table 5. Shoulder Range of Motion, by Continent
Metric (number of studies) | North America | Europe | Asia | Australia | P-value |
Flexion | 18 | 22 | 1 | 1 |
|
Preoperative | 57.6 ± 17.9 | 65.5 ± 17.2 | 91.0 | 30.0 | 0.060 |
Postoperative | 126.6 ± 14.4 | 121.8 ± 19.0 | 133.0 | 150.0 | 0.360 |
Change | +69.0 ± 24.5 | +56.3 ± 11.3 | +42.0 | 120.0 | 0.004 |
Abduction | 11 | 12 | 1 | 0 |
|
Preoperative | 53.7 ± 25.0 | 52.0 ± 19.0 | 88.0 | - | 0.311 |
Postoperative | 109.3 ± 15.1 | 105.4 ± 19.8 | 131.0 | - | 0.386 |
Change | 55.5 ± 25.5 | 53.3 ± 8.3 | 43.0 | - | 0.804 |
External rotation | 17 | 19 | 0 | 0 |
|
Preoperative | 19.4 ± 9.9 | 11.2 ± 6.1 | - | - | 0.005 |
Postoperative | 34.1 ± 13.3 | 19.3 ± 8.9 | - | - | <0.001 |
Change | +14.7 ± 13.2 | +8.1 ± 8.5 | - | - | 0.079 |
Continue to: DISCUSSION...
DISCUSSION
RTSA is a common procedure performed in many different areas of the world for a variety of indications. The study hypotheses were partially confirmed, as there were no significant differences seen in the characteristics of the studies published and patients analyzed; although, the majority of studies from North America reported rotator cuff tear arthropathy as the primary indication for RTSA, whereas studies from Europe were split between rotator cuff tear arthropathy and pseudoparalysis as the primary indication. Hence, based on the current literature the study proved that we are treating the same patients. Despite this finding, we may be treating them for different reasons with an RTSA.
RTSA has become a standard procedure in the United States, with >20,000 RTSAs performed in 2011.10 This number will continue to increase as it has over the past 20 years given the aging population in the United States, as well as the expanding indications for RTSA.11 Indications of RTSA have become broad, although the main indication remains as rotator cuff tear arthropathy (>60% of all patients included in this study), and pseudoparalysis (>15% of all patients included in this study). Results for RTSA for rotator cuff tear arthropathy and pseudoparalysis have been encouraging.16,17 Frankle and colleagues16 evaluated 60 patients who underwent RTSA for rotator cuff tear arthropathy at a minimum of 2 years follow-up (average, 33 months). The authors found significant improvements in all measured clinical outcome variables (P < .0001) (ASES, mean function score, mean pain score, and VAS) as well as ROM, specifically forward flexion increased from 55° to 105.1°, and abduction increased from 41.4° to 101.8°. Similarly, Werner and colleagues17 evaluated 58 consecutive patients who underwent RTSA for pseudoparalysis secondary to irreparable rotator cuff dysfunction at a mean follow-up of 38 months. Overall, significant improvements (P < .0001) were seen in the SSV score, relative Constant score, and Constant score for pain, active anterior elevation (42° to 100° following RTSA), and active abduction (43° to 90° following RTSA).
It is essential to understand the similarities and differences between patients undergoing RTSA in different parts of the world so the literature from various countries can be compared between regions, and conclusions extrapolated to the correct patients. For example, an interesting finding in this study is that the majority of patients in North America have their prosthesis cemented whereas the majority of patients in Australia have their prosthesis press-fit. While the patients each continent is treating are not significantly different (mostly older women), the difference in surgical technique could have implications in long- or short-term functional outcomes. Prior studies have shown no difference in axial micromotion between cemented and press-fit humeral components, but the clinical implications surrounding this are not well defined.18 Small series comparing cementless to cemented humeral prosthesis in RTSA have found no significant differences in clinical outcomes or postoperative ROM, but larger series are necessary to validate these outcomes.19 However, studies have shown lower rates of postoperative infections in patients who receive antibiotic-loaded cement compared with those who receive plain bone cement following RTSA.20
Similarly, as the vast majority of patients in North America had an RTSA for rotator cuff arthropathy (75.8%) whereas those from Europe had RTSA almost equally for rotator cuff arthropathy (33.5%) and pseudoparalysis (29.7%), one must ensure similar patient populations before attempting to extrapolate results of a study from a different country to patients in other areas. Fortunately, the clinical results following RTSA for either indication have been good.6,21,22
One final point to consider is the cost effectiveness of the implant. Recent evidence has shown that RTSA is associated with a higher risk for in-hospital death, multiple perioperative complications, prolonged hospital stay, and increased hospital cost when compared with TSA.23 This data may be biased as the patient selection for RTSA varies from that of TSA, but it is a point that must be considered. Other studies have shown that an RTSA is a cost-effective treatment option for treating patients with rotator cuff tear arthropathy, and is a more cost-effective option in treating rotator cuff tear arthropathy than hemiarthroplasty.24,25 Similarly, RTSA offers a more cost-effective treatment option with better outcomes for patients with acute proximal humerus fractures when compared with open reduction internal fixation and hemiarthroplasty.26 However, TSA is a more cost-effective treatment option than RTSA for patients with glenohumeral osteoarthritis.27 With changing reimbursement in healthcare, surgeons must scrutinize not only anticipated outcomes with specific implants but the cost effectiveness of these implants as well. Further cost analysis studies are necessary to determine the ideal candidate for an RTSA.
LIMITATIONS
Despite its extensive review of the literature, this study had several limitations. While 2 independent authors searched for studies, it is possible that some studies were missed during the search process, introducing possible selection bias. No abstracts or unpublished works were included which could have introduced publication bias. Several studies did not report all variables the authors examined, and this could have skewed some of the results since the reporting of additional variables could have altered the data to show significant differences in some measured variables. As outcome measures for various pathologies were not compared, conclusions cannot be drawn on the best treatment option for various indications. As case reports were included, this could have lowered both the MCMS as well as the average in studies reporting outcomes. Furthermore, given the overall poor quality of the underlying data available for this study, the validity/generalizability of the results could be limited as the level of evidence of this systematic review is only as high as the studies it includes. There are subtle differences between rotator cuff arthropathy and pseudoparalysis, and some studies may have classified patients differently than others, causing differences in indications. Finally, as the primary goal of this study was to report on demographics, no evaluation of concomitant pathology at the time of surgery or rehabilitation protocols was performed.
CONCLUSION
The quantity, but not the quality of RTSA studies is increasing. Indications for RTSA varied by continent although most patients underwent RTSA for rotator cuff arthropathy. The majority of patients undergoing RTSA are female over the age of 60 years for a diagnosis of rotator cuff arthropathy with pseudoparalysis.
This paper will be judged for the Resident Writer’s Award.
ABSTRACT
Reverse total shoulder arthroplasty (RTSA) is a common treatment for rotator cuff tear arthropathy. We performed a systematic review of all the RTSA literature to answer if we are treating the same patients with RTSA, across the world.
A systematic review was registered with PROSPERO, the international prospective register of systematic reviews, and performed with Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines using 3 publicly available free databases. Therapeutic clinical outcome investigations reporting RTSA outcomes with levels of evidence I to IV were eligible for inclusion. All study, subject, and surgical technique demographics were analyzed and compared between continents. Statistical comparisons were conducted using linear regression, analysis of variance (ANOVA), Fisher's exact test, and Pearson's chi-square test.
There were 103 studies included in the analysis (8973 patients; 62% female; mean age, 70.9 ± 6.7 years; mean length of follow-up, 34.3 ± 19.3 months) that had a low Modified Coleman Methodology Score (MCMS) (mean, 36.9 ± 8.7: poor). Most patients (60.8%) underwent RTSA for a diagnosis of rotator cuff arthropathy, whereas 1% underwent RTSA for fracture; indications varied by continent. There were no consistent reports of preopeartive or postoperative scores from studies in any region. Studies from North America reported significantly higher postoperative external rotation (34.1° ± 13.3° vs 19.3° ± 8.9°) (P < .001) and a greater change in flexion (69.0° ± 24.5° vs 56.3° ± 11.3°) (P = .004) compared with studies from Europe. North America had the greatest total number of publications followed by Europe. The total yearly number of publications increased each year (P < .001), whereas the MCMS decreased each year (P = .037).
The quantity, but not the quality of RTSA studies is increasing. Indications for RTSA varied by continent, although most patients underwent RTSA for rotator cuff arthropathy. The majority of patients undergoing RTSA are female over the age of 60 years for a diagnosis of rotator cuff arthropathy with pseudoparalysis.
Continue to: Reverse total shoulder arthroplasty...
Reverse total shoulder arthroplasty (RTSA) is a common procedure with indications including rotator cuff tear arthropathy, proximal humerus fractures, and others.1,2 Studies have shown excellent, reliable, short- and mid-term outcomes in patients treated with RTSA for various indications.3-5 Al-Hadithy and colleagues6 reviewed 41 patients who underwent RTSA for pseudoparalysis secondary to rotator cuff tear arthropathy and, at a mean follow-up of 5 years, found significant improvements in range of motion (ROM) as well as age-adjusted Constant and Oxford Outcome scores. Similarly, Ross and colleagues7 evaluated outcomes of RTSA in 28 patients in whom RTSA was performed for 3- or 4-part proximal humerus fractures, and found both good clinical and radiographic outcomes with no revision surgeries at a mean follow-up of 54.9 months. RTSA is performed across the world, with specific implant designs, specifically humeral head inclination, but is more common in some areas when compared with others.3,8,9
The number of RTSAs performed has steadily increased over the past 20 years, with recent estimates of approximately 20,000 RTSAs performed in the United States in 2011.10,11 However, there is little information about the similarities and differences between those patients undergoing RTSA in various parts of the world regarding surgical indications, patient demographics, and outcomes. The purpose of this study is to perform a systematic review and meta-analysis of the RTSA body of literature to both identify and compare characteristics of studies published (level of evidence, whether a conflict of interest existed), patients analyzed (age, gender), and surgical indications performed across both continents and countries. Essentially, the study aims to answer the question, "Across the world, are we treating the same patients?" The authors hypothesized that there would be no significant differences in RTSA publications, subjects, and indications based on both the continent and country of publication.
METHODS
A systematic review was conducted according to PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) guidelines using a PRISMA checklist.12 A systematic review registration was performed using PROSPERO, the international prospective register of systematic reviews (registration number CRD42014010578).13Two reviewers independently conducted the search on March 25, 2014, using the following databases: Medline, Cochrane Central Register of Controlled Trials, SportDiscus, and CINAHL. The electronic search citation algorithm utilized was: (((((reverse[Title/Abstract]) AND shoulder[Title/Abstract]) AND arthroplasty[Title/Abstract]) NOT arthroscopic[Title/Abstract]) NOT cadaver[Title/Abstract]) NOT biomechanical[Title/Abstract]. English language Level I to IV evidence (2011 update by the Oxford Centre for Evidence-Based Medicine14) clinical studies were eligible. Medical conference abstracts were ineligible for inclusion. All references within included studies were cross-referenced for inclusion if missed by the initial search with any additionally located studies screened for inclusion. Duplicate subject publications within separate unique studies were not reported twice, but rather the study with longer duration follow-up or, if follow-up was equal, the study with the greater number of patients was included. Level V evidence reviews, letters to the editor, basic science, biomechanical and cadaver studies, total shoulder arthroplasty (TSA) papers, arthroscopic shoulder surgery papers, imaging, surgical techniques, and classification studies were excluded.
A total of 255 studies were identified, and, after implementation of the exclusion criteria, 103 studies were included in the final analysis (Figure 1). Subjects of interest in this systematic review underwent RTSA for one of many indications including rotator cuff tear arthropathy, osteoarthritis, rheumatoid arthritis, posttraumatic arthritis, instability, revision from a previous RTSA for instability, infection, acute proximal humerus fracture, revision from a prior proximal humerus fracture, revision from a prior hemiarthroplasty, revision from a prior TSA, osteonecrosis, pseudoparalysis, tumor, and a locked shoulder dislocation. There was no minimum follow-up or rehabilitation requirement. Study and subject demographic parameters analyzed included year of publication, years of subject enrollment, presence of study financial conflict of interest, number of subjects and shoulders, gender, age, body mass index, diagnoses treated, and surgical positioning. Clinical outcome scores sought were the DASH (Disability of the Arm, Shoulder, and Hand), SPADI (Shoulder Pain And Disability Index), Absolute Constant, ASES (American Shoulder and Elbow Score), KSS (Korean Shoulder Score), SST-12 (Simple Shoulder Test), SF-12 (12-item Short Form), SF-36 (36-item Short Form), SSV (Subjective Shoulder Value), EQ-5D (EuroQol-5 Dimension), SANE (Single Assessment Numeric Evaluation), Rowe Score for Instability, Oxford Instability Score, UCLA (University of California, Los Angeles) activity score, Penn Shoulder Score, and VAS (visual analog scale). In addition, ROM (forward elevation, abduction, external rotation, internal rotation) was analyzed. Radiographs and magnetic resonance imaging data were extracted when available. The methodological quality of the study was evaluated using the MCMS (Modified Coleman Methodology Score).15
STATISTICAL ANALYSIS
First, the number of publications per year, level of evidence, and Modified Coleman Methodology Score were tested for association with the calendar year using linear regression. Second, demographic data were tested for association with the continent using Pearson’s chi-square test or ANOVA. Third, indications were tested for association with the continent using Fisher’s exact test. Finally, clinical outcome scores and ROM were tested for association with the continent using ANOVA. Statistical significance was extracted from studies when available. Statistical significance was defined as P < .05.
Continue to: RESULTS...
RESULTS
There were 103 studies included in the analysis (Figure 1). A total of 8973 patients were included, 62% of whom were female with a mean age of 70.9 ± 6.7 years (Table 1). The average follow-up was 34.3 ± 19.3 months. North America had the overall greatest total number of publications on RTSA, followed by Europe (Figure 2). The total yearly number of publications increased by a mean of 1.95 publications each year (P < .001). There was no association between the mean level of evidence with the year of publication (P = .296) (Figure 3). Overall, the rating of studies was poor for the MCMS (mean 36.9 ± 8.7). The MCMS decreased each year by a mean of 0.76 points (P = .037) (Figure 4).
Table 1. Demographic Data by Continent
| North America | Europe | Asia | Australia | Total | P-value |
Number of studies | 52 | 43 | 4 | 4 | 103 | - |
Number of subjects | 6158 | 2609 | 51 | 155 | 8973 | - |
Level of evidence |
|
|
|
|
| 0.693 |
II | 5 (10%) | 3 (7%) | 0 (0%) | 0 (0%) | 8 (8%) |
|
III | 10 (19%) | 4 (9%) | 0 (0%) | 1 (25%) | 15 (15%) |
|
IV | 37 (71%) | 36 (84%) | 4 (100%) | 3 (75%) | 80 (78%) |
|
Mean MCMS | 34.6 ± 8.4 | 40.2 ± 8.0 | 32.5 12.4 | 34.5 ± 6.6 | 36.9 ± 8.7 | 0.010 |
Institutional collaboration |
|
|
|
|
| 1.000 |
Multi-center | 7 (14%) | 6 (14%) | 0 (0%) | 0 (0%) | 13 (13%) |
|
Single-center | 45 (86%) | 37 (86%) | 4 (100%) | 4 (100%) | 90 (87%) |
|
Financial conflict of interest |
|
|
|
|
| 0.005 |
Present | 28 (54%) | 15 (35%) | 0 (0%) | 0 (0%) | 43 (42%) |
|
Not present | 19 (37%) | 16 (37%) | 4 (100%) | 4 (100%) | 43 (42%) |
|
Not reported | 5 (10%) | 12 (28%) | 0 (0%) | 0 (0%) | 17 (17%) |
|
Sex |
|
|
|
|
| N/A |
Male | 2157 (38%) | 1026 (39%) | 13 (25%) | 61 (39%) | 3257 (38%) |
|
Female | 3520 (62%) | 1622 (61%) | 38 (75%) | 94 (61%) | 5274 (62%) |
|
Mean age (years) | 71.3 ± 5.6 | 70.1 ± 7.9 | 68.1 ± 5.3 | 76.9 ± 3.0 | 70.9 ± 6.7 | 0.191 |
Minimum age (mean across studies) | 56.9 ± 12.8 | 52.8 ± 15.7 | 62.8 ± 6.2 | 68.0 ± 12.1 | 55.6 ± 14.3 | 0.160 |
Maximum age (mean across studies) | 82.1 ± 8.6 | 83.0 ± 5.5 | 73.0 ± 9.4 | 85.0 ± 7.9 | 82.2 ± 7.6 | 0.079 |
Mean length of follow-up (months) | 26.5 ± 13.7 | 43.1 ± 21.7 | 29.4 ± 7.9 | 34.2 ± 16.6 | 34.3 ± 19.3 | <0.001 |
Prosthesis type |
|
|
|
|
| N/A |
Cemented | 988 (89%) | 969 (72%) | 0 (0%) | 8 (16%) | 1965 (78%) |
|
Press fit | 120 (11%) | 379 (28%) | 0 (0%) | 41 (84%) | 540 (22%) |
|
Abbreviations: MCMS, Modified Coleman Methodology Score; N/A, not available.
In studies that reported press-fit vs cemented prostheses, the highest percentage of press-fit prostheses compared with cemented prostheses was seen in Australia (84% press-fit), whereas the highest percentage of cemented prostheses was seen in North America (89% cemented). A higher percentage of studies from North America had a financial conflict of interest (COI) than did those from other countries (54% had a COI).
Continue to: Rotator cuff tear arthropathy...
Rotator cuff tear arthropathy was the most common indication for RTSA overall in 5459 patients, followed by pseudoparalysis in 1352 patients (Tables 2 and 3). While studies in North America reported rotator cuff tear arthropathy as the indication for RTSA in 4418 (75.8%) patients, and pseudoparalysis as the next most common indication in 535 (9.2%) patients, studies from Europe reported rotator cuff tear arthropathy as the indication in 895 (33.5%) patients, and pseudoparalysis as the indication in 795 (29.7%) patients. Studies from Asia also had a relatively even split between rotator cuff tear arthropathy and pseudoparalysis (45.3% vs 37.8%), whereas those from Australia were mostly rotator cuff tear arthropathy (77.7%).
Table 2. Number (Percent) of Studies With Each Indication by Continent
| North America | Europe | Asia | Australia | Total | P-value |
Rotator cuff arthropathy | 29 (56%) | 19 (44%) | 3 (75%) | 3 (75%) | 54 (52%) | 0.390 |
Osteoarthritis | 4 (8%) | 10 (23%) | 1 (25%) | 1 (25%) | 16 (16%) | 0.072 |
Rheumatoid arthritis | 9 (17%) | 10 (23%) | 0 (0%) | 2 (50%) | 21 (20%) | 0.278 |
Post-traumatic arthritis | 3 (6%) | 5 (12%) | 0 (0%) | 1 (25%) | 9 (9%) | 0.358 |
Instability | 6 (12%) | 3 (7%) | 0 (0%) | 1 (25%) | 10 (10%) | 0.450 |
Revision of previous RTSA for instability | 5 (10%) | 1 (2%) | 0 (0%) | 1 (25%) | 7 (7%) | 0.192 |
Infection | 4 (8%) | 1 (2%) | 1 (25%) | 0 (0%) | 6 (6%) | 0.207 |
Unclassified acute proximal humerus fracture | 9 (17%) | 5 (12%) | 1 (25%) | 1 (25%) | 16 (16%) | 0.443 |
Acute 2-part proximal humerus fracture | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | N/A |
Acute 3-part proximal humerus fracture | 2 (4%) | 0 (0%) | 0 (0%) | 0 (0%) | 2 (2%) | 0.574 |
Acute 4-part proximal humerus fracture | 5 (10%) | 0 (0%) | 0 (0%) | 0 (0%) | 5 (5%) | 0.183 |
Acute 3- or 4-part proximal humerus fracture | 6 (12%) | 2 (5%) | 0 (0%) | 0 (0%) | 8 (8%) | 0.635 |
Revised from previous nonop proximal humerus fracture | 7 (13%) | 3 (7%) | 0 (0%) | 0 (0%) | 10 (10%) | 0.787 |
Revised from ORIF | 1 (2%) | 1 (2%) | 0 (0%) | 0 (0%) | 2 (2%) | 1.000 |
Revised from CRPP | 0 (0%) | 1 (2%) | 0 (0%) | 0 (0%) | 1 (1%) | 0.495 |
Revised from hemi | 8 (15%) | 4 (9%) | 0 (0%) | 1 (25%) | 13 (13%) | 0.528 |
Revised from TSA | 15 (29%) | 11 (26%) | 0 (0%) | 2 (50%) | 28 (27%) | 0.492 |
Osteonecrosis | 4 (8%) | 2 (5%) | 1 (25%) | 0 (0%) | 7 (7%) | 0.401 |
Pseudoparalysis irreparable tear without arthritis | 20 (38%) | 18 (42%) | 2 (50%) | 1 (25%) | 41 (40%) | 0.919 |
Bone tumors | 0 (0%) | 4 (9.3%) | 0 (0%) | 0 (0%) | 4 (4%) | 0.120 |
Locked shoulder dislocation | 0 (0%) | 0 (0%) | 1 (25%) | 0 (0%) | 1 (1%) | 0.078 |
Abbreviations: CRPP, closed reduction and percutaneous pinning; ORIF, open reduction internal fixation; RTSA, reverse total shoulder arthroplasty; TSA, total shoulder arthroplasty.
Table 3. Number of Patients With Each Indication as Reported by Individual Studies by Continent
| North America | Europe | Asia | Australia | Total |
Rotator cuff arthropathy | 4418 | 895 | 24 | 122 | 5459 |
Osteoarthritis | 90 | 251 | 1 | 14 | 356 |
Rheumatoid arthritis | 59 | 87 | 0 | 2 | 148 |
Post-traumatic arthritis | 62 | 136 | 0 | 1 | 199 |
Instability | 23 | 15 | 0 | 1 | 39 |
Revision of previous RTSA for instability | 29 | 2 | 0 | 1 | 32 |
Infection | 28 | 11 | 2 | 0 | 41 |
Unclassified acute proximal humerus fracture | 42 | 30 | 4 | 8 | 84 |
Acute 3-part proximal humerus fracture | 60 | 0 | 0 | 0 | 6 |
Acute 4-part proximal humerus fracture | 42 | 0 | 0 | 0 | 42 |
Acute 3- or 4-part proximal humerus fracture | 92 | 46 | 0 | 0 | 138 |
Revised from previous nonop proximal humerus fracture | 43 | 53 | 0 | 0 | 96 |
Revised from ORIF | 3 | 9 | 0 | 0 | 12 |
Revised from CRPP | 0 | 3 | 0 | 0 | 3 |
Revised from hemi | 105 | 51 | 0 | 1 | 157 |
Revised from TSA | 192 | 246 | 0 | 5 | 443 |
Osteonecrosis | 9 | 6 | 1 | 0 | 16 |
Pseudoparalysis irreparable tear without arthritis | 535 | 795 | 20 | 2 | 1352 |
Bone tumors | 0 | 38 | 0 | 0 | 38 |
Locked shoulder dislocation | 0 | 0 | 1 | 0 | 1 |
Abbreviations: CRPP, closed reduction and percutaneous pinning; ORIF, open reduction internal fixation; RTSA, reverse total shoulder arthroplasty; TSA, total shoulder arthroplasty.
The ASES, SST-12, and VAS scores were the most frequently reported outcome scores in studies from North America, whereas the Absolute Constant score was the most common score reported in studies from Europe (Table 4). Studies from North America reported significantly higher postoperative external rotation (34.1° ± 13.3° vs 19.3° ± 8.9°) (P < .001) and a greater change in flexion (69.0° ± 24.5° vs 56.3° +/- 11.3°) (P = .004) compared with studies from Europe (Table 5).
Table 4. Outcomes by Continent
Metric (number of studies) | North America | Europe | Asia | Australia | P-value |
DASH | 1 | 2 | 0 | 0 |
|
Preoperative | 54.0 | 62.0 ± 8.5 | - | - | 0.582 |
Postoperative | 24.0 | 32.0 ± 2.8 | - | - | 0.260 |
Change | -30.0 | -30.0 ± 11.3 | - | - | 1.000 |
SPADI | 2 | 0 | 0 | 0 |
|
Preoperative | 80.0 ± 4.2 | - | - | - | N/A |
Postoperative | 34.8 ± 1.1 | - | - | - | N/A |
Change | -45.3 ± 3.2 | - | - | - | N/A |
Absolute constant | 2 | 27 | 0 | 1 |
|
Preopeartive | 33.0 ± 0.0 | 28.2 ± 7.1 | - | 20.0 | 0.329 |
Postoperative | 54.5 ± 7.8 | 62.9 ± 9.0 | - | 65.0 | 0.432 |
Change | +21.5 ± 7.8 | +34.7 ± 8.0 | - | +45.0 | 0.044 |
ASES | 13 | 0 | 2 | 0 |
|
Preoperative | 33.2 ± 5.4 | - | 32.5 ± 3.5 | - | 0.867 |
Postoperative | 73.9 ± 6.8 | - | 75.7 ± 10.8 | - | 0.752 |
Change | +40.7 ± 6.5 | - | +43.2 ± 14.4 | - | 0.670 |
UCLA | 3 | 2 | 1 | 0 |
|
Preoperative | 10.1 ± 3.4 | 11.2 ± 5.7 | 12.0 | - | 0.925 |
Postoperative | 24.5 ± 3.1 | 24.3 ± 3.7 | 24.0 | - | 0.991 |
Change | +14.4 ± 1.6 | +13.1 ± 2.0 | +12.0 | - | 0.524 |
KSS | 0 | 0 | 2 | 0 |
|
Preopeartive | - | - | 38.2 ± 1.1 | - | N/A |
Postoperative | - | - | 72.3 ± 6.0 | - | N/A |
Change | - | - | +34.1 ± 7.1 | - | N/A |
SST-12 | 12 | 1 | 0 | 0 |
|
Preoperative | 1.9 ± 0.8 | 1.2 | - | - | N/A |
Postoperative | 7.1 ± 1.5 | 5.6 | - | - | N/A |
Change | +5.3 ± 1.2 | +4.4 | - | - | N/A |
SF-12 | 1 | 0 | 0 | 0 |
|
Preoperative | 34.5 | - | - | - | N/A |
Postoperative | 38.5 | - | - | - | N/A |
Change | +4.0 | - | - | - | N/A |
SSV | 0 | 5 | 0 | 0 |
|
Preopeartive | - | 22.0 ± 7.4 | - | - | N/A |
Postoperative | - | 63.4 ± 7.9 | - | - | N/A |
Change | - | +41.4 ± 2.1 | - | - | N/A |
EQ-5D | 0 | 2 | 0 | 0 |
|
Preoperative | - | 0.5 ± 0.2 | - | - | N/A |
Postoperative | - | 0.8 ± 0.1 | - | - | N/A |
Change | - | +0.3 ± 0.1 | - | - | N/A |
OOS | 1 | 0 | 0 | 0 |
|
Preoperative | 24.7 | - | - | - | N/A |
Postoperative | 14.9 | - | - | - | N/A |
Change | -9.9 | - | - | - | N/A |
Rowe | 0 | 1 | 0 | 0 |
|
Preoperative | - | 50.2 | - | - | N/A |
Postoperative | - | 82.1 | - | - | N/A |
Change | - | 31.9 | - | - | N/A |
Oxford | 0 | 2 | 0 | 0 |
|
Preoperative | - | 119.9 ± 138.8 | - | - | N/A |
Postoperative | - | 39.9 ± 3.3 | - | - | N/A |
Change | - | -80.6 ± 142.2 | - | - | N/A |
Penn | 1 | 0 | 0 | 0 |
|
Preoperative | 24.9 | - | - | - | N/A |
Postoperative | 66.4 | - | - | - | N/A |
Change | +41.5 | - | - | - | N/A |
VAS | 10 | 1 | 1 | 1 |
|
Preoperative | 6.6 ± 0.8 | 7.0 | 8.4 | 7.0 | N/A |
Postoperative | 2.0 ± 0.7 | 1.0 | 0.8 | 0.8 | N/A |
Change | -4.6 ± 0.8 | -6.0 | -7.6 | -6.2 | N/A |
SF-36 physical | 2 | 0 | 0 | 0 |
|
Preoperative | 32.7 ± 1.2 | - | - | - | N/A |
Postoperative | 39.6 ± 4.0 | - | - | - | N/A |
Change | +7.0 ± 2.8 | - | - | - | N/A |
SF-36 mental | 2 | 0 | 0 | 0 |
|
Preoperative | 43.6 ± 2.8 | - | - | - | N/A |
Postoperative | 48.1 ± 1.0 | - | - | - | N/A |
Change | +4.5 ± 1.8 | - | - | - | N/A |
Abbreviations: ASES, American Shoulder and Elbow Surgeon score; DASH, Disability of the Arm, Shoulder, and Hand; EQ-5D, EuroQol-5 Dimension; KSS, Korean Shoulder Scoring system; N/A, not available; OOS, Orthopaedic Outcome Score; SF, short form; SPADI, Shoulder Pain and Disability Index; SST, Simple Shoulder Test; SSV, Subjective Shoulder Value; UCLA, University of California, Los Angeles; VAS, visual analog scale.
Table 5. Shoulder Range of Motion, by Continent
Metric (number of studies) | North America | Europe | Asia | Australia | P-value |
Flexion | 18 | 22 | 1 | 1 |
|
Preoperative | 57.6 ± 17.9 | 65.5 ± 17.2 | 91.0 | 30.0 | 0.060 |
Postoperative | 126.6 ± 14.4 | 121.8 ± 19.0 | 133.0 | 150.0 | 0.360 |
Change | +69.0 ± 24.5 | +56.3 ± 11.3 | +42.0 | 120.0 | 0.004 |
Abduction | 11 | 12 | 1 | 0 |
|
Preoperative | 53.7 ± 25.0 | 52.0 ± 19.0 | 88.0 | - | 0.311 |
Postoperative | 109.3 ± 15.1 | 105.4 ± 19.8 | 131.0 | - | 0.386 |
Change | 55.5 ± 25.5 | 53.3 ± 8.3 | 43.0 | - | 0.804 |
External rotation | 17 | 19 | 0 | 0 |
|
Preoperative | 19.4 ± 9.9 | 11.2 ± 6.1 | - | - | 0.005 |
Postoperative | 34.1 ± 13.3 | 19.3 ± 8.9 | - | - | <0.001 |
Change | +14.7 ± 13.2 | +8.1 ± 8.5 | - | - | 0.079 |
Continue to: DISCUSSION...
DISCUSSION
RTSA is a common procedure performed in many different areas of the world for a variety of indications. The study hypotheses were partially confirmed, as there were no significant differences seen in the characteristics of the studies published and patients analyzed; although, the majority of studies from North America reported rotator cuff tear arthropathy as the primary indication for RTSA, whereas studies from Europe were split between rotator cuff tear arthropathy and pseudoparalysis as the primary indication. Hence, based on the current literature the study proved that we are treating the same patients. Despite this finding, we may be treating them for different reasons with an RTSA.
RTSA has become a standard procedure in the United States, with >20,000 RTSAs performed in 2011.10 This number will continue to increase as it has over the past 20 years given the aging population in the United States, as well as the expanding indications for RTSA.11 Indications of RTSA have become broad, although the main indication remains as rotator cuff tear arthropathy (>60% of all patients included in this study), and pseudoparalysis (>15% of all patients included in this study). Results for RTSA for rotator cuff tear arthropathy and pseudoparalysis have been encouraging.16,17 Frankle and colleagues16 evaluated 60 patients who underwent RTSA for rotator cuff tear arthropathy at a minimum of 2 years follow-up (average, 33 months). The authors found significant improvements in all measured clinical outcome variables (P < .0001) (ASES, mean function score, mean pain score, and VAS) as well as ROM, specifically forward flexion increased from 55° to 105.1°, and abduction increased from 41.4° to 101.8°. Similarly, Werner and colleagues17 evaluated 58 consecutive patients who underwent RTSA for pseudoparalysis secondary to irreparable rotator cuff dysfunction at a mean follow-up of 38 months. Overall, significant improvements (P < .0001) were seen in the SSV score, relative Constant score, and Constant score for pain, active anterior elevation (42° to 100° following RTSA), and active abduction (43° to 90° following RTSA).
It is essential to understand the similarities and differences between patients undergoing RTSA in different parts of the world so the literature from various countries can be compared between regions, and conclusions extrapolated to the correct patients. For example, an interesting finding in this study is that the majority of patients in North America have their prosthesis cemented whereas the majority of patients in Australia have their prosthesis press-fit. While the patients each continent is treating are not significantly different (mostly older women), the difference in surgical technique could have implications in long- or short-term functional outcomes. Prior studies have shown no difference in axial micromotion between cemented and press-fit humeral components, but the clinical implications surrounding this are not well defined.18 Small series comparing cementless to cemented humeral prosthesis in RTSA have found no significant differences in clinical outcomes or postoperative ROM, but larger series are necessary to validate these outcomes.19 However, studies have shown lower rates of postoperative infections in patients who receive antibiotic-loaded cement compared with those who receive plain bone cement following RTSA.20
Similarly, as the vast majority of patients in North America had an RTSA for rotator cuff arthropathy (75.8%) whereas those from Europe had RTSA almost equally for rotator cuff arthropathy (33.5%) and pseudoparalysis (29.7%), one must ensure similar patient populations before attempting to extrapolate results of a study from a different country to patients in other areas. Fortunately, the clinical results following RTSA for either indication have been good.6,21,22
One final point to consider is the cost effectiveness of the implant. Recent evidence has shown that RTSA is associated with a higher risk for in-hospital death, multiple perioperative complications, prolonged hospital stay, and increased hospital cost when compared with TSA.23 This data may be biased as the patient selection for RTSA varies from that of TSA, but it is a point that must be considered. Other studies have shown that an RTSA is a cost-effective treatment option for treating patients with rotator cuff tear arthropathy, and is a more cost-effective option in treating rotator cuff tear arthropathy than hemiarthroplasty.24,25 Similarly, RTSA offers a more cost-effective treatment option with better outcomes for patients with acute proximal humerus fractures when compared with open reduction internal fixation and hemiarthroplasty.26 However, TSA is a more cost-effective treatment option than RTSA for patients with glenohumeral osteoarthritis.27 With changing reimbursement in healthcare, surgeons must scrutinize not only anticipated outcomes with specific implants but the cost effectiveness of these implants as well. Further cost analysis studies are necessary to determine the ideal candidate for an RTSA.
LIMITATIONS
Despite its extensive review of the literature, this study had several limitations. While 2 independent authors searched for studies, it is possible that some studies were missed during the search process, introducing possible selection bias. No abstracts or unpublished works were included which could have introduced publication bias. Several studies did not report all variables the authors examined, and this could have skewed some of the results since the reporting of additional variables could have altered the data to show significant differences in some measured variables. As outcome measures for various pathologies were not compared, conclusions cannot be drawn on the best treatment option for various indications. As case reports were included, this could have lowered both the MCMS as well as the average in studies reporting outcomes. Furthermore, given the overall poor quality of the underlying data available for this study, the validity/generalizability of the results could be limited as the level of evidence of this systematic review is only as high as the studies it includes. There are subtle differences between rotator cuff arthropathy and pseudoparalysis, and some studies may have classified patients differently than others, causing differences in indications. Finally, as the primary goal of this study was to report on demographics, no evaluation of concomitant pathology at the time of surgery or rehabilitation protocols was performed.
CONCLUSION
The quantity, but not the quality of RTSA studies is increasing. Indications for RTSA varied by continent although most patients underwent RTSA for rotator cuff arthropathy. The majority of patients undergoing RTSA are female over the age of 60 years for a diagnosis of rotator cuff arthropathy with pseudoparalysis.
This paper will be judged for the Resident Writer’s Award.
1. Boileau P, Moineau G, Roussanne Y, O'Shea K. Bony increased-offset reversed shoulder arthroplasty: minimizing scapular impingement while maximizing glenoid fixation. Clin Orthop Relat Res. 2011;469(9):2558-2567. doi:10.1007/s11999-011-1775-4.
2. Gupta AK, Harris JD, Erickson BJ, et al. Surgical management of complex proximal humerus fractures-a systematic review of 92 studies including 4,500 patients. J Orthop Trauma. 2014;29(1):54-59.
3. Cazeneuve JF, Cristofari DJ. Grammont reversed prosthesis for acute complex fracture of the proximal humerus in an elderly population with 5 to 12 years follow-up. Orthop Traumatol Surg Res. 2014;100(1):93-97. doi:10.1016/j.otsr.2013.12.005.
4. Clark JC, Ritchie J, Song FS, et al. Complication rates, dislocation, pain, and postoperative range of motion after reverse shoulder arthroplasty in patients with and without repair of the subscapularis. J Shoulder Elbow Surg. 2012;21(1):36-41. doi:10.1016/j.jse.2011.04.009.
5. De Biase CF, Delcogliano M, Borroni M, Castagna A. Reverse total shoulder arthroplasty: radiological and clinical result using an eccentric glenosphere. Musculoskelet Surg. 2012;96(suppl 1):S27-SS34. doi:10.1007/s12306-012-0193-4.
6. Al-Hadithy N, Domos P, Sewell MD, Pandit R. Reverse shoulder arthroplasty in 41 patients with cuff tear arthropathy with a mean follow-up period of 5 years. J Shoulder Elbow Surg. 2014;23(11):1662-1668. doi:10.1016/j.jse.2014.03.001.
7. Ross M, Hope B, Stokes A, Peters SE, McLeod I, Duke PF. Reverse shoulder arthroplasty for the treatment of three-part and four-part proximal humeral fractures in the elderly. J Shoulder Elbow Surg. 2015;24(2):215-222. doi:10.1016/j.jse.2014.05.022.
8. Mulieri P, Dunning P, Klein S, Pupello D, Frankle M. Reverse shoulder arthroplasty for the treatment of irreparable rotator cuff tear without glenohumeral arthritis. J Bone Joint Surg Am. 2010;92(15):2544-2556. doi:10.2106/JBJS.I.00912.
9. Erickson BJ, Frank RM, Harris JD, Mall N, Romeo AA. The influence of humeral head inclination in reverse total shoulder arthroplasty: a systematic review. J Shoulder Elbow Surg. 2015;24(6):988-993. doi:10.1016/j.jse.2015.01.001.
10. Schairer WW, Nwachukwu BU, Lyman S, Craig EV, Gulotta LV. National utilization of reverse total shoulder arthroplasty in the United States. J Shoulder Elbow Surg. 2015;24(1):91-97. doi:10.1016/j.jse.2014.08.026.
11. Kim SH, Wise BL, Zhang Y, Szabo RM. Increasing incidence of shoulder arthroplasty in the United States. J Bone Joint Surg Am. 2011;93(24):2249-2254. doi:10.2106/JBJS.J.01994.
12. Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. J Clin Epidemiol. 2009;62(10):e1-e34. doi:10.1016/j.jclinepi.2009.06.006.
13. University of York Centre for Reviews and Dissemination, National Institute for Health Research. PROSPERO International prospective register of systematic reviews. University of York Web site. http://www.crd.york.ac.uk/PROSPERO/. Accessed November 1, 2016.
14. Oxford Centre for Evidence-based Medicine – Levels of evidence (March 2009). University of Oxford Web site: https://www.cebm.net/2009/06/oxford-centre-evidence-based-medicine-levels-evidence-march-2009/. Accessed November 1, 2016.
15. Cowan J, Lozano-Calderón S, Ring D. Quality of prospective controlled randomized trials. Analysis of trials of treatment for lateral epicondylitis as an example. J Bone Joint Surg Am. 2007;89(8):1693-1699. doi:10.2106/JBJS.F.00858.
16. Frankle M, Levy JC, Pupello D, et al. The reverse shoulder prosthesis for glenohumeral arthritis associated with severe rotator cuff deficiency. A minimum two-year follow-up study of sixty patients surgical technique. J Bone Joint Surg Am. 2006;88(suppl 1 Pt 2):178-190. doi:10.2106/JBJS.F.00123.
17. Werner CM, Steinmann PA, Gilbart M, Gerber C. Treatment of painful pseudoparesis due to irreparable rotator cuff dysfunction with the Delta III reverse-ball-and-socket total shoulder prosthesis. J Bone Joint Surg Am. 2005;87(7):1476-1486. doi:10.2106/JBJS.D.02342.
18. Peppers TA, Jobe CM, Dai QG, Williams PA, Libanati C. Fixation of humeral prostheses and axial micromotion. J Shoulder Elbow Surg. 1998;7(4):414-418. doi:10.1016/S1058-2746(98)90034-9.
19. Wiater JM, Moravek JE Jr, Budge MD, Koueiter DM, Marcantonio D, Wiater BP. Clinical and radiographic results of cementless reverse total shoulder arthroplasty: a comparative study with 2 to 5 years of follow-up. J Shoulder Elbow Surg. 2014;23(8):1208-1214. doi:10.1016/j.jse.2013.11.032.
20. Nowinski RJ, Gillespie RJ, Shishani Y, Cohen B, Walch G, Gobezie R. Antibiotic-loaded bone cement reduces deep infection rates for primary reverse total shoulder arthroplasty: a retrospective, cohort study of 501 shoulders. J Shoulder Elbow Surg. 2012;21(3):324-328. doi:10.1016/j.jse.2011.08.072.
21. Favard L, Levigne C, Nerot C, Gerber C, De Wilde L, Mole D. Reverse prostheses in arthropathies with cuff tear: are survivorship and function maintained over time? Clin Orthop Relat Res. 2011;469(9):2469-2475. doi:10.1007/s11999-011-1833-y.
22. Naveed MA, Kitson J, Bunker TD. The Delta III reverse shoulder replacement for cuff tear arthropathy: a single-centre study of 50 consecutive procedures. J Bone Joint Surg Br. 2011;93(1):57-61. doi:10.1302/0301-620X.93B1.24218.
23. Ponce BA, Oladeji LO, Rogers ME, Menendez ME. Comparative analysis of anatomic and reverse total shoulder arthroplasty: in-hospital outcomes and costs. J Shoulder Elbow Surg. 2015;24(3):460-467. doi:10.1016/j.jse.2014.08.016.
24. Coe MP, Greiwe RM, Joshi R, et al. The cost-effectiveness of reverse total shoulder arthroplasty compared with hemiarthroplasty for rotator cuff tear arthropathy. J Shoulder Elbow Surg. 2012;21(10):1278-1288. doi:10.1016/j.jse.2011.10.010.
25. Renfree KJ, Hattrup SJ, Chang YH. Cost utility analysis of reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2013;22(12):1656-1661. doi:10.1016/j.jse.2013.08.002.
26. Chalmers PN, Slikker W, 3rd, Mall NA, et al. Reverse total shoulder arthroplasty for acute proximal humeral fracture: comparison to open reduction-internal fixation and hemiarthroplasty. J Shoulder Elbow Surg. 2014;23(2):197-204. doi:10.1016/j.jse.2013.07.044.
27. Steen BM, Cabezas AF, Santoni BG, et al. Outcome and value of reverse shoulder arthroplasty for treatment of glenohumeral osteoarthritis: a matched cohort. J Shoulder Elbow Surg. 2015;24(9):1433-1441. doi:10.1016/j.jse.2015.01.005.
1. Boileau P, Moineau G, Roussanne Y, O'Shea K. Bony increased-offset reversed shoulder arthroplasty: minimizing scapular impingement while maximizing glenoid fixation. Clin Orthop Relat Res. 2011;469(9):2558-2567. doi:10.1007/s11999-011-1775-4.
2. Gupta AK, Harris JD, Erickson BJ, et al. Surgical management of complex proximal humerus fractures-a systematic review of 92 studies including 4,500 patients. J Orthop Trauma. 2014;29(1):54-59.
3. Cazeneuve JF, Cristofari DJ. Grammont reversed prosthesis for acute complex fracture of the proximal humerus in an elderly population with 5 to 12 years follow-up. Orthop Traumatol Surg Res. 2014;100(1):93-97. doi:10.1016/j.otsr.2013.12.005.
4. Clark JC, Ritchie J, Song FS, et al. Complication rates, dislocation, pain, and postoperative range of motion after reverse shoulder arthroplasty in patients with and without repair of the subscapularis. J Shoulder Elbow Surg. 2012;21(1):36-41. doi:10.1016/j.jse.2011.04.009.
5. De Biase CF, Delcogliano M, Borroni M, Castagna A. Reverse total shoulder arthroplasty: radiological and clinical result using an eccentric glenosphere. Musculoskelet Surg. 2012;96(suppl 1):S27-SS34. doi:10.1007/s12306-012-0193-4.
6. Al-Hadithy N, Domos P, Sewell MD, Pandit R. Reverse shoulder arthroplasty in 41 patients with cuff tear arthropathy with a mean follow-up period of 5 years. J Shoulder Elbow Surg. 2014;23(11):1662-1668. doi:10.1016/j.jse.2014.03.001.
7. Ross M, Hope B, Stokes A, Peters SE, McLeod I, Duke PF. Reverse shoulder arthroplasty for the treatment of three-part and four-part proximal humeral fractures in the elderly. J Shoulder Elbow Surg. 2015;24(2):215-222. doi:10.1016/j.jse.2014.05.022.
8. Mulieri P, Dunning P, Klein S, Pupello D, Frankle M. Reverse shoulder arthroplasty for the treatment of irreparable rotator cuff tear without glenohumeral arthritis. J Bone Joint Surg Am. 2010;92(15):2544-2556. doi:10.2106/JBJS.I.00912.
9. Erickson BJ, Frank RM, Harris JD, Mall N, Romeo AA. The influence of humeral head inclination in reverse total shoulder arthroplasty: a systematic review. J Shoulder Elbow Surg. 2015;24(6):988-993. doi:10.1016/j.jse.2015.01.001.
10. Schairer WW, Nwachukwu BU, Lyman S, Craig EV, Gulotta LV. National utilization of reverse total shoulder arthroplasty in the United States. J Shoulder Elbow Surg. 2015;24(1):91-97. doi:10.1016/j.jse.2014.08.026.
11. Kim SH, Wise BL, Zhang Y, Szabo RM. Increasing incidence of shoulder arthroplasty in the United States. J Bone Joint Surg Am. 2011;93(24):2249-2254. doi:10.2106/JBJS.J.01994.
12. Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. J Clin Epidemiol. 2009;62(10):e1-e34. doi:10.1016/j.jclinepi.2009.06.006.
13. University of York Centre for Reviews and Dissemination, National Institute for Health Research. PROSPERO International prospective register of systematic reviews. University of York Web site. http://www.crd.york.ac.uk/PROSPERO/. Accessed November 1, 2016.
14. Oxford Centre for Evidence-based Medicine – Levels of evidence (March 2009). University of Oxford Web site: https://www.cebm.net/2009/06/oxford-centre-evidence-based-medicine-levels-evidence-march-2009/. Accessed November 1, 2016.
15. Cowan J, Lozano-Calderón S, Ring D. Quality of prospective controlled randomized trials. Analysis of trials of treatment for lateral epicondylitis as an example. J Bone Joint Surg Am. 2007;89(8):1693-1699. doi:10.2106/JBJS.F.00858.
16. Frankle M, Levy JC, Pupello D, et al. The reverse shoulder prosthesis for glenohumeral arthritis associated with severe rotator cuff deficiency. A minimum two-year follow-up study of sixty patients surgical technique. J Bone Joint Surg Am. 2006;88(suppl 1 Pt 2):178-190. doi:10.2106/JBJS.F.00123.
17. Werner CM, Steinmann PA, Gilbart M, Gerber C. Treatment of painful pseudoparesis due to irreparable rotator cuff dysfunction with the Delta III reverse-ball-and-socket total shoulder prosthesis. J Bone Joint Surg Am. 2005;87(7):1476-1486. doi:10.2106/JBJS.D.02342.
18. Peppers TA, Jobe CM, Dai QG, Williams PA, Libanati C. Fixation of humeral prostheses and axial micromotion. J Shoulder Elbow Surg. 1998;7(4):414-418. doi:10.1016/S1058-2746(98)90034-9.
19. Wiater JM, Moravek JE Jr, Budge MD, Koueiter DM, Marcantonio D, Wiater BP. Clinical and radiographic results of cementless reverse total shoulder arthroplasty: a comparative study with 2 to 5 years of follow-up. J Shoulder Elbow Surg. 2014;23(8):1208-1214. doi:10.1016/j.jse.2013.11.032.
20. Nowinski RJ, Gillespie RJ, Shishani Y, Cohen B, Walch G, Gobezie R. Antibiotic-loaded bone cement reduces deep infection rates for primary reverse total shoulder arthroplasty: a retrospective, cohort study of 501 shoulders. J Shoulder Elbow Surg. 2012;21(3):324-328. doi:10.1016/j.jse.2011.08.072.
21. Favard L, Levigne C, Nerot C, Gerber C, De Wilde L, Mole D. Reverse prostheses in arthropathies with cuff tear: are survivorship and function maintained over time? Clin Orthop Relat Res. 2011;469(9):2469-2475. doi:10.1007/s11999-011-1833-y.
22. Naveed MA, Kitson J, Bunker TD. The Delta III reverse shoulder replacement for cuff tear arthropathy: a single-centre study of 50 consecutive procedures. J Bone Joint Surg Br. 2011;93(1):57-61. doi:10.1302/0301-620X.93B1.24218.
23. Ponce BA, Oladeji LO, Rogers ME, Menendez ME. Comparative analysis of anatomic and reverse total shoulder arthroplasty: in-hospital outcomes and costs. J Shoulder Elbow Surg. 2015;24(3):460-467. doi:10.1016/j.jse.2014.08.016.
24. Coe MP, Greiwe RM, Joshi R, et al. The cost-effectiveness of reverse total shoulder arthroplasty compared with hemiarthroplasty for rotator cuff tear arthropathy. J Shoulder Elbow Surg. 2012;21(10):1278-1288. doi:10.1016/j.jse.2011.10.010.
25. Renfree KJ, Hattrup SJ, Chang YH. Cost utility analysis of reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2013;22(12):1656-1661. doi:10.1016/j.jse.2013.08.002.
26. Chalmers PN, Slikker W, 3rd, Mall NA, et al. Reverse total shoulder arthroplasty for acute proximal humeral fracture: comparison to open reduction-internal fixation and hemiarthroplasty. J Shoulder Elbow Surg. 2014;23(2):197-204. doi:10.1016/j.jse.2013.07.044.
27. Steen BM, Cabezas AF, Santoni BG, et al. Outcome and value of reverse shoulder arthroplasty for treatment of glenohumeral osteoarthritis: a matched cohort. J Shoulder Elbow Surg. 2015;24(9):1433-1441. doi:10.1016/j.jse.2015.01.005.
TAKE-HOME POINTS
- RTSA is an effective treatment for rotator cuff tear arthropathy (the most common reason patients undergo RTSA).
- While there has been a plethora of literature surrounding outcomes of RTSA over the past several years, the methodological quality of this literature has been limited.
- Similarly, this study found the number of publications surrounding RTSA is increasing each year while the average methodological quality of these studies is decreasing.
- Females undergo RTSA more commonly than males, and the average age of patients undergoing RTSA is 71 years.
- Interestingly, patients’ postoperative external rotation was higher in studies out of North America compared to other continents. Further research into this area is needed to understand more about this finding.
The Flint Lock: A Novel Technique in Total Knee Arthroplasty Closure
ABSTRACT
Conventional interrupted sutures are traditionally used in extensor mechanism closure during total knee arthroplasty (TKA). In recent years, barbed suture has been introduced with the proposed benefits of decreased closure time and a watertight seal that is superior to interrupted sutures. Complication rates using barbed sutures and conventional interrupted sutures are similar. We propose a novel closure technique known as the Flint Lock, which is a double continuous interlocking stitch. The Flint Lock provides a quick and efficient closure to the extensor mechanism in TKA. In addition, similar to barbed suture, the Flint Lock should provide a superior watertight seal. It utilizes relatively inexpensive and readily available materials.
Continue to: In 2003, more than 400,000 total knee replacements...
In 2003, more than 400,000 total knee replacements were performed in the United States. This number is expected to increase in the coming decades to 3 million by the year 2030.1 The surgical approach to knee arthroplasty always involves a capsular incision that needs to be repaired after implantation of the components. The capsular incision repair should be strong enough to allow for immediate range of motion.
Traditionally, repair of the arthrotomy is performed using interrupted sutures. Recently, a running technique using barbed suture has been demonstrated to enable faster closure times.2-6 In addition, a running suture technique using barbed suture provides a superior watertight closure compared with an interrupted suture.7 It has been reported that the barbed suture has the same safety profile as that of interrupted sutures,2,3,4 although extensor mechanism repair failure8 and wound complications9,10 have been reported.
This study proposes a novel technique for arthrotomy closure in total knee arthroplasty (TKA). It is a double continuous interlocking stitch, termed the “Flint Lock.” Based on our clinical experience using this method, this technique has been found to be safe and effective.
TECHNIQUE
The Flint Lock was developed for closure in TKA, which was performed through a standard medial parapatellar approach. Before creating the arthrotomy, a horizontal line is drawn along the medial side of the patella to ensure anatomic alignment of the extensor mechanism during closure of the capsule.
The Flint Lock is performed by 2 people working simultaneously. Closure begins at the proximal end of the arthrotomy using 2 No. 1 Vicryl (Ethicon) sutures. Each suture is thrown a single time at the most proximal extent of the arthrotomy with the knee in 30° to 40° of flexion. These sutures are tied off independently from each other (Figure 1). At this point, the knee is flexed to 90° and the sutures are thrown alternately, with the first operator passing medial to lateral through the capsule and the second operator passing lateral to medial. While 1 operator is passing a suture, the other operator holds the other suture tight to maintain tension on the closure. The alternating throws create an interlocking weave as the pattern is repeated and progressively moves distally (Figure 2). This technique results in 2 continuous sutures running in opposing directions. Each No. 1 Vicryl suture is specific to each operator. Therefore, each operator uses the same suture for the entirety of the closure.
When the superior pole of the patella is reached, the 2 sutures are tied together, thus creating a segmental closure (Figure 3). Following this tie off, the closure is continued in a similar manner until the inferior pole of the patella is reached. The sutures are then tied off to each other again, creating another segmental closure (Figure 4). The remainder of the arthrotomy is closed continuing the Flint Lock technique, and the 2 sutures are tied off to each other at the distal end of the arthrotomy and cut (Figure 5).
Continue to: The superficial layers are closed at the surgeon’s discretion...
The superficial layers are closed at the surgeon’s discretion. The authors prefer interrupted 2-0 Vicryl sutures followed by a running 3-0 Monocryl (Ethicon) suture in the subcutaneous layer. Dermabond (Ethicon) skin glue and an Aquacel Ag (ConvaTec) dressing are applied, followed by a compressive bandage.
DISCUSSION
The importance of a strong, tight closure of the arthrotomy in TKA is critical to the success of the procedure. Nevertheless, there are multiple methods to achieve closure. The Flint Lock technique is a novel method that employs basic concepts of surgical technique in an original manner. The continuous nature of the closure should provide a tighter seal, leading to less wound drainage. Persistent wound drainage has been associated with deep wound infections following total joint arthroplasty.11,12 In addition, the double suture provides a safeguard to a single suture rupture, while the segmental quality protects against complete arthrotomy failure.
A potential downside of this technique is that it requires 2 individuals operating 2 needles simultaneously. This presents a potential for a sharp injury to the operators; however, this has not occurred in our experience. A comparable risk with interrupted sutures is probably present because there are often multiple sutures utilized during closure via the interrupted technique.
In 2015, the cost of a single No. 1 barbed suture was $13.14 at our institution, whereas the cost of 2 No. 1 Vicryl sutures was $3.66. Although pricing differs across hospitals, the Vicryl sutures are probably less costly compared with the barbed sutures.
Our experience with the Flint Lock technique has been favorable thus far, with no incidences of postoperative drainage, infection, or extensor mechanism failure. Our current use has been in closure of the knee, but it could be considered in closure of long incisions about the hip as well. A more in-depth analysis of relevant factors, such as time for closure, mechanical strength, cost savings, and clinical outcomes, is needed to further evaluate this method of closure. In addition, biomechanical analysis of the technique would aid in its evaluation. Future studies are needed to analyze these factors to verify the benefits and viability of the Flint Lock technique.
1. Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007;89(4):780-785. doi:10.2106/JBJS.F.00222.
2. Eickmann T, Quane E. Total knee arthroplasty closure with barbed sutures. J Knee Surg. 2010;23(3):163-167. doi:10.1055/s-0030-1268692.
3. Gililland JM, Anderson LA, Sun G, Erickson JA, Peters CL. Perioperative closure-related complication rates and cost analysis of barbed suture for closure in TKA. Clin Orthop Relat Res. 2012;470(1):125-129. doi:10.1007/s11999-011-2104-7.
4. Ting NT, Moric MM, Della Valle CJ, Levine BR. Use of knotless suture for closure of total hip and knee arthroplasties: a prospective, randomized clinical trial. J Arthroplasty. 2012;27(10):1783-1788. doi:10.1016/j.arth.2012.05.022.
5. Stephens S, Politi J, Taylor BC. Evaluation of primary total knee arthroplasty incision closure with use of continuous bidirectional barbed suture. Surg Technol Int. 2011;21:199-203.
6. Levine BR, Ting N, Della Valle CJ. Use of a barbed suture in the closure of hip and knee arthroplasty wounds. Orthopedics. 2011;34(9):e473-e475. doi:10.3928/01477447-20110714-35.
7. Nett M, Avelar R, Sheehan M, Cushner F. Water-tight knee arthrotomy closure: comparison of a novel single bidirectional barbed self-retaining running suture versus conventional interrupted sutures. J Knee Surg. 2011;24(1):55-59. doi:10.1055/s-0031-1275400.
8. Wright RC, Gillis CT, Yacoubian SV, Raven RB 3rd, Falkinstein Y, Yacoubian SV. Extensor mechanism repair failure with use of birectional barbed suture in total knee arthroplasty. J Arthroplasty. 2012;27(7):1413.e1-e4. doi:10.1016/j.arth.2011.08.013.
9. Campbell AL, Patrick DA Jr, Liabaud B, Geller JA. Superficial wound closure complications with barbed sutures following knee arthroplasty. J Arthroplasty. 2014;29(5):966-969. doi:10.1016/j.arth.2013.09.045.
10. Smith EL, DiSegna ST, Shukla PY, Matzkin EG. Barbed versus traditional sutures: closure time, cost, and wound related outcomes in total joint arthroplasty. J Arthroplasty. 2014;29(2):283-287. doi:10.1016/j.arth.2013.05.031.
11. Saleh K, Olson M, Resig S, et al. Predictors of wound infection in hip and knee joint replacement: results from a 20 year surveillance program. J Orthop Res. 2002;20(3):506-515. doi:10.1016/S0736-0266(01)00153-X.
12. Weiss AP, Krackow KA. Persistent wound drainage after primary total knee arthroplasty. J Arthroplasty. 1993;8(3):285-289. doi:10.1016/S0883-5403(06)80091-4.
ABSTRACT
Conventional interrupted sutures are traditionally used in extensor mechanism closure during total knee arthroplasty (TKA). In recent years, barbed suture has been introduced with the proposed benefits of decreased closure time and a watertight seal that is superior to interrupted sutures. Complication rates using barbed sutures and conventional interrupted sutures are similar. We propose a novel closure technique known as the Flint Lock, which is a double continuous interlocking stitch. The Flint Lock provides a quick and efficient closure to the extensor mechanism in TKA. In addition, similar to barbed suture, the Flint Lock should provide a superior watertight seal. It utilizes relatively inexpensive and readily available materials.
Continue to: In 2003, more than 400,000 total knee replacements...
In 2003, more than 400,000 total knee replacements were performed in the United States. This number is expected to increase in the coming decades to 3 million by the year 2030.1 The surgical approach to knee arthroplasty always involves a capsular incision that needs to be repaired after implantation of the components. The capsular incision repair should be strong enough to allow for immediate range of motion.
Traditionally, repair of the arthrotomy is performed using interrupted sutures. Recently, a running technique using barbed suture has been demonstrated to enable faster closure times.2-6 In addition, a running suture technique using barbed suture provides a superior watertight closure compared with an interrupted suture.7 It has been reported that the barbed suture has the same safety profile as that of interrupted sutures,2,3,4 although extensor mechanism repair failure8 and wound complications9,10 have been reported.
This study proposes a novel technique for arthrotomy closure in total knee arthroplasty (TKA). It is a double continuous interlocking stitch, termed the “Flint Lock.” Based on our clinical experience using this method, this technique has been found to be safe and effective.
TECHNIQUE
The Flint Lock was developed for closure in TKA, which was performed through a standard medial parapatellar approach. Before creating the arthrotomy, a horizontal line is drawn along the medial side of the patella to ensure anatomic alignment of the extensor mechanism during closure of the capsule.
The Flint Lock is performed by 2 people working simultaneously. Closure begins at the proximal end of the arthrotomy using 2 No. 1 Vicryl (Ethicon) sutures. Each suture is thrown a single time at the most proximal extent of the arthrotomy with the knee in 30° to 40° of flexion. These sutures are tied off independently from each other (Figure 1). At this point, the knee is flexed to 90° and the sutures are thrown alternately, with the first operator passing medial to lateral through the capsule and the second operator passing lateral to medial. While 1 operator is passing a suture, the other operator holds the other suture tight to maintain tension on the closure. The alternating throws create an interlocking weave as the pattern is repeated and progressively moves distally (Figure 2). This technique results in 2 continuous sutures running in opposing directions. Each No. 1 Vicryl suture is specific to each operator. Therefore, each operator uses the same suture for the entirety of the closure.
When the superior pole of the patella is reached, the 2 sutures are tied together, thus creating a segmental closure (Figure 3). Following this tie off, the closure is continued in a similar manner until the inferior pole of the patella is reached. The sutures are then tied off to each other again, creating another segmental closure (Figure 4). The remainder of the arthrotomy is closed continuing the Flint Lock technique, and the 2 sutures are tied off to each other at the distal end of the arthrotomy and cut (Figure 5).
Continue to: The superficial layers are closed at the surgeon’s discretion...
The superficial layers are closed at the surgeon’s discretion. The authors prefer interrupted 2-0 Vicryl sutures followed by a running 3-0 Monocryl (Ethicon) suture in the subcutaneous layer. Dermabond (Ethicon) skin glue and an Aquacel Ag (ConvaTec) dressing are applied, followed by a compressive bandage.
DISCUSSION
The importance of a strong, tight closure of the arthrotomy in TKA is critical to the success of the procedure. Nevertheless, there are multiple methods to achieve closure. The Flint Lock technique is a novel method that employs basic concepts of surgical technique in an original manner. The continuous nature of the closure should provide a tighter seal, leading to less wound drainage. Persistent wound drainage has been associated with deep wound infections following total joint arthroplasty.11,12 In addition, the double suture provides a safeguard to a single suture rupture, while the segmental quality protects against complete arthrotomy failure.
A potential downside of this technique is that it requires 2 individuals operating 2 needles simultaneously. This presents a potential for a sharp injury to the operators; however, this has not occurred in our experience. A comparable risk with interrupted sutures is probably present because there are often multiple sutures utilized during closure via the interrupted technique.
In 2015, the cost of a single No. 1 barbed suture was $13.14 at our institution, whereas the cost of 2 No. 1 Vicryl sutures was $3.66. Although pricing differs across hospitals, the Vicryl sutures are probably less costly compared with the barbed sutures.
Our experience with the Flint Lock technique has been favorable thus far, with no incidences of postoperative drainage, infection, or extensor mechanism failure. Our current use has been in closure of the knee, but it could be considered in closure of long incisions about the hip as well. A more in-depth analysis of relevant factors, such as time for closure, mechanical strength, cost savings, and clinical outcomes, is needed to further evaluate this method of closure. In addition, biomechanical analysis of the technique would aid in its evaluation. Future studies are needed to analyze these factors to verify the benefits and viability of the Flint Lock technique.
ABSTRACT
Conventional interrupted sutures are traditionally used in extensor mechanism closure during total knee arthroplasty (TKA). In recent years, barbed suture has been introduced with the proposed benefits of decreased closure time and a watertight seal that is superior to interrupted sutures. Complication rates using barbed sutures and conventional interrupted sutures are similar. We propose a novel closure technique known as the Flint Lock, which is a double continuous interlocking stitch. The Flint Lock provides a quick and efficient closure to the extensor mechanism in TKA. In addition, similar to barbed suture, the Flint Lock should provide a superior watertight seal. It utilizes relatively inexpensive and readily available materials.
Continue to: In 2003, more than 400,000 total knee replacements...
In 2003, more than 400,000 total knee replacements were performed in the United States. This number is expected to increase in the coming decades to 3 million by the year 2030.1 The surgical approach to knee arthroplasty always involves a capsular incision that needs to be repaired after implantation of the components. The capsular incision repair should be strong enough to allow for immediate range of motion.
Traditionally, repair of the arthrotomy is performed using interrupted sutures. Recently, a running technique using barbed suture has been demonstrated to enable faster closure times.2-6 In addition, a running suture technique using barbed suture provides a superior watertight closure compared with an interrupted suture.7 It has been reported that the barbed suture has the same safety profile as that of interrupted sutures,2,3,4 although extensor mechanism repair failure8 and wound complications9,10 have been reported.
This study proposes a novel technique for arthrotomy closure in total knee arthroplasty (TKA). It is a double continuous interlocking stitch, termed the “Flint Lock.” Based on our clinical experience using this method, this technique has been found to be safe and effective.
TECHNIQUE
The Flint Lock was developed for closure in TKA, which was performed through a standard medial parapatellar approach. Before creating the arthrotomy, a horizontal line is drawn along the medial side of the patella to ensure anatomic alignment of the extensor mechanism during closure of the capsule.
The Flint Lock is performed by 2 people working simultaneously. Closure begins at the proximal end of the arthrotomy using 2 No. 1 Vicryl (Ethicon) sutures. Each suture is thrown a single time at the most proximal extent of the arthrotomy with the knee in 30° to 40° of flexion. These sutures are tied off independently from each other (Figure 1). At this point, the knee is flexed to 90° and the sutures are thrown alternately, with the first operator passing medial to lateral through the capsule and the second operator passing lateral to medial. While 1 operator is passing a suture, the other operator holds the other suture tight to maintain tension on the closure. The alternating throws create an interlocking weave as the pattern is repeated and progressively moves distally (Figure 2). This technique results in 2 continuous sutures running in opposing directions. Each No. 1 Vicryl suture is specific to each operator. Therefore, each operator uses the same suture for the entirety of the closure.
When the superior pole of the patella is reached, the 2 sutures are tied together, thus creating a segmental closure (Figure 3). Following this tie off, the closure is continued in a similar manner until the inferior pole of the patella is reached. The sutures are then tied off to each other again, creating another segmental closure (Figure 4). The remainder of the arthrotomy is closed continuing the Flint Lock technique, and the 2 sutures are tied off to each other at the distal end of the arthrotomy and cut (Figure 5).
Continue to: The superficial layers are closed at the surgeon’s discretion...
The superficial layers are closed at the surgeon’s discretion. The authors prefer interrupted 2-0 Vicryl sutures followed by a running 3-0 Monocryl (Ethicon) suture in the subcutaneous layer. Dermabond (Ethicon) skin glue and an Aquacel Ag (ConvaTec) dressing are applied, followed by a compressive bandage.
DISCUSSION
The importance of a strong, tight closure of the arthrotomy in TKA is critical to the success of the procedure. Nevertheless, there are multiple methods to achieve closure. The Flint Lock technique is a novel method that employs basic concepts of surgical technique in an original manner. The continuous nature of the closure should provide a tighter seal, leading to less wound drainage. Persistent wound drainage has been associated with deep wound infections following total joint arthroplasty.11,12 In addition, the double suture provides a safeguard to a single suture rupture, while the segmental quality protects against complete arthrotomy failure.
A potential downside of this technique is that it requires 2 individuals operating 2 needles simultaneously. This presents a potential for a sharp injury to the operators; however, this has not occurred in our experience. A comparable risk with interrupted sutures is probably present because there are often multiple sutures utilized during closure via the interrupted technique.
In 2015, the cost of a single No. 1 barbed suture was $13.14 at our institution, whereas the cost of 2 No. 1 Vicryl sutures was $3.66. Although pricing differs across hospitals, the Vicryl sutures are probably less costly compared with the barbed sutures.
Our experience with the Flint Lock technique has been favorable thus far, with no incidences of postoperative drainage, infection, or extensor mechanism failure. Our current use has been in closure of the knee, but it could be considered in closure of long incisions about the hip as well. A more in-depth analysis of relevant factors, such as time for closure, mechanical strength, cost savings, and clinical outcomes, is needed to further evaluate this method of closure. In addition, biomechanical analysis of the technique would aid in its evaluation. Future studies are needed to analyze these factors to verify the benefits and viability of the Flint Lock technique.
1. Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007;89(4):780-785. doi:10.2106/JBJS.F.00222.
2. Eickmann T, Quane E. Total knee arthroplasty closure with barbed sutures. J Knee Surg. 2010;23(3):163-167. doi:10.1055/s-0030-1268692.
3. Gililland JM, Anderson LA, Sun G, Erickson JA, Peters CL. Perioperative closure-related complication rates and cost analysis of barbed suture for closure in TKA. Clin Orthop Relat Res. 2012;470(1):125-129. doi:10.1007/s11999-011-2104-7.
4. Ting NT, Moric MM, Della Valle CJ, Levine BR. Use of knotless suture for closure of total hip and knee arthroplasties: a prospective, randomized clinical trial. J Arthroplasty. 2012;27(10):1783-1788. doi:10.1016/j.arth.2012.05.022.
5. Stephens S, Politi J, Taylor BC. Evaluation of primary total knee arthroplasty incision closure with use of continuous bidirectional barbed suture. Surg Technol Int. 2011;21:199-203.
6. Levine BR, Ting N, Della Valle CJ. Use of a barbed suture in the closure of hip and knee arthroplasty wounds. Orthopedics. 2011;34(9):e473-e475. doi:10.3928/01477447-20110714-35.
7. Nett M, Avelar R, Sheehan M, Cushner F. Water-tight knee arthrotomy closure: comparison of a novel single bidirectional barbed self-retaining running suture versus conventional interrupted sutures. J Knee Surg. 2011;24(1):55-59. doi:10.1055/s-0031-1275400.
8. Wright RC, Gillis CT, Yacoubian SV, Raven RB 3rd, Falkinstein Y, Yacoubian SV. Extensor mechanism repair failure with use of birectional barbed suture in total knee arthroplasty. J Arthroplasty. 2012;27(7):1413.e1-e4. doi:10.1016/j.arth.2011.08.013.
9. Campbell AL, Patrick DA Jr, Liabaud B, Geller JA. Superficial wound closure complications with barbed sutures following knee arthroplasty. J Arthroplasty. 2014;29(5):966-969. doi:10.1016/j.arth.2013.09.045.
10. Smith EL, DiSegna ST, Shukla PY, Matzkin EG. Barbed versus traditional sutures: closure time, cost, and wound related outcomes in total joint arthroplasty. J Arthroplasty. 2014;29(2):283-287. doi:10.1016/j.arth.2013.05.031.
11. Saleh K, Olson M, Resig S, et al. Predictors of wound infection in hip and knee joint replacement: results from a 20 year surveillance program. J Orthop Res. 2002;20(3):506-515. doi:10.1016/S0736-0266(01)00153-X.
12. Weiss AP, Krackow KA. Persistent wound drainage after primary total knee arthroplasty. J Arthroplasty. 1993;8(3):285-289. doi:10.1016/S0883-5403(06)80091-4.
1. Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007;89(4):780-785. doi:10.2106/JBJS.F.00222.
2. Eickmann T, Quane E. Total knee arthroplasty closure with barbed sutures. J Knee Surg. 2010;23(3):163-167. doi:10.1055/s-0030-1268692.
3. Gililland JM, Anderson LA, Sun G, Erickson JA, Peters CL. Perioperative closure-related complication rates and cost analysis of barbed suture for closure in TKA. Clin Orthop Relat Res. 2012;470(1):125-129. doi:10.1007/s11999-011-2104-7.
4. Ting NT, Moric MM, Della Valle CJ, Levine BR. Use of knotless suture for closure of total hip and knee arthroplasties: a prospective, randomized clinical trial. J Arthroplasty. 2012;27(10):1783-1788. doi:10.1016/j.arth.2012.05.022.
5. Stephens S, Politi J, Taylor BC. Evaluation of primary total knee arthroplasty incision closure with use of continuous bidirectional barbed suture. Surg Technol Int. 2011;21:199-203.
6. Levine BR, Ting N, Della Valle CJ. Use of a barbed suture in the closure of hip and knee arthroplasty wounds. Orthopedics. 2011;34(9):e473-e475. doi:10.3928/01477447-20110714-35.
7. Nett M, Avelar R, Sheehan M, Cushner F. Water-tight knee arthrotomy closure: comparison of a novel single bidirectional barbed self-retaining running suture versus conventional interrupted sutures. J Knee Surg. 2011;24(1):55-59. doi:10.1055/s-0031-1275400.
8. Wright RC, Gillis CT, Yacoubian SV, Raven RB 3rd, Falkinstein Y, Yacoubian SV. Extensor mechanism repair failure with use of birectional barbed suture in total knee arthroplasty. J Arthroplasty. 2012;27(7):1413.e1-e4. doi:10.1016/j.arth.2011.08.013.
9. Campbell AL, Patrick DA Jr, Liabaud B, Geller JA. Superficial wound closure complications with barbed sutures following knee arthroplasty. J Arthroplasty. 2014;29(5):966-969. doi:10.1016/j.arth.2013.09.045.
10. Smith EL, DiSegna ST, Shukla PY, Matzkin EG. Barbed versus traditional sutures: closure time, cost, and wound related outcomes in total joint arthroplasty. J Arthroplasty. 2014;29(2):283-287. doi:10.1016/j.arth.2013.05.031.
11. Saleh K, Olson M, Resig S, et al. Predictors of wound infection in hip and knee joint replacement: results from a 20 year surveillance program. J Orthop Res. 2002;20(3):506-515. doi:10.1016/S0736-0266(01)00153-X.
12. Weiss AP, Krackow KA. Persistent wound drainage after primary total knee arthroplasty. J Arthroplasty. 1993;8(3):285-289. doi:10.1016/S0883-5403(06)80091-4.
TAKE-HOME POINTS
- The Flint Lock is a novel technique in TKA closure.
- Its continuous nature provides a tight seal with extensor mechanism closure.
- The utilization of a segmental closure with double suture provides a safeguard for suture failure.
- The suture used in the technique is less expensive than barbed suture.
- Future investigation is warranted to further validate the use of the Flint Lock.
Tranexamic Acid Reduces Perioperative Blood Loss and Hemarthrosis in Total Ankle Arthroplasty
ABSTRACT
Tranexamic acid (TXA) is an effective agent used for reducing perioperative blood loss and decreasing the potential for postoperative hemarthrosis. We hypothesized that patients who had received intraoperative TXA during total ankle arthroplasty (TAA) would have a reduction in postoperative drain output, thereby resulting in a reduced risk of postoperative hemarthrosis and lower wound complication rates.
A retrospective review was conducted on 50 consecutive patients, 25 receiving TXA (TXA-TAA) and 25 not receiving TXA (No TXA-TAA), who underwent an uncemented TAA between September 2011 and December 2015. Demographic characteristics, drain output, preoperative and postoperative hemoglobin levels, operative and postoperative course, and minor and major wound complications of the patients were reviewed.
Drain output was significantly less in the TXA-TAA group compared to that in the No TXA-TAA group (71.6 ± 60.3 vs 200.2 ± 117.0 mL, respectively, P < .0001). The overall wound complication rate in the No TXA-TAA group was higher (20%, 5/25) than that in the TXA-TAA group (8%, 2/25) (P = .114). The mean change in preoperative to postoperative hemoglobin level was significantly less in the TXA-TAA group compared to that in the No TXA-TAA group (1.5 ± 0.6 vs 2.0 ± 0.4 g/dL, respectively, P = .01).
TXA is an effective hemostatic agent when used during TAA. TXA reduces perioperative blood loss, hemarthrosis, and the risk of wound complications.
Continue to: End-stage ankle arthritis...
End-stage ankle arthritis is a disabling condition that may lead to poor quality of life and difficulties with activities of daily living.1 The associated mental and physical disability has been demonstrated to be as severe as in end-stage hip arthrosis.2 Operative treatment for symptomatic end-stage ankle arthritis includes arthrodesis or total ankle arthroplasty (TAA) in those refractory to nonoperative treatment.3 Newer generation implants have made TAA a more attractive option for both the surgeon and the patient.
Over the past decade, the utility of TAA has increased and attention has turned toward the management of perioperative factors that would maximize patient satisfaction and decrease the length of stay and complication rates, as well as hospital costs.4 Comprehensive literature on total knee arthroplasty (TKA) and total hip arthroplasty (THA) has demonstrated that the management of perioperative blood loss, specifically postoperative hemarthrosis, is a modifiable factor affecting patient recovery, complication rates, and hospital costs.5-8 Drain output has been used as a direct measure of intra-articular blood accumulation.9 Decreased drain output implies decreased hemarthrosis, which could potentially alleviate the pressure on the wound and decrease wound complications.
One of the major strategies that has been recognized for reducing blood loss and decreasing the potential for postoperative hemarthrosis is the use of intravenous (IV) or topical tranexamic acid (TXA).10,11 TXA is a synthetic antifibrinolytic medication that has been extensively used throughout the medical field since the 1960s to help control the bleeding cascade. This medication stabilizes clot formation without inducing a pro-coaguable state.12 Intraoperative administration of TXA has been shown to reduce drain output and decrease transfusion requirements after TKA and THA without an associated increase in patient morbidity and mortality.6,11,13-15
Currently, there is a lack of studies evaluating the utility of TXA during TAA. We hypothesize that compared with patients who had not received TXA, those who had received intraoperative TXA during TAA would have a reduction in postoperative drain output and therefore decreased hemarthrosis, lower wound complication rate, and a diminished change in preoperative to postoperative hemoglobin levels, reflecting a reduction in perioperative blood loss.
MATERIALS AND METHODS
This study was approved by the Institutional Review Board at the University at Buffalo, State University of New York. A retrospective chart review was conducted on 50 consecutive patients who underwent an uncemented TAA with the Salto Talaris total ankle prosthesis (Tornier, Inc) between September 2011 and December 2015. All surgeries were performed at 1 institution by a single fellowship surgeon trained in foot and ankle surgery through the anterior approach where a midline incision was made over the ankle. The interval between the tibialis anterior tendon and the extensor hallucis longus tendon was used. We had incorporated intraoperative TXA into the TAA surgical protocol at our institution in January 2014. We evaluated the first 25 consecutive patients who underwent TAA after TXA use began (TXA-TAA) and another 25 consecutive patients who underwent TAA before the routine use of TXA (No TXA-TAA). Inclusion criteria were patients who presented with pain, decreased function, and radiographic parameters of end-stage tibiotalar arthritis due to degenerative arthritis, rheumatoid arthritis, or posttraumatic arthritis who subsequently underwent a TAA. Exclusion criteria were patients with a contraindication for IV TXA use, a preexisting coagulopathy, or where drain output was not recorded. Contraindications for IV TXA use included patients with impaired renal clearance, recent cardiac surgery, myocardial infarction, ischemic stroke, or venous thromboembolism (VTE). Seven patients were ultimately excluded from this study based on the inclusion and exclusion criteria, 3 patients from the TXA-TAA group and 4 patients from the No TXA-TAA group.
Continue to: Charts were reviewed for demographics...
Charts were reviewed for demographics, preoperative and postoperative hemoglobin levels, indications for surgery, surgical procedures, length of surgery, postoperative drain output, length of stay, postoperative pain visual analog scale (VAS) score, minor and major wound complications, and postoperative complications. Minor wound complications were defined as the anterior surgical incision that required local wound care in office or oral antibiotics without subsequent consequences. Major wound complications were defined as requiring surgical débridement and/or any additional treatment in the operating room.16 Postoperative complications other than wound complications were defined as those requiring a subsequent surgical intervention. Patient demographics and clinical and procedural characteristics of patients in both the TXA-TAA and the No TXA-TAA groups are outlined in Table 1. There were 14 males and 11 females in the TXA-TAA group and 16 males and 9 females in the No TXA-TAA group. The mean age was 65.8 ± 10.9 years in the TXA-TAA group and 66.9 ± 8.0 years in the No TXA-TAA group (P = .69). Mean body mass index (BMI) was 31.6 ± 6.3 in the TXA-TAA group and 29.4 ± 4.9 in the No TXA-TAA group (P = .18). The primary indication for TAA was degenerative osteoarthritis in 26 patients, posttraumatic arthritis in 21 patients, and rheumatoid arthritis in 3 patients. The most common associated procedure was Achilles tendon lengthening in both groups. The mean follow-up in the TXA-TAA group was 9.3 ± 5.8 months (range, 2.0-24.0 months). Postoperative complications due to TXA administration as described in previous literature were defined as VTE, myocardial infarction, or ischemic cerebral event. The TXA-TAA group received a standard 1 g dose of IV TXA 20 minutes prior to tourniquet inflation. A tourniquet was used intraoperatively on all patients included in this study. A postoperative 400-mL surgical drain (Hemovac, Zimmer Biomet) was placed in the ankle joint in all patients and subsequently discontinued on postoperative day 1. Recent literature has reported the minor wound complication rate associated with TAA to be as high as 25% and the major wound complication rate to be 8.5%.16 To assist in reducing the risk for wound complications, our protocol traditionally uses an intra-articular surgical drain to decrease any pressure on the wound from postoperative hemarthrosis.
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aP value was calculated from t-test continuous variables and Chi-square test for categorical variables (TXA-TAA vs No TXA-TAA comparison).
Abbreviations: ASA, American Society of Anesthesiologists; BMI, body mass index.
Total drain output was recorded in milliliters (mL) in all patients. The change between the preoperative hemoglobin level and the hemoglobin level on postoperative day 1 was calculated for each patient. The calculated blood loss was determined using Meunier’s equation, which estimates the total blood volume using Nadler’s formula and then uses preoperative hemoglobin and postoperative day 1 hemoglobin values to calculate blood loss.17,18 VAS scores (scale, 1-10) were obtained every 4 hours on postoperative day 1 according to the nursing protocol. The number 1 on the scale represents the least amount of pain, whereas 10 indicates the worst pain. The VAS scores were then averaged for each patient.
A power analysis using preliminary data determined that 15 patients were needed in each group to detect a 50% reduction in drain output at a power of 80% and a P value of 0.05. Descriptive statistics were used to analyze demographic data. We compared the demographic and clinical characteristics of patients in the TXA-TAA group with those of patients in the No TXA-TAA group using unpaired student t-tests for continuous variables and Chi-square or Fischer’s exact tests for categorical variables. Simple and adjusted linear regression analyses were used to examine the difference in drain output and blood loss between the 2 groups (TXA-TAA vs No TXA-TAA). Multivariate models were adjusted for age, BMI, and length of surgery. A P value <.05 was considered to be statistically significant. We performed all analyses using a statistical software package (SAS version 9.2, SAS Institute).
RESULTS
Drain output was significantly less in the TXA-TAA group compared to that in the No TXA-TAA group (71.6 ± 60.3 vs 200.2 ± 117.0 mL, respectively, P = .0001) (Figure). The clinical characteristics of the patients who underwent TAA with the use of TXA are outlined in Table 2. The mean change in preoperative to postoperative hemoglobin levels was significantly lower in the TXA-TAA group than in the No TXA-TAA group (1.5 ± 0.6 vs 2.0 ± 0.4 g/dL, respectively; P = .01). The calculated blood loss in patients in the TXA-TAA group was significantly lower than that in patients in the No TXA-TAA group (649.9 ± 332.7 vs 906.8 ± 287.4 mL, respectively; P = .01). No patient in either group received a blood transfusion. We did not observe a significant difference in the length of surgery between the TXA-TAA and the No TXA-TAA groups (112.8 ± 24.8 vs 108.6 ± 26.0 min, respectively; P = .57). The average American Society of Anesthesiologists’ (ASA) classification was similar between the groups (2.2 ± 0.6 and 2.2 ± 0.5, respectively; P = 1.00) as was the age-adjusted Charlson Comorbidity Index (2.8 ± 1.7 vs 2.9 ± 1.6, respectively; P = .93). Mean VAS scores on postoperative day 1 in the TXA-TAA and the No TXA-TAA group were 4.9 ± 1.7 and 5.3 ± 1.4, respectively (P = .71). The average length of stay in the TXA-TAA group was 1.6 ± 0.7 days vs 1.3 ± 0.6 days in the No TXA-TAA group (P = .23). Two patients in the TXA-TAA group had an extended hospital length of stay of 5 days due to discharge planning and social issues.
Table 2. Clinical Characteristics of Total Ankle Arthroplasty (TAA) Patients by Use of Tranexamic Acid (TXA), N = 50 | |||
|---|---|---|---|
| TXA use in TAA | P valuea | |
| Yes (n = 25 cases) | No (n = 25 controls) |
|
Clinical Characteristic |
|
|
|
Drain Output (ml), mean ± SD
| 71.6 ± 60.3 | 200.2 ± 117.0 | <0.0001 |
Preoperative to Postoperative Hgb Change (g/dL), mean ± SD
| 1.5 ± 0.6 | 2.0 ± 0.4 | 0.01 |
Blood Loss Calculated (ml), mean ± SD
| 649.9 ± 332.73 | 906.8 ± 287.4 | 0.01 |
Length of Surgery (min), mean ± SD
| 112.8 ± 24.8 | 108.6 ± 26.0 | 0.57 |
VAS scores on the POD (No.), mean ± SD
| 4.9 ± 1.7 | 5.3 ±1.4 | 0.71 |
LOS (day), mean ± SD
| 1.6 ± 0.7 | 1.3 ± 0.6 | 0.23 |
aP value was calculated from t-test for continuous variables, and Chi-square test for categorical variables (TXA-TAA vs No TXA-TAA comparison).
Abbreviations: LOS, length of stay; VAS, visual analog scale; POD, postoperative day.
Table 3. Linear Regression Analyses of Drain Output and Blood Loss using Tranexamic Acid (TXA) in Total Ankle Arthroplasty (TAA), Unadjusted and Adjusted Models for Length of Surgery, N = 50 | ||||
| TXA Use in TAA (Yes vs No) | |||
Drain Output (mL)
| Regression coefficient (β) | SE | Test statistics (t) | P valuea |
Unadjusted Model | -128.6 | 26.3 | -4.89 | < 0.0001 |
Adjusted for Age | -129.6 | 26.5 | -4.89 | <0.0001 |
Adjusted for BMI | -121.8 | 26.6 | -4.57 | <0.0001 |
Adjusted for Length of Surgery | -129.6 | 26.6 | -4.86 | <0.0001 |
Multivariable Modelb | -123.4 | 27.1 | -4.55 | <0.0001 |
Blood Loss (mL)
|
|
|
|
|
Unadjusted Model | -257.0 | 87.9 | -2.92 | 0.005 |
Adjusted for Age | -263.7 | 87.4 | -3.02 | 0.004 |
Adjusted for BMI | -268.7 | 90.2 | -2.98 | 0.005 |
Adjusted for Length of Surgery | -261.3 | 88.6 | -2.94 | 0.005 |
Multivariable Modelb | -275.6 | 90.7 | -3.04 | 0.004 |
aLinear regression was used to calculate the P value. bAdjusted for age, BMI and length of surgery.
Abbreviation: BMI, body mass index.
Table 4. Patient Wound Complication Categories by Use of Tranexamic Acid (TXA) in Total Ankle Arthroplasty (TAA), N = 50 | |||
|---|---|---|---|
| TXA Use in TAA | P valuea | |
Wound Complication | Yes (n = 25 cases) | No (n = 25 controls) | 0.114 |
None, n = 46 (86%) | 23 (40%) | 20 (46%) |
|
Minor, n = 6 (12%) | 2 (4%) | 4 (8%) |
|
Major, n = 1 (2%) | 0 (0%) | 1 (4%) |
|
aP value was calculated from Fisher’s Exact test (67% cells had count <5) test for categorical variables (TXA-TAA vs No TXA-TAA comparison).
The crude linear regression model revealed a significant difference in drain output between the TXA-TAA and the No TXA-TAA groups (β = −128.6 ± 26.3, P < .0001) (Table 3). Further adjustment for age and length of surgery slightly strengthened the association (β = −129.6 ± 26.6, P < .0001). The nature of regression coefficient β showed that the mean estimate of drain output was 129.6 mL lower in the TXA-TAA group than that in the No TXA-TAA group. There was a significant difference in blood loss between the TXA-TAA and the No TXA-TAA groups in the crude linear regression model (β = −257.0 ± 87.9, P = .005). Additional adjustment for age, BMI, and length of surgery slightly strengthened the association (β = −275.6 ± 90.7, P = .004). The nature of regression coefficient β showed that the mean estimate of blood loss was 275.6 mL lower in the TXA-TAA group than in the No TXA-TAA group (Table 3).
Continue to: There was no statistically significant difference...
There was no statistically significant difference in wound complications between the TXA-TAA and the No TXA-TAA groups in this study population (P = .114). However, our results showed a higher overall wound complication rate in the No TXA-TAA group than in the TXA-TAA group (20% (5/25) vs 8% (2/25), respectively) (Table 4). In the No TXA-TAA group, there were 4 minor and 1 major wound complications. All 5 patients experiencing a postoperative wound complication required oral antibiotics for a minimum of 4 weeks and local wound care. One patient underwent a surgical débridement meeting the criteria for major wound complications. In the TXA-TAA group, there were 2 minor wound complications and no major wound complications. One patient was administered prophylactic oral antibiotics for 7 days with local wound care for blister formation without evidence of infection. The second patient experiencing a minor wound complication required 3 weeks of oral antibiotics and local wound care. No patients in either group had a deep infection requiring implant removal, IV antibiotics, or subsequent hospital admission. The surgical incisions in all patients healed after the aforementioned treatments with no persistent drainage or development of chronic wounds.
In the TXA-TAA group, there was 1 patient who sustained an intraoperative medial malleolus fracture. One patient developed an extensor hallucis longus contracture 5 months postoperatively that subsequently underwent release and lengthening. There was 1 patient in this group who sustained a distal tibia fracture 5 cm proximal to the prosthesis 3 months postoperatively after a mechanical fall. In the No TXA-TAA group, there were 2 patients who sustained intraoperative medial malleolus fractures. One patient underwent a revision of the tibial component 24 months postoperatively due to aseptic loosening. In addition, another patient in this group who sustained an Achilles tendon rupture 5 months postoperatively after a fall subsequently underwent repair with tibialis anterior tendon allograft.
There were no patients in either group who experienced any hospital readmissions in the acute follow-up period as defined by a 90-day period after discharge. There were no complications associated with TXA administration in either group.
DISCUSSION
Recent advances in total ankle prosthetic design coupled with increased survival and improved short- to midterm follow-up results make TAA an effective treatment option for end-stage ankle arthritis. Management of perioperative blood loss and reducing the potential for significant hemarthrosis and subsequent wound complications are important factors to consider for patients undergoing TAA. TXA administration is used in several centers as part of an intraoperative strategy to reduce blood loss and decrease intra-articular blood accumulation. To our knowledge, this is the first study to evaluate the management of blood loss and hemarthrosis using TXA during TAA.
IV and topical administrations of TXA have been demonstrated to be highly effective hemostatic agents in the perioperative period for TKA and THA.11 Recent literature has demonstrated a significant reduction in drain output and mean change in preoperative to postoperative hemoglobin levels in patients who received TXA compared to that in patients who did not receive TXA. The patients who did not receive TXA had more than twice as much drain output.5,10,14,19-21
Continue to: The ankle has a thin...
The ankle has a thin soft tissue envelope that does not have elaborate elastic properties. The soft tissue release and bleeding surfaces of the bone during TAA are not as extensive when compared with TKA and THA, but the intra-articular volume is smaller and the surrounding soft tissues may be less yielding when blood accumulation occurs.22 The vascular supply can be rich surrounding the ankle in the absence of arterial disease and is not as apt to tolerate dislocation and subluxation as in the case of THA or TKA.23 Shear forces can easily tear the branches of the anterior tibial artery that lie within the fascia that is continuous with the periosteum on the distal tibia.24 Reduction of hemarthrosis within the ankle joint may lead to a decrease in postoperative swelling, decreased pain, and increased range of motion due to the diminished potential for fibrosis. We also believe that there could be a reduced risk for wound complications. The current literature reports the rate of wound complications to be anywhere from 2% to 25%, with diabetes, inflammatory conditions, coronary artery disease, peripheral vascular disease, and smoking history >12-pack-years as risk factors.16,25,26 In this study, we observed a significant reduction in drain output and an overall reduced percentage of postoperative wound complications in patients who received TXA. These results demonstrate that TXA use decreases postoperative hemarthrosis.
TXA use in TKA and THA has been shown to decrease direct hospital costs and hospital length of stay.7,14,27 A recent study by Moskal and colleagues7 showed that topical TXA use has the potential to significantly decrease hospital man-hours for those patients undergoing TKA and achieve larger cost savings. Although there was no significant difference in the length of stay between the 2 groups, the average length of stay after TAA was shorter in both groups compared to the reported national average (1.49 vs 2.2 days, respectively).4 The administration of TXA in the appropriate patient has the potential to decrease hospital costs by controlling postoperative pain and swelling, allowing for earlier discharge. Long-term cost benefits could also include decreased infection rates and wound complications, and improved clinical outcomes because of improved range of motion and function scores.
The limitations of this study include the retrospective nature of its design and the relatively small sample size. The results showed nonstatistically significant differences in wound complications between the TXA-TAA and the No TXA-TAA groups, consistent with an insufficient sample size and thus inadequate power to detect the significant difference. However, this study clearly showed that the wound complication rates were higher in the No TXA-TAA group than in the TXA-TAA group, suggesting the importance of further similar studies using a larger sample size.
CONCLUSION
Current TAA offers a viable alternative to arthrodesis for end-stage ankle arthritis. TXA is an inexpensive and effective hemostatic agent used during TAA. If no major contraindication is present, routine use of TXA is recommended to assist in blood loss management, decrease postoperative hemarthrosis, and help to reduce the risk of postoperative wound complications.
1. Saltzman CL, Salamon ML, Blanchard GM, et al. Epidemiology of ankle arthritis: report of a consecutive series of 639 patients from a tertiary orthopaedic center. Iowa Orthop J. 2005;25:44-46.
2. Glazebrook M, Daniels T, Younger A, et al. Comparison of health-related quality of life between patients with end-stage ankle and hip arthrosis. J Bone Joint Surg Am. 2008;90(3):499-505. doi:10.2106/JBJS.F.01299.
3. Thomas RH, Daniels TR. Ankle arthritis. J Bone Joint Surg Am. 2003;85-A(5):923-936.
4. Zhou H, Yakavonis M, Shaw JJ, Patel A, Li X. In-patient trends and complications after total ankle arthroplasty in the United States. Orthopedics. 2016:1-6. doi:10.3928/01477447-20151228-05.
5. Benoni G, Fredin H. Fibrinolytic inhibition with tranexamic acid reduces blood loss and blood transfusion after knee arthroplasty: a prospective, randomised, double-blind study of 86 patients. J Bone Joint Surg Br. 1996;78(3):434-440.
6. Alshryda S, Sukeik M, Sarda P, Blenkinsopp J, Haddad FS, Mason JM. A systematic review and meta-analysis of the topical administration of tranexamic acid in total hip and knee replacement. Bone Joint J. 2014;96-B(8):1005-1015. doi:10.1302/0301-620X.96B8.33745.
7. Moskal JT, Harris RN, Capps SG. Transfusion cost savings with tranexamic acid in primary total knee arthroplasty from 2009 to 2012. J Arthroplasty. 2015;30(3):365-368. doi:10.1016/j.arth.2014.10.008.
8. Friedman R, Homering M, Holberg G, Berkowitz SD. Allogeneic blood transfusions and postoperative infections after total hip or knee arthroplasty. J Bone Joint Surg Am. 2014;96(4):272-278. doi:10.2106/JBJS.L.01268.
9. Aggarwal AK, Singh N, Sudesh P. Topical vs intravenous tranexamic acid in reducing blood loss after bilateral total knee arthroplasty: a prospective study. J Arthroplasty. 2016;31(7):1442-1448. doi:10.1016/j.arth.2015.12.033.
10. Su EP, Su S. Strategies for reducing peri-operative blood loss in total knee arthroplasty. Bone Joint J. 2016;98-B(1 Suppl A):98-100. doi:10.1302/0301-620X.98B.36430.
11. Gomez-Barrena E, Ortega-Andreu M, Padilla-Eguiluz NG, Perez-Chrzanowska H, Figueredo-Zalve R. Topical intra-articular compared with intravenous tranexamic acid to reduce blood loss in primary total knee replacement: a double-blind, randomized, controlled, noninferiority clinical trial. J Bone Joint Surg Am. 2014;96(23):1937-1944. doi:10.2106/JBJS.N.00060.
12. Cap AP, Baer DG, Orman JA, Aden J, Ryan K, Blackbourne LH. Tranexamic acid for trauma patients: a critical review of the literature. J Trauma. 2011;71(1 Suppl):S9-14. doi:10.1097/TA.0b013e31822114af.
13. Duncan CM, Gillette BP, Jacob AK, Sierra RJ, Sanchez-Sotelo J, Smith HM. Venous thromboembolism and mortality associated with tranexamic acid use during total hip and knee arthroplasty. J Arthroplasty. 2015;30(2):272-276. doi:10.1016/j.arth.2014.08.022.
14. Alshryda S, Mason J, Vaghela M, et al. Topical (intra-articular) tranexamic acid reduces blood loss and transfusion rates following total knee replacement: a randomized controlled trial (TRANX-K). J Bone Joint Surg Am. 2013;95(21):1961-1968. doi:10.2106/JBJS.L.00907.
15. Ng W, Jerath A, Wasowicz M. Tranexamic acid: a clinical review. Anaesthesiol Intensive Ther. 2015;47(4):339-350. doi:10.5603/AIT.a2015.0011.
16. Raikin SM, Kane J, Ciminiello ME. Risk factors for incision-healing complications following total ankle arthroplasty. J Bone Joint Surg Am. 2010;92(12):2150-2155. doi:10.2106/JBJS.I.00870.
17. Meunier A, Petersson A, Good L, Berlin G. Validation of a haemoglobin dilution method for estimation of blood loss. Vox Sang. 2008;95(2):120-124. doi:10.1111/j.1423-0410.2008.01071.x.
18. Gibon E, Courpied JP, Hamadouche M. Total joint replacement and blood loss: what is the best equation? Int Orthop. 2013;37(4):735-739. doi:10.1007/s00264-013-1801-0
19. Chareancholvanich K, Siriwattanasakul P, Narkbunnam R, Pornrattanamaneewong C. Temporary clamping of drain combined with tranexamic acid reduce blood loss after total knee arthroplasty: a prospective randomized controlled trial. BMC Musculoskelet Disord. 2012;13:124.
20. Orpen NM, Little C, Walker G, Crawfurd EJ. Tranexamic acid reduces early post-operative blood loss after total knee arthroplasty: a prospective randomised controlled trial of 29 patients. Knee. 2006;13(2):106-110. doi:10.1016/j.knee.2005.11.001.
21. Veien M, Sorensen JV, Madsen F, Juelsgaard P. Tranexamic acid given intraoperatively reduces blood loss after total knee replacement: a randomized, controlled study. Acta Anaesthesiol Scand. 2002;46(10):1206-1211.
22. Draeger RW, Singh B, Parekh SG. Quantifying normal ankle joint volume: An anatomic study. Indian J Orthop. 2009;43(1):72-75. doi:10.4103/0019-5413.45326.
23. Gill LH. Challenges in total ankle arthroplasty. Foot Ankle Int. 2004;25(4):195-207. doi:10.1177/107110070402500402.
24. Taylor GI, Pan WR. Angiosomes of the leg: anatomic study and clinical implications. Plast Reconstr Surg. 1998;102(3):599-616; discussion 617-598. doi:10.1097/00006534-199809030-00001.
25. Gougoulias N, Khanna A, Maffulli N. How successful are current ankle replacements?: a systematic review of the literature. Clin Orthop Relat Res. 2010;468(1):199-208. doi:10.1007/s11999-009-0987-3.
26. Noelle S, Egidy CC, Cross MB, Gebauer M, Klauser W. Complication rates after total ankle arthroplasty in one hundred consecutive prostheses. Int Orthop. 2013;37(9):1789-1794. doi:10.1007/s00264-013-1971-9.
27. Chimento GF, Huff T, Ochsner JL Jr, Meyer M, Brandner L, Babin S. An evaluation of the use of topical tranexamic acid in total knee arthroplasty. J Arthroplasty. 2013;28(8 Suppl):74-77. doi:10.1016/j.arth.2013.06.037.
ABSTRACT
Tranexamic acid (TXA) is an effective agent used for reducing perioperative blood loss and decreasing the potential for postoperative hemarthrosis. We hypothesized that patients who had received intraoperative TXA during total ankle arthroplasty (TAA) would have a reduction in postoperative drain output, thereby resulting in a reduced risk of postoperative hemarthrosis and lower wound complication rates.
A retrospective review was conducted on 50 consecutive patients, 25 receiving TXA (TXA-TAA) and 25 not receiving TXA (No TXA-TAA), who underwent an uncemented TAA between September 2011 and December 2015. Demographic characteristics, drain output, preoperative and postoperative hemoglobin levels, operative and postoperative course, and minor and major wound complications of the patients were reviewed.
Drain output was significantly less in the TXA-TAA group compared to that in the No TXA-TAA group (71.6 ± 60.3 vs 200.2 ± 117.0 mL, respectively, P < .0001). The overall wound complication rate in the No TXA-TAA group was higher (20%, 5/25) than that in the TXA-TAA group (8%, 2/25) (P = .114). The mean change in preoperative to postoperative hemoglobin level was significantly less in the TXA-TAA group compared to that in the No TXA-TAA group (1.5 ± 0.6 vs 2.0 ± 0.4 g/dL, respectively, P = .01).
TXA is an effective hemostatic agent when used during TAA. TXA reduces perioperative blood loss, hemarthrosis, and the risk of wound complications.
Continue to: End-stage ankle arthritis...
End-stage ankle arthritis is a disabling condition that may lead to poor quality of life and difficulties with activities of daily living.1 The associated mental and physical disability has been demonstrated to be as severe as in end-stage hip arthrosis.2 Operative treatment for symptomatic end-stage ankle arthritis includes arthrodesis or total ankle arthroplasty (TAA) in those refractory to nonoperative treatment.3 Newer generation implants have made TAA a more attractive option for both the surgeon and the patient.
Over the past decade, the utility of TAA has increased and attention has turned toward the management of perioperative factors that would maximize patient satisfaction and decrease the length of stay and complication rates, as well as hospital costs.4 Comprehensive literature on total knee arthroplasty (TKA) and total hip arthroplasty (THA) has demonstrated that the management of perioperative blood loss, specifically postoperative hemarthrosis, is a modifiable factor affecting patient recovery, complication rates, and hospital costs.5-8 Drain output has been used as a direct measure of intra-articular blood accumulation.9 Decreased drain output implies decreased hemarthrosis, which could potentially alleviate the pressure on the wound and decrease wound complications.
One of the major strategies that has been recognized for reducing blood loss and decreasing the potential for postoperative hemarthrosis is the use of intravenous (IV) or topical tranexamic acid (TXA).10,11 TXA is a synthetic antifibrinolytic medication that has been extensively used throughout the medical field since the 1960s to help control the bleeding cascade. This medication stabilizes clot formation without inducing a pro-coaguable state.12 Intraoperative administration of TXA has been shown to reduce drain output and decrease transfusion requirements after TKA and THA without an associated increase in patient morbidity and mortality.6,11,13-15
Currently, there is a lack of studies evaluating the utility of TXA during TAA. We hypothesize that compared with patients who had not received TXA, those who had received intraoperative TXA during TAA would have a reduction in postoperative drain output and therefore decreased hemarthrosis, lower wound complication rate, and a diminished change in preoperative to postoperative hemoglobin levels, reflecting a reduction in perioperative blood loss.
MATERIALS AND METHODS
This study was approved by the Institutional Review Board at the University at Buffalo, State University of New York. A retrospective chart review was conducted on 50 consecutive patients who underwent an uncemented TAA with the Salto Talaris total ankle prosthesis (Tornier, Inc) between September 2011 and December 2015. All surgeries were performed at 1 institution by a single fellowship surgeon trained in foot and ankle surgery through the anterior approach where a midline incision was made over the ankle. The interval between the tibialis anterior tendon and the extensor hallucis longus tendon was used. We had incorporated intraoperative TXA into the TAA surgical protocol at our institution in January 2014. We evaluated the first 25 consecutive patients who underwent TAA after TXA use began (TXA-TAA) and another 25 consecutive patients who underwent TAA before the routine use of TXA (No TXA-TAA). Inclusion criteria were patients who presented with pain, decreased function, and radiographic parameters of end-stage tibiotalar arthritis due to degenerative arthritis, rheumatoid arthritis, or posttraumatic arthritis who subsequently underwent a TAA. Exclusion criteria were patients with a contraindication for IV TXA use, a preexisting coagulopathy, or where drain output was not recorded. Contraindications for IV TXA use included patients with impaired renal clearance, recent cardiac surgery, myocardial infarction, ischemic stroke, or venous thromboembolism (VTE). Seven patients were ultimately excluded from this study based on the inclusion and exclusion criteria, 3 patients from the TXA-TAA group and 4 patients from the No TXA-TAA group.
Continue to: Charts were reviewed for demographics...
Charts were reviewed for demographics, preoperative and postoperative hemoglobin levels, indications for surgery, surgical procedures, length of surgery, postoperative drain output, length of stay, postoperative pain visual analog scale (VAS) score, minor and major wound complications, and postoperative complications. Minor wound complications were defined as the anterior surgical incision that required local wound care in office or oral antibiotics without subsequent consequences. Major wound complications were defined as requiring surgical débridement and/or any additional treatment in the operating room.16 Postoperative complications other than wound complications were defined as those requiring a subsequent surgical intervention. Patient demographics and clinical and procedural characteristics of patients in both the TXA-TAA and the No TXA-TAA groups are outlined in Table 1. There were 14 males and 11 females in the TXA-TAA group and 16 males and 9 females in the No TXA-TAA group. The mean age was 65.8 ± 10.9 years in the TXA-TAA group and 66.9 ± 8.0 years in the No TXA-TAA group (P = .69). Mean body mass index (BMI) was 31.6 ± 6.3 in the TXA-TAA group and 29.4 ± 4.9 in the No TXA-TAA group (P = .18). The primary indication for TAA was degenerative osteoarthritis in 26 patients, posttraumatic arthritis in 21 patients, and rheumatoid arthritis in 3 patients. The most common associated procedure was Achilles tendon lengthening in both groups. The mean follow-up in the TXA-TAA group was 9.3 ± 5.8 months (range, 2.0-24.0 months). Postoperative complications due to TXA administration as described in previous literature were defined as VTE, myocardial infarction, or ischemic cerebral event. The TXA-TAA group received a standard 1 g dose of IV TXA 20 minutes prior to tourniquet inflation. A tourniquet was used intraoperatively on all patients included in this study. A postoperative 400-mL surgical drain (Hemovac, Zimmer Biomet) was placed in the ankle joint in all patients and subsequently discontinued on postoperative day 1. Recent literature has reported the minor wound complication rate associated with TAA to be as high as 25% and the major wound complication rate to be 8.5%.16 To assist in reducing the risk for wound complications, our protocol traditionally uses an intra-articular surgical drain to decrease any pressure on the wound from postoperative hemarthrosis.
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aP value was calculated from t-test continuous variables and Chi-square test for categorical variables (TXA-TAA vs No TXA-TAA comparison).
Abbreviations: ASA, American Society of Anesthesiologists; BMI, body mass index.
Total drain output was recorded in milliliters (mL) in all patients. The change between the preoperative hemoglobin level and the hemoglobin level on postoperative day 1 was calculated for each patient. The calculated blood loss was determined using Meunier’s equation, which estimates the total blood volume using Nadler’s formula and then uses preoperative hemoglobin and postoperative day 1 hemoglobin values to calculate blood loss.17,18 VAS scores (scale, 1-10) were obtained every 4 hours on postoperative day 1 according to the nursing protocol. The number 1 on the scale represents the least amount of pain, whereas 10 indicates the worst pain. The VAS scores were then averaged for each patient.
A power analysis using preliminary data determined that 15 patients were needed in each group to detect a 50% reduction in drain output at a power of 80% and a P value of 0.05. Descriptive statistics were used to analyze demographic data. We compared the demographic and clinical characteristics of patients in the TXA-TAA group with those of patients in the No TXA-TAA group using unpaired student t-tests for continuous variables and Chi-square or Fischer’s exact tests for categorical variables. Simple and adjusted linear regression analyses were used to examine the difference in drain output and blood loss between the 2 groups (TXA-TAA vs No TXA-TAA). Multivariate models were adjusted for age, BMI, and length of surgery. A P value <.05 was considered to be statistically significant. We performed all analyses using a statistical software package (SAS version 9.2, SAS Institute).
RESULTS
Drain output was significantly less in the TXA-TAA group compared to that in the No TXA-TAA group (71.6 ± 60.3 vs 200.2 ± 117.0 mL, respectively, P = .0001) (Figure). The clinical characteristics of the patients who underwent TAA with the use of TXA are outlined in Table 2. The mean change in preoperative to postoperative hemoglobin levels was significantly lower in the TXA-TAA group than in the No TXA-TAA group (1.5 ± 0.6 vs 2.0 ± 0.4 g/dL, respectively; P = .01). The calculated blood loss in patients in the TXA-TAA group was significantly lower than that in patients in the No TXA-TAA group (649.9 ± 332.7 vs 906.8 ± 287.4 mL, respectively; P = .01). No patient in either group received a blood transfusion. We did not observe a significant difference in the length of surgery between the TXA-TAA and the No TXA-TAA groups (112.8 ± 24.8 vs 108.6 ± 26.0 min, respectively; P = .57). The average American Society of Anesthesiologists’ (ASA) classification was similar between the groups (2.2 ± 0.6 and 2.2 ± 0.5, respectively; P = 1.00) as was the age-adjusted Charlson Comorbidity Index (2.8 ± 1.7 vs 2.9 ± 1.6, respectively; P = .93). Mean VAS scores on postoperative day 1 in the TXA-TAA and the No TXA-TAA group were 4.9 ± 1.7 and 5.3 ± 1.4, respectively (P = .71). The average length of stay in the TXA-TAA group was 1.6 ± 0.7 days vs 1.3 ± 0.6 days in the No TXA-TAA group (P = .23). Two patients in the TXA-TAA group had an extended hospital length of stay of 5 days due to discharge planning and social issues.
Table 2. Clinical Characteristics of Total Ankle Arthroplasty (TAA) Patients by Use of Tranexamic Acid (TXA), N = 50 | |||
|---|---|---|---|
| TXA use in TAA | P valuea | |
| Yes (n = 25 cases) | No (n = 25 controls) |
|
Clinical Characteristic |
|
|
|
Drain Output (ml), mean ± SD
| 71.6 ± 60.3 | 200.2 ± 117.0 | <0.0001 |
Preoperative to Postoperative Hgb Change (g/dL), mean ± SD
| 1.5 ± 0.6 | 2.0 ± 0.4 | 0.01 |
Blood Loss Calculated (ml), mean ± SD
| 649.9 ± 332.73 | 906.8 ± 287.4 | 0.01 |
Length of Surgery (min), mean ± SD
| 112.8 ± 24.8 | 108.6 ± 26.0 | 0.57 |
VAS scores on the POD (No.), mean ± SD
| 4.9 ± 1.7 | 5.3 ±1.4 | 0.71 |
LOS (day), mean ± SD
| 1.6 ± 0.7 | 1.3 ± 0.6 | 0.23 |
aP value was calculated from t-test for continuous variables, and Chi-square test for categorical variables (TXA-TAA vs No TXA-TAA comparison).
Abbreviations: LOS, length of stay; VAS, visual analog scale; POD, postoperative day.
Table 3. Linear Regression Analyses of Drain Output and Blood Loss using Tranexamic Acid (TXA) in Total Ankle Arthroplasty (TAA), Unadjusted and Adjusted Models for Length of Surgery, N = 50 | ||||
| TXA Use in TAA (Yes vs No) | |||
Drain Output (mL)
| Regression coefficient (β) | SE | Test statistics (t) | P valuea |
Unadjusted Model | -128.6 | 26.3 | -4.89 | < 0.0001 |
Adjusted for Age | -129.6 | 26.5 | -4.89 | <0.0001 |
Adjusted for BMI | -121.8 | 26.6 | -4.57 | <0.0001 |
Adjusted for Length of Surgery | -129.6 | 26.6 | -4.86 | <0.0001 |
Multivariable Modelb | -123.4 | 27.1 | -4.55 | <0.0001 |
Blood Loss (mL)
|
|
|
|
|
Unadjusted Model | -257.0 | 87.9 | -2.92 | 0.005 |
Adjusted for Age | -263.7 | 87.4 | -3.02 | 0.004 |
Adjusted for BMI | -268.7 | 90.2 | -2.98 | 0.005 |
Adjusted for Length of Surgery | -261.3 | 88.6 | -2.94 | 0.005 |
Multivariable Modelb | -275.6 | 90.7 | -3.04 | 0.004 |
aLinear regression was used to calculate the P value. bAdjusted for age, BMI and length of surgery.
Abbreviation: BMI, body mass index.
Table 4. Patient Wound Complication Categories by Use of Tranexamic Acid (TXA) in Total Ankle Arthroplasty (TAA), N = 50 | |||
|---|---|---|---|
| TXA Use in TAA | P valuea | |
Wound Complication | Yes (n = 25 cases) | No (n = 25 controls) | 0.114 |
None, n = 46 (86%) | 23 (40%) | 20 (46%) |
|
Minor, n = 6 (12%) | 2 (4%) | 4 (8%) |
|
Major, n = 1 (2%) | 0 (0%) | 1 (4%) |
|
aP value was calculated from Fisher’s Exact test (67% cells had count <5) test for categorical variables (TXA-TAA vs No TXA-TAA comparison).
The crude linear regression model revealed a significant difference in drain output between the TXA-TAA and the No TXA-TAA groups (β = −128.6 ± 26.3, P < .0001) (Table 3). Further adjustment for age and length of surgery slightly strengthened the association (β = −129.6 ± 26.6, P < .0001). The nature of regression coefficient β showed that the mean estimate of drain output was 129.6 mL lower in the TXA-TAA group than that in the No TXA-TAA group. There was a significant difference in blood loss between the TXA-TAA and the No TXA-TAA groups in the crude linear regression model (β = −257.0 ± 87.9, P = .005). Additional adjustment for age, BMI, and length of surgery slightly strengthened the association (β = −275.6 ± 90.7, P = .004). The nature of regression coefficient β showed that the mean estimate of blood loss was 275.6 mL lower in the TXA-TAA group than in the No TXA-TAA group (Table 3).
Continue to: There was no statistically significant difference...
There was no statistically significant difference in wound complications between the TXA-TAA and the No TXA-TAA groups in this study population (P = .114). However, our results showed a higher overall wound complication rate in the No TXA-TAA group than in the TXA-TAA group (20% (5/25) vs 8% (2/25), respectively) (Table 4). In the No TXA-TAA group, there were 4 minor and 1 major wound complications. All 5 patients experiencing a postoperative wound complication required oral antibiotics for a minimum of 4 weeks and local wound care. One patient underwent a surgical débridement meeting the criteria for major wound complications. In the TXA-TAA group, there were 2 minor wound complications and no major wound complications. One patient was administered prophylactic oral antibiotics for 7 days with local wound care for blister formation without evidence of infection. The second patient experiencing a minor wound complication required 3 weeks of oral antibiotics and local wound care. No patients in either group had a deep infection requiring implant removal, IV antibiotics, or subsequent hospital admission. The surgical incisions in all patients healed after the aforementioned treatments with no persistent drainage or development of chronic wounds.
In the TXA-TAA group, there was 1 patient who sustained an intraoperative medial malleolus fracture. One patient developed an extensor hallucis longus contracture 5 months postoperatively that subsequently underwent release and lengthening. There was 1 patient in this group who sustained a distal tibia fracture 5 cm proximal to the prosthesis 3 months postoperatively after a mechanical fall. In the No TXA-TAA group, there were 2 patients who sustained intraoperative medial malleolus fractures. One patient underwent a revision of the tibial component 24 months postoperatively due to aseptic loosening. In addition, another patient in this group who sustained an Achilles tendon rupture 5 months postoperatively after a fall subsequently underwent repair with tibialis anterior tendon allograft.
There were no patients in either group who experienced any hospital readmissions in the acute follow-up period as defined by a 90-day period after discharge. There were no complications associated with TXA administration in either group.
DISCUSSION
Recent advances in total ankle prosthetic design coupled with increased survival and improved short- to midterm follow-up results make TAA an effective treatment option for end-stage ankle arthritis. Management of perioperative blood loss and reducing the potential for significant hemarthrosis and subsequent wound complications are important factors to consider for patients undergoing TAA. TXA administration is used in several centers as part of an intraoperative strategy to reduce blood loss and decrease intra-articular blood accumulation. To our knowledge, this is the first study to evaluate the management of blood loss and hemarthrosis using TXA during TAA.
IV and topical administrations of TXA have been demonstrated to be highly effective hemostatic agents in the perioperative period for TKA and THA.11 Recent literature has demonstrated a significant reduction in drain output and mean change in preoperative to postoperative hemoglobin levels in patients who received TXA compared to that in patients who did not receive TXA. The patients who did not receive TXA had more than twice as much drain output.5,10,14,19-21
Continue to: The ankle has a thin...
The ankle has a thin soft tissue envelope that does not have elaborate elastic properties. The soft tissue release and bleeding surfaces of the bone during TAA are not as extensive when compared with TKA and THA, but the intra-articular volume is smaller and the surrounding soft tissues may be less yielding when blood accumulation occurs.22 The vascular supply can be rich surrounding the ankle in the absence of arterial disease and is not as apt to tolerate dislocation and subluxation as in the case of THA or TKA.23 Shear forces can easily tear the branches of the anterior tibial artery that lie within the fascia that is continuous with the periosteum on the distal tibia.24 Reduction of hemarthrosis within the ankle joint may lead to a decrease in postoperative swelling, decreased pain, and increased range of motion due to the diminished potential for fibrosis. We also believe that there could be a reduced risk for wound complications. The current literature reports the rate of wound complications to be anywhere from 2% to 25%, with diabetes, inflammatory conditions, coronary artery disease, peripheral vascular disease, and smoking history >12-pack-years as risk factors.16,25,26 In this study, we observed a significant reduction in drain output and an overall reduced percentage of postoperative wound complications in patients who received TXA. These results demonstrate that TXA use decreases postoperative hemarthrosis.
TXA use in TKA and THA has been shown to decrease direct hospital costs and hospital length of stay.7,14,27 A recent study by Moskal and colleagues7 showed that topical TXA use has the potential to significantly decrease hospital man-hours for those patients undergoing TKA and achieve larger cost savings. Although there was no significant difference in the length of stay between the 2 groups, the average length of stay after TAA was shorter in both groups compared to the reported national average (1.49 vs 2.2 days, respectively).4 The administration of TXA in the appropriate patient has the potential to decrease hospital costs by controlling postoperative pain and swelling, allowing for earlier discharge. Long-term cost benefits could also include decreased infection rates and wound complications, and improved clinical outcomes because of improved range of motion and function scores.
The limitations of this study include the retrospective nature of its design and the relatively small sample size. The results showed nonstatistically significant differences in wound complications between the TXA-TAA and the No TXA-TAA groups, consistent with an insufficient sample size and thus inadequate power to detect the significant difference. However, this study clearly showed that the wound complication rates were higher in the No TXA-TAA group than in the TXA-TAA group, suggesting the importance of further similar studies using a larger sample size.
CONCLUSION
Current TAA offers a viable alternative to arthrodesis for end-stage ankle arthritis. TXA is an inexpensive and effective hemostatic agent used during TAA. If no major contraindication is present, routine use of TXA is recommended to assist in blood loss management, decrease postoperative hemarthrosis, and help to reduce the risk of postoperative wound complications.
ABSTRACT
Tranexamic acid (TXA) is an effective agent used for reducing perioperative blood loss and decreasing the potential for postoperative hemarthrosis. We hypothesized that patients who had received intraoperative TXA during total ankle arthroplasty (TAA) would have a reduction in postoperative drain output, thereby resulting in a reduced risk of postoperative hemarthrosis and lower wound complication rates.
A retrospective review was conducted on 50 consecutive patients, 25 receiving TXA (TXA-TAA) and 25 not receiving TXA (No TXA-TAA), who underwent an uncemented TAA between September 2011 and December 2015. Demographic characteristics, drain output, preoperative and postoperative hemoglobin levels, operative and postoperative course, and minor and major wound complications of the patients were reviewed.
Drain output was significantly less in the TXA-TAA group compared to that in the No TXA-TAA group (71.6 ± 60.3 vs 200.2 ± 117.0 mL, respectively, P < .0001). The overall wound complication rate in the No TXA-TAA group was higher (20%, 5/25) than that in the TXA-TAA group (8%, 2/25) (P = .114). The mean change in preoperative to postoperative hemoglobin level was significantly less in the TXA-TAA group compared to that in the No TXA-TAA group (1.5 ± 0.6 vs 2.0 ± 0.4 g/dL, respectively, P = .01).
TXA is an effective hemostatic agent when used during TAA. TXA reduces perioperative blood loss, hemarthrosis, and the risk of wound complications.
Continue to: End-stage ankle arthritis...
End-stage ankle arthritis is a disabling condition that may lead to poor quality of life and difficulties with activities of daily living.1 The associated mental and physical disability has been demonstrated to be as severe as in end-stage hip arthrosis.2 Operative treatment for symptomatic end-stage ankle arthritis includes arthrodesis or total ankle arthroplasty (TAA) in those refractory to nonoperative treatment.3 Newer generation implants have made TAA a more attractive option for both the surgeon and the patient.
Over the past decade, the utility of TAA has increased and attention has turned toward the management of perioperative factors that would maximize patient satisfaction and decrease the length of stay and complication rates, as well as hospital costs.4 Comprehensive literature on total knee arthroplasty (TKA) and total hip arthroplasty (THA) has demonstrated that the management of perioperative blood loss, specifically postoperative hemarthrosis, is a modifiable factor affecting patient recovery, complication rates, and hospital costs.5-8 Drain output has been used as a direct measure of intra-articular blood accumulation.9 Decreased drain output implies decreased hemarthrosis, which could potentially alleviate the pressure on the wound and decrease wound complications.
One of the major strategies that has been recognized for reducing blood loss and decreasing the potential for postoperative hemarthrosis is the use of intravenous (IV) or topical tranexamic acid (TXA).10,11 TXA is a synthetic antifibrinolytic medication that has been extensively used throughout the medical field since the 1960s to help control the bleeding cascade. This medication stabilizes clot formation without inducing a pro-coaguable state.12 Intraoperative administration of TXA has been shown to reduce drain output and decrease transfusion requirements after TKA and THA without an associated increase in patient morbidity and mortality.6,11,13-15
Currently, there is a lack of studies evaluating the utility of TXA during TAA. We hypothesize that compared with patients who had not received TXA, those who had received intraoperative TXA during TAA would have a reduction in postoperative drain output and therefore decreased hemarthrosis, lower wound complication rate, and a diminished change in preoperative to postoperative hemoglobin levels, reflecting a reduction in perioperative blood loss.
MATERIALS AND METHODS
This study was approved by the Institutional Review Board at the University at Buffalo, State University of New York. A retrospective chart review was conducted on 50 consecutive patients who underwent an uncemented TAA with the Salto Talaris total ankle prosthesis (Tornier, Inc) between September 2011 and December 2015. All surgeries were performed at 1 institution by a single fellowship surgeon trained in foot and ankle surgery through the anterior approach where a midline incision was made over the ankle. The interval between the tibialis anterior tendon and the extensor hallucis longus tendon was used. We had incorporated intraoperative TXA into the TAA surgical protocol at our institution in January 2014. We evaluated the first 25 consecutive patients who underwent TAA after TXA use began (TXA-TAA) and another 25 consecutive patients who underwent TAA before the routine use of TXA (No TXA-TAA). Inclusion criteria were patients who presented with pain, decreased function, and radiographic parameters of end-stage tibiotalar arthritis due to degenerative arthritis, rheumatoid arthritis, or posttraumatic arthritis who subsequently underwent a TAA. Exclusion criteria were patients with a contraindication for IV TXA use, a preexisting coagulopathy, or where drain output was not recorded. Contraindications for IV TXA use included patients with impaired renal clearance, recent cardiac surgery, myocardial infarction, ischemic stroke, or venous thromboembolism (VTE). Seven patients were ultimately excluded from this study based on the inclusion and exclusion criteria, 3 patients from the TXA-TAA group and 4 patients from the No TXA-TAA group.
Continue to: Charts were reviewed for demographics...
Charts were reviewed for demographics, preoperative and postoperative hemoglobin levels, indications for surgery, surgical procedures, length of surgery, postoperative drain output, length of stay, postoperative pain visual analog scale (VAS) score, minor and major wound complications, and postoperative complications. Minor wound complications were defined as the anterior surgical incision that required local wound care in office or oral antibiotics without subsequent consequences. Major wound complications were defined as requiring surgical débridement and/or any additional treatment in the operating room.16 Postoperative complications other than wound complications were defined as those requiring a subsequent surgical intervention. Patient demographics and clinical and procedural characteristics of patients in both the TXA-TAA and the No TXA-TAA groups are outlined in Table 1. There were 14 males and 11 females in the TXA-TAA group and 16 males and 9 females in the No TXA-TAA group. The mean age was 65.8 ± 10.9 years in the TXA-TAA group and 66.9 ± 8.0 years in the No TXA-TAA group (P = .69). Mean body mass index (BMI) was 31.6 ± 6.3 in the TXA-TAA group and 29.4 ± 4.9 in the No TXA-TAA group (P = .18). The primary indication for TAA was degenerative osteoarthritis in 26 patients, posttraumatic arthritis in 21 patients, and rheumatoid arthritis in 3 patients. The most common associated procedure was Achilles tendon lengthening in both groups. The mean follow-up in the TXA-TAA group was 9.3 ± 5.8 months (range, 2.0-24.0 months). Postoperative complications due to TXA administration as described in previous literature were defined as VTE, myocardial infarction, or ischemic cerebral event. The TXA-TAA group received a standard 1 g dose of IV TXA 20 minutes prior to tourniquet inflation. A tourniquet was used intraoperatively on all patients included in this study. A postoperative 400-mL surgical drain (Hemovac, Zimmer Biomet) was placed in the ankle joint in all patients and subsequently discontinued on postoperative day 1. Recent literature has reported the minor wound complication rate associated with TAA to be as high as 25% and the major wound complication rate to be 8.5%.16 To assist in reducing the risk for wound complications, our protocol traditionally uses an intra-articular surgical drain to decrease any pressure on the wound from postoperative hemarthrosis.
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aP value was calculated from t-test continuous variables and Chi-square test for categorical variables (TXA-TAA vs No TXA-TAA comparison).
Abbreviations: ASA, American Society of Anesthesiologists; BMI, body mass index.
Total drain output was recorded in milliliters (mL) in all patients. The change between the preoperative hemoglobin level and the hemoglobin level on postoperative day 1 was calculated for each patient. The calculated blood loss was determined using Meunier’s equation, which estimates the total blood volume using Nadler’s formula and then uses preoperative hemoglobin and postoperative day 1 hemoglobin values to calculate blood loss.17,18 VAS scores (scale, 1-10) were obtained every 4 hours on postoperative day 1 according to the nursing protocol. The number 1 on the scale represents the least amount of pain, whereas 10 indicates the worst pain. The VAS scores were then averaged for each patient.
A power analysis using preliminary data determined that 15 patients were needed in each group to detect a 50% reduction in drain output at a power of 80% and a P value of 0.05. Descriptive statistics were used to analyze demographic data. We compared the demographic and clinical characteristics of patients in the TXA-TAA group with those of patients in the No TXA-TAA group using unpaired student t-tests for continuous variables and Chi-square or Fischer’s exact tests for categorical variables. Simple and adjusted linear regression analyses were used to examine the difference in drain output and blood loss between the 2 groups (TXA-TAA vs No TXA-TAA). Multivariate models were adjusted for age, BMI, and length of surgery. A P value <.05 was considered to be statistically significant. We performed all analyses using a statistical software package (SAS version 9.2, SAS Institute).
RESULTS
Drain output was significantly less in the TXA-TAA group compared to that in the No TXA-TAA group (71.6 ± 60.3 vs 200.2 ± 117.0 mL, respectively, P = .0001) (Figure). The clinical characteristics of the patients who underwent TAA with the use of TXA are outlined in Table 2. The mean change in preoperative to postoperative hemoglobin levels was significantly lower in the TXA-TAA group than in the No TXA-TAA group (1.5 ± 0.6 vs 2.0 ± 0.4 g/dL, respectively; P = .01). The calculated blood loss in patients in the TXA-TAA group was significantly lower than that in patients in the No TXA-TAA group (649.9 ± 332.7 vs 906.8 ± 287.4 mL, respectively; P = .01). No patient in either group received a blood transfusion. We did not observe a significant difference in the length of surgery between the TXA-TAA and the No TXA-TAA groups (112.8 ± 24.8 vs 108.6 ± 26.0 min, respectively; P = .57). The average American Society of Anesthesiologists’ (ASA) classification was similar between the groups (2.2 ± 0.6 and 2.2 ± 0.5, respectively; P = 1.00) as was the age-adjusted Charlson Comorbidity Index (2.8 ± 1.7 vs 2.9 ± 1.6, respectively; P = .93). Mean VAS scores on postoperative day 1 in the TXA-TAA and the No TXA-TAA group were 4.9 ± 1.7 and 5.3 ± 1.4, respectively (P = .71). The average length of stay in the TXA-TAA group was 1.6 ± 0.7 days vs 1.3 ± 0.6 days in the No TXA-TAA group (P = .23). Two patients in the TXA-TAA group had an extended hospital length of stay of 5 days due to discharge planning and social issues.
Table 2. Clinical Characteristics of Total Ankle Arthroplasty (TAA) Patients by Use of Tranexamic Acid (TXA), N = 50 | |||
|---|---|---|---|
| TXA use in TAA | P valuea | |
| Yes (n = 25 cases) | No (n = 25 controls) |
|
Clinical Characteristic |
|
|
|
Drain Output (ml), mean ± SD
| 71.6 ± 60.3 | 200.2 ± 117.0 | <0.0001 |
Preoperative to Postoperative Hgb Change (g/dL), mean ± SD
| 1.5 ± 0.6 | 2.0 ± 0.4 | 0.01 |
Blood Loss Calculated (ml), mean ± SD
| 649.9 ± 332.73 | 906.8 ± 287.4 | 0.01 |
Length of Surgery (min), mean ± SD
| 112.8 ± 24.8 | 108.6 ± 26.0 | 0.57 |
VAS scores on the POD (No.), mean ± SD
| 4.9 ± 1.7 | 5.3 ±1.4 | 0.71 |
LOS (day), mean ± SD
| 1.6 ± 0.7 | 1.3 ± 0.6 | 0.23 |
aP value was calculated from t-test for continuous variables, and Chi-square test for categorical variables (TXA-TAA vs No TXA-TAA comparison).
Abbreviations: LOS, length of stay; VAS, visual analog scale; POD, postoperative day.
Table 3. Linear Regression Analyses of Drain Output and Blood Loss using Tranexamic Acid (TXA) in Total Ankle Arthroplasty (TAA), Unadjusted and Adjusted Models for Length of Surgery, N = 50 | ||||
| TXA Use in TAA (Yes vs No) | |||
Drain Output (mL)
| Regression coefficient (β) | SE | Test statistics (t) | P valuea |
Unadjusted Model | -128.6 | 26.3 | -4.89 | < 0.0001 |
Adjusted for Age | -129.6 | 26.5 | -4.89 | <0.0001 |
Adjusted for BMI | -121.8 | 26.6 | -4.57 | <0.0001 |
Adjusted for Length of Surgery | -129.6 | 26.6 | -4.86 | <0.0001 |
Multivariable Modelb | -123.4 | 27.1 | -4.55 | <0.0001 |
Blood Loss (mL)
|
|
|
|
|
Unadjusted Model | -257.0 | 87.9 | -2.92 | 0.005 |
Adjusted for Age | -263.7 | 87.4 | -3.02 | 0.004 |
Adjusted for BMI | -268.7 | 90.2 | -2.98 | 0.005 |
Adjusted for Length of Surgery | -261.3 | 88.6 | -2.94 | 0.005 |
Multivariable Modelb | -275.6 | 90.7 | -3.04 | 0.004 |
aLinear regression was used to calculate the P value. bAdjusted for age, BMI and length of surgery.
Abbreviation: BMI, body mass index.
Table 4. Patient Wound Complication Categories by Use of Tranexamic Acid (TXA) in Total Ankle Arthroplasty (TAA), N = 50 | |||
|---|---|---|---|
| TXA Use in TAA | P valuea | |
Wound Complication | Yes (n = 25 cases) | No (n = 25 controls) | 0.114 |
None, n = 46 (86%) | 23 (40%) | 20 (46%) |
|
Minor, n = 6 (12%) | 2 (4%) | 4 (8%) |
|
Major, n = 1 (2%) | 0 (0%) | 1 (4%) |
|
aP value was calculated from Fisher’s Exact test (67% cells had count <5) test for categorical variables (TXA-TAA vs No TXA-TAA comparison).
The crude linear regression model revealed a significant difference in drain output between the TXA-TAA and the No TXA-TAA groups (β = −128.6 ± 26.3, P < .0001) (Table 3). Further adjustment for age and length of surgery slightly strengthened the association (β = −129.6 ± 26.6, P < .0001). The nature of regression coefficient β showed that the mean estimate of drain output was 129.6 mL lower in the TXA-TAA group than that in the No TXA-TAA group. There was a significant difference in blood loss between the TXA-TAA and the No TXA-TAA groups in the crude linear regression model (β = −257.0 ± 87.9, P = .005). Additional adjustment for age, BMI, and length of surgery slightly strengthened the association (β = −275.6 ± 90.7, P = .004). The nature of regression coefficient β showed that the mean estimate of blood loss was 275.6 mL lower in the TXA-TAA group than in the No TXA-TAA group (Table 3).
Continue to: There was no statistically significant difference...
There was no statistically significant difference in wound complications between the TXA-TAA and the No TXA-TAA groups in this study population (P = .114). However, our results showed a higher overall wound complication rate in the No TXA-TAA group than in the TXA-TAA group (20% (5/25) vs 8% (2/25), respectively) (Table 4). In the No TXA-TAA group, there were 4 minor and 1 major wound complications. All 5 patients experiencing a postoperative wound complication required oral antibiotics for a minimum of 4 weeks and local wound care. One patient underwent a surgical débridement meeting the criteria for major wound complications. In the TXA-TAA group, there were 2 minor wound complications and no major wound complications. One patient was administered prophylactic oral antibiotics for 7 days with local wound care for blister formation without evidence of infection. The second patient experiencing a minor wound complication required 3 weeks of oral antibiotics and local wound care. No patients in either group had a deep infection requiring implant removal, IV antibiotics, or subsequent hospital admission. The surgical incisions in all patients healed after the aforementioned treatments with no persistent drainage or development of chronic wounds.
In the TXA-TAA group, there was 1 patient who sustained an intraoperative medial malleolus fracture. One patient developed an extensor hallucis longus contracture 5 months postoperatively that subsequently underwent release and lengthening. There was 1 patient in this group who sustained a distal tibia fracture 5 cm proximal to the prosthesis 3 months postoperatively after a mechanical fall. In the No TXA-TAA group, there were 2 patients who sustained intraoperative medial malleolus fractures. One patient underwent a revision of the tibial component 24 months postoperatively due to aseptic loosening. In addition, another patient in this group who sustained an Achilles tendon rupture 5 months postoperatively after a fall subsequently underwent repair with tibialis anterior tendon allograft.
There were no patients in either group who experienced any hospital readmissions in the acute follow-up period as defined by a 90-day period after discharge. There were no complications associated with TXA administration in either group.
DISCUSSION
Recent advances in total ankle prosthetic design coupled with increased survival and improved short- to midterm follow-up results make TAA an effective treatment option for end-stage ankle arthritis. Management of perioperative blood loss and reducing the potential for significant hemarthrosis and subsequent wound complications are important factors to consider for patients undergoing TAA. TXA administration is used in several centers as part of an intraoperative strategy to reduce blood loss and decrease intra-articular blood accumulation. To our knowledge, this is the first study to evaluate the management of blood loss and hemarthrosis using TXA during TAA.
IV and topical administrations of TXA have been demonstrated to be highly effective hemostatic agents in the perioperative period for TKA and THA.11 Recent literature has demonstrated a significant reduction in drain output and mean change in preoperative to postoperative hemoglobin levels in patients who received TXA compared to that in patients who did not receive TXA. The patients who did not receive TXA had more than twice as much drain output.5,10,14,19-21
Continue to: The ankle has a thin...
The ankle has a thin soft tissue envelope that does not have elaborate elastic properties. The soft tissue release and bleeding surfaces of the bone during TAA are not as extensive when compared with TKA and THA, but the intra-articular volume is smaller and the surrounding soft tissues may be less yielding when blood accumulation occurs.22 The vascular supply can be rich surrounding the ankle in the absence of arterial disease and is not as apt to tolerate dislocation and subluxation as in the case of THA or TKA.23 Shear forces can easily tear the branches of the anterior tibial artery that lie within the fascia that is continuous with the periosteum on the distal tibia.24 Reduction of hemarthrosis within the ankle joint may lead to a decrease in postoperative swelling, decreased pain, and increased range of motion due to the diminished potential for fibrosis. We also believe that there could be a reduced risk for wound complications. The current literature reports the rate of wound complications to be anywhere from 2% to 25%, with diabetes, inflammatory conditions, coronary artery disease, peripheral vascular disease, and smoking history >12-pack-years as risk factors.16,25,26 In this study, we observed a significant reduction in drain output and an overall reduced percentage of postoperative wound complications in patients who received TXA. These results demonstrate that TXA use decreases postoperative hemarthrosis.
TXA use in TKA and THA has been shown to decrease direct hospital costs and hospital length of stay.7,14,27 A recent study by Moskal and colleagues7 showed that topical TXA use has the potential to significantly decrease hospital man-hours for those patients undergoing TKA and achieve larger cost savings. Although there was no significant difference in the length of stay between the 2 groups, the average length of stay after TAA was shorter in both groups compared to the reported national average (1.49 vs 2.2 days, respectively).4 The administration of TXA in the appropriate patient has the potential to decrease hospital costs by controlling postoperative pain and swelling, allowing for earlier discharge. Long-term cost benefits could also include decreased infection rates and wound complications, and improved clinical outcomes because of improved range of motion and function scores.
The limitations of this study include the retrospective nature of its design and the relatively small sample size. The results showed nonstatistically significant differences in wound complications between the TXA-TAA and the No TXA-TAA groups, consistent with an insufficient sample size and thus inadequate power to detect the significant difference. However, this study clearly showed that the wound complication rates were higher in the No TXA-TAA group than in the TXA-TAA group, suggesting the importance of further similar studies using a larger sample size.
CONCLUSION
Current TAA offers a viable alternative to arthrodesis for end-stage ankle arthritis. TXA is an inexpensive and effective hemostatic agent used during TAA. If no major contraindication is present, routine use of TXA is recommended to assist in blood loss management, decrease postoperative hemarthrosis, and help to reduce the risk of postoperative wound complications.
1. Saltzman CL, Salamon ML, Blanchard GM, et al. Epidemiology of ankle arthritis: report of a consecutive series of 639 patients from a tertiary orthopaedic center. Iowa Orthop J. 2005;25:44-46.
2. Glazebrook M, Daniels T, Younger A, et al. Comparison of health-related quality of life between patients with end-stage ankle and hip arthrosis. J Bone Joint Surg Am. 2008;90(3):499-505. doi:10.2106/JBJS.F.01299.
3. Thomas RH, Daniels TR. Ankle arthritis. J Bone Joint Surg Am. 2003;85-A(5):923-936.
4. Zhou H, Yakavonis M, Shaw JJ, Patel A, Li X. In-patient trends and complications after total ankle arthroplasty in the United States. Orthopedics. 2016:1-6. doi:10.3928/01477447-20151228-05.
5. Benoni G, Fredin H. Fibrinolytic inhibition with tranexamic acid reduces blood loss and blood transfusion after knee arthroplasty: a prospective, randomised, double-blind study of 86 patients. J Bone Joint Surg Br. 1996;78(3):434-440.
6. Alshryda S, Sukeik M, Sarda P, Blenkinsopp J, Haddad FS, Mason JM. A systematic review and meta-analysis of the topical administration of tranexamic acid in total hip and knee replacement. Bone Joint J. 2014;96-B(8):1005-1015. doi:10.1302/0301-620X.96B8.33745.
7. Moskal JT, Harris RN, Capps SG. Transfusion cost savings with tranexamic acid in primary total knee arthroplasty from 2009 to 2012. J Arthroplasty. 2015;30(3):365-368. doi:10.1016/j.arth.2014.10.008.
8. Friedman R, Homering M, Holberg G, Berkowitz SD. Allogeneic blood transfusions and postoperative infections after total hip or knee arthroplasty. J Bone Joint Surg Am. 2014;96(4):272-278. doi:10.2106/JBJS.L.01268.
9. Aggarwal AK, Singh N, Sudesh P. Topical vs intravenous tranexamic acid in reducing blood loss after bilateral total knee arthroplasty: a prospective study. J Arthroplasty. 2016;31(7):1442-1448. doi:10.1016/j.arth.2015.12.033.
10. Su EP, Su S. Strategies for reducing peri-operative blood loss in total knee arthroplasty. Bone Joint J. 2016;98-B(1 Suppl A):98-100. doi:10.1302/0301-620X.98B.36430.
11. Gomez-Barrena E, Ortega-Andreu M, Padilla-Eguiluz NG, Perez-Chrzanowska H, Figueredo-Zalve R. Topical intra-articular compared with intravenous tranexamic acid to reduce blood loss in primary total knee replacement: a double-blind, randomized, controlled, noninferiority clinical trial. J Bone Joint Surg Am. 2014;96(23):1937-1944. doi:10.2106/JBJS.N.00060.
12. Cap AP, Baer DG, Orman JA, Aden J, Ryan K, Blackbourne LH. Tranexamic acid for trauma patients: a critical review of the literature. J Trauma. 2011;71(1 Suppl):S9-14. doi:10.1097/TA.0b013e31822114af.
13. Duncan CM, Gillette BP, Jacob AK, Sierra RJ, Sanchez-Sotelo J, Smith HM. Venous thromboembolism and mortality associated with tranexamic acid use during total hip and knee arthroplasty. J Arthroplasty. 2015;30(2):272-276. doi:10.1016/j.arth.2014.08.022.
14. Alshryda S, Mason J, Vaghela M, et al. Topical (intra-articular) tranexamic acid reduces blood loss and transfusion rates following total knee replacement: a randomized controlled trial (TRANX-K). J Bone Joint Surg Am. 2013;95(21):1961-1968. doi:10.2106/JBJS.L.00907.
15. Ng W, Jerath A, Wasowicz M. Tranexamic acid: a clinical review. Anaesthesiol Intensive Ther. 2015;47(4):339-350. doi:10.5603/AIT.a2015.0011.
16. Raikin SM, Kane J, Ciminiello ME. Risk factors for incision-healing complications following total ankle arthroplasty. J Bone Joint Surg Am. 2010;92(12):2150-2155. doi:10.2106/JBJS.I.00870.
17. Meunier A, Petersson A, Good L, Berlin G. Validation of a haemoglobin dilution method for estimation of blood loss. Vox Sang. 2008;95(2):120-124. doi:10.1111/j.1423-0410.2008.01071.x.
18. Gibon E, Courpied JP, Hamadouche M. Total joint replacement and blood loss: what is the best equation? Int Orthop. 2013;37(4):735-739. doi:10.1007/s00264-013-1801-0
19. Chareancholvanich K, Siriwattanasakul P, Narkbunnam R, Pornrattanamaneewong C. Temporary clamping of drain combined with tranexamic acid reduce blood loss after total knee arthroplasty: a prospective randomized controlled trial. BMC Musculoskelet Disord. 2012;13:124.
20. Orpen NM, Little C, Walker G, Crawfurd EJ. Tranexamic acid reduces early post-operative blood loss after total knee arthroplasty: a prospective randomised controlled trial of 29 patients. Knee. 2006;13(2):106-110. doi:10.1016/j.knee.2005.11.001.
21. Veien M, Sorensen JV, Madsen F, Juelsgaard P. Tranexamic acid given intraoperatively reduces blood loss after total knee replacement: a randomized, controlled study. Acta Anaesthesiol Scand. 2002;46(10):1206-1211.
22. Draeger RW, Singh B, Parekh SG. Quantifying normal ankle joint volume: An anatomic study. Indian J Orthop. 2009;43(1):72-75. doi:10.4103/0019-5413.45326.
23. Gill LH. Challenges in total ankle arthroplasty. Foot Ankle Int. 2004;25(4):195-207. doi:10.1177/107110070402500402.
24. Taylor GI, Pan WR. Angiosomes of the leg: anatomic study and clinical implications. Plast Reconstr Surg. 1998;102(3):599-616; discussion 617-598. doi:10.1097/00006534-199809030-00001.
25. Gougoulias N, Khanna A, Maffulli N. How successful are current ankle replacements?: a systematic review of the literature. Clin Orthop Relat Res. 2010;468(1):199-208. doi:10.1007/s11999-009-0987-3.
26. Noelle S, Egidy CC, Cross MB, Gebauer M, Klauser W. Complication rates after total ankle arthroplasty in one hundred consecutive prostheses. Int Orthop. 2013;37(9):1789-1794. doi:10.1007/s00264-013-1971-9.
27. Chimento GF, Huff T, Ochsner JL Jr, Meyer M, Brandner L, Babin S. An evaluation of the use of topical tranexamic acid in total knee arthroplasty. J Arthroplasty. 2013;28(8 Suppl):74-77. doi:10.1016/j.arth.2013.06.037.
1. Saltzman CL, Salamon ML, Blanchard GM, et al. Epidemiology of ankle arthritis: report of a consecutive series of 639 patients from a tertiary orthopaedic center. Iowa Orthop J. 2005;25:44-46.
2. Glazebrook M, Daniels T, Younger A, et al. Comparison of health-related quality of life between patients with end-stage ankle and hip arthrosis. J Bone Joint Surg Am. 2008;90(3):499-505. doi:10.2106/JBJS.F.01299.
3. Thomas RH, Daniels TR. Ankle arthritis. J Bone Joint Surg Am. 2003;85-A(5):923-936.
4. Zhou H, Yakavonis M, Shaw JJ, Patel A, Li X. In-patient trends and complications after total ankle arthroplasty in the United States. Orthopedics. 2016:1-6. doi:10.3928/01477447-20151228-05.
5. Benoni G, Fredin H. Fibrinolytic inhibition with tranexamic acid reduces blood loss and blood transfusion after knee arthroplasty: a prospective, randomised, double-blind study of 86 patients. J Bone Joint Surg Br. 1996;78(3):434-440.
6. Alshryda S, Sukeik M, Sarda P, Blenkinsopp J, Haddad FS, Mason JM. A systematic review and meta-analysis of the topical administration of tranexamic acid in total hip and knee replacement. Bone Joint J. 2014;96-B(8):1005-1015. doi:10.1302/0301-620X.96B8.33745.
7. Moskal JT, Harris RN, Capps SG. Transfusion cost savings with tranexamic acid in primary total knee arthroplasty from 2009 to 2012. J Arthroplasty. 2015;30(3):365-368. doi:10.1016/j.arth.2014.10.008.
8. Friedman R, Homering M, Holberg G, Berkowitz SD. Allogeneic blood transfusions and postoperative infections after total hip or knee arthroplasty. J Bone Joint Surg Am. 2014;96(4):272-278. doi:10.2106/JBJS.L.01268.
9. Aggarwal AK, Singh N, Sudesh P. Topical vs intravenous tranexamic acid in reducing blood loss after bilateral total knee arthroplasty: a prospective study. J Arthroplasty. 2016;31(7):1442-1448. doi:10.1016/j.arth.2015.12.033.
10. Su EP, Su S. Strategies for reducing peri-operative blood loss in total knee arthroplasty. Bone Joint J. 2016;98-B(1 Suppl A):98-100. doi:10.1302/0301-620X.98B.36430.
11. Gomez-Barrena E, Ortega-Andreu M, Padilla-Eguiluz NG, Perez-Chrzanowska H, Figueredo-Zalve R. Topical intra-articular compared with intravenous tranexamic acid to reduce blood loss in primary total knee replacement: a double-blind, randomized, controlled, noninferiority clinical trial. J Bone Joint Surg Am. 2014;96(23):1937-1944. doi:10.2106/JBJS.N.00060.
12. Cap AP, Baer DG, Orman JA, Aden J, Ryan K, Blackbourne LH. Tranexamic acid for trauma patients: a critical review of the literature. J Trauma. 2011;71(1 Suppl):S9-14. doi:10.1097/TA.0b013e31822114af.
13. Duncan CM, Gillette BP, Jacob AK, Sierra RJ, Sanchez-Sotelo J, Smith HM. Venous thromboembolism and mortality associated with tranexamic acid use during total hip and knee arthroplasty. J Arthroplasty. 2015;30(2):272-276. doi:10.1016/j.arth.2014.08.022.
14. Alshryda S, Mason J, Vaghela M, et al. Topical (intra-articular) tranexamic acid reduces blood loss and transfusion rates following total knee replacement: a randomized controlled trial (TRANX-K). J Bone Joint Surg Am. 2013;95(21):1961-1968. doi:10.2106/JBJS.L.00907.
15. Ng W, Jerath A, Wasowicz M. Tranexamic acid: a clinical review. Anaesthesiol Intensive Ther. 2015;47(4):339-350. doi:10.5603/AIT.a2015.0011.
16. Raikin SM, Kane J, Ciminiello ME. Risk factors for incision-healing complications following total ankle arthroplasty. J Bone Joint Surg Am. 2010;92(12):2150-2155. doi:10.2106/JBJS.I.00870.
17. Meunier A, Petersson A, Good L, Berlin G. Validation of a haemoglobin dilution method for estimation of blood loss. Vox Sang. 2008;95(2):120-124. doi:10.1111/j.1423-0410.2008.01071.x.
18. Gibon E, Courpied JP, Hamadouche M. Total joint replacement and blood loss: what is the best equation? Int Orthop. 2013;37(4):735-739. doi:10.1007/s00264-013-1801-0
19. Chareancholvanich K, Siriwattanasakul P, Narkbunnam R, Pornrattanamaneewong C. Temporary clamping of drain combined with tranexamic acid reduce blood loss after total knee arthroplasty: a prospective randomized controlled trial. BMC Musculoskelet Disord. 2012;13:124.
20. Orpen NM, Little C, Walker G, Crawfurd EJ. Tranexamic acid reduces early post-operative blood loss after total knee arthroplasty: a prospective randomised controlled trial of 29 patients. Knee. 2006;13(2):106-110. doi:10.1016/j.knee.2005.11.001.
21. Veien M, Sorensen JV, Madsen F, Juelsgaard P. Tranexamic acid given intraoperatively reduces blood loss after total knee replacement: a randomized, controlled study. Acta Anaesthesiol Scand. 2002;46(10):1206-1211.
22. Draeger RW, Singh B, Parekh SG. Quantifying normal ankle joint volume: An anatomic study. Indian J Orthop. 2009;43(1):72-75. doi:10.4103/0019-5413.45326.
23. Gill LH. Challenges in total ankle arthroplasty. Foot Ankle Int. 2004;25(4):195-207. doi:10.1177/107110070402500402.
24. Taylor GI, Pan WR. Angiosomes of the leg: anatomic study and clinical implications. Plast Reconstr Surg. 1998;102(3):599-616; discussion 617-598. doi:10.1097/00006534-199809030-00001.
25. Gougoulias N, Khanna A, Maffulli N. How successful are current ankle replacements?: a systematic review of the literature. Clin Orthop Relat Res. 2010;468(1):199-208. doi:10.1007/s11999-009-0987-3.
26. Noelle S, Egidy CC, Cross MB, Gebauer M, Klauser W. Complication rates after total ankle arthroplasty in one hundred consecutive prostheses. Int Orthop. 2013;37(9):1789-1794. doi:10.1007/s00264-013-1971-9.
27. Chimento GF, Huff T, Ochsner JL Jr, Meyer M, Brandner L, Babin S. An evaluation of the use of topical tranexamic acid in total knee arthroplasty. J Arthroplasty. 2013;28(8 Suppl):74-77. doi:10.1016/j.arth.2013.06.037.
TAKE-HOME POINTS
- TXA is an inexpensive and effective hemostatic agent used during TAA.
- The ankle has a thin soft tissue envelope that does not have elaborate elastic properties. The soft tissue release and bleeding surfaces of bone during TAA are not as extensive when compared to TKA and THA, but the intra-articular volume is smaller and surrounding soft tissues may be less yielding when blood accumulation occurs.
- If no major contraindication is present, routine use of TXA is recommended to assist in blood loss management during TAA.
- TXA decreases postoperative hemarthrosis and helps to reduce the risk of postoperative wound complications.
- The administration of TXA in the appropriate patient has the potential to decrease hospital cost by controlling postoperative pain and swelling allowing for earlier discharge.
Total Joint Arthroplasty Quality Ratings: How Are They Similar and How Are They Different?
ABSTRACT
A patient’s perception of hospital or provider quality can have far-reaching effects, as it can impact reimbursement, patient selection of a surgeon, and healthcare competition. A variety of organizations offer quality designations for orthopedic surgery and its subspecialties. Our goal is to compare total joint arthroplasty (TJA) quality designation methodology across key quality rating organizations. One researcher conducted an initial Google search to determine organizations providing quality designations for hospitals and surgeons providing orthopedic procedures with a focus on TJA. Organizations that offer quality designation specific to TJA were determined. Organizations that provided general orthopedic surgery or only surgeon-specific quality designation were excluded from the analysis. The senior author confirmed the inclusion of the final organizations. Seven organizations fit our inclusion criteria. Only the private payers and The Joint Commission required hospital accreditation to meet quality designation criteria. Total arthroplasty volume was considered in 86% of the organizations’ methodologies, and 57% of organizations utilized process measurements such as antibiotic prophylaxis and care pathways. In addition, 57% of organizations included patient experience in their methodologies. Only 29% of organizations included a cost element in their methodology. All organizations utilized outcome data and publicly reported all hospitals receiving their quality designation. Hospital quality designation methodologies are inconsistent in the context of TJA. All stakeholders (ie, providers, payers, and patients) should be involved in deciding the definition of quality.
Continue to: Healthcare in the United States...
Healthcare in the United States has begun to move toward a system focused on value for patients, defined as health outcome per dollar expended.1 Indeed, an estimated 30% of Medicare payments are now made using the so-called alternative payment models (eg, bundled payments),2 and there is an expectation that consumerism in medicine will continue to expand.3 In addition, although there is a continuing debate regarding the benefits and pitfalls of hospital mergers, there is no question whether provider consolidation has increased dramatically in recent years.4 At the core of many of these changes is the push to improve healthcare quality and reduce costs.
Quality has the ability to affect payment, patient selection of providers, and hospital competition. Patients (ie, healthcare consumers) are increasingly using the Internet to find a variety of health information.5 Accessible provider quality information online would allow patients to make more informed decisions about where to seek care. In addition, the development of transparent quality ratings could assist payers in driving beneficiaries to higher quality and better value providers, which could mean more business for the highest quality physicians and better patient outcomes with fewer complications. Some payers such as the Centers for Medicare and Medicaid Services (CMS) have already started using quality measures as part of their reimbursement strategy.6 Because CMS is the largest payer in the United States, private insurers tend to follow their lead; thus, quality measurements will become even more common as a factor in reimbursement over the coming years.
To make quality ratings useful, “quality” must be clearly defined. Clarity around which factors are considered in a quality designation will create transparency for patients and allow providers to understand how their performance is being measured so that they focus on improving outcomes for their patients. Numerous organizations, including private payers, public payers, and both not-for-profit and for-profit entities, have created quality designation programs to rate providers. However, within orthopedics and several other medical specialties, there has been an ongoing debate about what measures best reflect quality.7 Although inconsistencies in quality ratings in arthroplasty care have been noted,8 it remains unknown how each quality designation program compares with the others in terms of the factors considered in deciding quality designations.
The purpose of this study is to evaluate publicly available information from key quality designation programs for total joint arthroplasty (TJA) providers to determine what factors are considered by each organization in awarding quality designations; what similarities and differences in quality designations exist across the different organizations; and how many of the organizations publish their quality designation methodologies and final rating results.
MATERIALS AND METHODS
A directed Google search was conducted to determine organizations (ie, payers, independent firms, and government entities) that rate hospitals and/or surgeons in orthopedic surgery. The identified organizations were then examined to determine whether they provided hospital ratings for total hip and/or knee arthroplasty. Entities were included if they provided quality designations for hospitals specifically addressing TJA. Organizations that provided only general hospital, other surgical procedures, orthopedic surgery, or orthopedic surgeon-specific quality designations were excluded. A list of all organizations determined to fit the inclusion criteria was then reviewed for completeness and approved by the senior author.
Continue to: One investigator reviewed the website of each organization...
One investigator reviewed the website of each organization fitting the inclusion criteria to determine the full rating methodology in 1 sitting on July 2, 2016. Detailed notes were taken on each program using publicly available information. For organizations that used proprietary criteria for quality designation (eg, The Joint Commission [TJC]), only publicly available information was used in the analysis. Therefore, the information reported is solely based on data available online to the public.
Detailed quality designation criteria were condensed into broader categories (accreditation, volume, structural, process, outcomes, patient experience, and cost/efficiency) to capture differences between each organization reviewed. In addition, we recorded whether each organization published a list of providers that received its quality designation.
RESULTS
A total of 7 organizations fit our inclusion criteria9-15 (Table). Of these 7 organizations, 3 were private payers (Aetna, UnitedHealth, and Blue Cross Blue Shield [BCBS]), 2 were nongovernmental not-for-profit organizations (TJC and Consumer Reports), and 2 were consumer-based and/or for-profit organizations (HealthGrades and US News & World Report [USNWR]). There were no government agencies that fit our inclusion criteria. BCBS had the following 2 separate quality designations: BCBS Blue Distinction and BCBS Blue Distinction+. The only difference between the 2 BCBS ratings is that BCBS Blue Distinction+ includes cost efficiency ratings, whereas BCBS Blue Distinction does not.
Only the 3 private payers and TJC, the primary hospital accreditation body in the United States, required accreditation as part of its quality designation criteria. TJC requires its own accreditation for quality designation consideration, whereas the 3 private payers allow accreditation from one of a variety of sources. Aetna Institutes of Quality for Orthopedic Surgery requires accreditation by TJC, Healthcare Facilities Accreditation Program, American Osteopathic Association, National Integrated Accreditation for Healthcare Organizations, or Det Norske Veritas Healthcare. UnitedHealth Premium Total Joint Replacement (TJR) Specialty Center requires accreditation by TJC and/or equivalent of TJC accreditation. However, TJC accreditation equivalents are not noted in the UnitedHealth handbook. BCBS Blue Distinction and Distinction+ require accreditation by TJC, Healthcare Facilities Accreditation Program, National Integrated Accreditation for Healthcare Organizations, or Center for Improvement in Healthcare Quality. In addition, BCBS is willing to consider alternative accreditations that are at least as stringent as the national alternatives noted. However, no detailed criteria that must be met to be equivalent to the national standards are noted in the relevant quality designation handbook.
The volume of completed total hip and knee arthroplasty procedures was considered in 6 of the organizations’ quality ratings methodologies. Of those 6, all private payers, TJC (not-for-profit), and 2 for-profit rating agencies were included. Surgeon specialization in TJA was only explicitly noted as a factor considered in UnitedHealth Premium TJR Specialty Center criteria; however, the requirements for surgeon specialization were not clearly defined. In addition, the presence of a multidisciplinary clinical pathway was only explicitly considered for Aetna Institutes of Quality for Orthopedic Surgery.
Structural requirements (eg, use of electronic health records [EHR], staffing levels, etc.) were taken into account in private payer and USNWR quality methodologies. Process measures (eg, antibiotic prophylaxis and other care pathways) were considered for the private payers and TJC but not for USNWR quality designation. Cost and/or efficiency measures were factors in the quality formula for Aetna Institutes of Quality for Orthopedic Surgery and BCBS Distinction+. Aetna utilizes its own cost data and risk-adjusts using a product known as Symmetry Episode Risk Groups to determine cost-effectiveness, while BCBS uses its own Composite Facility Cost Index. Patient experience (eg, Hospital Consumer Assessment of Healthcare Providers and Systems [HCAHPS]) was incorporated into the quality formulas for 4 of the 7 quality designation programs examined.
Continue to: All of the 7 quality designation programs included...
All of the 7 quality designation programs included outcomes (ie, readmission rates and/or mortality rates) and publicly reported the hospitals receiving their quality designation. In contrast, only Aetna explicitly included the presence of multidisciplinary clinical care pathways as part of their quality designation criteria. In addition, only UnitedHealth included surgeon specialization in joint arthroplasty as a factor for quality consideration for its quality designation program. BCBS Distinction+ and Aetna Institutes of Quality for Orthopedic Surgery were the only 2 quality designations that included at least 1 variable that fit into each of the 7 characteristics considered (accreditation, volume, structural, process, outcomes, patient experience, and cost/efficiency).
DISCUSSION
As healthcare continues to shift toward value-based delivery and payment models, quality becomes a critical factor in reimbursement and provider rankings. However, quality is a vague term. Several providers probably do not know what is required to be designated as high quality by a particular rating agency. Moreover, there are multiple quality designation programs, all using distinct criteria to determine “quality,” which further complicates the matter. Our objective was to determine the key stakeholders that provide quality designations in TJA and what criteria each organization uses in assessing quality.
Our idea of comprehensive quality is based on Avedis Donabedian’s enduring framework for healthcare quality focused on structure, process, and outcome.16 We expanded on these 3 areas and analyzed quality designations based on variables fitting into the following categories: accreditation, volume, structural, process, outcomes, patient experience, and cost/efficiency. We believe that these categories encompass a comprehensive rating system that addresses key elements of patient care. However, our results suggest that only 2 major quality designations (BCBS Distinction+ and Aetna Institutes of Quality for Orthopedic Surgery) take all such variables into account.
All quality designation programs that we analyzed required outcome data (ie, readmission and/or mortality rates within 30 days); however, only 2 programs utilized cost in their quality designation criteria (BCBS Distinction+ and Aetna Institutes of Quality for Orthopedic Surgery). Aetna Institutes of Quality for Orthopedic Surgery risk-adjusted for its cost-effectiveness calculations based on age, sex, and other unspecified conditions using a product known as Symmetry Episode Risk Groups. However, the organization also noted that although it did risk-adjust for inpatient mortality, it did not do so for pulmonary embolism or deep vein thrombosis. BCBS Distinction+ also utilized risk adjustment for its cost efficiency measure, and its step-by-step methodology is available online. Further, Consumer Reports does risk-adjust using logistic regression models in their quality analysis, but the description provided is minimal; it is noted that such risk adjustments are already completed by CMS prior to Consumer Reports acquiring the data. The CMS Compare model information is available on the CMS website. The data utilized by several organizations and presented on CMS Compare are already risk-adjusted using CMS’ approach. In contrast, UnitedHealth Premium TJR Specialty Center gathers its own data from providers and does not describe a risk adjustment methodology. Risk adjustment is important because the lack of risk adjustment may lead to physicians “cherry-picking” easy cases to boost positive outcomes, leading to increased financial benefits and higher quality ratings. Having a consistent risk adjustment formula will ensure accurate comparisons across outcomes and cost-effectiveness measures used by quality designation programs.
Factors considered for quality designation varied greatly from one organization to the other. The range of categories of factors considered varied from 1 (Consumer Reports only considered outcome data) to all 7 categories (BCBS Distinction+ and Aetna Institutes of Quality for Orthopedic Surgery). Our findings are consistent with the work by Keswani and colleagues,8 which showed that there is likely variation in factors considered when rating hospital quality more broadly. Our work suggests that quality designation formulas do not appear to get more consistent when focused on TJA.
We found that all organizations in our analysis published the providers earning their quality designation. However, TJC does not provide publicly a detailed methodology on how to qualify for its quality designation. The price to purchase the necessary manual for this information is $146.00 for accredited organizations and $186.00 for all others.17 For large healthcare providers, this is not a large sum of money. Nonetheless, this provides an additional hurdle for stakeholders to gain a full understanding of the requirements to receive a TJC Gold Seal for Orthopedics.
Previous work has evaluated the consistency of and the variety of means of gauging healthcare quality. Previous work by Rothberg and colleagues18 comparing hospital rankings across 5 common consumer-oriented websites found disagreement on hospital rankings within any diagnosis and even among metrics such as mortality. Another study by Halasyamani and Davis19 found that CMS Compare and USNWR rankings were dissimilar and the authors attributed the discrepancy to different methodologies. In addition, a study by Krumholz and colleagues20 focused on Internet report cards, which measured the appropriate use of select medications and mortality rates for acute myocardial infarction as the quality metrics. The authors found that, in aggregate, there was a clear difference in quality of care and outcomes but that comparisons between 2 hospitals provided poor discrimination.20 Other work has analyzed the increasing trend of online ratings of orthopedic surgeons by patients.21 However, there remains no agreed-upon definition of quality. Thus, the use of the term “quality” in several studies may be misleading.
Our results must be interpreted keeping the limitations of our work in mind. First, we used expert knowledge and a public search engine to develop our list of organizations that provide TJA quality designations. However, there is a possibility that we did not include all relevant organizations. Second, although all authors reviewed the final data, it is possible that there was human error in the analysis of each organization’s quality designation criteria.
CONCLUSION
As healthcare progresses further toward a system that rewards providers for delivering value to patients, accurately defining and measuring quality becomes critical because it can be suggestive of value to patients, payers, and providers. Furthermore, it gives providers a goal to focus on as they strive to improve the value of care they deliver to patients. Measuring healthcare quality is currently a novel, imperfect science,22 and there continues to be a debate about what factors should be included in a quality designation formula. Nonetheless, more and more quality designations and performance measurements are being created for orthopedic care, including total hip and total knee arthroplasty. In fact, in 2016, The Leapfrog Group added readmission for patients undergoing TJA to its survey.23 Consensus on a quality definition may facilitate the movement toward a value-based healthcare system. Future research should evaluate strategies for gaining consensus among stakeholders for a universal quality metric in TJA. Surgeons, hospitals, payers, and most importantly patients should play critical roles in defining quality.
- Porter ME. A strategy for health care reform--toward a value-based system. N Engl J Med. 2009;361(2):109-112. doi:10.1056/NEJMp0904131.
- Obama B. United States health care reform: progress to date and next steps. JAMA. 2016;316(5):525-532. doi:10.1001/jama.2016.9797.
- Mulvany C. The march to consumerism the evolution from patient to active shopper continues. Healthc Financ Manage. 2014;68(2):36-38.
- Tsai TC, Jha AK. Hospital consolidation, competition, and quality: is bigger necessarily better? JAMA. 2014;312(1):29-30. doi:10.1001/jama.2014.4692.
- Cline RJ, Haynes KM. Consumer health information seeking on the Internet: the state of the art. Health Educ Res. 2001;16(6):671-692. doi:10.1093/her/16.6.671.
- Werner RM, Kolstad JT, Stuart EA, Polsky D. The effect of pay-for-performance in hospitals: lessons for quality improvement. Health Aff (Millwood). 2011;30(4):690-698. doi:10.1377/hlthaff.2010.1277.
- Birkmeyer JD, Dimick JB, Birkmeyer NJ. Measuring the quality of surgical care: structure, process, or outcomes? J Am Coll Surg. 2004;198(4):626-632. doi:10.1016/j.jamcollsurg.2003.11.017.
- Keswani A, Uhler LM, Bozic KJ. What quality metrics is my hospital being evaluated on and what are the consequences? J Arthroplast. 2016;31(6):1139-1143. doi:10.1016/j.arth.2016.01.075.
- Aetna Inc. Aetna Institutes of Quality® facilities fact book. A comprehensive reference guide for Aetna members, doctors and health care professionals. http://www.aetna.com/individuals-families-health-insurance/document-libr.... Accessed July 2, 2016.
- United HealthCare. UnitedHealth Premium® Program. https://www.uhcprovider.com/en/reports-quality-programs/premium-designation.html. Accessed July 2, 2016.
- 11. Blue Cross Blue Shield. Association. Blue Distinction Specialty Care. Selection criteria and program documentation: knee and hip replacement and spine surgery. https://www.bcbs.com/sites/default/files/fileattachments/page/KneeHip.SelectionCriteria_0.pdf. Published October 2015. Accessed July 2, 2016.
- The Joint Commission. Advanced certification for total hip and total knee replacement eligibility. https://www.jointcommission.org/advanced_certification_for_total_hip_and.... Published December 10, 2015. Accessed July 2, 2016.
- Healthgrades Operating Company. Healthgrades methodology: anatomy of a rating. https://www.healthgrades.com/quality/ratings-awards/methodology. Accessed July 2, 2016.
- Comarow A, Harder B; Dr. Foster Project Team. Methodology: U.S. News & World Report best hospitals for common care. U.S. News & World Report Web site. http://www.usnews.com/pubfiles/BHCC_MethReport_2015.pdf. Published May 20, 2015. Accessed July 2, 2016.
- Consumer Reports. How we rate hospitals. http://static3.consumerreportscdn.org/content/dam/cro/news_articles/heal.... Accessed July 2, 2016.
- Ayanian JZ, Markel H. Donabedian’s lasting framework for health care quality. N Engl J Med. 2016;375(3):205-207. doi:10.1056/NEJMp1605101.
- The Joint Commission. 2016 Certification Manuals. 2016; http://www.jcrinc.com/2016-certification-manuals/. Accessed July 2, 2016.
- Rothberg MB, Morsi E, Benjamin EM, Pekow PS, Lindenauer PK. Choosing the best hospital: the limitations of public quality reporting. Health Aff (Millwood). 2008;27(6):1680-1687. doi:10.1377/hlthaff.27.6.1680.
- Halasyamani LK, Davis MM. Conflicting measures of hospital quality: ratings from "Hospital Compare" versus "Best Hospitals". J Hosp Med. 2007;2(3):128-134. doi:10.1002/jhm.176.
- Krumholz HM, Rathore SS, Chen J, Wang Y, Radford MJ. Evaluation of a consumer-oriented internet health care report card: the risk of quality ratings based on mortality data. JAMA. 2002;287(10):1277-1287.
- Frost C, Mesfin A. Online reviews of orthopedic surgeons: an emerging trend. Orthopedics. 2015;38(4):e257-e262. doi:10.3928/01477447-20150402-52.
- Harder B, Comarow A. Hospital Quality reporting by US News & World Report: why, how, and what's ahead. JAMA. 2015;313(19):1903-1904. doi:10.1001/jama.2015.4566.
- The Leapfrog Group. New in 2016. http://www.leapfroggroup.org/ratings-reports/new-2016. Accessed July 2, 2016.
ABSTRACT
A patient’s perception of hospital or provider quality can have far-reaching effects, as it can impact reimbursement, patient selection of a surgeon, and healthcare competition. A variety of organizations offer quality designations for orthopedic surgery and its subspecialties. Our goal is to compare total joint arthroplasty (TJA) quality designation methodology across key quality rating organizations. One researcher conducted an initial Google search to determine organizations providing quality designations for hospitals and surgeons providing orthopedic procedures with a focus on TJA. Organizations that offer quality designation specific to TJA were determined. Organizations that provided general orthopedic surgery or only surgeon-specific quality designation were excluded from the analysis. The senior author confirmed the inclusion of the final organizations. Seven organizations fit our inclusion criteria. Only the private payers and The Joint Commission required hospital accreditation to meet quality designation criteria. Total arthroplasty volume was considered in 86% of the organizations’ methodologies, and 57% of organizations utilized process measurements such as antibiotic prophylaxis and care pathways. In addition, 57% of organizations included patient experience in their methodologies. Only 29% of organizations included a cost element in their methodology. All organizations utilized outcome data and publicly reported all hospitals receiving their quality designation. Hospital quality designation methodologies are inconsistent in the context of TJA. All stakeholders (ie, providers, payers, and patients) should be involved in deciding the definition of quality.
Continue to: Healthcare in the United States...
Healthcare in the United States has begun to move toward a system focused on value for patients, defined as health outcome per dollar expended.1 Indeed, an estimated 30% of Medicare payments are now made using the so-called alternative payment models (eg, bundled payments),2 and there is an expectation that consumerism in medicine will continue to expand.3 In addition, although there is a continuing debate regarding the benefits and pitfalls of hospital mergers, there is no question whether provider consolidation has increased dramatically in recent years.4 At the core of many of these changes is the push to improve healthcare quality and reduce costs.
Quality has the ability to affect payment, patient selection of providers, and hospital competition. Patients (ie, healthcare consumers) are increasingly using the Internet to find a variety of health information.5 Accessible provider quality information online would allow patients to make more informed decisions about where to seek care. In addition, the development of transparent quality ratings could assist payers in driving beneficiaries to higher quality and better value providers, which could mean more business for the highest quality physicians and better patient outcomes with fewer complications. Some payers such as the Centers for Medicare and Medicaid Services (CMS) have already started using quality measures as part of their reimbursement strategy.6 Because CMS is the largest payer in the United States, private insurers tend to follow their lead; thus, quality measurements will become even more common as a factor in reimbursement over the coming years.
To make quality ratings useful, “quality” must be clearly defined. Clarity around which factors are considered in a quality designation will create transparency for patients and allow providers to understand how their performance is being measured so that they focus on improving outcomes for their patients. Numerous organizations, including private payers, public payers, and both not-for-profit and for-profit entities, have created quality designation programs to rate providers. However, within orthopedics and several other medical specialties, there has been an ongoing debate about what measures best reflect quality.7 Although inconsistencies in quality ratings in arthroplasty care have been noted,8 it remains unknown how each quality designation program compares with the others in terms of the factors considered in deciding quality designations.
The purpose of this study is to evaluate publicly available information from key quality designation programs for total joint arthroplasty (TJA) providers to determine what factors are considered by each organization in awarding quality designations; what similarities and differences in quality designations exist across the different organizations; and how many of the organizations publish their quality designation methodologies and final rating results.
MATERIALS AND METHODS
A directed Google search was conducted to determine organizations (ie, payers, independent firms, and government entities) that rate hospitals and/or surgeons in orthopedic surgery. The identified organizations were then examined to determine whether they provided hospital ratings for total hip and/or knee arthroplasty. Entities were included if they provided quality designations for hospitals specifically addressing TJA. Organizations that provided only general hospital, other surgical procedures, orthopedic surgery, or orthopedic surgeon-specific quality designations were excluded. A list of all organizations determined to fit the inclusion criteria was then reviewed for completeness and approved by the senior author.
Continue to: One investigator reviewed the website of each organization...
One investigator reviewed the website of each organization fitting the inclusion criteria to determine the full rating methodology in 1 sitting on July 2, 2016. Detailed notes were taken on each program using publicly available information. For organizations that used proprietary criteria for quality designation (eg, The Joint Commission [TJC]), only publicly available information was used in the analysis. Therefore, the information reported is solely based on data available online to the public.
Detailed quality designation criteria were condensed into broader categories (accreditation, volume, structural, process, outcomes, patient experience, and cost/efficiency) to capture differences between each organization reviewed. In addition, we recorded whether each organization published a list of providers that received its quality designation.
RESULTS
A total of 7 organizations fit our inclusion criteria9-15 (Table). Of these 7 organizations, 3 were private payers (Aetna, UnitedHealth, and Blue Cross Blue Shield [BCBS]), 2 were nongovernmental not-for-profit organizations (TJC and Consumer Reports), and 2 were consumer-based and/or for-profit organizations (HealthGrades and US News & World Report [USNWR]). There were no government agencies that fit our inclusion criteria. BCBS had the following 2 separate quality designations: BCBS Blue Distinction and BCBS Blue Distinction+. The only difference between the 2 BCBS ratings is that BCBS Blue Distinction+ includes cost efficiency ratings, whereas BCBS Blue Distinction does not.
Only the 3 private payers and TJC, the primary hospital accreditation body in the United States, required accreditation as part of its quality designation criteria. TJC requires its own accreditation for quality designation consideration, whereas the 3 private payers allow accreditation from one of a variety of sources. Aetna Institutes of Quality for Orthopedic Surgery requires accreditation by TJC, Healthcare Facilities Accreditation Program, American Osteopathic Association, National Integrated Accreditation for Healthcare Organizations, or Det Norske Veritas Healthcare. UnitedHealth Premium Total Joint Replacement (TJR) Specialty Center requires accreditation by TJC and/or equivalent of TJC accreditation. However, TJC accreditation equivalents are not noted in the UnitedHealth handbook. BCBS Blue Distinction and Distinction+ require accreditation by TJC, Healthcare Facilities Accreditation Program, National Integrated Accreditation for Healthcare Organizations, or Center for Improvement in Healthcare Quality. In addition, BCBS is willing to consider alternative accreditations that are at least as stringent as the national alternatives noted. However, no detailed criteria that must be met to be equivalent to the national standards are noted in the relevant quality designation handbook.
The volume of completed total hip and knee arthroplasty procedures was considered in 6 of the organizations’ quality ratings methodologies. Of those 6, all private payers, TJC (not-for-profit), and 2 for-profit rating agencies were included. Surgeon specialization in TJA was only explicitly noted as a factor considered in UnitedHealth Premium TJR Specialty Center criteria; however, the requirements for surgeon specialization were not clearly defined. In addition, the presence of a multidisciplinary clinical pathway was only explicitly considered for Aetna Institutes of Quality for Orthopedic Surgery.
Structural requirements (eg, use of electronic health records [EHR], staffing levels, etc.) were taken into account in private payer and USNWR quality methodologies. Process measures (eg, antibiotic prophylaxis and other care pathways) were considered for the private payers and TJC but not for USNWR quality designation. Cost and/or efficiency measures were factors in the quality formula for Aetna Institutes of Quality for Orthopedic Surgery and BCBS Distinction+. Aetna utilizes its own cost data and risk-adjusts using a product known as Symmetry Episode Risk Groups to determine cost-effectiveness, while BCBS uses its own Composite Facility Cost Index. Patient experience (eg, Hospital Consumer Assessment of Healthcare Providers and Systems [HCAHPS]) was incorporated into the quality formulas for 4 of the 7 quality designation programs examined.
Continue to: All of the 7 quality designation programs included...
All of the 7 quality designation programs included outcomes (ie, readmission rates and/or mortality rates) and publicly reported the hospitals receiving their quality designation. In contrast, only Aetna explicitly included the presence of multidisciplinary clinical care pathways as part of their quality designation criteria. In addition, only UnitedHealth included surgeon specialization in joint arthroplasty as a factor for quality consideration for its quality designation program. BCBS Distinction+ and Aetna Institutes of Quality for Orthopedic Surgery were the only 2 quality designations that included at least 1 variable that fit into each of the 7 characteristics considered (accreditation, volume, structural, process, outcomes, patient experience, and cost/efficiency).
DISCUSSION
As healthcare continues to shift toward value-based delivery and payment models, quality becomes a critical factor in reimbursement and provider rankings. However, quality is a vague term. Several providers probably do not know what is required to be designated as high quality by a particular rating agency. Moreover, there are multiple quality designation programs, all using distinct criteria to determine “quality,” which further complicates the matter. Our objective was to determine the key stakeholders that provide quality designations in TJA and what criteria each organization uses in assessing quality.
Our idea of comprehensive quality is based on Avedis Donabedian’s enduring framework for healthcare quality focused on structure, process, and outcome.16 We expanded on these 3 areas and analyzed quality designations based on variables fitting into the following categories: accreditation, volume, structural, process, outcomes, patient experience, and cost/efficiency. We believe that these categories encompass a comprehensive rating system that addresses key elements of patient care. However, our results suggest that only 2 major quality designations (BCBS Distinction+ and Aetna Institutes of Quality for Orthopedic Surgery) take all such variables into account.
All quality designation programs that we analyzed required outcome data (ie, readmission and/or mortality rates within 30 days); however, only 2 programs utilized cost in their quality designation criteria (BCBS Distinction+ and Aetna Institutes of Quality for Orthopedic Surgery). Aetna Institutes of Quality for Orthopedic Surgery risk-adjusted for its cost-effectiveness calculations based on age, sex, and other unspecified conditions using a product known as Symmetry Episode Risk Groups. However, the organization also noted that although it did risk-adjust for inpatient mortality, it did not do so for pulmonary embolism or deep vein thrombosis. BCBS Distinction+ also utilized risk adjustment for its cost efficiency measure, and its step-by-step methodology is available online. Further, Consumer Reports does risk-adjust using logistic regression models in their quality analysis, but the description provided is minimal; it is noted that such risk adjustments are already completed by CMS prior to Consumer Reports acquiring the data. The CMS Compare model information is available on the CMS website. The data utilized by several organizations and presented on CMS Compare are already risk-adjusted using CMS’ approach. In contrast, UnitedHealth Premium TJR Specialty Center gathers its own data from providers and does not describe a risk adjustment methodology. Risk adjustment is important because the lack of risk adjustment may lead to physicians “cherry-picking” easy cases to boost positive outcomes, leading to increased financial benefits and higher quality ratings. Having a consistent risk adjustment formula will ensure accurate comparisons across outcomes and cost-effectiveness measures used by quality designation programs.
Factors considered for quality designation varied greatly from one organization to the other. The range of categories of factors considered varied from 1 (Consumer Reports only considered outcome data) to all 7 categories (BCBS Distinction+ and Aetna Institutes of Quality for Orthopedic Surgery). Our findings are consistent with the work by Keswani and colleagues,8 which showed that there is likely variation in factors considered when rating hospital quality more broadly. Our work suggests that quality designation formulas do not appear to get more consistent when focused on TJA.
We found that all organizations in our analysis published the providers earning their quality designation. However, TJC does not provide publicly a detailed methodology on how to qualify for its quality designation. The price to purchase the necessary manual for this information is $146.00 for accredited organizations and $186.00 for all others.17 For large healthcare providers, this is not a large sum of money. Nonetheless, this provides an additional hurdle for stakeholders to gain a full understanding of the requirements to receive a TJC Gold Seal for Orthopedics.
Previous work has evaluated the consistency of and the variety of means of gauging healthcare quality. Previous work by Rothberg and colleagues18 comparing hospital rankings across 5 common consumer-oriented websites found disagreement on hospital rankings within any diagnosis and even among metrics such as mortality. Another study by Halasyamani and Davis19 found that CMS Compare and USNWR rankings were dissimilar and the authors attributed the discrepancy to different methodologies. In addition, a study by Krumholz and colleagues20 focused on Internet report cards, which measured the appropriate use of select medications and mortality rates for acute myocardial infarction as the quality metrics. The authors found that, in aggregate, there was a clear difference in quality of care and outcomes but that comparisons between 2 hospitals provided poor discrimination.20 Other work has analyzed the increasing trend of online ratings of orthopedic surgeons by patients.21 However, there remains no agreed-upon definition of quality. Thus, the use of the term “quality” in several studies may be misleading.
Our results must be interpreted keeping the limitations of our work in mind. First, we used expert knowledge and a public search engine to develop our list of organizations that provide TJA quality designations. However, there is a possibility that we did not include all relevant organizations. Second, although all authors reviewed the final data, it is possible that there was human error in the analysis of each organization’s quality designation criteria.
CONCLUSION
As healthcare progresses further toward a system that rewards providers for delivering value to patients, accurately defining and measuring quality becomes critical because it can be suggestive of value to patients, payers, and providers. Furthermore, it gives providers a goal to focus on as they strive to improve the value of care they deliver to patients. Measuring healthcare quality is currently a novel, imperfect science,22 and there continues to be a debate about what factors should be included in a quality designation formula. Nonetheless, more and more quality designations and performance measurements are being created for orthopedic care, including total hip and total knee arthroplasty. In fact, in 2016, The Leapfrog Group added readmission for patients undergoing TJA to its survey.23 Consensus on a quality definition may facilitate the movement toward a value-based healthcare system. Future research should evaluate strategies for gaining consensus among stakeholders for a universal quality metric in TJA. Surgeons, hospitals, payers, and most importantly patients should play critical roles in defining quality.
ABSTRACT
A patient’s perception of hospital or provider quality can have far-reaching effects, as it can impact reimbursement, patient selection of a surgeon, and healthcare competition. A variety of organizations offer quality designations for orthopedic surgery and its subspecialties. Our goal is to compare total joint arthroplasty (TJA) quality designation methodology across key quality rating organizations. One researcher conducted an initial Google search to determine organizations providing quality designations for hospitals and surgeons providing orthopedic procedures with a focus on TJA. Organizations that offer quality designation specific to TJA were determined. Organizations that provided general orthopedic surgery or only surgeon-specific quality designation were excluded from the analysis. The senior author confirmed the inclusion of the final organizations. Seven organizations fit our inclusion criteria. Only the private payers and The Joint Commission required hospital accreditation to meet quality designation criteria. Total arthroplasty volume was considered in 86% of the organizations’ methodologies, and 57% of organizations utilized process measurements such as antibiotic prophylaxis and care pathways. In addition, 57% of organizations included patient experience in their methodologies. Only 29% of organizations included a cost element in their methodology. All organizations utilized outcome data and publicly reported all hospitals receiving their quality designation. Hospital quality designation methodologies are inconsistent in the context of TJA. All stakeholders (ie, providers, payers, and patients) should be involved in deciding the definition of quality.
Continue to: Healthcare in the United States...
Healthcare in the United States has begun to move toward a system focused on value for patients, defined as health outcome per dollar expended.1 Indeed, an estimated 30% of Medicare payments are now made using the so-called alternative payment models (eg, bundled payments),2 and there is an expectation that consumerism in medicine will continue to expand.3 In addition, although there is a continuing debate regarding the benefits and pitfalls of hospital mergers, there is no question whether provider consolidation has increased dramatically in recent years.4 At the core of many of these changes is the push to improve healthcare quality and reduce costs.
Quality has the ability to affect payment, patient selection of providers, and hospital competition. Patients (ie, healthcare consumers) are increasingly using the Internet to find a variety of health information.5 Accessible provider quality information online would allow patients to make more informed decisions about where to seek care. In addition, the development of transparent quality ratings could assist payers in driving beneficiaries to higher quality and better value providers, which could mean more business for the highest quality physicians and better patient outcomes with fewer complications. Some payers such as the Centers for Medicare and Medicaid Services (CMS) have already started using quality measures as part of their reimbursement strategy.6 Because CMS is the largest payer in the United States, private insurers tend to follow their lead; thus, quality measurements will become even more common as a factor in reimbursement over the coming years.
To make quality ratings useful, “quality” must be clearly defined. Clarity around which factors are considered in a quality designation will create transparency for patients and allow providers to understand how their performance is being measured so that they focus on improving outcomes for their patients. Numerous organizations, including private payers, public payers, and both not-for-profit and for-profit entities, have created quality designation programs to rate providers. However, within orthopedics and several other medical specialties, there has been an ongoing debate about what measures best reflect quality.7 Although inconsistencies in quality ratings in arthroplasty care have been noted,8 it remains unknown how each quality designation program compares with the others in terms of the factors considered in deciding quality designations.
The purpose of this study is to evaluate publicly available information from key quality designation programs for total joint arthroplasty (TJA) providers to determine what factors are considered by each organization in awarding quality designations; what similarities and differences in quality designations exist across the different organizations; and how many of the organizations publish their quality designation methodologies and final rating results.
MATERIALS AND METHODS
A directed Google search was conducted to determine organizations (ie, payers, independent firms, and government entities) that rate hospitals and/or surgeons in orthopedic surgery. The identified organizations were then examined to determine whether they provided hospital ratings for total hip and/or knee arthroplasty. Entities were included if they provided quality designations for hospitals specifically addressing TJA. Organizations that provided only general hospital, other surgical procedures, orthopedic surgery, or orthopedic surgeon-specific quality designations were excluded. A list of all organizations determined to fit the inclusion criteria was then reviewed for completeness and approved by the senior author.
Continue to: One investigator reviewed the website of each organization...
One investigator reviewed the website of each organization fitting the inclusion criteria to determine the full rating methodology in 1 sitting on July 2, 2016. Detailed notes were taken on each program using publicly available information. For organizations that used proprietary criteria for quality designation (eg, The Joint Commission [TJC]), only publicly available information was used in the analysis. Therefore, the information reported is solely based on data available online to the public.
Detailed quality designation criteria were condensed into broader categories (accreditation, volume, structural, process, outcomes, patient experience, and cost/efficiency) to capture differences between each organization reviewed. In addition, we recorded whether each organization published a list of providers that received its quality designation.
RESULTS
A total of 7 organizations fit our inclusion criteria9-15 (Table). Of these 7 organizations, 3 were private payers (Aetna, UnitedHealth, and Blue Cross Blue Shield [BCBS]), 2 were nongovernmental not-for-profit organizations (TJC and Consumer Reports), and 2 were consumer-based and/or for-profit organizations (HealthGrades and US News & World Report [USNWR]). There were no government agencies that fit our inclusion criteria. BCBS had the following 2 separate quality designations: BCBS Blue Distinction and BCBS Blue Distinction+. The only difference between the 2 BCBS ratings is that BCBS Blue Distinction+ includes cost efficiency ratings, whereas BCBS Blue Distinction does not.
Only the 3 private payers and TJC, the primary hospital accreditation body in the United States, required accreditation as part of its quality designation criteria. TJC requires its own accreditation for quality designation consideration, whereas the 3 private payers allow accreditation from one of a variety of sources. Aetna Institutes of Quality for Orthopedic Surgery requires accreditation by TJC, Healthcare Facilities Accreditation Program, American Osteopathic Association, National Integrated Accreditation for Healthcare Organizations, or Det Norske Veritas Healthcare. UnitedHealth Premium Total Joint Replacement (TJR) Specialty Center requires accreditation by TJC and/or equivalent of TJC accreditation. However, TJC accreditation equivalents are not noted in the UnitedHealth handbook. BCBS Blue Distinction and Distinction+ require accreditation by TJC, Healthcare Facilities Accreditation Program, National Integrated Accreditation for Healthcare Organizations, or Center for Improvement in Healthcare Quality. In addition, BCBS is willing to consider alternative accreditations that are at least as stringent as the national alternatives noted. However, no detailed criteria that must be met to be equivalent to the national standards are noted in the relevant quality designation handbook.
The volume of completed total hip and knee arthroplasty procedures was considered in 6 of the organizations’ quality ratings methodologies. Of those 6, all private payers, TJC (not-for-profit), and 2 for-profit rating agencies were included. Surgeon specialization in TJA was only explicitly noted as a factor considered in UnitedHealth Premium TJR Specialty Center criteria; however, the requirements for surgeon specialization were not clearly defined. In addition, the presence of a multidisciplinary clinical pathway was only explicitly considered for Aetna Institutes of Quality for Orthopedic Surgery.
Structural requirements (eg, use of electronic health records [EHR], staffing levels, etc.) were taken into account in private payer and USNWR quality methodologies. Process measures (eg, antibiotic prophylaxis and other care pathways) were considered for the private payers and TJC but not for USNWR quality designation. Cost and/or efficiency measures were factors in the quality formula for Aetna Institutes of Quality for Orthopedic Surgery and BCBS Distinction+. Aetna utilizes its own cost data and risk-adjusts using a product known as Symmetry Episode Risk Groups to determine cost-effectiveness, while BCBS uses its own Composite Facility Cost Index. Patient experience (eg, Hospital Consumer Assessment of Healthcare Providers and Systems [HCAHPS]) was incorporated into the quality formulas for 4 of the 7 quality designation programs examined.
Continue to: All of the 7 quality designation programs included...
All of the 7 quality designation programs included outcomes (ie, readmission rates and/or mortality rates) and publicly reported the hospitals receiving their quality designation. In contrast, only Aetna explicitly included the presence of multidisciplinary clinical care pathways as part of their quality designation criteria. In addition, only UnitedHealth included surgeon specialization in joint arthroplasty as a factor for quality consideration for its quality designation program. BCBS Distinction+ and Aetna Institutes of Quality for Orthopedic Surgery were the only 2 quality designations that included at least 1 variable that fit into each of the 7 characteristics considered (accreditation, volume, structural, process, outcomes, patient experience, and cost/efficiency).
DISCUSSION
As healthcare continues to shift toward value-based delivery and payment models, quality becomes a critical factor in reimbursement and provider rankings. However, quality is a vague term. Several providers probably do not know what is required to be designated as high quality by a particular rating agency. Moreover, there are multiple quality designation programs, all using distinct criteria to determine “quality,” which further complicates the matter. Our objective was to determine the key stakeholders that provide quality designations in TJA and what criteria each organization uses in assessing quality.
Our idea of comprehensive quality is based on Avedis Donabedian’s enduring framework for healthcare quality focused on structure, process, and outcome.16 We expanded on these 3 areas and analyzed quality designations based on variables fitting into the following categories: accreditation, volume, structural, process, outcomes, patient experience, and cost/efficiency. We believe that these categories encompass a comprehensive rating system that addresses key elements of patient care. However, our results suggest that only 2 major quality designations (BCBS Distinction+ and Aetna Institutes of Quality for Orthopedic Surgery) take all such variables into account.
All quality designation programs that we analyzed required outcome data (ie, readmission and/or mortality rates within 30 days); however, only 2 programs utilized cost in their quality designation criteria (BCBS Distinction+ and Aetna Institutes of Quality for Orthopedic Surgery). Aetna Institutes of Quality for Orthopedic Surgery risk-adjusted for its cost-effectiveness calculations based on age, sex, and other unspecified conditions using a product known as Symmetry Episode Risk Groups. However, the organization also noted that although it did risk-adjust for inpatient mortality, it did not do so for pulmonary embolism or deep vein thrombosis. BCBS Distinction+ also utilized risk adjustment for its cost efficiency measure, and its step-by-step methodology is available online. Further, Consumer Reports does risk-adjust using logistic regression models in their quality analysis, but the description provided is minimal; it is noted that such risk adjustments are already completed by CMS prior to Consumer Reports acquiring the data. The CMS Compare model information is available on the CMS website. The data utilized by several organizations and presented on CMS Compare are already risk-adjusted using CMS’ approach. In contrast, UnitedHealth Premium TJR Specialty Center gathers its own data from providers and does not describe a risk adjustment methodology. Risk adjustment is important because the lack of risk adjustment may lead to physicians “cherry-picking” easy cases to boost positive outcomes, leading to increased financial benefits and higher quality ratings. Having a consistent risk adjustment formula will ensure accurate comparisons across outcomes and cost-effectiveness measures used by quality designation programs.
Factors considered for quality designation varied greatly from one organization to the other. The range of categories of factors considered varied from 1 (Consumer Reports only considered outcome data) to all 7 categories (BCBS Distinction+ and Aetna Institutes of Quality for Orthopedic Surgery). Our findings are consistent with the work by Keswani and colleagues,8 which showed that there is likely variation in factors considered when rating hospital quality more broadly. Our work suggests that quality designation formulas do not appear to get more consistent when focused on TJA.
We found that all organizations in our analysis published the providers earning their quality designation. However, TJC does not provide publicly a detailed methodology on how to qualify for its quality designation. The price to purchase the necessary manual for this information is $146.00 for accredited organizations and $186.00 for all others.17 For large healthcare providers, this is not a large sum of money. Nonetheless, this provides an additional hurdle for stakeholders to gain a full understanding of the requirements to receive a TJC Gold Seal for Orthopedics.
Previous work has evaluated the consistency of and the variety of means of gauging healthcare quality. Previous work by Rothberg and colleagues18 comparing hospital rankings across 5 common consumer-oriented websites found disagreement on hospital rankings within any diagnosis and even among metrics such as mortality. Another study by Halasyamani and Davis19 found that CMS Compare and USNWR rankings were dissimilar and the authors attributed the discrepancy to different methodologies. In addition, a study by Krumholz and colleagues20 focused on Internet report cards, which measured the appropriate use of select medications and mortality rates for acute myocardial infarction as the quality metrics. The authors found that, in aggregate, there was a clear difference in quality of care and outcomes but that comparisons between 2 hospitals provided poor discrimination.20 Other work has analyzed the increasing trend of online ratings of orthopedic surgeons by patients.21 However, there remains no agreed-upon definition of quality. Thus, the use of the term “quality” in several studies may be misleading.
Our results must be interpreted keeping the limitations of our work in mind. First, we used expert knowledge and a public search engine to develop our list of organizations that provide TJA quality designations. However, there is a possibility that we did not include all relevant organizations. Second, although all authors reviewed the final data, it is possible that there was human error in the analysis of each organization’s quality designation criteria.
CONCLUSION
As healthcare progresses further toward a system that rewards providers for delivering value to patients, accurately defining and measuring quality becomes critical because it can be suggestive of value to patients, payers, and providers. Furthermore, it gives providers a goal to focus on as they strive to improve the value of care they deliver to patients. Measuring healthcare quality is currently a novel, imperfect science,22 and there continues to be a debate about what factors should be included in a quality designation formula. Nonetheless, more and more quality designations and performance measurements are being created for orthopedic care, including total hip and total knee arthroplasty. In fact, in 2016, The Leapfrog Group added readmission for patients undergoing TJA to its survey.23 Consensus on a quality definition may facilitate the movement toward a value-based healthcare system. Future research should evaluate strategies for gaining consensus among stakeholders for a universal quality metric in TJA. Surgeons, hospitals, payers, and most importantly patients should play critical roles in defining quality.
- Porter ME. A strategy for health care reform--toward a value-based system. N Engl J Med. 2009;361(2):109-112. doi:10.1056/NEJMp0904131.
- Obama B. United States health care reform: progress to date and next steps. JAMA. 2016;316(5):525-532. doi:10.1001/jama.2016.9797.
- Mulvany C. The march to consumerism the evolution from patient to active shopper continues. Healthc Financ Manage. 2014;68(2):36-38.
- Tsai TC, Jha AK. Hospital consolidation, competition, and quality: is bigger necessarily better? JAMA. 2014;312(1):29-30. doi:10.1001/jama.2014.4692.
- Cline RJ, Haynes KM. Consumer health information seeking on the Internet: the state of the art. Health Educ Res. 2001;16(6):671-692. doi:10.1093/her/16.6.671.
- Werner RM, Kolstad JT, Stuart EA, Polsky D. The effect of pay-for-performance in hospitals: lessons for quality improvement. Health Aff (Millwood). 2011;30(4):690-698. doi:10.1377/hlthaff.2010.1277.
- Birkmeyer JD, Dimick JB, Birkmeyer NJ. Measuring the quality of surgical care: structure, process, or outcomes? J Am Coll Surg. 2004;198(4):626-632. doi:10.1016/j.jamcollsurg.2003.11.017.
- Keswani A, Uhler LM, Bozic KJ. What quality metrics is my hospital being evaluated on and what are the consequences? J Arthroplast. 2016;31(6):1139-1143. doi:10.1016/j.arth.2016.01.075.
- Aetna Inc. Aetna Institutes of Quality® facilities fact book. A comprehensive reference guide for Aetna members, doctors and health care professionals. http://www.aetna.com/individuals-families-health-insurance/document-libr.... Accessed July 2, 2016.
- United HealthCare. UnitedHealth Premium® Program. https://www.uhcprovider.com/en/reports-quality-programs/premium-designation.html. Accessed July 2, 2016.
- 11. Blue Cross Blue Shield. Association. Blue Distinction Specialty Care. Selection criteria and program documentation: knee and hip replacement and spine surgery. https://www.bcbs.com/sites/default/files/fileattachments/page/KneeHip.SelectionCriteria_0.pdf. Published October 2015. Accessed July 2, 2016.
- The Joint Commission. Advanced certification for total hip and total knee replacement eligibility. https://www.jointcommission.org/advanced_certification_for_total_hip_and.... Published December 10, 2015. Accessed July 2, 2016.
- Healthgrades Operating Company. Healthgrades methodology: anatomy of a rating. https://www.healthgrades.com/quality/ratings-awards/methodology. Accessed July 2, 2016.
- Comarow A, Harder B; Dr. Foster Project Team. Methodology: U.S. News & World Report best hospitals for common care. U.S. News & World Report Web site. http://www.usnews.com/pubfiles/BHCC_MethReport_2015.pdf. Published May 20, 2015. Accessed July 2, 2016.
- Consumer Reports. How we rate hospitals. http://static3.consumerreportscdn.org/content/dam/cro/news_articles/heal.... Accessed July 2, 2016.
- Ayanian JZ, Markel H. Donabedian’s lasting framework for health care quality. N Engl J Med. 2016;375(3):205-207. doi:10.1056/NEJMp1605101.
- The Joint Commission. 2016 Certification Manuals. 2016; http://www.jcrinc.com/2016-certification-manuals/. Accessed July 2, 2016.
- Rothberg MB, Morsi E, Benjamin EM, Pekow PS, Lindenauer PK. Choosing the best hospital: the limitations of public quality reporting. Health Aff (Millwood). 2008;27(6):1680-1687. doi:10.1377/hlthaff.27.6.1680.
- Halasyamani LK, Davis MM. Conflicting measures of hospital quality: ratings from "Hospital Compare" versus "Best Hospitals". J Hosp Med. 2007;2(3):128-134. doi:10.1002/jhm.176.
- Krumholz HM, Rathore SS, Chen J, Wang Y, Radford MJ. Evaluation of a consumer-oriented internet health care report card: the risk of quality ratings based on mortality data. JAMA. 2002;287(10):1277-1287.
- Frost C, Mesfin A. Online reviews of orthopedic surgeons: an emerging trend. Orthopedics. 2015;38(4):e257-e262. doi:10.3928/01477447-20150402-52.
- Harder B, Comarow A. Hospital Quality reporting by US News & World Report: why, how, and what's ahead. JAMA. 2015;313(19):1903-1904. doi:10.1001/jama.2015.4566.
- The Leapfrog Group. New in 2016. http://www.leapfroggroup.org/ratings-reports/new-2016. Accessed July 2, 2016.
- Porter ME. A strategy for health care reform--toward a value-based system. N Engl J Med. 2009;361(2):109-112. doi:10.1056/NEJMp0904131.
- Obama B. United States health care reform: progress to date and next steps. JAMA. 2016;316(5):525-532. doi:10.1001/jama.2016.9797.
- Mulvany C. The march to consumerism the evolution from patient to active shopper continues. Healthc Financ Manage. 2014;68(2):36-38.
- Tsai TC, Jha AK. Hospital consolidation, competition, and quality: is bigger necessarily better? JAMA. 2014;312(1):29-30. doi:10.1001/jama.2014.4692.
- Cline RJ, Haynes KM. Consumer health information seeking on the Internet: the state of the art. Health Educ Res. 2001;16(6):671-692. doi:10.1093/her/16.6.671.
- Werner RM, Kolstad JT, Stuart EA, Polsky D. The effect of pay-for-performance in hospitals: lessons for quality improvement. Health Aff (Millwood). 2011;30(4):690-698. doi:10.1377/hlthaff.2010.1277.
- Birkmeyer JD, Dimick JB, Birkmeyer NJ. Measuring the quality of surgical care: structure, process, or outcomes? J Am Coll Surg. 2004;198(4):626-632. doi:10.1016/j.jamcollsurg.2003.11.017.
- Keswani A, Uhler LM, Bozic KJ. What quality metrics is my hospital being evaluated on and what are the consequences? J Arthroplast. 2016;31(6):1139-1143. doi:10.1016/j.arth.2016.01.075.
- Aetna Inc. Aetna Institutes of Quality® facilities fact book. A comprehensive reference guide for Aetna members, doctors and health care professionals. http://www.aetna.com/individuals-families-health-insurance/document-libr.... Accessed July 2, 2016.
- United HealthCare. UnitedHealth Premium® Program. https://www.uhcprovider.com/en/reports-quality-programs/premium-designation.html. Accessed July 2, 2016.
- 11. Blue Cross Blue Shield. Association. Blue Distinction Specialty Care. Selection criteria and program documentation: knee and hip replacement and spine surgery. https://www.bcbs.com/sites/default/files/fileattachments/page/KneeHip.SelectionCriteria_0.pdf. Published October 2015. Accessed July 2, 2016.
- The Joint Commission. Advanced certification for total hip and total knee replacement eligibility. https://www.jointcommission.org/advanced_certification_for_total_hip_and.... Published December 10, 2015. Accessed July 2, 2016.
- Healthgrades Operating Company. Healthgrades methodology: anatomy of a rating. https://www.healthgrades.com/quality/ratings-awards/methodology. Accessed July 2, 2016.
- Comarow A, Harder B; Dr. Foster Project Team. Methodology: U.S. News & World Report best hospitals for common care. U.S. News & World Report Web site. http://www.usnews.com/pubfiles/BHCC_MethReport_2015.pdf. Published May 20, 2015. Accessed July 2, 2016.
- Consumer Reports. How we rate hospitals. http://static3.consumerreportscdn.org/content/dam/cro/news_articles/heal.... Accessed July 2, 2016.
- Ayanian JZ, Markel H. Donabedian’s lasting framework for health care quality. N Engl J Med. 2016;375(3):205-207. doi:10.1056/NEJMp1605101.
- The Joint Commission. 2016 Certification Manuals. 2016; http://www.jcrinc.com/2016-certification-manuals/. Accessed July 2, 2016.
- Rothberg MB, Morsi E, Benjamin EM, Pekow PS, Lindenauer PK. Choosing the best hospital: the limitations of public quality reporting. Health Aff (Millwood). 2008;27(6):1680-1687. doi:10.1377/hlthaff.27.6.1680.
- Halasyamani LK, Davis MM. Conflicting measures of hospital quality: ratings from "Hospital Compare" versus "Best Hospitals". J Hosp Med. 2007;2(3):128-134. doi:10.1002/jhm.176.
- Krumholz HM, Rathore SS, Chen J, Wang Y, Radford MJ. Evaluation of a consumer-oriented internet health care report card: the risk of quality ratings based on mortality data. JAMA. 2002;287(10):1277-1287.
- Frost C, Mesfin A. Online reviews of orthopedic surgeons: an emerging trend. Orthopedics. 2015;38(4):e257-e262. doi:10.3928/01477447-20150402-52.
- Harder B, Comarow A. Hospital Quality reporting by US News & World Report: why, how, and what's ahead. JAMA. 2015;313(19):1903-1904. doi:10.1001/jama.2015.4566.
- The Leapfrog Group. New in 2016. http://www.leapfroggroup.org/ratings-reports/new-2016. Accessed July 2, 2016.
TAKE-HOME POINTS
- TJA quality designation methodologies differ substantially across rating organizations.
- Only 29% of TJA quality rating methodologies evaluated include a cost element.
- Only 57% of TJA quality rating methodologies evaluated include patient experience.
- Only 57% of TJA quality rating methodologies evaluated include process measurements, including antibiotic prophylaxis and standardized care pathways.
- There is a need for consistent definitions of quality as healthcare stakeholders continue to shift focus from volume to value.
Reasons for Readmission Following Primary Total Shoulder Arthroplasty
ABSTRACT
An increasing interest focuses on the rates and risk factors for hospital readmission. However, little is known regarding the readmission following total shoulder arthroplasty (TSA). This study aims to determine the rates, risk factors, and reasons for hospital readmission following primary TSA. Patients undergoing TSA (anatomic or reverse) as part of the American College of Surgeons National Surgical Quality Improvement Program in 2011 to 2013 were identified. The rate of unplanned readmission to the hospital within 30 postoperative days was characterized. Using multivariate regression, demographic and comorbidity factors were tested for independent association with readmission. Finally, the reasons for readmission were characterized. A total of 3627 patients were identified. Among the admitted patients, 93 (2.56%) were readmitted within 30 days of surgery. The independent risk factors for readmission included old age (for age 60-69 years, relative risk [RR] = 1.6; for age 70-79 years, RR = 2.3; for age ≥80 years, RR = 23.1; P = .042), male sex (RR = 1.6, P = .025), anemia (RR = 1.9, P = .005), and dependent functional status (RR = 2.8, P = .012). The reasons for readmission were available for 84 of the 93 readmitted patients. The most common reasons for readmission comprised pneumonia (14 cases, 16.7%), dislocation (7 cases, 8.3%), pulmonary embolism (7 cases, 8.3%), and surgical site infection (6 cases, 7.1%). Unplanned readmission occurs following about 1 in 40 cases of TSA. The most common causes of readmission include pneumonia, dislocation, pulmonary embolism, and surgical site infection. Patients with old age, male sex, anemia, and dependent functional status are at higher risk for readmission and should be counseled and monitored accordingly.
Continue to: Total shoulder arthroplasty...
Total shoulder arthroplasty (TSA) is performed with increasing frequency in the United States and is considered to be cost-effective.1-4 Following the procedure, patients generally achieve shoulder function and pain relief.5-8 Despite the success of the procedure, the growing literature on TSA has also reported rates of complications between 3.6% and 25% of the treated patients.9-16
In recent years, an increasing interest has focused on the rates and risk factors for unplanned hospital readmissions; these variables may not only reflect the quality of patient care but also result in considerable costs to the healthcare system. For instance, among Medicare patients, readmissions within 30 days of discharge occur in almost 20% of cases, costing $17.4 billion per year.17 Readmission rates increasingly factor into hospital performance metrics and reimbursement, including the Hospital Readmissions Reduction Program of the Patient Protection and Affordable Care Act that reduces Centers for Medicare and Medicaid Services payments to hospitals with high 30-day readmission rates.18
To date, only a few studies have evaluated readmission following TSA, with 30- to 90-day readmission rates ranging from 4.5% to 7.3%.19-23 These studies comprised single institution series20,22 and analyses of administrative databases.19,21,23 Most studies have shown that readmission occurs more often for medical than surgical reasons, with surgical reasons most commonly including infection and dislocation.19-23 However, only limited analyses have been conducted regarding risk factors for readmission.21,23 To date and to our knowledge, no study has investigated reasons for readmission following TSA using nationwide data.
This study aims to determine the rates, risk factors, and reasons for hospital readmission following primary TSA in the United States using the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database.
METHODS
DATA SOURCE
The NSQIP database was utilized to address the study purpose. NSQIP is a nationwide prospective surgical registry established by the American College of Surgeons and reports data from academic and community hospitals across the United States.24 Patients undertaking surgery at these centers are followed by the surgical clinical reviewers at the participating NSQIP sites prospectively for 30 days following the procedure to record complications including readmission. Preoperative and surgical data, such as demographics, medical comorbid diseases, and operative time, are also included. Previous studies have analyzed the complications of various orthopedic surgeries using the NSQIP data.14,16,25-30
DATA COLLECTION
We retrospectively identified from NSQIP the patients who underwent primary TSA (anatomic or reverse) in 2013 to 2014. The timeframe 2013 to 2014 was used because NSQIP only began recording reasons for readmission in 2013. The inclusion criteria were as follows: Current Procedural Terminology (CPT) code for TSA (23472); preoperative diagnosis according to the International Classification of Diseases, Ninth Revision (ICD-9) codes 714.0, 715.11, 715.31, 715.91, 715.21, 715.89, 716.xx 718.xx, 719.xx, 726.x, 727.xx, and 733.41 (where x is a wild card digit); and no missing demographic, comorbidity, or outcome data. Anatomic and reverse TSA were analyzed together because they share the same CPT code, and the NSQIP database prevents searching by the ICD-9 procedure code.
The rate of unplanned readmission to the hospital within 30 postoperative days was characterized. The reasons for readmission in this 30-day period were only available in 2013 and were determined using the ICD-9 diagnosis codes. Patient demographics were recorded for use in identifying potential risk factors for readmission; the demographic data included sex, age, smoking status, body mass index (BMI), and comorbidities, including end-stage renal disease, dyspnea on exertion, congestive heart failure, diabetes mellitus, hypertension, and chronic obstructive pulmonary disease (COPD).
Continue to: Statistical analysis...
STATISTICAL ANALYSIS
Statistical analyses were performed using Stata version 13.1 (StataCorp). First, using bivariate and multivariate regression, demographic and comorbidity factors were tested for independent association with readmission to the hospital within 30 days of surgery. Second, among the readmitted patients, the reasons for readmission were tabulated. Of note, the reasons for readmission were only documented for the procedures performed in 2013. All tests were 2-tailed and conducted at an α level of 0.05.
RESTULTS
A total of 3627 TSA patients were identified. The mean age (± standard deviation) was 69.4 ± 9.5 years, 55.8% of patients were female, and mean BMI was 30.1 ± 7.0 years. Table 1 provides the additional demographic data. Of the 3627 included patients, 93 (2.56%) were readmitted within 30 days of surgery. The 95% confidence interval for the estimated rate of readmission reached 2.05% to 3.08%.
Table 1. Patient Population
| Number | Percent |
Total | 3627 | 100.0% |
Age |
|
|
18-59 | 539 | 14.9% |
60-69 | 1235 | 34.1% |
70-79 | 1317 | 36.3% |
≥80 | 536 | 14.8% |
Sex |
|
|
Male | 1603 | 44.2% |
Female | 2024 | 55.8% |
Body mass index |
|
|
Normal (<25 kg/m2) | 650 | 17.9% |
Overweight (25-30 kg/m2) | 1147 | 31.6% |
Obese (≥30 kg/m2) | 1830 | 50.5% |
Functional status |
|
|
Independent | 3544 | 97.7% |
Dependent | 83 | 2.3% |
Diabetes mellitus |
|
|
No | 3022 | 83.3% |
Yes | 605 | 16.7% |
Dyspnea on exertion |
|
|
No | 3393 | 93.6% |
Yes | 234 | 6.5% |
Hypertension |
|
|
No | 1192 | 32.9% |
Yes | 2435 | 67.1% |
COPD |
|
|
No | 3384 | 93.3% |
Yes | 243 | 6.7% |
Current smoker |
|
|
No | 3249 | 89.6% |
Yes | 378 | 10.4% |
Anemia |
|
|
No | 3051 | 84.1% |
Yes | 576 | 15.9% |
Abbreviation: COPD, chronic obstructive pulmonary disease.
In the bivariate analyses (Table 2), the following factors were positively associated readmission: older age (60-69 years, relative risk [RR] = 1.6; 70-79 years, RR = 2.2; ≥80 years, RR = 3.3; P = .011), dependent functional status (RR = 2.9, P = .008), and anemia (RR = 2.2, P < .001).
Table 2. Bivariate Analysis of Risk Factors for Readmission
| Rate | RR | 95% CI | P-value |
Age |
|
|
| 0.011 |
18-59 | 1.30% | Ref. | - |
|
60-69 | 2.02% | 1.6 | 0.7-3.6 |
|
70-79 | 2.89% | 2.2 | 1.0-4.9 |
|
≥80 | 4.29% | 3.3 | 1.4-7.6 |
|
Sex |
|
|
| 0.099 |
Female | 2.17% | Ref. | - |
|
Male | 3.06% | 1.4 | 0.9-2.1 |
|
Body mass index |
|
|
| 0.764 |
Normal (<25 kg/m2) | 2.92% | Ref. | - |
|
Overweight (25-30 kg/m2) | 2.35% | 0.8 | 0.5-1.4 |
|
Obese (≥30 kg/m2) | 2.57% | 0.9 | 0.5-1.5 |
|
Functional status |
|
|
| 0.008 |
Independent | 2.45% | Ref. | - |
|
Dependent | 7.23% | 2.9 | 1.3-6.5 |
|
Diabetes mellitus |
|
|
| 0.483 |
No | 2.48% | Ref. | - |
|
Yes | 2.98% | 1.2 | 0.7-2.0 |
|
Dyspnea on exertion |
|
|
| 0.393 |
No | 2.51% | Ref. | - |
|
Yes | 3.42% | 1.4 | 0.7-2.8 |
|
Hypertension |
|
|
| 0.145 |
No | 2.01% | Ref. | - |
|
Yes | 2.83% | 1.4 | 0.9-2.2 |
|
COPD |
|
|
| 0.457 |
No | 2.51% | Ref. | - |
|
Yes | 3.29% | 1.3 | 0.6-2.7 |
|
Current smoker |
|
|
| 0.116 |
No | 2.71% | Ref. | - |
|
Yes | 1.32% | 0.5 | 0.2-1.2 |
|
Anemia |
|
|
| <0.001 |
No | 2.16% | Ref. | - |
|
Yes | 4.69% | 2.2 | 1.4-3.4 |
|
Abbreviations: CI, confidence interval; COPD, chronic obstructive pulmonary disease; RR, relative risk.
In the multivariate analyses (Table 3), the following factors were independent risk factors for readmission: older age (60-69 years, RR = 1.6; 70-79 years, RR = 2.3; ≥80 years, RR = 3.1; P =.027), male sex (RR = 1.6, P = .025), anemia (RR = 1.9, P = .005), and dependent functional status (RR = 2.8, P = .012). Interestingly, readmission showed no independent association with diabetes, dyspnea on exertion, BMI, COPD, hypertension, or current smoking status (P > .05 for each).
Table 3. Independent Risk Factors for Readmission on Multivariate Analysis
| Rate | RR | 95% CI | P-value |
Age |
|
|
| 0.027 |
18-59 | 1.30% | Ref | - |
|
60-69 | 2.02% | 1.6 | 0.7-3.6 |
|
70-79 | 2.89% | 2.3 | 1.0-5.1 |
|
≥80 | 4.29% | 3.1 | 1.3-7.4 |
|
Sex |
|
|
| 0.025 |
Female | 2.17% | Ref. | - |
|
Male | 3.06% | 1.6 | 1.1-2.4 |
|
Anemia |
|
|
| 0.005 |
No | 2.16% | Ref | - |
|
Yes | 4.69% | 1.9 | 1.2-3.0 |
|
Functional status |
|
|
| 0.012 |
Independent | 2.45% | Ref | - |
|
Dependent | 7.23% | 2.8 | 1.3-6.2 |
|
Abbreviations: CI, confidence interval; COPD, chronic obstructive pulmonary disease; RR, relative risk.
Continue to: Table 4...
The reasons for readmission were available for 84 of the 93 readmitted patients. The most common reasons for readmission included pneumonia (14 cases, 16.7%), dislocation (7 cases, 8.3%), pulmonary embolism (7 cases, 8.3%), and surgical site infection (6 cases, 7.1%) (Table 4).
Table 4. Reasons for Readmission
| Number | Percent |
Pneumonia | 14 | 16.7% |
Dislocation | 7 | 8.3% |
Pulmonary embolism | 7 | 8.3% |
Surgical site infection | 6 | 7.1% |
Atrial fibrillation | 4 | 4.8% |
Hematoma | 4 | 4.8% |
Altered mental status | 3 | 3.6% |
Chest pain | 3 | 3.6% |
Renal insufficiency/kidney failure | 3 | 3.6% |
Urinary tract infection | 3 | 3.6% |
Acute gastric or duodenal ulcer | 2 | 2.4% |
Dermatitis/other allergic reaction | 2 | 2.4% |
Orthostatic hypotension/syncope | 2 | 2.4% |
Pain | 2 | 2.4% |
Respiratory distress | 2 | 2.4% |
Sepsis | 2 | 2.4% |
Urinary retention | 2 | 2.4% |
Acute cholecystitis | 1 | 1.2% |
Cerebrovascular accident | 1 | 1.2% |
Constipation | 1 | 1.2% |
Contusion of shoulder | 1 | 1.2% |
Deep venous thrombosis requiring therapy | 1 | 1.2% |
Gastrointestinal hemorrhage | 1 | 1.2% |
Gout | 1 | 1.2% |
Hepatic encephalopathy | 1 | 1.2% |
Intestinal infection | 1 | 1.2% |
Narcotic overdose | 1 | 1.2% |
Nausea/vomiting | 1 | 1.2% |
Proximal humerus fracture | 1 | 1.2% |
Rotator cuff tear | 1 | 1.2% |
Seroma | 1 | 1.2% |
Unspecified disease of pericardium | 1 | 1.2% |
Weakness | 1 | 1.2% |
DISCUSSION
Our analysis of 3042 TSAs from the NSQIP database suggests that unplanned readmission to the hospital occurs following about 1 in 40 cases of TSA. The study also suggests that the most common reasons for readmission encompass pneumonia, dislocation, pulmonary embolism, and surgical site infection. Old age, male sex, anemia, and dependent functional status serve as risk factors for readmission, and patients with such factors should be counseled and monitored accordingly.
In recent years, an increasing emphasis has centered on reducing rates of hospital readmission, with programs such as the Hospital Readmissions Reduction Program of the Affordable Care Act cutting reimbursements for hospitals with high 30-day readmission rates.17,18 To date, only a few studies have evaluated the reasons for readmission and readmission rates for TSA.19-23 Initial reports consisted of single-institution TSA registry reviews. For example, Mahoney and colleagues20 retrospectively evaluated shoulder arthroplasty procedures at their institution to document the readmission rates, finding a 5.9% readmission rate at 30 days. Readmission occurred more frequently in the first 30 days following discharge than in the 30- to 90-day period, with the most common reasons for readmission including medical complications, infection, and dislocation. Streubel and colleagues22 evaluated reoperation rates from their institution’s TSA registry, finding a 0.6% reoperation rate for primary TSA at 30 days and 1.5% for revision TSA. Instability and infection were the most common indications for reoperation. Our findings confirm these single-institution results and demonstrate their application to a nationwide sample of TSA, not just to high-volume academic centers. We similarly observed that dislocation, surgical site infection, and medical complications (mostly pneumonia and pulmonary embolism) were common causes of readmission, and that the 30-day readmission rate was about 1 in 40.
Several authors have since used statewide databases to analyze and determine risk factors for readmission following TSA. Lyman and colleagues19 used the New York State Database to show that higher hospital TSA surgical volume was associated with a lower rate of readmission when age and comorbidities were controlled for in a multivariate model. Old age was also associated with an increased readmission rate in their multivariate analysis, but comorbidities (as measured by the Charlson comorbidity index) presented a nonsignificant associative trend. These authors opted not to determine specific causes of readmission. Schairer and colleagues21 used State Inpatient Databases from 7 states, finding a 90-day readmission rate of 7.3%, 82% of which were due to medical complications and 18% of which were due to surgical complications (mostly infection and dislocation). Their multivariate regression revealed that male sex, reverse TSA, Medicaid insurance, patients discharged to inpatient rehabilitation or nursing facilities, medical comorbidities, and low-volume TSA hospitals were associated with readmission. Zhang and colleagues23 used the same source to show that the 90-day readmission rate reached 14% for surgically treated proximal humerus fractures and higher for patients who underwent open reduction internal fixation, were female, were African American, were discharged to a nursing facility, possessed Medicaid insurance, or experienced medical comorbidities. Most recently, Basques and colleagues31 analyzed 1505 TSA cases from 2011 and 2012 in the NSQIP database, finding a 3.3% rate of readmission, with heart disease and hypertension as risk factors for readmission. Although the limitations of the NSQIP database prevented us from analyzing surgeon and hospital TSA volume or reverse vs anatomic TSA, our results confirm that the findings from statewide database studies apply to the United States nationwide NSQIP database. Old patient age, male sex, and medical comorbidities (anemia and dependent functional status) are independent risk factors for TSA readmission. We identified pneumonia, dislocation, pulmonary embolism, and surgical site infection as the most common reasons for readmission.
This study features several limitations that should be considered when interpreting the results. Anatomic and reverse TSA share a CPT code and were not separated using NSQIP data. A number of studies have reported that reverse TSA may place patients at higher risk for readmission;20,21 however, confounding by other patient factors could play a role in this finding. The 30-day timeframe for readmission is another potential limitation; however, this timeframe is frequently used in other studies and is the relevant timeframe for the reduced reimbursement penalties from the Hospital Readmissions Reduction Program of the Affordable Care Act.18 Furthermore, the NSQIP database contains no information on surgeon or hospital TSA volume, which is a result of safeguards for patient and provider privacy. Additionally, readmission data were only available for 2011 to 2013, with causes of readmission only present in 2013. Although provided with such current information, we cannot analyze readmission trends over time, such as in response to the Affordable Care Act of 2010. Finally, although NSQIP surgical clinical reviewers strive to identify readmissions to other hospitals during their reviews of outpatient medical records, proportions of these readmissions are possibly missed. Therefore, our 30-day readmission rate may slightly underestimate the true rate.
Despite these limitations, the NSQIP database offers a unique opportunity to examine risk factors and reasons for readmission following TSA. The prior literature on readmission following TSA stemmed either from limited samples or administrative data, which feature known limitations.32 By utilizing a large, prospective, non-administrative, nationwide sample, our findings are probably both more reliable and generalizable to the country as a whole.
CONCLUSION
Unplanned readmission occurs following about 1 in 40 cases of TSA. The most common causes of readmission include pneumonia, dislocation, pulmonary embolism, and surgical site infection. Patients with old age, male sex, anemia, and dependent functional status are at a higher risk for readmission and should be counseled and monitored accordingly.
This paper will be judged for the Resident Writer’s Award.
- Adams JE, Sperling JW, Hoskin TL, Melton LJ, Cofield RH. Shoulder arthroplasty in Olmsted County, Minnesota, 1976-2000: a population-based study. J Shoulder Elbow Surg.2006;15(1):50-55. doi:10.1016/j.jse.2005.04.009.
- Jain NB, Higgins LD, Guller U, Pietrobon R, Katz JN. Trends in the epidemiology of total shoulder arthroplasty in the United States from 1990-2000. Arthritis Rheum.2006;55(4):591-597. doi:10.1002/art.22102.
- Kim SH, Wise BL, Zhang Y, Szabo RM. Increasing incidence of shoulder arthroplasty in the United States. J Bone Joint Surg Am. 2011;93(24):2249-2254. doi:10.2106/JBJS.J.01994. doi:10.2106/JBJS.J.01994.
- Mather RC, Watters TS, Orlando LA, Bolognesi MP, Moorman CT. Cost effectiveness analysis of hemiarthroplasty and total shoulder arthroplasty. J Shoulder Elbow Surg.2010;19(3):325-334. doi:10.1016/j.jse.2009.11.057.
- Carter MJ, Mikuls TR, Nayak S, Fehringer EV, Michaud K. Impact of total shoulder arthroplasty on generic and shoulder-specific health-related quality-of-life measures: a systematic literature review and meta-analysis. J Bone Joint Surg Am. 2012;94(17):e127. doi:10.2106/JBJS.K.00204.
- Deshmukh AV, Koris M, Zurakowski D, Thornhill TS. Total shoulder arthroplasty: long-term survivorship, functional outcome, and quality of life. J Shoulder Elbow Surg. 2005;14(5):471-479. doi:10.1016/j.jse.2005.02.009.
- Montoya F, Magosch P, Scheiderer B, Lichtenberg S, Melean P, Habermeyer P. Midterm results of a total shoulder prosthesis fixed with a cementless glenoid component. J Shoulder Elbow Surg. 2013;22(5):628-635. doi:10.1016/j.jse.2012.07.005.
- Raiss P, Bruckner T, Rickert M, Walch G. Longitudinal observational study of total shoulder replacements with cement: fifteen to twenty-year follow-up. J Bone Joint Surg Am.2014;96(3):198-205. doi:10.2106/JBJS.M.00079.
- Bohsali KI, Wirth MA, Rockwood CA. Complications of total shoulder arthroplasty. J Bone Joint Surg Am. 2006;88(10):2279-2292. doi:10.2106/JBJS.F.00125.
- Chalmers PN, Gupta AK, Rahman Z, Bruce B, Romeo AA, Nicholson GP. Predictors of early complications of total shoulder arthroplasty. J Arthroplasty. 2014;29(4):856-860. doi:10.1016/j.arth.2013.07.002.
- Cheung E, Willis M, Walker M, Clark R, Frankle MA. Complications in reverse total shoulder arthroplasty. J Am Acad Orthop Surg. 2011;19(7):439-449.
- Papadonikolakis A, Neradilek MB, Matsen FA. Failure of the glenoid component in anatomic total shoulder arthroplasty: a systematic review of the English-language literature between 2006 and 2012. J Bone Joint Surg Am. 2013;95(24):2205-2212. doi:10.2106/JBJS.L.00552.
- Saltzman BM, Chalmers PN, Gupta AK, Romeo AA, Nicholson GP. Complication rates comparing primary with revision reverse total shoulder arthroplasty. J Shoulder Elbow Surg.2014;23(11):1647-1654. doi:10.1016/j.jse.2014.04.015.
- Shields E, Iannuzzi JC, Thorsness R, Noyes K, Voloshin I. Perioperative complications after hemiarthroplasty and total shoulder arthroplasty are equivalent. J Shoulder Elbow Surg. 2014;23(10):1449-1453. doi:10.1016/j.jse.2014.01.052.
- Sperling JW, Hawkins RJ, Walch G, Mahoney AP, Zuckerman JD. Complications in total shoulder arthroplasty. Instr Course Lect. 2013;62:135-141.
- Shields E, Thirukumaran C, Thorsness R, Noyes K, Voloshin I. An analysis of adult patient risk factors and complications within 30 days after arthroscopic shoulder surgery. Arthroscopy. 2015;31(5):807-815. doi:10.1016/j.arthro.2014.12.011.
- Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009;360(14):1418-1428. doi:10.1056/NEJMsa0803563.
- Centers for Medicare & Medicaid Services. Readmissions reduction program (HRRP). . Updated April 27, 2018. Accessed June 29, 2018.
- Lyman S, Jones EC, Bach PB, Peterson MG, Marx RG. The association between hospital volume and total shoulder arthroplasty outcomes. Clin Orthop Relat Res. 2005;432:132-137. doi:10.1097/01.blo.0000150571.51381.9a.
- Mahoney A, Bosco JA, Zuckerman JD. Readmission after shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(3):377-381. doi:10.1016/j.jse.2013.08.007.
- Schairer WW, Zhang AL, Feeley BT. Hospital readmissions after primary shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(9):1349-1355. doi:10.1016/j.jse.2013.12.004.
- Streubel PN, Simone JP, Sperling JW, Cofield R. Thirty and ninety-day reoperation rates after shoulder arthroplasty. J Bone Joint Surg Am. 2014;96(3):e17. doi:10.2106/JBJS.M.00127.
- Zhang AL, Schairer WW, Feeley BT. Hospital readmissions after surgical treatment of proximal humerus fractures: is arthroplasty safer than open reduction internal fixation? Clin Orthop Relat Res. 2014;472(8):2317-2324. doi:10.1007/s11999-014-3613-y.
- American College of Surgeons. ACS National Surgical Quality Improvement Program. http://www.acsnsqip.org. Accessed July 15, 2015.
- Basques BA, Gardner EC, Varthi AG, et al. Risk factors for short-term adverse events and readmission after arthroscopic meniscectomy: does age matter? Am J Sports Med.2015;43(1):169-175. doi:10.1177/0363546514551923.
- Haughom BD, Schairer WW, Hellman MD, Yi PH, Levine BR. Does resident involvement impact post-operative complications following primary total knee arthroplasty? An analysis of 24,529 cases. J Arthroplasty. 2014;29(7):1468-1472.e2. doi:10.1016/j.arth.2014.02.036.
- Haughom BD, Schairer WW, Hellman MD, Yi PH, Levine BR. Resident involvement does not influence complication after total hip arthroplasty: an analysis of 13,109 cases. J Arthroplasty. 2014;29(10):1919-1924. doi:10.1016/j.arth.2014.06.003.
- Martin CT, Gao Y, Pugely AJ, Wolf BR. 30-day morbidity and mortality after elective shoulder arthroscopy: a review of 9410 cases. J Shoulder Elbow Surg. 2013;22(12):1667-1675.e1. doi:10.1016/j.jse.2013.06.022.
- Martin CT, Pugely AJ, Gao Y, Wolf BR. Risk factors for thirty-day morbidity and mortality following knee arthroscopy: a review of 12,271 patients from the national surgical quality improvement program database. J Bone Joint Surg Am. 2013;95(14):e98 1-10. doi:10.2106/JBJS.L.01440.
- Waterman BR, Dunn JC, Bader J, Urrea L, Schoenfeld AJ, Belmont PJ. Thirty-day morbidity and mortality after elective total shoulder arthroplasty: patient-based and surgical risk factors. J Shoulder Elbow Surg. 2015;24(1):24-30. doi:10.1016/j.jse.2014.05.016.
- Basques BA, Gardner EC, Toy JO, Golinvaux NS, Bohl DD, Grauer JN. Length of stay and readmission after total shoulder arthroplasty: an analysis of 1505 cases. Am J Orthop.2015;44(8):E268-E271.
- Bohl DD, Russo GS, Basques BA, et al. Variations in data collection methods between national databases affect study results: a comparison of the nationwide inpatient sample and national surgical quality improvement program databases for lumbar spine fusion procedures. J Bone Joint Surg Am. 2014;96(23):e193. doi:10.2106/JBJS.M.01490.
ABSTRACT
An increasing interest focuses on the rates and risk factors for hospital readmission. However, little is known regarding the readmission following total shoulder arthroplasty (TSA). This study aims to determine the rates, risk factors, and reasons for hospital readmission following primary TSA. Patients undergoing TSA (anatomic or reverse) as part of the American College of Surgeons National Surgical Quality Improvement Program in 2011 to 2013 were identified. The rate of unplanned readmission to the hospital within 30 postoperative days was characterized. Using multivariate regression, demographic and comorbidity factors were tested for independent association with readmission. Finally, the reasons for readmission were characterized. A total of 3627 patients were identified. Among the admitted patients, 93 (2.56%) were readmitted within 30 days of surgery. The independent risk factors for readmission included old age (for age 60-69 years, relative risk [RR] = 1.6; for age 70-79 years, RR = 2.3; for age ≥80 years, RR = 23.1; P = .042), male sex (RR = 1.6, P = .025), anemia (RR = 1.9, P = .005), and dependent functional status (RR = 2.8, P = .012). The reasons for readmission were available for 84 of the 93 readmitted patients. The most common reasons for readmission comprised pneumonia (14 cases, 16.7%), dislocation (7 cases, 8.3%), pulmonary embolism (7 cases, 8.3%), and surgical site infection (6 cases, 7.1%). Unplanned readmission occurs following about 1 in 40 cases of TSA. The most common causes of readmission include pneumonia, dislocation, pulmonary embolism, and surgical site infection. Patients with old age, male sex, anemia, and dependent functional status are at higher risk for readmission and should be counseled and monitored accordingly.
Continue to: Total shoulder arthroplasty...
Total shoulder arthroplasty (TSA) is performed with increasing frequency in the United States and is considered to be cost-effective.1-4 Following the procedure, patients generally achieve shoulder function and pain relief.5-8 Despite the success of the procedure, the growing literature on TSA has also reported rates of complications between 3.6% and 25% of the treated patients.9-16
In recent years, an increasing interest has focused on the rates and risk factors for unplanned hospital readmissions; these variables may not only reflect the quality of patient care but also result in considerable costs to the healthcare system. For instance, among Medicare patients, readmissions within 30 days of discharge occur in almost 20% of cases, costing $17.4 billion per year.17 Readmission rates increasingly factor into hospital performance metrics and reimbursement, including the Hospital Readmissions Reduction Program of the Patient Protection and Affordable Care Act that reduces Centers for Medicare and Medicaid Services payments to hospitals with high 30-day readmission rates.18
To date, only a few studies have evaluated readmission following TSA, with 30- to 90-day readmission rates ranging from 4.5% to 7.3%.19-23 These studies comprised single institution series20,22 and analyses of administrative databases.19,21,23 Most studies have shown that readmission occurs more often for medical than surgical reasons, with surgical reasons most commonly including infection and dislocation.19-23 However, only limited analyses have been conducted regarding risk factors for readmission.21,23 To date and to our knowledge, no study has investigated reasons for readmission following TSA using nationwide data.
This study aims to determine the rates, risk factors, and reasons for hospital readmission following primary TSA in the United States using the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database.
METHODS
DATA SOURCE
The NSQIP database was utilized to address the study purpose. NSQIP is a nationwide prospective surgical registry established by the American College of Surgeons and reports data from academic and community hospitals across the United States.24 Patients undertaking surgery at these centers are followed by the surgical clinical reviewers at the participating NSQIP sites prospectively for 30 days following the procedure to record complications including readmission. Preoperative and surgical data, such as demographics, medical comorbid diseases, and operative time, are also included. Previous studies have analyzed the complications of various orthopedic surgeries using the NSQIP data.14,16,25-30
DATA COLLECTION
We retrospectively identified from NSQIP the patients who underwent primary TSA (anatomic or reverse) in 2013 to 2014. The timeframe 2013 to 2014 was used because NSQIP only began recording reasons for readmission in 2013. The inclusion criteria were as follows: Current Procedural Terminology (CPT) code for TSA (23472); preoperative diagnosis according to the International Classification of Diseases, Ninth Revision (ICD-9) codes 714.0, 715.11, 715.31, 715.91, 715.21, 715.89, 716.xx 718.xx, 719.xx, 726.x, 727.xx, and 733.41 (where x is a wild card digit); and no missing demographic, comorbidity, or outcome data. Anatomic and reverse TSA were analyzed together because they share the same CPT code, and the NSQIP database prevents searching by the ICD-9 procedure code.
The rate of unplanned readmission to the hospital within 30 postoperative days was characterized. The reasons for readmission in this 30-day period were only available in 2013 and were determined using the ICD-9 diagnosis codes. Patient demographics were recorded for use in identifying potential risk factors for readmission; the demographic data included sex, age, smoking status, body mass index (BMI), and comorbidities, including end-stage renal disease, dyspnea on exertion, congestive heart failure, diabetes mellitus, hypertension, and chronic obstructive pulmonary disease (COPD).
Continue to: Statistical analysis...
STATISTICAL ANALYSIS
Statistical analyses were performed using Stata version 13.1 (StataCorp). First, using bivariate and multivariate regression, demographic and comorbidity factors were tested for independent association with readmission to the hospital within 30 days of surgery. Second, among the readmitted patients, the reasons for readmission were tabulated. Of note, the reasons for readmission were only documented for the procedures performed in 2013. All tests were 2-tailed and conducted at an α level of 0.05.
RESTULTS
A total of 3627 TSA patients were identified. The mean age (± standard deviation) was 69.4 ± 9.5 years, 55.8% of patients were female, and mean BMI was 30.1 ± 7.0 years. Table 1 provides the additional demographic data. Of the 3627 included patients, 93 (2.56%) were readmitted within 30 days of surgery. The 95% confidence interval for the estimated rate of readmission reached 2.05% to 3.08%.
Table 1. Patient Population
| Number | Percent |
Total | 3627 | 100.0% |
Age |
|
|
18-59 | 539 | 14.9% |
60-69 | 1235 | 34.1% |
70-79 | 1317 | 36.3% |
≥80 | 536 | 14.8% |
Sex |
|
|
Male | 1603 | 44.2% |
Female | 2024 | 55.8% |
Body mass index |
|
|
Normal (<25 kg/m2) | 650 | 17.9% |
Overweight (25-30 kg/m2) | 1147 | 31.6% |
Obese (≥30 kg/m2) | 1830 | 50.5% |
Functional status |
|
|
Independent | 3544 | 97.7% |
Dependent | 83 | 2.3% |
Diabetes mellitus |
|
|
No | 3022 | 83.3% |
Yes | 605 | 16.7% |
Dyspnea on exertion |
|
|
No | 3393 | 93.6% |
Yes | 234 | 6.5% |
Hypertension |
|
|
No | 1192 | 32.9% |
Yes | 2435 | 67.1% |
COPD |
|
|
No | 3384 | 93.3% |
Yes | 243 | 6.7% |
Current smoker |
|
|
No | 3249 | 89.6% |
Yes | 378 | 10.4% |
Anemia |
|
|
No | 3051 | 84.1% |
Yes | 576 | 15.9% |
Abbreviation: COPD, chronic obstructive pulmonary disease.
In the bivariate analyses (Table 2), the following factors were positively associated readmission: older age (60-69 years, relative risk [RR] = 1.6; 70-79 years, RR = 2.2; ≥80 years, RR = 3.3; P = .011), dependent functional status (RR = 2.9, P = .008), and anemia (RR = 2.2, P < .001).
Table 2. Bivariate Analysis of Risk Factors for Readmission
| Rate | RR | 95% CI | P-value |
Age |
|
|
| 0.011 |
18-59 | 1.30% | Ref. | - |
|
60-69 | 2.02% | 1.6 | 0.7-3.6 |
|
70-79 | 2.89% | 2.2 | 1.0-4.9 |
|
≥80 | 4.29% | 3.3 | 1.4-7.6 |
|
Sex |
|
|
| 0.099 |
Female | 2.17% | Ref. | - |
|
Male | 3.06% | 1.4 | 0.9-2.1 |
|
Body mass index |
|
|
| 0.764 |
Normal (<25 kg/m2) | 2.92% | Ref. | - |
|
Overweight (25-30 kg/m2) | 2.35% | 0.8 | 0.5-1.4 |
|
Obese (≥30 kg/m2) | 2.57% | 0.9 | 0.5-1.5 |
|
Functional status |
|
|
| 0.008 |
Independent | 2.45% | Ref. | - |
|
Dependent | 7.23% | 2.9 | 1.3-6.5 |
|
Diabetes mellitus |
|
|
| 0.483 |
No | 2.48% | Ref. | - |
|
Yes | 2.98% | 1.2 | 0.7-2.0 |
|
Dyspnea on exertion |
|
|
| 0.393 |
No | 2.51% | Ref. | - |
|
Yes | 3.42% | 1.4 | 0.7-2.8 |
|
Hypertension |
|
|
| 0.145 |
No | 2.01% | Ref. | - |
|
Yes | 2.83% | 1.4 | 0.9-2.2 |
|
COPD |
|
|
| 0.457 |
No | 2.51% | Ref. | - |
|
Yes | 3.29% | 1.3 | 0.6-2.7 |
|
Current smoker |
|
|
| 0.116 |
No | 2.71% | Ref. | - |
|
Yes | 1.32% | 0.5 | 0.2-1.2 |
|
Anemia |
|
|
| <0.001 |
No | 2.16% | Ref. | - |
|
Yes | 4.69% | 2.2 | 1.4-3.4 |
|
Abbreviations: CI, confidence interval; COPD, chronic obstructive pulmonary disease; RR, relative risk.
In the multivariate analyses (Table 3), the following factors were independent risk factors for readmission: older age (60-69 years, RR = 1.6; 70-79 years, RR = 2.3; ≥80 years, RR = 3.1; P =.027), male sex (RR = 1.6, P = .025), anemia (RR = 1.9, P = .005), and dependent functional status (RR = 2.8, P = .012). Interestingly, readmission showed no independent association with diabetes, dyspnea on exertion, BMI, COPD, hypertension, or current smoking status (P > .05 for each).
Table 3. Independent Risk Factors for Readmission on Multivariate Analysis
| Rate | RR | 95% CI | P-value |
Age |
|
|
| 0.027 |
18-59 | 1.30% | Ref | - |
|
60-69 | 2.02% | 1.6 | 0.7-3.6 |
|
70-79 | 2.89% | 2.3 | 1.0-5.1 |
|
≥80 | 4.29% | 3.1 | 1.3-7.4 |
|
Sex |
|
|
| 0.025 |
Female | 2.17% | Ref. | - |
|
Male | 3.06% | 1.6 | 1.1-2.4 |
|
Anemia |
|
|
| 0.005 |
No | 2.16% | Ref | - |
|
Yes | 4.69% | 1.9 | 1.2-3.0 |
|
Functional status |
|
|
| 0.012 |
Independent | 2.45% | Ref | - |
|
Dependent | 7.23% | 2.8 | 1.3-6.2 |
|
Abbreviations: CI, confidence interval; COPD, chronic obstructive pulmonary disease; RR, relative risk.
Continue to: Table 4...
The reasons for readmission were available for 84 of the 93 readmitted patients. The most common reasons for readmission included pneumonia (14 cases, 16.7%), dislocation (7 cases, 8.3%), pulmonary embolism (7 cases, 8.3%), and surgical site infection (6 cases, 7.1%) (Table 4).
Table 4. Reasons for Readmission
| Number | Percent |
Pneumonia | 14 | 16.7% |
Dislocation | 7 | 8.3% |
Pulmonary embolism | 7 | 8.3% |
Surgical site infection | 6 | 7.1% |
Atrial fibrillation | 4 | 4.8% |
Hematoma | 4 | 4.8% |
Altered mental status | 3 | 3.6% |
Chest pain | 3 | 3.6% |
Renal insufficiency/kidney failure | 3 | 3.6% |
Urinary tract infection | 3 | 3.6% |
Acute gastric or duodenal ulcer | 2 | 2.4% |
Dermatitis/other allergic reaction | 2 | 2.4% |
Orthostatic hypotension/syncope | 2 | 2.4% |
Pain | 2 | 2.4% |
Respiratory distress | 2 | 2.4% |
Sepsis | 2 | 2.4% |
Urinary retention | 2 | 2.4% |
Acute cholecystitis | 1 | 1.2% |
Cerebrovascular accident | 1 | 1.2% |
Constipation | 1 | 1.2% |
Contusion of shoulder | 1 | 1.2% |
Deep venous thrombosis requiring therapy | 1 | 1.2% |
Gastrointestinal hemorrhage | 1 | 1.2% |
Gout | 1 | 1.2% |
Hepatic encephalopathy | 1 | 1.2% |
Intestinal infection | 1 | 1.2% |
Narcotic overdose | 1 | 1.2% |
Nausea/vomiting | 1 | 1.2% |
Proximal humerus fracture | 1 | 1.2% |
Rotator cuff tear | 1 | 1.2% |
Seroma | 1 | 1.2% |
Unspecified disease of pericardium | 1 | 1.2% |
Weakness | 1 | 1.2% |
DISCUSSION
Our analysis of 3042 TSAs from the NSQIP database suggests that unplanned readmission to the hospital occurs following about 1 in 40 cases of TSA. The study also suggests that the most common reasons for readmission encompass pneumonia, dislocation, pulmonary embolism, and surgical site infection. Old age, male sex, anemia, and dependent functional status serve as risk factors for readmission, and patients with such factors should be counseled and monitored accordingly.
In recent years, an increasing emphasis has centered on reducing rates of hospital readmission, with programs such as the Hospital Readmissions Reduction Program of the Affordable Care Act cutting reimbursements for hospitals with high 30-day readmission rates.17,18 To date, only a few studies have evaluated the reasons for readmission and readmission rates for TSA.19-23 Initial reports consisted of single-institution TSA registry reviews. For example, Mahoney and colleagues20 retrospectively evaluated shoulder arthroplasty procedures at their institution to document the readmission rates, finding a 5.9% readmission rate at 30 days. Readmission occurred more frequently in the first 30 days following discharge than in the 30- to 90-day period, with the most common reasons for readmission including medical complications, infection, and dislocation. Streubel and colleagues22 evaluated reoperation rates from their institution’s TSA registry, finding a 0.6% reoperation rate for primary TSA at 30 days and 1.5% for revision TSA. Instability and infection were the most common indications for reoperation. Our findings confirm these single-institution results and demonstrate their application to a nationwide sample of TSA, not just to high-volume academic centers. We similarly observed that dislocation, surgical site infection, and medical complications (mostly pneumonia and pulmonary embolism) were common causes of readmission, and that the 30-day readmission rate was about 1 in 40.
Several authors have since used statewide databases to analyze and determine risk factors for readmission following TSA. Lyman and colleagues19 used the New York State Database to show that higher hospital TSA surgical volume was associated with a lower rate of readmission when age and comorbidities were controlled for in a multivariate model. Old age was also associated with an increased readmission rate in their multivariate analysis, but comorbidities (as measured by the Charlson comorbidity index) presented a nonsignificant associative trend. These authors opted not to determine specific causes of readmission. Schairer and colleagues21 used State Inpatient Databases from 7 states, finding a 90-day readmission rate of 7.3%, 82% of which were due to medical complications and 18% of which were due to surgical complications (mostly infection and dislocation). Their multivariate regression revealed that male sex, reverse TSA, Medicaid insurance, patients discharged to inpatient rehabilitation or nursing facilities, medical comorbidities, and low-volume TSA hospitals were associated with readmission. Zhang and colleagues23 used the same source to show that the 90-day readmission rate reached 14% for surgically treated proximal humerus fractures and higher for patients who underwent open reduction internal fixation, were female, were African American, were discharged to a nursing facility, possessed Medicaid insurance, or experienced medical comorbidities. Most recently, Basques and colleagues31 analyzed 1505 TSA cases from 2011 and 2012 in the NSQIP database, finding a 3.3% rate of readmission, with heart disease and hypertension as risk factors for readmission. Although the limitations of the NSQIP database prevented us from analyzing surgeon and hospital TSA volume or reverse vs anatomic TSA, our results confirm that the findings from statewide database studies apply to the United States nationwide NSQIP database. Old patient age, male sex, and medical comorbidities (anemia and dependent functional status) are independent risk factors for TSA readmission. We identified pneumonia, dislocation, pulmonary embolism, and surgical site infection as the most common reasons for readmission.
This study features several limitations that should be considered when interpreting the results. Anatomic and reverse TSA share a CPT code and were not separated using NSQIP data. A number of studies have reported that reverse TSA may place patients at higher risk for readmission;20,21 however, confounding by other patient factors could play a role in this finding. The 30-day timeframe for readmission is another potential limitation; however, this timeframe is frequently used in other studies and is the relevant timeframe for the reduced reimbursement penalties from the Hospital Readmissions Reduction Program of the Affordable Care Act.18 Furthermore, the NSQIP database contains no information on surgeon or hospital TSA volume, which is a result of safeguards for patient and provider privacy. Additionally, readmission data were only available for 2011 to 2013, with causes of readmission only present in 2013. Although provided with such current information, we cannot analyze readmission trends over time, such as in response to the Affordable Care Act of 2010. Finally, although NSQIP surgical clinical reviewers strive to identify readmissions to other hospitals during their reviews of outpatient medical records, proportions of these readmissions are possibly missed. Therefore, our 30-day readmission rate may slightly underestimate the true rate.
Despite these limitations, the NSQIP database offers a unique opportunity to examine risk factors and reasons for readmission following TSA. The prior literature on readmission following TSA stemmed either from limited samples or administrative data, which feature known limitations.32 By utilizing a large, prospective, non-administrative, nationwide sample, our findings are probably both more reliable and generalizable to the country as a whole.
CONCLUSION
Unplanned readmission occurs following about 1 in 40 cases of TSA. The most common causes of readmission include pneumonia, dislocation, pulmonary embolism, and surgical site infection. Patients with old age, male sex, anemia, and dependent functional status are at a higher risk for readmission and should be counseled and monitored accordingly.
This paper will be judged for the Resident Writer’s Award.
ABSTRACT
An increasing interest focuses on the rates and risk factors for hospital readmission. However, little is known regarding the readmission following total shoulder arthroplasty (TSA). This study aims to determine the rates, risk factors, and reasons for hospital readmission following primary TSA. Patients undergoing TSA (anatomic or reverse) as part of the American College of Surgeons National Surgical Quality Improvement Program in 2011 to 2013 were identified. The rate of unplanned readmission to the hospital within 30 postoperative days was characterized. Using multivariate regression, demographic and comorbidity factors were tested for independent association with readmission. Finally, the reasons for readmission were characterized. A total of 3627 patients were identified. Among the admitted patients, 93 (2.56%) were readmitted within 30 days of surgery. The independent risk factors for readmission included old age (for age 60-69 years, relative risk [RR] = 1.6; for age 70-79 years, RR = 2.3; for age ≥80 years, RR = 23.1; P = .042), male sex (RR = 1.6, P = .025), anemia (RR = 1.9, P = .005), and dependent functional status (RR = 2.8, P = .012). The reasons for readmission were available for 84 of the 93 readmitted patients. The most common reasons for readmission comprised pneumonia (14 cases, 16.7%), dislocation (7 cases, 8.3%), pulmonary embolism (7 cases, 8.3%), and surgical site infection (6 cases, 7.1%). Unplanned readmission occurs following about 1 in 40 cases of TSA. The most common causes of readmission include pneumonia, dislocation, pulmonary embolism, and surgical site infection. Patients with old age, male sex, anemia, and dependent functional status are at higher risk for readmission and should be counseled and monitored accordingly.
Continue to: Total shoulder arthroplasty...
Total shoulder arthroplasty (TSA) is performed with increasing frequency in the United States and is considered to be cost-effective.1-4 Following the procedure, patients generally achieve shoulder function and pain relief.5-8 Despite the success of the procedure, the growing literature on TSA has also reported rates of complications between 3.6% and 25% of the treated patients.9-16
In recent years, an increasing interest has focused on the rates and risk factors for unplanned hospital readmissions; these variables may not only reflect the quality of patient care but also result in considerable costs to the healthcare system. For instance, among Medicare patients, readmissions within 30 days of discharge occur in almost 20% of cases, costing $17.4 billion per year.17 Readmission rates increasingly factor into hospital performance metrics and reimbursement, including the Hospital Readmissions Reduction Program of the Patient Protection and Affordable Care Act that reduces Centers for Medicare and Medicaid Services payments to hospitals with high 30-day readmission rates.18
To date, only a few studies have evaluated readmission following TSA, with 30- to 90-day readmission rates ranging from 4.5% to 7.3%.19-23 These studies comprised single institution series20,22 and analyses of administrative databases.19,21,23 Most studies have shown that readmission occurs more often for medical than surgical reasons, with surgical reasons most commonly including infection and dislocation.19-23 However, only limited analyses have been conducted regarding risk factors for readmission.21,23 To date and to our knowledge, no study has investigated reasons for readmission following TSA using nationwide data.
This study aims to determine the rates, risk factors, and reasons for hospital readmission following primary TSA in the United States using the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database.
METHODS
DATA SOURCE
The NSQIP database was utilized to address the study purpose. NSQIP is a nationwide prospective surgical registry established by the American College of Surgeons and reports data from academic and community hospitals across the United States.24 Patients undertaking surgery at these centers are followed by the surgical clinical reviewers at the participating NSQIP sites prospectively for 30 days following the procedure to record complications including readmission. Preoperative and surgical data, such as demographics, medical comorbid diseases, and operative time, are also included. Previous studies have analyzed the complications of various orthopedic surgeries using the NSQIP data.14,16,25-30
DATA COLLECTION
We retrospectively identified from NSQIP the patients who underwent primary TSA (anatomic or reverse) in 2013 to 2014. The timeframe 2013 to 2014 was used because NSQIP only began recording reasons for readmission in 2013. The inclusion criteria were as follows: Current Procedural Terminology (CPT) code for TSA (23472); preoperative diagnosis according to the International Classification of Diseases, Ninth Revision (ICD-9) codes 714.0, 715.11, 715.31, 715.91, 715.21, 715.89, 716.xx 718.xx, 719.xx, 726.x, 727.xx, and 733.41 (where x is a wild card digit); and no missing demographic, comorbidity, or outcome data. Anatomic and reverse TSA were analyzed together because they share the same CPT code, and the NSQIP database prevents searching by the ICD-9 procedure code.
The rate of unplanned readmission to the hospital within 30 postoperative days was characterized. The reasons for readmission in this 30-day period were only available in 2013 and were determined using the ICD-9 diagnosis codes. Patient demographics were recorded for use in identifying potential risk factors for readmission; the demographic data included sex, age, smoking status, body mass index (BMI), and comorbidities, including end-stage renal disease, dyspnea on exertion, congestive heart failure, diabetes mellitus, hypertension, and chronic obstructive pulmonary disease (COPD).
Continue to: Statistical analysis...
STATISTICAL ANALYSIS
Statistical analyses were performed using Stata version 13.1 (StataCorp). First, using bivariate and multivariate regression, demographic and comorbidity factors were tested for independent association with readmission to the hospital within 30 days of surgery. Second, among the readmitted patients, the reasons for readmission were tabulated. Of note, the reasons for readmission were only documented for the procedures performed in 2013. All tests were 2-tailed and conducted at an α level of 0.05.
RESTULTS
A total of 3627 TSA patients were identified. The mean age (± standard deviation) was 69.4 ± 9.5 years, 55.8% of patients were female, and mean BMI was 30.1 ± 7.0 years. Table 1 provides the additional demographic data. Of the 3627 included patients, 93 (2.56%) were readmitted within 30 days of surgery. The 95% confidence interval for the estimated rate of readmission reached 2.05% to 3.08%.
Table 1. Patient Population
| Number | Percent |
Total | 3627 | 100.0% |
Age |
|
|
18-59 | 539 | 14.9% |
60-69 | 1235 | 34.1% |
70-79 | 1317 | 36.3% |
≥80 | 536 | 14.8% |
Sex |
|
|
Male | 1603 | 44.2% |
Female | 2024 | 55.8% |
Body mass index |
|
|
Normal (<25 kg/m2) | 650 | 17.9% |
Overweight (25-30 kg/m2) | 1147 | 31.6% |
Obese (≥30 kg/m2) | 1830 | 50.5% |
Functional status |
|
|
Independent | 3544 | 97.7% |
Dependent | 83 | 2.3% |
Diabetes mellitus |
|
|
No | 3022 | 83.3% |
Yes | 605 | 16.7% |
Dyspnea on exertion |
|
|
No | 3393 | 93.6% |
Yes | 234 | 6.5% |
Hypertension |
|
|
No | 1192 | 32.9% |
Yes | 2435 | 67.1% |
COPD |
|
|
No | 3384 | 93.3% |
Yes | 243 | 6.7% |
Current smoker |
|
|
No | 3249 | 89.6% |
Yes | 378 | 10.4% |
Anemia |
|
|
No | 3051 | 84.1% |
Yes | 576 | 15.9% |
Abbreviation: COPD, chronic obstructive pulmonary disease.
In the bivariate analyses (Table 2), the following factors were positively associated readmission: older age (60-69 years, relative risk [RR] = 1.6; 70-79 years, RR = 2.2; ≥80 years, RR = 3.3; P = .011), dependent functional status (RR = 2.9, P = .008), and anemia (RR = 2.2, P < .001).
Table 2. Bivariate Analysis of Risk Factors for Readmission
| Rate | RR | 95% CI | P-value |
Age |
|
|
| 0.011 |
18-59 | 1.30% | Ref. | - |
|
60-69 | 2.02% | 1.6 | 0.7-3.6 |
|
70-79 | 2.89% | 2.2 | 1.0-4.9 |
|
≥80 | 4.29% | 3.3 | 1.4-7.6 |
|
Sex |
|
|
| 0.099 |
Female | 2.17% | Ref. | - |
|
Male | 3.06% | 1.4 | 0.9-2.1 |
|
Body mass index |
|
|
| 0.764 |
Normal (<25 kg/m2) | 2.92% | Ref. | - |
|
Overweight (25-30 kg/m2) | 2.35% | 0.8 | 0.5-1.4 |
|
Obese (≥30 kg/m2) | 2.57% | 0.9 | 0.5-1.5 |
|
Functional status |
|
|
| 0.008 |
Independent | 2.45% | Ref. | - |
|
Dependent | 7.23% | 2.9 | 1.3-6.5 |
|
Diabetes mellitus |
|
|
| 0.483 |
No | 2.48% | Ref. | - |
|
Yes | 2.98% | 1.2 | 0.7-2.0 |
|
Dyspnea on exertion |
|
|
| 0.393 |
No | 2.51% | Ref. | - |
|
Yes | 3.42% | 1.4 | 0.7-2.8 |
|
Hypertension |
|
|
| 0.145 |
No | 2.01% | Ref. | - |
|
Yes | 2.83% | 1.4 | 0.9-2.2 |
|
COPD |
|
|
| 0.457 |
No | 2.51% | Ref. | - |
|
Yes | 3.29% | 1.3 | 0.6-2.7 |
|
Current smoker |
|
|
| 0.116 |
No | 2.71% | Ref. | - |
|
Yes | 1.32% | 0.5 | 0.2-1.2 |
|
Anemia |
|
|
| <0.001 |
No | 2.16% | Ref. | - |
|
Yes | 4.69% | 2.2 | 1.4-3.4 |
|
Abbreviations: CI, confidence interval; COPD, chronic obstructive pulmonary disease; RR, relative risk.
In the multivariate analyses (Table 3), the following factors were independent risk factors for readmission: older age (60-69 years, RR = 1.6; 70-79 years, RR = 2.3; ≥80 years, RR = 3.1; P =.027), male sex (RR = 1.6, P = .025), anemia (RR = 1.9, P = .005), and dependent functional status (RR = 2.8, P = .012). Interestingly, readmission showed no independent association with diabetes, dyspnea on exertion, BMI, COPD, hypertension, or current smoking status (P > .05 for each).
Table 3. Independent Risk Factors for Readmission on Multivariate Analysis
| Rate | RR | 95% CI | P-value |
Age |
|
|
| 0.027 |
18-59 | 1.30% | Ref | - |
|
60-69 | 2.02% | 1.6 | 0.7-3.6 |
|
70-79 | 2.89% | 2.3 | 1.0-5.1 |
|
≥80 | 4.29% | 3.1 | 1.3-7.4 |
|
Sex |
|
|
| 0.025 |
Female | 2.17% | Ref. | - |
|
Male | 3.06% | 1.6 | 1.1-2.4 |
|
Anemia |
|
|
| 0.005 |
No | 2.16% | Ref | - |
|
Yes | 4.69% | 1.9 | 1.2-3.0 |
|
Functional status |
|
|
| 0.012 |
Independent | 2.45% | Ref | - |
|
Dependent | 7.23% | 2.8 | 1.3-6.2 |
|
Abbreviations: CI, confidence interval; COPD, chronic obstructive pulmonary disease; RR, relative risk.
Continue to: Table 4...
The reasons for readmission were available for 84 of the 93 readmitted patients. The most common reasons for readmission included pneumonia (14 cases, 16.7%), dislocation (7 cases, 8.3%), pulmonary embolism (7 cases, 8.3%), and surgical site infection (6 cases, 7.1%) (Table 4).
Table 4. Reasons for Readmission
| Number | Percent |
Pneumonia | 14 | 16.7% |
Dislocation | 7 | 8.3% |
Pulmonary embolism | 7 | 8.3% |
Surgical site infection | 6 | 7.1% |
Atrial fibrillation | 4 | 4.8% |
Hematoma | 4 | 4.8% |
Altered mental status | 3 | 3.6% |
Chest pain | 3 | 3.6% |
Renal insufficiency/kidney failure | 3 | 3.6% |
Urinary tract infection | 3 | 3.6% |
Acute gastric or duodenal ulcer | 2 | 2.4% |
Dermatitis/other allergic reaction | 2 | 2.4% |
Orthostatic hypotension/syncope | 2 | 2.4% |
Pain | 2 | 2.4% |
Respiratory distress | 2 | 2.4% |
Sepsis | 2 | 2.4% |
Urinary retention | 2 | 2.4% |
Acute cholecystitis | 1 | 1.2% |
Cerebrovascular accident | 1 | 1.2% |
Constipation | 1 | 1.2% |
Contusion of shoulder | 1 | 1.2% |
Deep venous thrombosis requiring therapy | 1 | 1.2% |
Gastrointestinal hemorrhage | 1 | 1.2% |
Gout | 1 | 1.2% |
Hepatic encephalopathy | 1 | 1.2% |
Intestinal infection | 1 | 1.2% |
Narcotic overdose | 1 | 1.2% |
Nausea/vomiting | 1 | 1.2% |
Proximal humerus fracture | 1 | 1.2% |
Rotator cuff tear | 1 | 1.2% |
Seroma | 1 | 1.2% |
Unspecified disease of pericardium | 1 | 1.2% |
Weakness | 1 | 1.2% |
DISCUSSION
Our analysis of 3042 TSAs from the NSQIP database suggests that unplanned readmission to the hospital occurs following about 1 in 40 cases of TSA. The study also suggests that the most common reasons for readmission encompass pneumonia, dislocation, pulmonary embolism, and surgical site infection. Old age, male sex, anemia, and dependent functional status serve as risk factors for readmission, and patients with such factors should be counseled and monitored accordingly.
In recent years, an increasing emphasis has centered on reducing rates of hospital readmission, with programs such as the Hospital Readmissions Reduction Program of the Affordable Care Act cutting reimbursements for hospitals with high 30-day readmission rates.17,18 To date, only a few studies have evaluated the reasons for readmission and readmission rates for TSA.19-23 Initial reports consisted of single-institution TSA registry reviews. For example, Mahoney and colleagues20 retrospectively evaluated shoulder arthroplasty procedures at their institution to document the readmission rates, finding a 5.9% readmission rate at 30 days. Readmission occurred more frequently in the first 30 days following discharge than in the 30- to 90-day period, with the most common reasons for readmission including medical complications, infection, and dislocation. Streubel and colleagues22 evaluated reoperation rates from their institution’s TSA registry, finding a 0.6% reoperation rate for primary TSA at 30 days and 1.5% for revision TSA. Instability and infection were the most common indications for reoperation. Our findings confirm these single-institution results and demonstrate their application to a nationwide sample of TSA, not just to high-volume academic centers. We similarly observed that dislocation, surgical site infection, and medical complications (mostly pneumonia and pulmonary embolism) were common causes of readmission, and that the 30-day readmission rate was about 1 in 40.
Several authors have since used statewide databases to analyze and determine risk factors for readmission following TSA. Lyman and colleagues19 used the New York State Database to show that higher hospital TSA surgical volume was associated with a lower rate of readmission when age and comorbidities were controlled for in a multivariate model. Old age was also associated with an increased readmission rate in their multivariate analysis, but comorbidities (as measured by the Charlson comorbidity index) presented a nonsignificant associative trend. These authors opted not to determine specific causes of readmission. Schairer and colleagues21 used State Inpatient Databases from 7 states, finding a 90-day readmission rate of 7.3%, 82% of which were due to medical complications and 18% of which were due to surgical complications (mostly infection and dislocation). Their multivariate regression revealed that male sex, reverse TSA, Medicaid insurance, patients discharged to inpatient rehabilitation or nursing facilities, medical comorbidities, and low-volume TSA hospitals were associated with readmission. Zhang and colleagues23 used the same source to show that the 90-day readmission rate reached 14% for surgically treated proximal humerus fractures and higher for patients who underwent open reduction internal fixation, were female, were African American, were discharged to a nursing facility, possessed Medicaid insurance, or experienced medical comorbidities. Most recently, Basques and colleagues31 analyzed 1505 TSA cases from 2011 and 2012 in the NSQIP database, finding a 3.3% rate of readmission, with heart disease and hypertension as risk factors for readmission. Although the limitations of the NSQIP database prevented us from analyzing surgeon and hospital TSA volume or reverse vs anatomic TSA, our results confirm that the findings from statewide database studies apply to the United States nationwide NSQIP database. Old patient age, male sex, and medical comorbidities (anemia and dependent functional status) are independent risk factors for TSA readmission. We identified pneumonia, dislocation, pulmonary embolism, and surgical site infection as the most common reasons for readmission.
This study features several limitations that should be considered when interpreting the results. Anatomic and reverse TSA share a CPT code and were not separated using NSQIP data. A number of studies have reported that reverse TSA may place patients at higher risk for readmission;20,21 however, confounding by other patient factors could play a role in this finding. The 30-day timeframe for readmission is another potential limitation; however, this timeframe is frequently used in other studies and is the relevant timeframe for the reduced reimbursement penalties from the Hospital Readmissions Reduction Program of the Affordable Care Act.18 Furthermore, the NSQIP database contains no information on surgeon or hospital TSA volume, which is a result of safeguards for patient and provider privacy. Additionally, readmission data were only available for 2011 to 2013, with causes of readmission only present in 2013. Although provided with such current information, we cannot analyze readmission trends over time, such as in response to the Affordable Care Act of 2010. Finally, although NSQIP surgical clinical reviewers strive to identify readmissions to other hospitals during their reviews of outpatient medical records, proportions of these readmissions are possibly missed. Therefore, our 30-day readmission rate may slightly underestimate the true rate.
Despite these limitations, the NSQIP database offers a unique opportunity to examine risk factors and reasons for readmission following TSA. The prior literature on readmission following TSA stemmed either from limited samples or administrative data, which feature known limitations.32 By utilizing a large, prospective, non-administrative, nationwide sample, our findings are probably both more reliable and generalizable to the country as a whole.
CONCLUSION
Unplanned readmission occurs following about 1 in 40 cases of TSA. The most common causes of readmission include pneumonia, dislocation, pulmonary embolism, and surgical site infection. Patients with old age, male sex, anemia, and dependent functional status are at a higher risk for readmission and should be counseled and monitored accordingly.
This paper will be judged for the Resident Writer’s Award.
- Adams JE, Sperling JW, Hoskin TL, Melton LJ, Cofield RH. Shoulder arthroplasty in Olmsted County, Minnesota, 1976-2000: a population-based study. J Shoulder Elbow Surg.2006;15(1):50-55. doi:10.1016/j.jse.2005.04.009.
- Jain NB, Higgins LD, Guller U, Pietrobon R, Katz JN. Trends in the epidemiology of total shoulder arthroplasty in the United States from 1990-2000. Arthritis Rheum.2006;55(4):591-597. doi:10.1002/art.22102.
- Kim SH, Wise BL, Zhang Y, Szabo RM. Increasing incidence of shoulder arthroplasty in the United States. J Bone Joint Surg Am. 2011;93(24):2249-2254. doi:10.2106/JBJS.J.01994. doi:10.2106/JBJS.J.01994.
- Mather RC, Watters TS, Orlando LA, Bolognesi MP, Moorman CT. Cost effectiveness analysis of hemiarthroplasty and total shoulder arthroplasty. J Shoulder Elbow Surg.2010;19(3):325-334. doi:10.1016/j.jse.2009.11.057.
- Carter MJ, Mikuls TR, Nayak S, Fehringer EV, Michaud K. Impact of total shoulder arthroplasty on generic and shoulder-specific health-related quality-of-life measures: a systematic literature review and meta-analysis. J Bone Joint Surg Am. 2012;94(17):e127. doi:10.2106/JBJS.K.00204.
- Deshmukh AV, Koris M, Zurakowski D, Thornhill TS. Total shoulder arthroplasty: long-term survivorship, functional outcome, and quality of life. J Shoulder Elbow Surg. 2005;14(5):471-479. doi:10.1016/j.jse.2005.02.009.
- Montoya F, Magosch P, Scheiderer B, Lichtenberg S, Melean P, Habermeyer P. Midterm results of a total shoulder prosthesis fixed with a cementless glenoid component. J Shoulder Elbow Surg. 2013;22(5):628-635. doi:10.1016/j.jse.2012.07.005.
- Raiss P, Bruckner T, Rickert M, Walch G. Longitudinal observational study of total shoulder replacements with cement: fifteen to twenty-year follow-up. J Bone Joint Surg Am.2014;96(3):198-205. doi:10.2106/JBJS.M.00079.
- Bohsali KI, Wirth MA, Rockwood CA. Complications of total shoulder arthroplasty. J Bone Joint Surg Am. 2006;88(10):2279-2292. doi:10.2106/JBJS.F.00125.
- Chalmers PN, Gupta AK, Rahman Z, Bruce B, Romeo AA, Nicholson GP. Predictors of early complications of total shoulder arthroplasty. J Arthroplasty. 2014;29(4):856-860. doi:10.1016/j.arth.2013.07.002.
- Cheung E, Willis M, Walker M, Clark R, Frankle MA. Complications in reverse total shoulder arthroplasty. J Am Acad Orthop Surg. 2011;19(7):439-449.
- Papadonikolakis A, Neradilek MB, Matsen FA. Failure of the glenoid component in anatomic total shoulder arthroplasty: a systematic review of the English-language literature between 2006 and 2012. J Bone Joint Surg Am. 2013;95(24):2205-2212. doi:10.2106/JBJS.L.00552.
- Saltzman BM, Chalmers PN, Gupta AK, Romeo AA, Nicholson GP. Complication rates comparing primary with revision reverse total shoulder arthroplasty. J Shoulder Elbow Surg.2014;23(11):1647-1654. doi:10.1016/j.jse.2014.04.015.
- Shields E, Iannuzzi JC, Thorsness R, Noyes K, Voloshin I. Perioperative complications after hemiarthroplasty and total shoulder arthroplasty are equivalent. J Shoulder Elbow Surg. 2014;23(10):1449-1453. doi:10.1016/j.jse.2014.01.052.
- Sperling JW, Hawkins RJ, Walch G, Mahoney AP, Zuckerman JD. Complications in total shoulder arthroplasty. Instr Course Lect. 2013;62:135-141.
- Shields E, Thirukumaran C, Thorsness R, Noyes K, Voloshin I. An analysis of adult patient risk factors and complications within 30 days after arthroscopic shoulder surgery. Arthroscopy. 2015;31(5):807-815. doi:10.1016/j.arthro.2014.12.011.
- Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009;360(14):1418-1428. doi:10.1056/NEJMsa0803563.
- Centers for Medicare & Medicaid Services. Readmissions reduction program (HRRP). . Updated April 27, 2018. Accessed June 29, 2018.
- Lyman S, Jones EC, Bach PB, Peterson MG, Marx RG. The association between hospital volume and total shoulder arthroplasty outcomes. Clin Orthop Relat Res. 2005;432:132-137. doi:10.1097/01.blo.0000150571.51381.9a.
- Mahoney A, Bosco JA, Zuckerman JD. Readmission after shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(3):377-381. doi:10.1016/j.jse.2013.08.007.
- Schairer WW, Zhang AL, Feeley BT. Hospital readmissions after primary shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(9):1349-1355. doi:10.1016/j.jse.2013.12.004.
- Streubel PN, Simone JP, Sperling JW, Cofield R. Thirty and ninety-day reoperation rates after shoulder arthroplasty. J Bone Joint Surg Am. 2014;96(3):e17. doi:10.2106/JBJS.M.00127.
- Zhang AL, Schairer WW, Feeley BT. Hospital readmissions after surgical treatment of proximal humerus fractures: is arthroplasty safer than open reduction internal fixation? Clin Orthop Relat Res. 2014;472(8):2317-2324. doi:10.1007/s11999-014-3613-y.
- American College of Surgeons. ACS National Surgical Quality Improvement Program. http://www.acsnsqip.org. Accessed July 15, 2015.
- Basques BA, Gardner EC, Varthi AG, et al. Risk factors for short-term adverse events and readmission after arthroscopic meniscectomy: does age matter? Am J Sports Med.2015;43(1):169-175. doi:10.1177/0363546514551923.
- Haughom BD, Schairer WW, Hellman MD, Yi PH, Levine BR. Does resident involvement impact post-operative complications following primary total knee arthroplasty? An analysis of 24,529 cases. J Arthroplasty. 2014;29(7):1468-1472.e2. doi:10.1016/j.arth.2014.02.036.
- Haughom BD, Schairer WW, Hellman MD, Yi PH, Levine BR. Resident involvement does not influence complication after total hip arthroplasty: an analysis of 13,109 cases. J Arthroplasty. 2014;29(10):1919-1924. doi:10.1016/j.arth.2014.06.003.
- Martin CT, Gao Y, Pugely AJ, Wolf BR. 30-day morbidity and mortality after elective shoulder arthroscopy: a review of 9410 cases. J Shoulder Elbow Surg. 2013;22(12):1667-1675.e1. doi:10.1016/j.jse.2013.06.022.
- Martin CT, Pugely AJ, Gao Y, Wolf BR. Risk factors for thirty-day morbidity and mortality following knee arthroscopy: a review of 12,271 patients from the national surgical quality improvement program database. J Bone Joint Surg Am. 2013;95(14):e98 1-10. doi:10.2106/JBJS.L.01440.
- Waterman BR, Dunn JC, Bader J, Urrea L, Schoenfeld AJ, Belmont PJ. Thirty-day morbidity and mortality after elective total shoulder arthroplasty: patient-based and surgical risk factors. J Shoulder Elbow Surg. 2015;24(1):24-30. doi:10.1016/j.jse.2014.05.016.
- Basques BA, Gardner EC, Toy JO, Golinvaux NS, Bohl DD, Grauer JN. Length of stay and readmission after total shoulder arthroplasty: an analysis of 1505 cases. Am J Orthop.2015;44(8):E268-E271.
- Bohl DD, Russo GS, Basques BA, et al. Variations in data collection methods between national databases affect study results: a comparison of the nationwide inpatient sample and national surgical quality improvement program databases for lumbar spine fusion procedures. J Bone Joint Surg Am. 2014;96(23):e193. doi:10.2106/JBJS.M.01490.
- Adams JE, Sperling JW, Hoskin TL, Melton LJ, Cofield RH. Shoulder arthroplasty in Olmsted County, Minnesota, 1976-2000: a population-based study. J Shoulder Elbow Surg.2006;15(1):50-55. doi:10.1016/j.jse.2005.04.009.
- Jain NB, Higgins LD, Guller U, Pietrobon R, Katz JN. Trends in the epidemiology of total shoulder arthroplasty in the United States from 1990-2000. Arthritis Rheum.2006;55(4):591-597. doi:10.1002/art.22102.
- Kim SH, Wise BL, Zhang Y, Szabo RM. Increasing incidence of shoulder arthroplasty in the United States. J Bone Joint Surg Am. 2011;93(24):2249-2254. doi:10.2106/JBJS.J.01994. doi:10.2106/JBJS.J.01994.
- Mather RC, Watters TS, Orlando LA, Bolognesi MP, Moorman CT. Cost effectiveness analysis of hemiarthroplasty and total shoulder arthroplasty. J Shoulder Elbow Surg.2010;19(3):325-334. doi:10.1016/j.jse.2009.11.057.
- Carter MJ, Mikuls TR, Nayak S, Fehringer EV, Michaud K. Impact of total shoulder arthroplasty on generic and shoulder-specific health-related quality-of-life measures: a systematic literature review and meta-analysis. J Bone Joint Surg Am. 2012;94(17):e127. doi:10.2106/JBJS.K.00204.
- Deshmukh AV, Koris M, Zurakowski D, Thornhill TS. Total shoulder arthroplasty: long-term survivorship, functional outcome, and quality of life. J Shoulder Elbow Surg. 2005;14(5):471-479. doi:10.1016/j.jse.2005.02.009.
- Montoya F, Magosch P, Scheiderer B, Lichtenberg S, Melean P, Habermeyer P. Midterm results of a total shoulder prosthesis fixed with a cementless glenoid component. J Shoulder Elbow Surg. 2013;22(5):628-635. doi:10.1016/j.jse.2012.07.005.
- Raiss P, Bruckner T, Rickert M, Walch G. Longitudinal observational study of total shoulder replacements with cement: fifteen to twenty-year follow-up. J Bone Joint Surg Am.2014;96(3):198-205. doi:10.2106/JBJS.M.00079.
- Bohsali KI, Wirth MA, Rockwood CA. Complications of total shoulder arthroplasty. J Bone Joint Surg Am. 2006;88(10):2279-2292. doi:10.2106/JBJS.F.00125.
- Chalmers PN, Gupta AK, Rahman Z, Bruce B, Romeo AA, Nicholson GP. Predictors of early complications of total shoulder arthroplasty. J Arthroplasty. 2014;29(4):856-860. doi:10.1016/j.arth.2013.07.002.
- Cheung E, Willis M, Walker M, Clark R, Frankle MA. Complications in reverse total shoulder arthroplasty. J Am Acad Orthop Surg. 2011;19(7):439-449.
- Papadonikolakis A, Neradilek MB, Matsen FA. Failure of the glenoid component in anatomic total shoulder arthroplasty: a systematic review of the English-language literature between 2006 and 2012. J Bone Joint Surg Am. 2013;95(24):2205-2212. doi:10.2106/JBJS.L.00552.
- Saltzman BM, Chalmers PN, Gupta AK, Romeo AA, Nicholson GP. Complication rates comparing primary with revision reverse total shoulder arthroplasty. J Shoulder Elbow Surg.2014;23(11):1647-1654. doi:10.1016/j.jse.2014.04.015.
- Shields E, Iannuzzi JC, Thorsness R, Noyes K, Voloshin I. Perioperative complications after hemiarthroplasty and total shoulder arthroplasty are equivalent. J Shoulder Elbow Surg. 2014;23(10):1449-1453. doi:10.1016/j.jse.2014.01.052.
- Sperling JW, Hawkins RJ, Walch G, Mahoney AP, Zuckerman JD. Complications in total shoulder arthroplasty. Instr Course Lect. 2013;62:135-141.
- Shields E, Thirukumaran C, Thorsness R, Noyes K, Voloshin I. An analysis of adult patient risk factors and complications within 30 days after arthroscopic shoulder surgery. Arthroscopy. 2015;31(5):807-815. doi:10.1016/j.arthro.2014.12.011.
- Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009;360(14):1418-1428. doi:10.1056/NEJMsa0803563.
- Centers for Medicare & Medicaid Services. Readmissions reduction program (HRRP). . Updated April 27, 2018. Accessed June 29, 2018.
- Lyman S, Jones EC, Bach PB, Peterson MG, Marx RG. The association between hospital volume and total shoulder arthroplasty outcomes. Clin Orthop Relat Res. 2005;432:132-137. doi:10.1097/01.blo.0000150571.51381.9a.
- Mahoney A, Bosco JA, Zuckerman JD. Readmission after shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(3):377-381. doi:10.1016/j.jse.2013.08.007.
- Schairer WW, Zhang AL, Feeley BT. Hospital readmissions after primary shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(9):1349-1355. doi:10.1016/j.jse.2013.12.004.
- Streubel PN, Simone JP, Sperling JW, Cofield R. Thirty and ninety-day reoperation rates after shoulder arthroplasty. J Bone Joint Surg Am. 2014;96(3):e17. doi:10.2106/JBJS.M.00127.
- Zhang AL, Schairer WW, Feeley BT. Hospital readmissions after surgical treatment of proximal humerus fractures: is arthroplasty safer than open reduction internal fixation? Clin Orthop Relat Res. 2014;472(8):2317-2324. doi:10.1007/s11999-014-3613-y.
- American College of Surgeons. ACS National Surgical Quality Improvement Program. http://www.acsnsqip.org. Accessed July 15, 2015.
- Basques BA, Gardner EC, Varthi AG, et al. Risk factors for short-term adverse events and readmission after arthroscopic meniscectomy: does age matter? Am J Sports Med.2015;43(1):169-175. doi:10.1177/0363546514551923.
- Haughom BD, Schairer WW, Hellman MD, Yi PH, Levine BR. Does resident involvement impact post-operative complications following primary total knee arthroplasty? An analysis of 24,529 cases. J Arthroplasty. 2014;29(7):1468-1472.e2. doi:10.1016/j.arth.2014.02.036.
- Haughom BD, Schairer WW, Hellman MD, Yi PH, Levine BR. Resident involvement does not influence complication after total hip arthroplasty: an analysis of 13,109 cases. J Arthroplasty. 2014;29(10):1919-1924. doi:10.1016/j.arth.2014.06.003.
- Martin CT, Gao Y, Pugely AJ, Wolf BR. 30-day morbidity and mortality after elective shoulder arthroscopy: a review of 9410 cases. J Shoulder Elbow Surg. 2013;22(12):1667-1675.e1. doi:10.1016/j.jse.2013.06.022.
- Martin CT, Pugely AJ, Gao Y, Wolf BR. Risk factors for thirty-day morbidity and mortality following knee arthroscopy: a review of 12,271 patients from the national surgical quality improvement program database. J Bone Joint Surg Am. 2013;95(14):e98 1-10. doi:10.2106/JBJS.L.01440.
- Waterman BR, Dunn JC, Bader J, Urrea L, Schoenfeld AJ, Belmont PJ. Thirty-day morbidity and mortality after elective total shoulder arthroplasty: patient-based and surgical risk factors. J Shoulder Elbow Surg. 2015;24(1):24-30. doi:10.1016/j.jse.2014.05.016.
- Basques BA, Gardner EC, Toy JO, Golinvaux NS, Bohl DD, Grauer JN. Length of stay and readmission after total shoulder arthroplasty: an analysis of 1505 cases. Am J Orthop.2015;44(8):E268-E271.
- Bohl DD, Russo GS, Basques BA, et al. Variations in data collection methods between national databases affect study results: a comparison of the nationwide inpatient sample and national surgical quality improvement program databases for lumbar spine fusion procedures. J Bone Joint Surg Am. 2014;96(23):e193. doi:10.2106/JBJS.M.01490.
TAKE-HOME POINTS
- Shoulder arthroplasty is an increasingly commonly performed procedure for shoulder arthritis and other conditions.
- Unplanned readmission in the 30 days after shoulder arthroplasty occurred in about 1 of 40 cases.
- Increasing age was associated with readmission, particularly age >80 years.
- Other risk factors for readmission were male sex, anemia, and dependent functional status.
- The most common reasons for readmission were pneumonia, dislocation, pulmonary embolism, and surgical site infection.
Rheumatoid Arthritis vs Osteoarthritis: Comparison of Demographics and Trends of Joint Replacement Data from the Nationwide Inpatient Sample
ABSTRACT
Current literature regarding complications following total joint arthroplasty have primarily focused on patients with osteoarthritis (OA), with less emphasis on the trends and in-hospital outcomes of rheumatoid arthritis (RA) patients undergoing these procedures. The purpose of this study is to analyze the outcomes and trends of RA patients undergoing total knee arthroplasty (TKA) or total hip arthroplasty (THA) compared to OA patients.
Data from the Nationwide Inpatient Sample from 2006 to 2011 was extracted using the International Classification of Diseases, Ninth Revision codes for patients that received a TKA or THA. Outcome measures included cardiovascular complications, cerebrovascular complications, pulmonary complications, wound dehiscence, and infection. Inpatient and hospital demographics including primary diagnosis, age, gender, primary payer, hospital teaching status, Charlson Comorbidity Index score, hospital bed size, location, and median household income were analyzed.
Logistic regression analysis of OA vs RA patients with patient outcomes revealed that osteoarthritic THA candidates had lower risk for cardiovascular complications, pulmonary complications, wound dehiscence, infections, and systemic complications, compared to rheumatoid patients. There was a significantly elevated risk of cerebrovascular complication in osteoarthritic THA compared to RA THA. OA patients undergoing TKA had significantly higher risk for cardiovascular and cerebrovascular complications. There were significant decreases in mechanical wounds, infection, and systemic complications in the OA TKA patients.
RA patients are at higher risk for postoperative infection, wound dehiscence, and systemic complications after TKA and THA compared to OA patients. These findings highlight the importance of preoperative medical clearance and management to optimize RA patients and improve the postoperative outcomes.
Continue to: RA is a chronic systemic inflammatory disease...
Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease that causes joint deterioration, leading to pain, disability, systemic complications, short lifespan, and decline in quality of life.1-3 The deterioration primarily affects the synovial membranes of joints, causing arthritis and resulting in extra-articular sequelae such as cardiovascular disease,4 pulmonary disease,5 and increased infection rates.3,6 RA is the most prevalent inflammatory arthritis worldwide and affects up to 50 cases per 100,000 in both the US and northern Europe.2,7-9 Although the gold standard of care for these patients is medical management with immunosuppressant drugs such as disease-modifying anti-rheumatic drugs (DMARDs), total joint arthroplasty (TJA) remains an important tool in the management of joint deterioration in such patients.
Total knee arthroplasty (TKA) and total hip arthroplasty (THA) are common procedures utilized to treat disorders that cause joint pain and hindered joint mobility, including osteoarthritis (OA) and RA. Given the aging population, the amount of TKAs and THAs performed in the US has consistently increased each year, with the vast majority of this increase composed of patients with OA.10 As a result, previous studies investigated the trends and outcomes of these procedures in patients with OA, but relatively less is known about the outcomes and trends of patients with RA undergoing the same surgeries.
Given that RA is a fundamentally different condition with its own pathological characteristics, an understanding of how these differences may impact postoperative outcomes in patients with RA is important. This study aims to present a comparative analysis of the trends and postoperative outcomes between patients with RA and OA undergoing TKA and THA (Figure 1, Tables 1 and 2).
Table 1. Demographics of Total Knee Arthroplasty Patients Based on Primary Diagnosis of Osteoarthritis
| OA | RA | Total | P Value | |||
| No. | Percent | No. | Percent | No. | Percent | (RA vs OA) |
Age group |
|
|
|
|
|
| <.0001 |
<64 years | 295,637 | 42.42 | 11,325 | 48.90 | 306,962 | 42.63 |
|
65 to 79 years | 329,034 | 47.22 | 10,055 | 43.42 | 339,089 | 47.09 |
|
≥80 years | 72,197 | 10.36 | 1780 | 7.69 | 73,977 | 10.27 |
|
Gender |
|
|
|
|
|
| <.0001 |
Male | 259,192 | 37.19 | 4887 | 21.12 | 264,079 | 36.68 |
|
Female | 435,855 | 62.54 | 18,248 | 78.88 | 454,103 | 63.07 |
|
Race |
|
|
|
|
|
| <.0001 |
White | 468,632 | 67.25 | 14,532 | 77.18 | 483,164 | 67.10 |
|
Black | 39,691 | 5.7 | 2119 | 11.25 | 41,810 | 5.81 |
|
Hispanic | 28,573 | 4.1 | 1395 | 7.41 | 29,968 | 4.16 |
|
Other | 21,306 | 3.06 | 783 | 4.16 | 22,089 | 3.07 |
|
Region of hospital |
|
|
|
|
|
| <.0001 |
Northeast | 112,031 | 16.08 | 3417 | 14.75 | 115,448 | 16.03 |
|
Midwest | 192,595 | 27.64 | 5975 | 25.80 | 198,570 | 27.58 |
|
South | 257,855 | 37 | 9422 | 40.68 | 267,277 | 37.12 |
|
West | 134,387 | 19.28 | 4346 | 18.77 | 138,733 | 19.27 |
|
Location/teaching status of hospital |
|
|
|
|
|
| <.0001 |
Rural | 86,321 | 12.39 | 2709 | 11.79 | 89,030 | 12.36 |
|
Urban non-teaching | 333,043 | 47.79 | 10,905 | 47.46 | 343,948 | 47.77 |
|
Urban teaching | 273,326 | 39.22 | 9363 | 40.75 | 282,689 | 39.26 |
|
Hospital location |
|
|
|
|
|
| .0024 |
Rural | 86,321 | 12.39 | 2709 | 11.79 | 89,030 | 12.36 |
|
Urban | 606,369 | 87.01 | 20,268 | 88.21 | 626,637 | 87.03 |
|
Hospital teaching status |
|
|
|
|
|
| <.0001 |
Teaching | 409,465 | 58.76 | 13,275 | 57.78 | 422,740 | 58.71 |
|
Non-teaching | 283,225 | 40.64 | 9702 | 42.22 | 292,927 | 40.68 |
|
Comorbidities |
|
|
|
|
|
|
|
Obstructive sleep apnea | 65,342 | 9.38 | 1946 | 8.40 | 67,288 | 9.35 | <.0001 |
Diabetes | 147,292 | 21.14 | 4289 | 18.52 | 151,581 | 21.05 | <.0001 |
Obesity | 129,277 | 18.55 | 3730 | 16.11 | 133,007 | 18.47 | <.0001 |
Abbreviations: OA, osteoarthritis; RA, rheumatoid arthritis.
Table 2. Demographics of Total Hip Arthroplasty Patients Based on Primary Diagnosis of Osteoarthritis or Rheumatoid Arthritis
| OA | RA | Total | P Value | |||
| No. | Percent | No. | Percent | No. | Percent | (RA vs OA) |
Age group |
|
|
|
|
|
| <.0001 |
<64 years | 133,645 | 45.18 | 4679 | 48.02 | 138,324 | 45.27 |
|
65 to 79 years | 123,628 | 41.8 | 3992 | 40.97 | 127,620 | 41.77 |
|
≥80 years | 38,513 | 13.02 | 1073 | 11.01 | 39,586 | 12.96 |
|
Gender |
|
|
|
|
|
| <.0001 |
Male | 129,708 | 43.85 | 2457 | 25.24 | 132,165 | 43.26 |
|
Female | 165,010 | 55.79 | 7278 | 74.76 | 172,288 | 56.39 |
|
Race |
|
|
|
|
|
| <.0001 |
White | 207,005 | 69.98 | 6322 | 80.08 | 213,327 | 69.82 |
|
Black | 15,505 | 5.24 | 771 | 9.77 | 16,276 | 5.33 |
|
Hispanic | 6784 | 2.29 | 522 | 6.61 | 7306 | 2.39 |
|
Other | 7209 | 2.44 | 280 | 3.55 | 7489 | 2.45 |
|
Region of hospital |
|
|
|
|
|
| <.0001 |
Northeast | 58,525 | 19.79 | 1683 | 17.27 | 60,208 | 19.71 |
|
Midwest | 79,040 | 26.72 | 2446 | 25.10 | 81,486 | 26.67 |
|
South | 95,337 | 32.23 | 3716 | 38.14 | 99,053 | 32.42 |
|
West | 62,884 | 21.26 | 1899 | 19.49 | 64,783 | 21.20 |
|
Location/teaching status of hospital |
|
|
|
|
|
| .0065 |
Rural | 30,954 | 10.46 | 993 | 10.26 | 31,947 | 10.46 |
|
Urban non-teaching | 133,061 | 44.99 | 4245 | 43.87 | 137,306 | 44.94 |
|
Urban teaching | 130,150 | 44 | 4439 | 45.87 | 134,589 | 44.05 |
|
Hospital location |
|
|
|
|
|
| .4098 |
Rural | 30,954 | 10.46 | 993 | 10.26 | 31,947 | 10.46 |
|
Urban | 263,211 | 88.99 | 8684 | 89.74 | 271,895 | 88.99 |
|
Hospital teaching status |
|
|
|
|
|
| .0077 |
Teaching | 159,313 | 53.86 | 5108 | 52.78 | 164,421 | 53.82 |
|
Non-teaching | 134,852 | 45.59 | 4569 | 47.22 | 139,421 | 45.63 |
|
Comorbidities |
|
|
|
|
|
|
|
Obstructive sleep apnea | 19,760 | 6.68 | 573 | 5.88 | 20,333 | 6.65 | .0028 |
Diabetes | 41,929 | 14.18 | 1325 | 13.60 | 43,254 | 14.16 | .1077 |
Obesity | 38,808 | 13.12 | 1100 | 11.29 | 39,908 | 13.06 | <.0001 |
Abbreviations: OA, osteoarthritis; RA, rheumatoid arthritis
Continue to: Methods...
METHODS
Exemptions were obtained from the Institutional Review Board. Data from the Nationwide Inpatient Sample (NIS) from 2006 to 2011 were extracted using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes for patients that received primary TKA or THA, as well as their comorbid conditions. No patients or populations were excluded from the sampling process. A list of all independent variables collected for analysis and provision of relevant ICD-9 codes is included in Figure 1. The NIS is the largest all-payer stratified survey of inpatient care in the US healthcare system. As of 2011, each year provides information on approximately 8 million inpatient stays from about 1000 hospitals in 46 states. All discharges from sampled hospitals are also represented in the database. All patient information is protected, and all methods were conducted in accordance with the highest ethical standards of Human and Animal Rights Research.
STATISTICAL ANALYSIS
SAS 9.2 and PROC FREQ statistics software were used to generate P values (chi square result) and analyze the trends (Cochran-Armitage). Results were weighted utilizing standard discharge weights from the NIS to ensure accurate comparison of data from different time points. P < .05 was considered statistically significant. Multivariable logistic regression analyses were performed to generate odds ratio and 95% confidence limits to assess outcomes across different demographic variables.
RESULTS
Data on 337,082 and 1,362,241 patients undergoing THA or TKA, respectively, between 2006 and 2011 were analyzed. Patients in both groups were further differentiated by a diagnosis of either OA or RA. OA was the most common diagnosis, constituting 96.8% of all arthritic THA and TKA patients. From 2006 to 2011, a 36% and 34% increase in total number of THAs and TKAs, respectively, were reported. The number of patients with OA undergoing THA and TKA steadily increased from 2006 to 2011 (Figure 2). The number of THA and TKA procedures in patients with RA followed a similar trend but at a comparatively slower rate (Figure 3). The TKA geographical trends mirrored those observed with THA. The majority of operations were performed at urban hospitals (89% THA, 87% TKA; P < .0001). Among patients with RA and OA, the majority of TKAs (47.77%; P < .0001) took place in urban non-teaching hospitals than in urban teaching hospitals (39.26%). This pattern was not the same for THA, with 44.94% being performed at urban teaching hospitals and 44.05% at urban non-teaching institutions (P < .0001). Rural hospitals accounted for a low percentage of operations for both procedures: 10.46% of THA and 12.36% of TKA (P < .0001). Large institutions (based on the number of beds) claimed the majority of cases (59% of THA and TKA).
Logistic regression analysis and odds ratios of patients with OA vs those with RA with patient outcomes adjusted for age, Charlson Comorbidity Index (CCI) score, and gender revealed that patients with OA undergoing THA had lower risk for cardiovascular (0.674; confidence interval (CI) 0.587-0.774) and pulmonary complications (0.416; CI 0.384-0.450), wound dehiscence (0.647; CI 0.561-0.747), infections (0.258; CI 0.221-0.301), and systemic complications (0.625; CI 0.562-0.695) than patients with RA. Patients with OA exhibited statistically significantly higher odds of experiencing cerebrovascular complications after THA than those with RA (1.946; CI 1.673-2.236) (Table 3). In a similar logistic regression analysis of OA vs RA in TKA, which was adjusted for age, CCI score, and gender, patients with OA had significantly higher risk for cardiovascular (1.329; CI 1.069-1.651) and cerebrovascular complications (1.635; CI 1.375-1.943) than patients with RA. Significant decreases in wound dehiscence (0.757; CI 0.639-0.896), infection (0.331; CI 0.286-0.383), and systemic complication (0.641; CI 0.565-0.729) were noted in the patients with OA and TKA (Table 4).
Table 3. Odds Ratio for In-Hospital Complications Following THA for OA Patients vs RA Patients
| Odds Ratio | Confidence Limits |
Cardiovascular complication | .674 | .587-.744 |
Cerebrovascular complication | 1.946 | 1.673-2.236 |
Pulmonary complication | .416 | .384-.450 |
Wound dehiscence | .647 | .561-.747 |
Infection | .258 | .221-.301 |
Systemic complication | .625 | .562-.695 |
Abbreviations: OA, osteoarthritis; RA, rheumatoid arthritis; THA, total hip arthroplasty.
Table 4. Odds Ratio for In-Hospital Complications Following TKA for OA Patients vs RA Patients
| Odds Ratio | Confidence Limits |
Cardiovascular complication | 1.329 | 1.069-1.651 |
Cerebrovascular complication | 1.635 | 1.375-1.943 |
Pulmonary complication | 1.03 | .995-1.223 |
Wound dehiscence | .757 | .639-.896 |
Infection | .331 | .286-.383 |
Systemic complication | .641 | .565-.729 |
Abbreviations: OA, osteoarthritis; RA, rheumatoid arthritis; TKA, total knee arthroplasty.
Continue to: Discussion...
DISCUSSION
Our results showed a continuous yearly increase from 2006 to 2011 in THA and TKA procedures at a rate of 36% and 34%, respectively; this result was consistent with existing literature.11 Despite a substantial increase in the amount of total THA and TKA procedures, the ratio of patients with RA undergoing these operations has decreased or remained nearly the same. Similar effects were found in Japan and the US when examining patients with RA undergoing TJA procedures between 2001 and 2007 and between 1992 and 2005, respectively.12-14 This observation may be explained by the advances and early initiation of pharmacologic treatment and the widespread use of DMARDs such as methotrexate (MTX), azathioprine, leflunomide, hydroxychloroquine, and biological response modifiers TNF-α and interleukin-1.15 These medications have drastically improved survival rates of patients with RA with impressive capabilities in symptom relief.15 With the increasing use of DMARDs and aggressive treatment early on in the disease process, patients with RA are showing markedly slow progression of joint deterioration, leading to a decreased need for orthopedic intervention compared with the general population.13,15
When analyzing the complication rates for patients undergoing TKA and THA, we observed that patients with RA exhibited a significant increase in the rates of infections, wound dehiscence, and systemic complications prior to discharge from the hospital compared with the OA population. The increased risk of infections was reported in previous studies assessing postoperative complication rates in TJA.16,17 A study utilizing the Norwegian Arthroplasty Registry noted an increased risk of late infection in patients with RA, leading to increased rates of revision TJA in comparison with patients with OA.16 Another study, which was based on the Canadian Institute for Health Information Discharge Abstract Database, showed that patients with RA are at an increased risk of infection only after THA and interestingly not after TKA.17 Although our study did not identify the causes of the increased infection rate, the inherent nature of the disease and the immunomodulatory drugs used to treat it may contribute to this increased infectious risk in patients with RA.6,18 Immunosuppressive DMARDs are some of the widely used medications employed to treat RA and are prime suspects of causing increased infection rates.15 The perioperative use of MTX has not been shown to cause short-term increases in infection for patients undergoing orthopedic intervention, but leflunomide and TNF-α inhibitors have been shown to cause a significant several-fold increase in risk for surgical wound infections.19,20
All patients with RA presented with significant increases for infection, wound dehiscence, and systemic complications, whereas only patients with RA undergoing THA showed increased risk of pulmonary and cardiovascular complications when compared with patients with OA. Surprisingly, in TKA, patients with RA were at a significantly decreased risk of cardiovascular complications. This observation was interesting due to cardiovascular disease being one of RA's most notable extra-articular features.4,21
Patients with RA undergoing TJA also showed significantly lower cerebrovascular complications than patients with OA. The significant reduction in risk for these complications has not been previously reported in the current literature, and it was an unexpected finding as past studies have found an increased risk in cerebrovascular disease in patients with RA. RA is an inflammatory disease exhibiting the upregulation of procoagulation factors,22 so we expected patients with RA to be at an increased risk for cerebrovascular and cardiovascular complications over patients with OA. Although we are unsure why these results were observed, we postulate that pharmaceutical interventions may confer some protection to patients with RA. For example, aspirin is commonly utilized in RA for its protective anti-platelet effect23 and may be a contributing factor to why we found low postoperative complication rates in cerebrovascular disease. However, the reason why aspirin may be protective against cerebrovascular and not cardiovascular complications remains unclear. Moreover, most guidelines suggest that aspirin be stopped prior to surgery.24 Although patients with RA were younger than those with OA, age was accounted for when analyzing the data.
A major strength of the study was the large sample size and the adjustment of potential confounding variables when examining the difference in complications between RA and OA. It is also a national US study that utilizes a validated database. Given that the patient samples in the NIS are reported in a uniform and de-identified manner, the database is considered ideal and has been extensively used for retrospective large observational cohort studies.25 However, the study also had some limitations due to the retrospective and administrative nature of the NIS database. Only data concerning patient complications during their inpatient stay at the hospital were available. Patients who may develop complications following discharge were not included in the data, providing a very small window of time for analysis. Another limitation with the database was its lack of ability to identify the severity of each patient's disease process or the medical treatment they received perioperatively. Finally, no patient-reported outcomes were determined, which would provide information on whether these complications affect the patients’ postoperational satisfaction in regard to their pain and disability.
CONCLUSION
As RA patients continue to utilize joint arthroplasty to repair deteriorated joints, understanding of how the disease process and its medical management may impact patient outcomes is important. This article reports significantly higher postoperational infection rates in RA than in patients with OA, which may be due to the medical management of the disease. Although new medications have been introduced and are being used to treat patients with RA, they have not altered the complication rate following TJA in this patient population. Thus, surgeons and other members of the management team should be familiar with the common medical conditions, co-morbidities, and medical treatments/side effects that are encountered in patients with RA. Future studies should delve into possible differences in long-term outcomes of patients with RA undergoing TKA and THA, as well as whether certain perioperative strategies and therapies (medical or physical) may decrease complications and improve outcomes.
This paper will be judged for the Resident Writer’s Award.
- Myasoedova E, Davis JM 3rd, Crowson CS, Gabriel SE. Epidemiology of rheumatoid arthritis: rheumatoid arthritis and mortality. Curr Rheumatol Rep. 2010;12(5):379-385. doi:10.1007/s11926-010-0117-y.
- Firestein GS. Evolving concepts of rheumatoid arthritis. Nature. 2003;423(6937):356-361. doi:10.1038/nature01661.
- Gullick NJ, Scott DL. Co-morbidities in established rheumatoid arthritis. Best Pract Res Clin Rheumatol. 2011;25(4):469-483. doi:10.1016/j.berh.2011.10.009.
- Masuda H, Miyazaki T, Shimada K, et al. Disease duration and severity impacts on long-term cardiovascular events in Japanese patients with rheumatoid arthritis. J Cardiol. 2014;64(5):366-370. doi:10.1016/j.jjcc.2014.02.018.
- Bongartz T, Nannini C, Medina-Velasquez YF, et al. Incidence and mortality of interstitial lung disease in rheumatoid arthritis: a population-based study. Arthritis Rheum.2010;62(6):1583-1591. doi:10.1002/art.27405.
- Doran MF, Crowson CS, Pond GR, O'Fallon WM, Gabriel SE. Frequency of infection in patients with rheumatoid arthritis compared with controls: a population-based study. Arthritis Rheum. 2002;46(9):2287-2293. doi:10.1002/art.10524.
- Rossini M, Rossi E, Bernardi D, et al. Prevalence and incidence of rheumatoid arthritis in Italy. Rheumatol Int. 2014;34(5):659664. doi:10.1007/s00296-014-2974-6.
- Alamanos Y, Voulgari PV, Drosos AA. Incidence and prevalence of rheumatoid arthritis, based on the 1987 American College of Rheumatology criteria: a systematic review. Semin Arthritis Rheum. 2006;36(3):182-188. doi:10.1016/j.semarthrit.2006.08.006.
- Carbonell J, Cobo T, Balsa A, Descalzo MA, Carmona L. The incidence of rheumatoid arthritis in Spain: results from a nationwide primary care registry. Rheumatology.2008;47(7):1088-1092. doi:10.1093/rheumatology/ken205.
- Skytta ET, Honkanen PB, Eskelinen A, Huhtala H, Remes V. Fewer and older patients with rheumatoid arthritis need total knee replacement. Scand J Rheumatol. 2012;41(5):345-349. doi:10.3109/03009742.2012.681061.
- Singh JA, Vessely MB, Harmsen WS, et al. A population-based study of trends in the use of total hip and total knee arthroplasty, 1969–2008. Mayo Clin Proc. 2010;85(10):898-904. doi:10.4065/mcp.2010.0115.
- Momohara S, Inoue E, Ikari K, et al. Decrease in orthopaedic operations, including total joint replacements, in patients with rheumatoid arthritis between 2001 and 2007: data from Japanese outpatients in a single institute-based large observational cohort (IORRA). Ann Rheum Dis. 2010;69(1):312-313. doi:10.1136/ard.2009.107599.
- Jain A, Stein BE, Skolasky RL, Jones LC, Hungerford MW. Total joint arthroplasty in patients with rheumatoid arthritis: a United States experience from 1992 through 2005. J Arthroplasty. 2012;27(6):881-888. doi:10.1016/j.arth.2011.12.027.
- Mertelsmann-Voss C, Lyman S, Pan TJ, Goodman SM, Figgie MP, Mandl LA. US trends in rates of arthroplasty for inflammatory arthritis including rheumatoid arthritis, juvenile idiopathic arthritis, and spondyloarthritis. Arthritis Rheumatol 2014;66(6):1432-1439. doi:10.1002/art.38384.
- Howe CR, Gardner GC, Kadel NJ. Perioperative medication management for the patient with rheumatoid arthritis. J Am Acad Orthop Surg. 2006;14(9):544-551. doi:10.5435/00124635-200609000-00004.
- Schrama JC, Espehaug B, Hallan G, et al. Risk of revision for infection in primary total hip and knee arthroplasty in patients with rheumatoid arthritis compared with osteoarthritis: a prospective, population-based study on 108,786 hip and knee joint arthroplasties from the Norwegian Arthroplasty Register. Arthritis Care Res. 2010;62(4):473-479. doi:10.1002/acr.20036.
- Ravi B, Croxford R, Hollands S, et al. Increased risk of complications following total joint arthroplasty in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014;66(2):254-263. doi:10.1002/art.38231.
- Au K, Reed G, Curtis JR, et al. High disease activity is associated with an increased risk of infection in patients with rheumatoid arthritis. Ann Rheum Dis. 2011;70(5):785-791. doi:10.1136/ard.2010.128637.
- Bongartz T, Sutton AJ, Sweeting MJ, Buchan I, Matteson EL, Montori V. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA. 2006;295(19):2275-2285. doi:10.1001/jama.295.19.2275.
- Scherrer CB, Mannion AF, Kyburz D, Vogt M, Kramers-de Quervain IA. Infection risk after orthopedic surgery in patients with inflammatory rheumatic diseases treated with immunosuppressive drugs. Arthritis Care Res. 2013;65(12):2032-2040. doi:10.1002/acr.22077.
- Bacani AK, Gabriel SE, Crowson CS, Heit JA, Matteson EL. Noncardiac vascular disease in rheumatoid arthritis: increase in venous thromboembolic events? Arthritis Rheum.2012;64(1):53-61. doi:10.1002/art.33322.
- Wallberg-Jonsson S, Dahlen GH, Nilsson TK, Ranby M, Rantapaa-Dahlqvist S. Tissue plasminogen activator, plasminogen activator inhibitor-1 and von Willebrand factor in rheumatoid arthritis. Clin Rheumatol. 1993;12(3):318324.
- van Heereveld HA, Laan RF, van den Hoogen FH, Malefijt MC, Novakova IR, van de Putte LB. Prevention of symptomatic thrombosis with short term (low molecular weight) heparin in patients with rheumatoid arthritis after hip or knee replacement. Ann Rheum Dis.2001;60(10):974-976. doi:10.1136/ard.60.10.974.
- Mont MA, Jacobs JJ, Boggio LN, et al. Preventing venous thromboembolic disease in patients undergoing elective hip and knee arthroplasty. J Am Acad Orthop Surg.2011;19(12):768-776.
- Bozic KJ, Bashyal RK, Anthony SG, Chiu V, Shulman B, Rubash HE. Is administratively coded comorbidity and complication data in total joint arthroplasty valid? Clin Orthop Relat Res. 2013;471(1):201-205. doi:10.1007/s11999-012-2352-1.
ABSTRACT
Current literature regarding complications following total joint arthroplasty have primarily focused on patients with osteoarthritis (OA), with less emphasis on the trends and in-hospital outcomes of rheumatoid arthritis (RA) patients undergoing these procedures. The purpose of this study is to analyze the outcomes and trends of RA patients undergoing total knee arthroplasty (TKA) or total hip arthroplasty (THA) compared to OA patients.
Data from the Nationwide Inpatient Sample from 2006 to 2011 was extracted using the International Classification of Diseases, Ninth Revision codes for patients that received a TKA or THA. Outcome measures included cardiovascular complications, cerebrovascular complications, pulmonary complications, wound dehiscence, and infection. Inpatient and hospital demographics including primary diagnosis, age, gender, primary payer, hospital teaching status, Charlson Comorbidity Index score, hospital bed size, location, and median household income were analyzed.
Logistic regression analysis of OA vs RA patients with patient outcomes revealed that osteoarthritic THA candidates had lower risk for cardiovascular complications, pulmonary complications, wound dehiscence, infections, and systemic complications, compared to rheumatoid patients. There was a significantly elevated risk of cerebrovascular complication in osteoarthritic THA compared to RA THA. OA patients undergoing TKA had significantly higher risk for cardiovascular and cerebrovascular complications. There were significant decreases in mechanical wounds, infection, and systemic complications in the OA TKA patients.
RA patients are at higher risk for postoperative infection, wound dehiscence, and systemic complications after TKA and THA compared to OA patients. These findings highlight the importance of preoperative medical clearance and management to optimize RA patients and improve the postoperative outcomes.
Continue to: RA is a chronic systemic inflammatory disease...
Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease that causes joint deterioration, leading to pain, disability, systemic complications, short lifespan, and decline in quality of life.1-3 The deterioration primarily affects the synovial membranes of joints, causing arthritis and resulting in extra-articular sequelae such as cardiovascular disease,4 pulmonary disease,5 and increased infection rates.3,6 RA is the most prevalent inflammatory arthritis worldwide and affects up to 50 cases per 100,000 in both the US and northern Europe.2,7-9 Although the gold standard of care for these patients is medical management with immunosuppressant drugs such as disease-modifying anti-rheumatic drugs (DMARDs), total joint arthroplasty (TJA) remains an important tool in the management of joint deterioration in such patients.
Total knee arthroplasty (TKA) and total hip arthroplasty (THA) are common procedures utilized to treat disorders that cause joint pain and hindered joint mobility, including osteoarthritis (OA) and RA. Given the aging population, the amount of TKAs and THAs performed in the US has consistently increased each year, with the vast majority of this increase composed of patients with OA.10 As a result, previous studies investigated the trends and outcomes of these procedures in patients with OA, but relatively less is known about the outcomes and trends of patients with RA undergoing the same surgeries.
Given that RA is a fundamentally different condition with its own pathological characteristics, an understanding of how these differences may impact postoperative outcomes in patients with RA is important. This study aims to present a comparative analysis of the trends and postoperative outcomes between patients with RA and OA undergoing TKA and THA (Figure 1, Tables 1 and 2).
Table 1. Demographics of Total Knee Arthroplasty Patients Based on Primary Diagnosis of Osteoarthritis
| OA | RA | Total | P Value | |||
| No. | Percent | No. | Percent | No. | Percent | (RA vs OA) |
Age group |
|
|
|
|
|
| <.0001 |
<64 years | 295,637 | 42.42 | 11,325 | 48.90 | 306,962 | 42.63 |
|
65 to 79 years | 329,034 | 47.22 | 10,055 | 43.42 | 339,089 | 47.09 |
|
≥80 years | 72,197 | 10.36 | 1780 | 7.69 | 73,977 | 10.27 |
|
Gender |
|
|
|
|
|
| <.0001 |
Male | 259,192 | 37.19 | 4887 | 21.12 | 264,079 | 36.68 |
|
Female | 435,855 | 62.54 | 18,248 | 78.88 | 454,103 | 63.07 |
|
Race |
|
|
|
|
|
| <.0001 |
White | 468,632 | 67.25 | 14,532 | 77.18 | 483,164 | 67.10 |
|
Black | 39,691 | 5.7 | 2119 | 11.25 | 41,810 | 5.81 |
|
Hispanic | 28,573 | 4.1 | 1395 | 7.41 | 29,968 | 4.16 |
|
Other | 21,306 | 3.06 | 783 | 4.16 | 22,089 | 3.07 |
|
Region of hospital |
|
|
|
|
|
| <.0001 |
Northeast | 112,031 | 16.08 | 3417 | 14.75 | 115,448 | 16.03 |
|
Midwest | 192,595 | 27.64 | 5975 | 25.80 | 198,570 | 27.58 |
|
South | 257,855 | 37 | 9422 | 40.68 | 267,277 | 37.12 |
|
West | 134,387 | 19.28 | 4346 | 18.77 | 138,733 | 19.27 |
|
Location/teaching status of hospital |
|
|
|
|
|
| <.0001 |
Rural | 86,321 | 12.39 | 2709 | 11.79 | 89,030 | 12.36 |
|
Urban non-teaching | 333,043 | 47.79 | 10,905 | 47.46 | 343,948 | 47.77 |
|
Urban teaching | 273,326 | 39.22 | 9363 | 40.75 | 282,689 | 39.26 |
|
Hospital location |
|
|
|
|
|
| .0024 |
Rural | 86,321 | 12.39 | 2709 | 11.79 | 89,030 | 12.36 |
|
Urban | 606,369 | 87.01 | 20,268 | 88.21 | 626,637 | 87.03 |
|
Hospital teaching status |
|
|
|
|
|
| <.0001 |
Teaching | 409,465 | 58.76 | 13,275 | 57.78 | 422,740 | 58.71 |
|
Non-teaching | 283,225 | 40.64 | 9702 | 42.22 | 292,927 | 40.68 |
|
Comorbidities |
|
|
|
|
|
|
|
Obstructive sleep apnea | 65,342 | 9.38 | 1946 | 8.40 | 67,288 | 9.35 | <.0001 |
Diabetes | 147,292 | 21.14 | 4289 | 18.52 | 151,581 | 21.05 | <.0001 |
Obesity | 129,277 | 18.55 | 3730 | 16.11 | 133,007 | 18.47 | <.0001 |
Abbreviations: OA, osteoarthritis; RA, rheumatoid arthritis.
Table 2. Demographics of Total Hip Arthroplasty Patients Based on Primary Diagnosis of Osteoarthritis or Rheumatoid Arthritis
| OA | RA | Total | P Value | |||
| No. | Percent | No. | Percent | No. | Percent | (RA vs OA) |
Age group |
|
|
|
|
|
| <.0001 |
<64 years | 133,645 | 45.18 | 4679 | 48.02 | 138,324 | 45.27 |
|
65 to 79 years | 123,628 | 41.8 | 3992 | 40.97 | 127,620 | 41.77 |
|
≥80 years | 38,513 | 13.02 | 1073 | 11.01 | 39,586 | 12.96 |
|
Gender |
|
|
|
|
|
| <.0001 |
Male | 129,708 | 43.85 | 2457 | 25.24 | 132,165 | 43.26 |
|
Female | 165,010 | 55.79 | 7278 | 74.76 | 172,288 | 56.39 |
|
Race |
|
|
|
|
|
| <.0001 |
White | 207,005 | 69.98 | 6322 | 80.08 | 213,327 | 69.82 |
|
Black | 15,505 | 5.24 | 771 | 9.77 | 16,276 | 5.33 |
|
Hispanic | 6784 | 2.29 | 522 | 6.61 | 7306 | 2.39 |
|
Other | 7209 | 2.44 | 280 | 3.55 | 7489 | 2.45 |
|
Region of hospital |
|
|
|
|
|
| <.0001 |
Northeast | 58,525 | 19.79 | 1683 | 17.27 | 60,208 | 19.71 |
|
Midwest | 79,040 | 26.72 | 2446 | 25.10 | 81,486 | 26.67 |
|
South | 95,337 | 32.23 | 3716 | 38.14 | 99,053 | 32.42 |
|
West | 62,884 | 21.26 | 1899 | 19.49 | 64,783 | 21.20 |
|
Location/teaching status of hospital |
|
|
|
|
|
| .0065 |
Rural | 30,954 | 10.46 | 993 | 10.26 | 31,947 | 10.46 |
|
Urban non-teaching | 133,061 | 44.99 | 4245 | 43.87 | 137,306 | 44.94 |
|
Urban teaching | 130,150 | 44 | 4439 | 45.87 | 134,589 | 44.05 |
|
Hospital location |
|
|
|
|
|
| .4098 |
Rural | 30,954 | 10.46 | 993 | 10.26 | 31,947 | 10.46 |
|
Urban | 263,211 | 88.99 | 8684 | 89.74 | 271,895 | 88.99 |
|
Hospital teaching status |
|
|
|
|
|
| .0077 |
Teaching | 159,313 | 53.86 | 5108 | 52.78 | 164,421 | 53.82 |
|
Non-teaching | 134,852 | 45.59 | 4569 | 47.22 | 139,421 | 45.63 |
|
Comorbidities |
|
|
|
|
|
|
|
Obstructive sleep apnea | 19,760 | 6.68 | 573 | 5.88 | 20,333 | 6.65 | .0028 |
Diabetes | 41,929 | 14.18 | 1325 | 13.60 | 43,254 | 14.16 | .1077 |
Obesity | 38,808 | 13.12 | 1100 | 11.29 | 39,908 | 13.06 | <.0001 |
Abbreviations: OA, osteoarthritis; RA, rheumatoid arthritis
Continue to: Methods...
METHODS
Exemptions were obtained from the Institutional Review Board. Data from the Nationwide Inpatient Sample (NIS) from 2006 to 2011 were extracted using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes for patients that received primary TKA or THA, as well as their comorbid conditions. No patients or populations were excluded from the sampling process. A list of all independent variables collected for analysis and provision of relevant ICD-9 codes is included in Figure 1. The NIS is the largest all-payer stratified survey of inpatient care in the US healthcare system. As of 2011, each year provides information on approximately 8 million inpatient stays from about 1000 hospitals in 46 states. All discharges from sampled hospitals are also represented in the database. All patient information is protected, and all methods were conducted in accordance with the highest ethical standards of Human and Animal Rights Research.
STATISTICAL ANALYSIS
SAS 9.2 and PROC FREQ statistics software were used to generate P values (chi square result) and analyze the trends (Cochran-Armitage). Results were weighted utilizing standard discharge weights from the NIS to ensure accurate comparison of data from different time points. P < .05 was considered statistically significant. Multivariable logistic regression analyses were performed to generate odds ratio and 95% confidence limits to assess outcomes across different demographic variables.
RESULTS
Data on 337,082 and 1,362,241 patients undergoing THA or TKA, respectively, between 2006 and 2011 were analyzed. Patients in both groups were further differentiated by a diagnosis of either OA or RA. OA was the most common diagnosis, constituting 96.8% of all arthritic THA and TKA patients. From 2006 to 2011, a 36% and 34% increase in total number of THAs and TKAs, respectively, were reported. The number of patients with OA undergoing THA and TKA steadily increased from 2006 to 2011 (Figure 2). The number of THA and TKA procedures in patients with RA followed a similar trend but at a comparatively slower rate (Figure 3). The TKA geographical trends mirrored those observed with THA. The majority of operations were performed at urban hospitals (89% THA, 87% TKA; P < .0001). Among patients with RA and OA, the majority of TKAs (47.77%; P < .0001) took place in urban non-teaching hospitals than in urban teaching hospitals (39.26%). This pattern was not the same for THA, with 44.94% being performed at urban teaching hospitals and 44.05% at urban non-teaching institutions (P < .0001). Rural hospitals accounted for a low percentage of operations for both procedures: 10.46% of THA and 12.36% of TKA (P < .0001). Large institutions (based on the number of beds) claimed the majority of cases (59% of THA and TKA).
Logistic regression analysis and odds ratios of patients with OA vs those with RA with patient outcomes adjusted for age, Charlson Comorbidity Index (CCI) score, and gender revealed that patients with OA undergoing THA had lower risk for cardiovascular (0.674; confidence interval (CI) 0.587-0.774) and pulmonary complications (0.416; CI 0.384-0.450), wound dehiscence (0.647; CI 0.561-0.747), infections (0.258; CI 0.221-0.301), and systemic complications (0.625; CI 0.562-0.695) than patients with RA. Patients with OA exhibited statistically significantly higher odds of experiencing cerebrovascular complications after THA than those with RA (1.946; CI 1.673-2.236) (Table 3). In a similar logistic regression analysis of OA vs RA in TKA, which was adjusted for age, CCI score, and gender, patients with OA had significantly higher risk for cardiovascular (1.329; CI 1.069-1.651) and cerebrovascular complications (1.635; CI 1.375-1.943) than patients with RA. Significant decreases in wound dehiscence (0.757; CI 0.639-0.896), infection (0.331; CI 0.286-0.383), and systemic complication (0.641; CI 0.565-0.729) were noted in the patients with OA and TKA (Table 4).
Table 3. Odds Ratio for In-Hospital Complications Following THA for OA Patients vs RA Patients
| Odds Ratio | Confidence Limits |
Cardiovascular complication | .674 | .587-.744 |
Cerebrovascular complication | 1.946 | 1.673-2.236 |
Pulmonary complication | .416 | .384-.450 |
Wound dehiscence | .647 | .561-.747 |
Infection | .258 | .221-.301 |
Systemic complication | .625 | .562-.695 |
Abbreviations: OA, osteoarthritis; RA, rheumatoid arthritis; THA, total hip arthroplasty.
Table 4. Odds Ratio for In-Hospital Complications Following TKA for OA Patients vs RA Patients
| Odds Ratio | Confidence Limits |
Cardiovascular complication | 1.329 | 1.069-1.651 |
Cerebrovascular complication | 1.635 | 1.375-1.943 |
Pulmonary complication | 1.03 | .995-1.223 |
Wound dehiscence | .757 | .639-.896 |
Infection | .331 | .286-.383 |
Systemic complication | .641 | .565-.729 |
Abbreviations: OA, osteoarthritis; RA, rheumatoid arthritis; TKA, total knee arthroplasty.
Continue to: Discussion...
DISCUSSION
Our results showed a continuous yearly increase from 2006 to 2011 in THA and TKA procedures at a rate of 36% and 34%, respectively; this result was consistent with existing literature.11 Despite a substantial increase in the amount of total THA and TKA procedures, the ratio of patients with RA undergoing these operations has decreased or remained nearly the same. Similar effects were found in Japan and the US when examining patients with RA undergoing TJA procedures between 2001 and 2007 and between 1992 and 2005, respectively.12-14 This observation may be explained by the advances and early initiation of pharmacologic treatment and the widespread use of DMARDs such as methotrexate (MTX), azathioprine, leflunomide, hydroxychloroquine, and biological response modifiers TNF-α and interleukin-1.15 These medications have drastically improved survival rates of patients with RA with impressive capabilities in symptom relief.15 With the increasing use of DMARDs and aggressive treatment early on in the disease process, patients with RA are showing markedly slow progression of joint deterioration, leading to a decreased need for orthopedic intervention compared with the general population.13,15
When analyzing the complication rates for patients undergoing TKA and THA, we observed that patients with RA exhibited a significant increase in the rates of infections, wound dehiscence, and systemic complications prior to discharge from the hospital compared with the OA population. The increased risk of infections was reported in previous studies assessing postoperative complication rates in TJA.16,17 A study utilizing the Norwegian Arthroplasty Registry noted an increased risk of late infection in patients with RA, leading to increased rates of revision TJA in comparison with patients with OA.16 Another study, which was based on the Canadian Institute for Health Information Discharge Abstract Database, showed that patients with RA are at an increased risk of infection only after THA and interestingly not after TKA.17 Although our study did not identify the causes of the increased infection rate, the inherent nature of the disease and the immunomodulatory drugs used to treat it may contribute to this increased infectious risk in patients with RA.6,18 Immunosuppressive DMARDs are some of the widely used medications employed to treat RA and are prime suspects of causing increased infection rates.15 The perioperative use of MTX has not been shown to cause short-term increases in infection for patients undergoing orthopedic intervention, but leflunomide and TNF-α inhibitors have been shown to cause a significant several-fold increase in risk for surgical wound infections.19,20
All patients with RA presented with significant increases for infection, wound dehiscence, and systemic complications, whereas only patients with RA undergoing THA showed increased risk of pulmonary and cardiovascular complications when compared with patients with OA. Surprisingly, in TKA, patients with RA were at a significantly decreased risk of cardiovascular complications. This observation was interesting due to cardiovascular disease being one of RA's most notable extra-articular features.4,21
Patients with RA undergoing TJA also showed significantly lower cerebrovascular complications than patients with OA. The significant reduction in risk for these complications has not been previously reported in the current literature, and it was an unexpected finding as past studies have found an increased risk in cerebrovascular disease in patients with RA. RA is an inflammatory disease exhibiting the upregulation of procoagulation factors,22 so we expected patients with RA to be at an increased risk for cerebrovascular and cardiovascular complications over patients with OA. Although we are unsure why these results were observed, we postulate that pharmaceutical interventions may confer some protection to patients with RA. For example, aspirin is commonly utilized in RA for its protective anti-platelet effect23 and may be a contributing factor to why we found low postoperative complication rates in cerebrovascular disease. However, the reason why aspirin may be protective against cerebrovascular and not cardiovascular complications remains unclear. Moreover, most guidelines suggest that aspirin be stopped prior to surgery.24 Although patients with RA were younger than those with OA, age was accounted for when analyzing the data.
A major strength of the study was the large sample size and the adjustment of potential confounding variables when examining the difference in complications between RA and OA. It is also a national US study that utilizes a validated database. Given that the patient samples in the NIS are reported in a uniform and de-identified manner, the database is considered ideal and has been extensively used for retrospective large observational cohort studies.25 However, the study also had some limitations due to the retrospective and administrative nature of the NIS database. Only data concerning patient complications during their inpatient stay at the hospital were available. Patients who may develop complications following discharge were not included in the data, providing a very small window of time for analysis. Another limitation with the database was its lack of ability to identify the severity of each patient's disease process or the medical treatment they received perioperatively. Finally, no patient-reported outcomes were determined, which would provide information on whether these complications affect the patients’ postoperational satisfaction in regard to their pain and disability.
CONCLUSION
As RA patients continue to utilize joint arthroplasty to repair deteriorated joints, understanding of how the disease process and its medical management may impact patient outcomes is important. This article reports significantly higher postoperational infection rates in RA than in patients with OA, which may be due to the medical management of the disease. Although new medications have been introduced and are being used to treat patients with RA, they have not altered the complication rate following TJA in this patient population. Thus, surgeons and other members of the management team should be familiar with the common medical conditions, co-morbidities, and medical treatments/side effects that are encountered in patients with RA. Future studies should delve into possible differences in long-term outcomes of patients with RA undergoing TKA and THA, as well as whether certain perioperative strategies and therapies (medical or physical) may decrease complications and improve outcomes.
This paper will be judged for the Resident Writer’s Award.
ABSTRACT
Current literature regarding complications following total joint arthroplasty have primarily focused on patients with osteoarthritis (OA), with less emphasis on the trends and in-hospital outcomes of rheumatoid arthritis (RA) patients undergoing these procedures. The purpose of this study is to analyze the outcomes and trends of RA patients undergoing total knee arthroplasty (TKA) or total hip arthroplasty (THA) compared to OA patients.
Data from the Nationwide Inpatient Sample from 2006 to 2011 was extracted using the International Classification of Diseases, Ninth Revision codes for patients that received a TKA or THA. Outcome measures included cardiovascular complications, cerebrovascular complications, pulmonary complications, wound dehiscence, and infection. Inpatient and hospital demographics including primary diagnosis, age, gender, primary payer, hospital teaching status, Charlson Comorbidity Index score, hospital bed size, location, and median household income were analyzed.
Logistic regression analysis of OA vs RA patients with patient outcomes revealed that osteoarthritic THA candidates had lower risk for cardiovascular complications, pulmonary complications, wound dehiscence, infections, and systemic complications, compared to rheumatoid patients. There was a significantly elevated risk of cerebrovascular complication in osteoarthritic THA compared to RA THA. OA patients undergoing TKA had significantly higher risk for cardiovascular and cerebrovascular complications. There were significant decreases in mechanical wounds, infection, and systemic complications in the OA TKA patients.
RA patients are at higher risk for postoperative infection, wound dehiscence, and systemic complications after TKA and THA compared to OA patients. These findings highlight the importance of preoperative medical clearance and management to optimize RA patients and improve the postoperative outcomes.
Continue to: RA is a chronic systemic inflammatory disease...
Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease that causes joint deterioration, leading to pain, disability, systemic complications, short lifespan, and decline in quality of life.1-3 The deterioration primarily affects the synovial membranes of joints, causing arthritis and resulting in extra-articular sequelae such as cardiovascular disease,4 pulmonary disease,5 and increased infection rates.3,6 RA is the most prevalent inflammatory arthritis worldwide and affects up to 50 cases per 100,000 in both the US and northern Europe.2,7-9 Although the gold standard of care for these patients is medical management with immunosuppressant drugs such as disease-modifying anti-rheumatic drugs (DMARDs), total joint arthroplasty (TJA) remains an important tool in the management of joint deterioration in such patients.
Total knee arthroplasty (TKA) and total hip arthroplasty (THA) are common procedures utilized to treat disorders that cause joint pain and hindered joint mobility, including osteoarthritis (OA) and RA. Given the aging population, the amount of TKAs and THAs performed in the US has consistently increased each year, with the vast majority of this increase composed of patients with OA.10 As a result, previous studies investigated the trends and outcomes of these procedures in patients with OA, but relatively less is known about the outcomes and trends of patients with RA undergoing the same surgeries.
Given that RA is a fundamentally different condition with its own pathological characteristics, an understanding of how these differences may impact postoperative outcomes in patients with RA is important. This study aims to present a comparative analysis of the trends and postoperative outcomes between patients with RA and OA undergoing TKA and THA (Figure 1, Tables 1 and 2).
Table 1. Demographics of Total Knee Arthroplasty Patients Based on Primary Diagnosis of Osteoarthritis
| OA | RA | Total | P Value | |||
| No. | Percent | No. | Percent | No. | Percent | (RA vs OA) |
Age group |
|
|
|
|
|
| <.0001 |
<64 years | 295,637 | 42.42 | 11,325 | 48.90 | 306,962 | 42.63 |
|
65 to 79 years | 329,034 | 47.22 | 10,055 | 43.42 | 339,089 | 47.09 |
|
≥80 years | 72,197 | 10.36 | 1780 | 7.69 | 73,977 | 10.27 |
|
Gender |
|
|
|
|
|
| <.0001 |
Male | 259,192 | 37.19 | 4887 | 21.12 | 264,079 | 36.68 |
|
Female | 435,855 | 62.54 | 18,248 | 78.88 | 454,103 | 63.07 |
|
Race |
|
|
|
|
|
| <.0001 |
White | 468,632 | 67.25 | 14,532 | 77.18 | 483,164 | 67.10 |
|
Black | 39,691 | 5.7 | 2119 | 11.25 | 41,810 | 5.81 |
|
Hispanic | 28,573 | 4.1 | 1395 | 7.41 | 29,968 | 4.16 |
|
Other | 21,306 | 3.06 | 783 | 4.16 | 22,089 | 3.07 |
|
Region of hospital |
|
|
|
|
|
| <.0001 |
Northeast | 112,031 | 16.08 | 3417 | 14.75 | 115,448 | 16.03 |
|
Midwest | 192,595 | 27.64 | 5975 | 25.80 | 198,570 | 27.58 |
|
South | 257,855 | 37 | 9422 | 40.68 | 267,277 | 37.12 |
|
West | 134,387 | 19.28 | 4346 | 18.77 | 138,733 | 19.27 |
|
Location/teaching status of hospital |
|
|
|
|
|
| <.0001 |
Rural | 86,321 | 12.39 | 2709 | 11.79 | 89,030 | 12.36 |
|
Urban non-teaching | 333,043 | 47.79 | 10,905 | 47.46 | 343,948 | 47.77 |
|
Urban teaching | 273,326 | 39.22 | 9363 | 40.75 | 282,689 | 39.26 |
|
Hospital location |
|
|
|
|
|
| .0024 |
Rural | 86,321 | 12.39 | 2709 | 11.79 | 89,030 | 12.36 |
|
Urban | 606,369 | 87.01 | 20,268 | 88.21 | 626,637 | 87.03 |
|
Hospital teaching status |
|
|
|
|
|
| <.0001 |
Teaching | 409,465 | 58.76 | 13,275 | 57.78 | 422,740 | 58.71 |
|
Non-teaching | 283,225 | 40.64 | 9702 | 42.22 | 292,927 | 40.68 |
|
Comorbidities |
|
|
|
|
|
|
|
Obstructive sleep apnea | 65,342 | 9.38 | 1946 | 8.40 | 67,288 | 9.35 | <.0001 |
Diabetes | 147,292 | 21.14 | 4289 | 18.52 | 151,581 | 21.05 | <.0001 |
Obesity | 129,277 | 18.55 | 3730 | 16.11 | 133,007 | 18.47 | <.0001 |
Abbreviations: OA, osteoarthritis; RA, rheumatoid arthritis.
Table 2. Demographics of Total Hip Arthroplasty Patients Based on Primary Diagnosis of Osteoarthritis or Rheumatoid Arthritis
| OA | RA | Total | P Value | |||
| No. | Percent | No. | Percent | No. | Percent | (RA vs OA) |
Age group |
|
|
|
|
|
| <.0001 |
<64 years | 133,645 | 45.18 | 4679 | 48.02 | 138,324 | 45.27 |
|
65 to 79 years | 123,628 | 41.8 | 3992 | 40.97 | 127,620 | 41.77 |
|
≥80 years | 38,513 | 13.02 | 1073 | 11.01 | 39,586 | 12.96 |
|
Gender |
|
|
|
|
|
| <.0001 |
Male | 129,708 | 43.85 | 2457 | 25.24 | 132,165 | 43.26 |
|
Female | 165,010 | 55.79 | 7278 | 74.76 | 172,288 | 56.39 |
|
Race |
|
|
|
|
|
| <.0001 |
White | 207,005 | 69.98 | 6322 | 80.08 | 213,327 | 69.82 |
|
Black | 15,505 | 5.24 | 771 | 9.77 | 16,276 | 5.33 |
|
Hispanic | 6784 | 2.29 | 522 | 6.61 | 7306 | 2.39 |
|
Other | 7209 | 2.44 | 280 | 3.55 | 7489 | 2.45 |
|
Region of hospital |
|
|
|
|
|
| <.0001 |
Northeast | 58,525 | 19.79 | 1683 | 17.27 | 60,208 | 19.71 |
|
Midwest | 79,040 | 26.72 | 2446 | 25.10 | 81,486 | 26.67 |
|
South | 95,337 | 32.23 | 3716 | 38.14 | 99,053 | 32.42 |
|
West | 62,884 | 21.26 | 1899 | 19.49 | 64,783 | 21.20 |
|
Location/teaching status of hospital |
|
|
|
|
|
| .0065 |
Rural | 30,954 | 10.46 | 993 | 10.26 | 31,947 | 10.46 |
|
Urban non-teaching | 133,061 | 44.99 | 4245 | 43.87 | 137,306 | 44.94 |
|
Urban teaching | 130,150 | 44 | 4439 | 45.87 | 134,589 | 44.05 |
|
Hospital location |
|
|
|
|
|
| .4098 |
Rural | 30,954 | 10.46 | 993 | 10.26 | 31,947 | 10.46 |
|
Urban | 263,211 | 88.99 | 8684 | 89.74 | 271,895 | 88.99 |
|
Hospital teaching status |
|
|
|
|
|
| .0077 |
Teaching | 159,313 | 53.86 | 5108 | 52.78 | 164,421 | 53.82 |
|
Non-teaching | 134,852 | 45.59 | 4569 | 47.22 | 139,421 | 45.63 |
|
Comorbidities |
|
|
|
|
|
|
|
Obstructive sleep apnea | 19,760 | 6.68 | 573 | 5.88 | 20,333 | 6.65 | .0028 |
Diabetes | 41,929 | 14.18 | 1325 | 13.60 | 43,254 | 14.16 | .1077 |
Obesity | 38,808 | 13.12 | 1100 | 11.29 | 39,908 | 13.06 | <.0001 |
Abbreviations: OA, osteoarthritis; RA, rheumatoid arthritis
Continue to: Methods...
METHODS
Exemptions were obtained from the Institutional Review Board. Data from the Nationwide Inpatient Sample (NIS) from 2006 to 2011 were extracted using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes for patients that received primary TKA or THA, as well as their comorbid conditions. No patients or populations were excluded from the sampling process. A list of all independent variables collected for analysis and provision of relevant ICD-9 codes is included in Figure 1. The NIS is the largest all-payer stratified survey of inpatient care in the US healthcare system. As of 2011, each year provides information on approximately 8 million inpatient stays from about 1000 hospitals in 46 states. All discharges from sampled hospitals are also represented in the database. All patient information is protected, and all methods were conducted in accordance with the highest ethical standards of Human and Animal Rights Research.
STATISTICAL ANALYSIS
SAS 9.2 and PROC FREQ statistics software were used to generate P values (chi square result) and analyze the trends (Cochran-Armitage). Results were weighted utilizing standard discharge weights from the NIS to ensure accurate comparison of data from different time points. P < .05 was considered statistically significant. Multivariable logistic regression analyses were performed to generate odds ratio and 95% confidence limits to assess outcomes across different demographic variables.
RESULTS
Data on 337,082 and 1,362,241 patients undergoing THA or TKA, respectively, between 2006 and 2011 were analyzed. Patients in both groups were further differentiated by a diagnosis of either OA or RA. OA was the most common diagnosis, constituting 96.8% of all arthritic THA and TKA patients. From 2006 to 2011, a 36% and 34% increase in total number of THAs and TKAs, respectively, were reported. The number of patients with OA undergoing THA and TKA steadily increased from 2006 to 2011 (Figure 2). The number of THA and TKA procedures in patients with RA followed a similar trend but at a comparatively slower rate (Figure 3). The TKA geographical trends mirrored those observed with THA. The majority of operations were performed at urban hospitals (89% THA, 87% TKA; P < .0001). Among patients with RA and OA, the majority of TKAs (47.77%; P < .0001) took place in urban non-teaching hospitals than in urban teaching hospitals (39.26%). This pattern was not the same for THA, with 44.94% being performed at urban teaching hospitals and 44.05% at urban non-teaching institutions (P < .0001). Rural hospitals accounted for a low percentage of operations for both procedures: 10.46% of THA and 12.36% of TKA (P < .0001). Large institutions (based on the number of beds) claimed the majority of cases (59% of THA and TKA).
Logistic regression analysis and odds ratios of patients with OA vs those with RA with patient outcomes adjusted for age, Charlson Comorbidity Index (CCI) score, and gender revealed that patients with OA undergoing THA had lower risk for cardiovascular (0.674; confidence interval (CI) 0.587-0.774) and pulmonary complications (0.416; CI 0.384-0.450), wound dehiscence (0.647; CI 0.561-0.747), infections (0.258; CI 0.221-0.301), and systemic complications (0.625; CI 0.562-0.695) than patients with RA. Patients with OA exhibited statistically significantly higher odds of experiencing cerebrovascular complications after THA than those with RA (1.946; CI 1.673-2.236) (Table 3). In a similar logistic regression analysis of OA vs RA in TKA, which was adjusted for age, CCI score, and gender, patients with OA had significantly higher risk for cardiovascular (1.329; CI 1.069-1.651) and cerebrovascular complications (1.635; CI 1.375-1.943) than patients with RA. Significant decreases in wound dehiscence (0.757; CI 0.639-0.896), infection (0.331; CI 0.286-0.383), and systemic complication (0.641; CI 0.565-0.729) were noted in the patients with OA and TKA (Table 4).
Table 3. Odds Ratio for In-Hospital Complications Following THA for OA Patients vs RA Patients
| Odds Ratio | Confidence Limits |
Cardiovascular complication | .674 | .587-.744 |
Cerebrovascular complication | 1.946 | 1.673-2.236 |
Pulmonary complication | .416 | .384-.450 |
Wound dehiscence | .647 | .561-.747 |
Infection | .258 | .221-.301 |
Systemic complication | .625 | .562-.695 |
Abbreviations: OA, osteoarthritis; RA, rheumatoid arthritis; THA, total hip arthroplasty.
Table 4. Odds Ratio for In-Hospital Complications Following TKA for OA Patients vs RA Patients
| Odds Ratio | Confidence Limits |
Cardiovascular complication | 1.329 | 1.069-1.651 |
Cerebrovascular complication | 1.635 | 1.375-1.943 |
Pulmonary complication | 1.03 | .995-1.223 |
Wound dehiscence | .757 | .639-.896 |
Infection | .331 | .286-.383 |
Systemic complication | .641 | .565-.729 |
Abbreviations: OA, osteoarthritis; RA, rheumatoid arthritis; TKA, total knee arthroplasty.
Continue to: Discussion...
DISCUSSION
Our results showed a continuous yearly increase from 2006 to 2011 in THA and TKA procedures at a rate of 36% and 34%, respectively; this result was consistent with existing literature.11 Despite a substantial increase in the amount of total THA and TKA procedures, the ratio of patients with RA undergoing these operations has decreased or remained nearly the same. Similar effects were found in Japan and the US when examining patients with RA undergoing TJA procedures between 2001 and 2007 and between 1992 and 2005, respectively.12-14 This observation may be explained by the advances and early initiation of pharmacologic treatment and the widespread use of DMARDs such as methotrexate (MTX), azathioprine, leflunomide, hydroxychloroquine, and biological response modifiers TNF-α and interleukin-1.15 These medications have drastically improved survival rates of patients with RA with impressive capabilities in symptom relief.15 With the increasing use of DMARDs and aggressive treatment early on in the disease process, patients with RA are showing markedly slow progression of joint deterioration, leading to a decreased need for orthopedic intervention compared with the general population.13,15
When analyzing the complication rates for patients undergoing TKA and THA, we observed that patients with RA exhibited a significant increase in the rates of infections, wound dehiscence, and systemic complications prior to discharge from the hospital compared with the OA population. The increased risk of infections was reported in previous studies assessing postoperative complication rates in TJA.16,17 A study utilizing the Norwegian Arthroplasty Registry noted an increased risk of late infection in patients with RA, leading to increased rates of revision TJA in comparison with patients with OA.16 Another study, which was based on the Canadian Institute for Health Information Discharge Abstract Database, showed that patients with RA are at an increased risk of infection only after THA and interestingly not after TKA.17 Although our study did not identify the causes of the increased infection rate, the inherent nature of the disease and the immunomodulatory drugs used to treat it may contribute to this increased infectious risk in patients with RA.6,18 Immunosuppressive DMARDs are some of the widely used medications employed to treat RA and are prime suspects of causing increased infection rates.15 The perioperative use of MTX has not been shown to cause short-term increases in infection for patients undergoing orthopedic intervention, but leflunomide and TNF-α inhibitors have been shown to cause a significant several-fold increase in risk for surgical wound infections.19,20
All patients with RA presented with significant increases for infection, wound dehiscence, and systemic complications, whereas only patients with RA undergoing THA showed increased risk of pulmonary and cardiovascular complications when compared with patients with OA. Surprisingly, in TKA, patients with RA were at a significantly decreased risk of cardiovascular complications. This observation was interesting due to cardiovascular disease being one of RA's most notable extra-articular features.4,21
Patients with RA undergoing TJA also showed significantly lower cerebrovascular complications than patients with OA. The significant reduction in risk for these complications has not been previously reported in the current literature, and it was an unexpected finding as past studies have found an increased risk in cerebrovascular disease in patients with RA. RA is an inflammatory disease exhibiting the upregulation of procoagulation factors,22 so we expected patients with RA to be at an increased risk for cerebrovascular and cardiovascular complications over patients with OA. Although we are unsure why these results were observed, we postulate that pharmaceutical interventions may confer some protection to patients with RA. For example, aspirin is commonly utilized in RA for its protective anti-platelet effect23 and may be a contributing factor to why we found low postoperative complication rates in cerebrovascular disease. However, the reason why aspirin may be protective against cerebrovascular and not cardiovascular complications remains unclear. Moreover, most guidelines suggest that aspirin be stopped prior to surgery.24 Although patients with RA were younger than those with OA, age was accounted for when analyzing the data.
A major strength of the study was the large sample size and the adjustment of potential confounding variables when examining the difference in complications between RA and OA. It is also a national US study that utilizes a validated database. Given that the patient samples in the NIS are reported in a uniform and de-identified manner, the database is considered ideal and has been extensively used for retrospective large observational cohort studies.25 However, the study also had some limitations due to the retrospective and administrative nature of the NIS database. Only data concerning patient complications during their inpatient stay at the hospital were available. Patients who may develop complications following discharge were not included in the data, providing a very small window of time for analysis. Another limitation with the database was its lack of ability to identify the severity of each patient's disease process or the medical treatment they received perioperatively. Finally, no patient-reported outcomes were determined, which would provide information on whether these complications affect the patients’ postoperational satisfaction in regard to their pain and disability.
CONCLUSION
As RA patients continue to utilize joint arthroplasty to repair deteriorated joints, understanding of how the disease process and its medical management may impact patient outcomes is important. This article reports significantly higher postoperational infection rates in RA than in patients with OA, which may be due to the medical management of the disease. Although new medications have been introduced and are being used to treat patients with RA, they have not altered the complication rate following TJA in this patient population. Thus, surgeons and other members of the management team should be familiar with the common medical conditions, co-morbidities, and medical treatments/side effects that are encountered in patients with RA. Future studies should delve into possible differences in long-term outcomes of patients with RA undergoing TKA and THA, as well as whether certain perioperative strategies and therapies (medical or physical) may decrease complications and improve outcomes.
This paper will be judged for the Resident Writer’s Award.
- Myasoedova E, Davis JM 3rd, Crowson CS, Gabriel SE. Epidemiology of rheumatoid arthritis: rheumatoid arthritis and mortality. Curr Rheumatol Rep. 2010;12(5):379-385. doi:10.1007/s11926-010-0117-y.
- Firestein GS. Evolving concepts of rheumatoid arthritis. Nature. 2003;423(6937):356-361. doi:10.1038/nature01661.
- Gullick NJ, Scott DL. Co-morbidities in established rheumatoid arthritis. Best Pract Res Clin Rheumatol. 2011;25(4):469-483. doi:10.1016/j.berh.2011.10.009.
- Masuda H, Miyazaki T, Shimada K, et al. Disease duration and severity impacts on long-term cardiovascular events in Japanese patients with rheumatoid arthritis. J Cardiol. 2014;64(5):366-370. doi:10.1016/j.jjcc.2014.02.018.
- Bongartz T, Nannini C, Medina-Velasquez YF, et al. Incidence and mortality of interstitial lung disease in rheumatoid arthritis: a population-based study. Arthritis Rheum.2010;62(6):1583-1591. doi:10.1002/art.27405.
- Doran MF, Crowson CS, Pond GR, O'Fallon WM, Gabriel SE. Frequency of infection in patients with rheumatoid arthritis compared with controls: a population-based study. Arthritis Rheum. 2002;46(9):2287-2293. doi:10.1002/art.10524.
- Rossini M, Rossi E, Bernardi D, et al. Prevalence and incidence of rheumatoid arthritis in Italy. Rheumatol Int. 2014;34(5):659664. doi:10.1007/s00296-014-2974-6.
- Alamanos Y, Voulgari PV, Drosos AA. Incidence and prevalence of rheumatoid arthritis, based on the 1987 American College of Rheumatology criteria: a systematic review. Semin Arthritis Rheum. 2006;36(3):182-188. doi:10.1016/j.semarthrit.2006.08.006.
- Carbonell J, Cobo T, Balsa A, Descalzo MA, Carmona L. The incidence of rheumatoid arthritis in Spain: results from a nationwide primary care registry. Rheumatology.2008;47(7):1088-1092. doi:10.1093/rheumatology/ken205.
- Skytta ET, Honkanen PB, Eskelinen A, Huhtala H, Remes V. Fewer and older patients with rheumatoid arthritis need total knee replacement. Scand J Rheumatol. 2012;41(5):345-349. doi:10.3109/03009742.2012.681061.
- Singh JA, Vessely MB, Harmsen WS, et al. A population-based study of trends in the use of total hip and total knee arthroplasty, 1969–2008. Mayo Clin Proc. 2010;85(10):898-904. doi:10.4065/mcp.2010.0115.
- Momohara S, Inoue E, Ikari K, et al. Decrease in orthopaedic operations, including total joint replacements, in patients with rheumatoid arthritis between 2001 and 2007: data from Japanese outpatients in a single institute-based large observational cohort (IORRA). Ann Rheum Dis. 2010;69(1):312-313. doi:10.1136/ard.2009.107599.
- Jain A, Stein BE, Skolasky RL, Jones LC, Hungerford MW. Total joint arthroplasty in patients with rheumatoid arthritis: a United States experience from 1992 through 2005. J Arthroplasty. 2012;27(6):881-888. doi:10.1016/j.arth.2011.12.027.
- Mertelsmann-Voss C, Lyman S, Pan TJ, Goodman SM, Figgie MP, Mandl LA. US trends in rates of arthroplasty for inflammatory arthritis including rheumatoid arthritis, juvenile idiopathic arthritis, and spondyloarthritis. Arthritis Rheumatol 2014;66(6):1432-1439. doi:10.1002/art.38384.
- Howe CR, Gardner GC, Kadel NJ. Perioperative medication management for the patient with rheumatoid arthritis. J Am Acad Orthop Surg. 2006;14(9):544-551. doi:10.5435/00124635-200609000-00004.
- Schrama JC, Espehaug B, Hallan G, et al. Risk of revision for infection in primary total hip and knee arthroplasty in patients with rheumatoid arthritis compared with osteoarthritis: a prospective, population-based study on 108,786 hip and knee joint arthroplasties from the Norwegian Arthroplasty Register. Arthritis Care Res. 2010;62(4):473-479. doi:10.1002/acr.20036.
- Ravi B, Croxford R, Hollands S, et al. Increased risk of complications following total joint arthroplasty in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014;66(2):254-263. doi:10.1002/art.38231.
- Au K, Reed G, Curtis JR, et al. High disease activity is associated with an increased risk of infection in patients with rheumatoid arthritis. Ann Rheum Dis. 2011;70(5):785-791. doi:10.1136/ard.2010.128637.
- Bongartz T, Sutton AJ, Sweeting MJ, Buchan I, Matteson EL, Montori V. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA. 2006;295(19):2275-2285. doi:10.1001/jama.295.19.2275.
- Scherrer CB, Mannion AF, Kyburz D, Vogt M, Kramers-de Quervain IA. Infection risk after orthopedic surgery in patients with inflammatory rheumatic diseases treated with immunosuppressive drugs. Arthritis Care Res. 2013;65(12):2032-2040. doi:10.1002/acr.22077.
- Bacani AK, Gabriel SE, Crowson CS, Heit JA, Matteson EL. Noncardiac vascular disease in rheumatoid arthritis: increase in venous thromboembolic events? Arthritis Rheum.2012;64(1):53-61. doi:10.1002/art.33322.
- Wallberg-Jonsson S, Dahlen GH, Nilsson TK, Ranby M, Rantapaa-Dahlqvist S. Tissue plasminogen activator, plasminogen activator inhibitor-1 and von Willebrand factor in rheumatoid arthritis. Clin Rheumatol. 1993;12(3):318324.
- van Heereveld HA, Laan RF, van den Hoogen FH, Malefijt MC, Novakova IR, van de Putte LB. Prevention of symptomatic thrombosis with short term (low molecular weight) heparin in patients with rheumatoid arthritis after hip or knee replacement. Ann Rheum Dis.2001;60(10):974-976. doi:10.1136/ard.60.10.974.
- Mont MA, Jacobs JJ, Boggio LN, et al. Preventing venous thromboembolic disease in patients undergoing elective hip and knee arthroplasty. J Am Acad Orthop Surg.2011;19(12):768-776.
- Bozic KJ, Bashyal RK, Anthony SG, Chiu V, Shulman B, Rubash HE. Is administratively coded comorbidity and complication data in total joint arthroplasty valid? Clin Orthop Relat Res. 2013;471(1):201-205. doi:10.1007/s11999-012-2352-1.
- Myasoedova E, Davis JM 3rd, Crowson CS, Gabriel SE. Epidemiology of rheumatoid arthritis: rheumatoid arthritis and mortality. Curr Rheumatol Rep. 2010;12(5):379-385. doi:10.1007/s11926-010-0117-y.
- Firestein GS. Evolving concepts of rheumatoid arthritis. Nature. 2003;423(6937):356-361. doi:10.1038/nature01661.
- Gullick NJ, Scott DL. Co-morbidities in established rheumatoid arthritis. Best Pract Res Clin Rheumatol. 2011;25(4):469-483. doi:10.1016/j.berh.2011.10.009.
- Masuda H, Miyazaki T, Shimada K, et al. Disease duration and severity impacts on long-term cardiovascular events in Japanese patients with rheumatoid arthritis. J Cardiol. 2014;64(5):366-370. doi:10.1016/j.jjcc.2014.02.018.
- Bongartz T, Nannini C, Medina-Velasquez YF, et al. Incidence and mortality of interstitial lung disease in rheumatoid arthritis: a population-based study. Arthritis Rheum.2010;62(6):1583-1591. doi:10.1002/art.27405.
- Doran MF, Crowson CS, Pond GR, O'Fallon WM, Gabriel SE. Frequency of infection in patients with rheumatoid arthritis compared with controls: a population-based study. Arthritis Rheum. 2002;46(9):2287-2293. doi:10.1002/art.10524.
- Rossini M, Rossi E, Bernardi D, et al. Prevalence and incidence of rheumatoid arthritis in Italy. Rheumatol Int. 2014;34(5):659664. doi:10.1007/s00296-014-2974-6.
- Alamanos Y, Voulgari PV, Drosos AA. Incidence and prevalence of rheumatoid arthritis, based on the 1987 American College of Rheumatology criteria: a systematic review. Semin Arthritis Rheum. 2006;36(3):182-188. doi:10.1016/j.semarthrit.2006.08.006.
- Carbonell J, Cobo T, Balsa A, Descalzo MA, Carmona L. The incidence of rheumatoid arthritis in Spain: results from a nationwide primary care registry. Rheumatology.2008;47(7):1088-1092. doi:10.1093/rheumatology/ken205.
- Skytta ET, Honkanen PB, Eskelinen A, Huhtala H, Remes V. Fewer and older patients with rheumatoid arthritis need total knee replacement. Scand J Rheumatol. 2012;41(5):345-349. doi:10.3109/03009742.2012.681061.
- Singh JA, Vessely MB, Harmsen WS, et al. A population-based study of trends in the use of total hip and total knee arthroplasty, 1969–2008. Mayo Clin Proc. 2010;85(10):898-904. doi:10.4065/mcp.2010.0115.
- Momohara S, Inoue E, Ikari K, et al. Decrease in orthopaedic operations, including total joint replacements, in patients with rheumatoid arthritis between 2001 and 2007: data from Japanese outpatients in a single institute-based large observational cohort (IORRA). Ann Rheum Dis. 2010;69(1):312-313. doi:10.1136/ard.2009.107599.
- Jain A, Stein BE, Skolasky RL, Jones LC, Hungerford MW. Total joint arthroplasty in patients with rheumatoid arthritis: a United States experience from 1992 through 2005. J Arthroplasty. 2012;27(6):881-888. doi:10.1016/j.arth.2011.12.027.
- Mertelsmann-Voss C, Lyman S, Pan TJ, Goodman SM, Figgie MP, Mandl LA. US trends in rates of arthroplasty for inflammatory arthritis including rheumatoid arthritis, juvenile idiopathic arthritis, and spondyloarthritis. Arthritis Rheumatol 2014;66(6):1432-1439. doi:10.1002/art.38384.
- Howe CR, Gardner GC, Kadel NJ. Perioperative medication management for the patient with rheumatoid arthritis. J Am Acad Orthop Surg. 2006;14(9):544-551. doi:10.5435/00124635-200609000-00004.
- Schrama JC, Espehaug B, Hallan G, et al. Risk of revision for infection in primary total hip and knee arthroplasty in patients with rheumatoid arthritis compared with osteoarthritis: a prospective, population-based study on 108,786 hip and knee joint arthroplasties from the Norwegian Arthroplasty Register. Arthritis Care Res. 2010;62(4):473-479. doi:10.1002/acr.20036.
- Ravi B, Croxford R, Hollands S, et al. Increased risk of complications following total joint arthroplasty in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014;66(2):254-263. doi:10.1002/art.38231.
- Au K, Reed G, Curtis JR, et al. High disease activity is associated with an increased risk of infection in patients with rheumatoid arthritis. Ann Rheum Dis. 2011;70(5):785-791. doi:10.1136/ard.2010.128637.
- Bongartz T, Sutton AJ, Sweeting MJ, Buchan I, Matteson EL, Montori V. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA. 2006;295(19):2275-2285. doi:10.1001/jama.295.19.2275.
- Scherrer CB, Mannion AF, Kyburz D, Vogt M, Kramers-de Quervain IA. Infection risk after orthopedic surgery in patients with inflammatory rheumatic diseases treated with immunosuppressive drugs. Arthritis Care Res. 2013;65(12):2032-2040. doi:10.1002/acr.22077.
- Bacani AK, Gabriel SE, Crowson CS, Heit JA, Matteson EL. Noncardiac vascular disease in rheumatoid arthritis: increase in venous thromboembolic events? Arthritis Rheum.2012;64(1):53-61. doi:10.1002/art.33322.
- Wallberg-Jonsson S, Dahlen GH, Nilsson TK, Ranby M, Rantapaa-Dahlqvist S. Tissue plasminogen activator, plasminogen activator inhibitor-1 and von Willebrand factor in rheumatoid arthritis. Clin Rheumatol. 1993;12(3):318324.
- van Heereveld HA, Laan RF, van den Hoogen FH, Malefijt MC, Novakova IR, van de Putte LB. Prevention of symptomatic thrombosis with short term (low molecular weight) heparin in patients with rheumatoid arthritis after hip or knee replacement. Ann Rheum Dis.2001;60(10):974-976. doi:10.1136/ard.60.10.974.
- Mont MA, Jacobs JJ, Boggio LN, et al. Preventing venous thromboembolic disease in patients undergoing elective hip and knee arthroplasty. J Am Acad Orthop Surg.2011;19(12):768-776.
- Bozic KJ, Bashyal RK, Anthony SG, Chiu V, Shulman B, Rubash HE. Is administratively coded comorbidity and complication data in total joint arthroplasty valid? Clin Orthop Relat Res. 2013;471(1):201-205. doi:10.1007/s11999-012-2352-1.
TAKE-HOME POINTS
- Patients undergoing THA for OA, when compared to those with RA undergoing THA, had lower risk for postoperative cardiovascular, pulmonary, wound dehiscence, infections, and systemic complications.
- Patients with OA undergoing THA had statistically significant higher risk of cerebrovascular complication compared to RA patients undergoing the same procedure.
- In TKA, OA patients had significantly higher risk for cardiovascular and cerebrovascular complications, and a significant lower risk for mechanical wounds, infection, and systemic complications.
- RA patients are at higher risk for postoperative infection, wound dehiscence, and systemic complications after TKA and THA compared to OA patients.
- These findings highlight the importance of preoperative medical clearance and management to optimize RA patients and improve the postoperative outcomes.
Minimum 5-Year Follow-up of Articular Surface Replacement Acetabular Components Used in Total Hip Arthroplasty
ABSTRACT
The articular surface replacement (ASR) monoblock metal-on-metal acetabular component was recalled due to a higher than expected early failure rate. We evaluated the survivorship of the device and variables that may be predictive of failure at a minimum of 5-year follow-up. A single-center, single-surgeon retrospective review was conducted in patients who received the DePuy Synthes ASR™ XL Acetabular hip system from December 2005 to November 2009. Mean values and percentages were calculated and compared using the Fisher’s exact test, simple logistic regression, and Student’s t-test. The significance level was P ≤ .05. This study included 29 patients (24 males, 5 females) with 32 ASR™ XL acetabular hip systems. Mean age and body mass index (BMI) reached 55.2 years and 28.9 kg/m2, respectively. Mean postoperative follow-up was 6.2 years. A total of 2 patients (6.9%) died of an unrelated cause and 1 patient was lost to follow-up (3.4%), leaving 26 patients with 28 hip replacements, all of whom were available for follow-up. The 5-year revision rate was 34.4% (10 patients with 11 hip replacements). Mean time to revision was 3.1 years. Age (P = .76), gender (P = .49), BMI (P = .29), acetabular component abduction angle (P = .12), and acetabulum size (P = .59) were not associated with the increased rate for hip failure. Blood cobalt (7.6 vs 6.8 µg/L, P = .58) and chromium (5.0 vs 2.2 µg/L, P = .31) levels were not significantly higher in the revised group when compared with those of the unrevised group. In the revised group, a 91% decrease in cobalt and 78% decrease in chromium levels were observed at a mean of 6 months following the revision. This study demonstrates a high rate of failure of ASR acetabular components used in total hip arthroplasty at a minimum of 5 years of follow-up. No variable that was predictive of failure could be identified in this series. Close clinical surveillance of these patients is required.
Continue to: Metal-on-metal...
Metal-on-metal (MoM) articulations have been widely explored as an alternative to polyethylene bearings in total hip arthroplasty (THA), with proposed benefits including improved range of motion, lower dislocation rates, and enhanced durability.1 Comprising cobalt and chromium, these MoM bearings gained widespread popularity in the United States, particularly in younger and more active patients looking for longer lasting devices.
The articular surface replacement (ASR) acetabular system (DePuy Synthes) was approved for sale by the US Food and Drug Administration in 2003 and implanted in an estimated 93,000 cases.2 Since then, however, the early failure rate of the prosthesis has been well documented,3-5 leading to a formal global product recall in August 2010. The Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) was amongst the first to report a 6.4% rate of failure of the device at 3 years when inserted with a Corail stem.6 An acceptable upper rate of hip prosthesis failure is considered to reach 1% per year, with the majority of implants reporting well below this value. A 10.9% failure rate at 5 years was documented when the prosthesis was inserted for resurfacing. The National Joint Registry of England and Wales confirmed these findings and observed a 13% and 12% rate of failure at 5 years for the acetabular and resurfacing systems, respectively.2 With the notable failure of the ASR system, this study reports our single-center 5-year survivorship experience and evaluates any variable that might be predictive of an early failure to aid in patient counseling.
METHODS
A single-center, single-surgeon, retrospective review of a consecutive series of patients was performed from December 2005 to November 2009. This study included all patients who underwent a primary THA with a DePuy Synthes ASR™ XL Acetabular hip system. No patients were excluded. Institutional Review Board approval was obtained. Patient demographics comprising of age, gender, and body mass index (BMI) were recorded. The primary endpoint of this study was 5-year survivorship rates. Secondary endpoints included duration to revision surgery, blood cobalt and chromium levels, time interval of blood ion tests, acetabulum size, acetabular component abduction angle, and duration to follow-up.
Candidates for the ASR™ XL Acetabular hip system included young patients and/or those considered to be physically active. In a select few, ASR devices were implanted upon patient request.
All patients underwent primary total hip replacement with a DePuy Synthes ASR™ XL uncemented acetabular component and an uncemented femoral stem (DePuy Synthes, Summit, or Tri-Lock) inserted via a standard posterior approach (Figure 1). Acetabulum sizes ranged from 52 mm to 68 mm in diameter.
All patients were followed-up yearly in the outpatient setting. Routine (yearly) metal-ion level sampling (whole blood) was started in 2010 for all patients. Laboratory tests were conducted at a single laboratory (Lab Corp.). Abduction cup inclination angles were measured by the providing surgeon using digital radiology software (GE Centricity systems).
The Student’s t-test was used to compare mean values (such as age, BMI, and metal ion levels) between the failure and no-failure groups. The 2-sided Fisher’s exact test analyzed differences in gender. Simple logistic regression analyzed variables associated with the failure group. Significance was P ≤ .05.
Continue to: Results...
RESULTS
A total of 29 patients (24 males, 5 females) with 32 ASR hip replacements were included in this study. Indications for surgery comprised osteoarthritis (28 hips, 87.5%) and avascular necrosis of the hip (4 hips, 12.5%). Mean age and BMI were 55.2 years and 28.9 kg/m2, respectively. A total of 2 patients (6.9%) died of an unrelated cause (1 myocardial infarct, 1 suicide), and 1 patient was lost to follow-up (3.4%), leaving 26 patients with 28 hip replacements, all of whom finished a 5-year minimum follow-up.
No implant failures were noted in the first year. The 5-year revision rate reached 34.4% (10 patients with 11 hip replacements). Mean time to revision for this subgroup was 3.1 years. Overall, an implant failure was observed in 37.5% of patients (11 patients with 12 hip replacements) at a mean postoperative follow-up of 6.2 years (Figure 2). Indications for implant revision were pain in 11 (92.7%) cases and infection in 1 (8.3%).
Of the 11 hips revised due to pain, 9 were performed by the original surgeon (8 were completed with primary acetabular components, 1 with a revision shell). Figure 3 shows a bilateral revision performed with primary acetabular components and retained DePuy Synthes Pinnacle femoral stems. In all these cases except 1, the ASR component was grossly loose. One case presented with pseudotumor and impingement between the femoral prosthetic neck and acetabular component after migration of a loose component. After revision, the patient returned with substantial anterior hip pain and heterotopic ossification, and failed conservative treatment, requiring another surgery with prosthesis retention, removal of heterotopic ossification, and iliopsoas lengthening. The surgery successfully relieved the symptoms. No other patients required additional surgery after their revision. In comparison to the original ASR component, the revision shell was 2 to 4 mm larger in diameter. No patient required component revision at a mean of 2.9 years after the revision surgery.
The patient with secondary revision developed a hematogenous streptococcal infection after a dental procedure performed without prophylactic antibiotics. The patient was initially lost to follow-up after the primary surgery and reported no antecedent pain prior to the revision. A substantial metal fluid collection was identified in the hip at the time of débridement and without component loosening. After débridement, the patient developed persistent metal stained wound drainage, necessitating ultimate successful treatment with a 2-stage exchange procedure.
Age (P = .76), gender (P = .49), BMI (P = .29), acetabular component abduction angle (P = .12), and acetabulum size (P = .59) were not associated with an increased rate for hip failure (Table). Blood cobalt (7.6 vs 6.8 µg/L, P = .58) and chromium (5.0 vs 2.2 µg/L, P = .31) levels were not significantly higher in the revised group when compared with those of the unrevised group. The upper limits of blood cobalt and chromium levels reached 18.9 and 15.9 µg/L for the revised group and 16.8 and 5.4 µg/L for the non-revised group, respectively. In the revised group, a 91% decrease in cobalt and 78% decrease in chromium levels were observed at a mean of 6 months after the revision (Figure 4).
Table. Variables Not Associated with Early ASR Failure
|
| No Failure (n = 20) | Failure (n = 12) | P value |
Age (years) | 55.4 ± 6.4 | 54.7 ± 6.3 | .76 | |
BMI (kg/m2) | 29.7 ± 6.7 | 27.4 ± 4.0 | .29 | |
Gender | .49 | |||
Female | 3 (15%) | 3 (25%) | ||
Male | 17 (85%) | 9 (75%) | ||
Acetabulum size (mm) | 59.1 ± 3.9 | 58.3 ± 3.8 | .59 | |
Abduction angle (degrees) | 44.9 ± 4.5 | 42.3 ± 3.8 | .12 | |
Serum levels (µg/L) | ||||
Cobalt | 6.8 ± 6.0 | 7.6 ± 4.7 | .58 | |
| Chromium | 2.2 ± 1.7 | 5.0 ± 5.0 | .31 |
Continue to: Discussion...
DISCUSSION
According to the Center for Disease Control and Prevention, 310,800 total hip replacements were performed among inpatients aged 45 years and older in the US in 2010.7 Specifically, in the 55- to 64-year-old age group, the number of procedures performed tripled from 2000 through 2010. As younger and more active patients opt for hip replacements, a growing need for prosthesis with enhanced durability is observed.
Despite the early proposed advantages of large head MoM bearings, our retrospective study of the DePuy Synthes ASR™ XL Acetabular hip system yielded 15.6% and 34.4% failure rates at 3 and 5 years, respectively. These higher-than-expected rates of failure are consistent with published data. The British Hip Society reported a 21% to 35% revision rate at 4 years and 49% at 6 years for the ASR XL prosthesis.8 In comparison, other MoM prosthesis, on average, report a 12% to 15% rate of failure at 5 years.
Considerable controversy surrounds the causes of adverse wear failure in MoM bearings.9,10 The non-modular design of the ASR prostheses is frequently implicated as a cause of early failure. The lack of a central hole in the 1-piece component compromises the tactile feel of insertion, thereby reducing the surgeon’s ability to assess complete seating.11 This condition may potentially increase the abduction angle at the time of insertion. Screw fixation of the non-modular device is not possible. The ASR XL device (148° to 160°) is less than a hemisphere (180°) in size and hence features a diminished functional articular surface, further compromising implant fixation.11 The functional articular surface is defined as the optimal surface area (10 mm) needed for a MoM implant.12 Griffin and colleagues13 reported a 48 mm ASR XL component, when implanted at 45° of abduction, to function similar to an implant at 59° of abduction, leading to diminished lubrication, metallosis, and edge loading. The version of the acetabular component may similarly and adversely affect implant wear characteristics. Furthermore, the variable thickness of the implant, which is thicker at the dome and thinner at the rim, may further promote edge loading by shifting the center of rotation of the femoral head out from the center of the acetabular prosthesis.11 Studies have also shown that increased wear of the MoM articulation is associated with an acetabular component inclination angle in excess of 55°10,14 and a failure of fixation at time of implantation.15 This study, however, found no correlation between the abduction angle and risk of early implant failure for the ASR acetabular component. No correlation was also detected between the acetabulum size and revision surgery.
The AOANJRR reported loosening (44%), infection (20%), metal sensitivity (12%), fracture (9%), and dislocation of prosthesis (7%) as the indications for revision surgery for the ASR prosthesis.6 Furthermore, a single-center retrospective review of 70 consecutive MoM THAs with ultra-large diameter femoral head and monoblock acetabular components showed that 17.1% required revision within 3 years for loosening, pain, and squeaking.1 Overall, 28.6% of patients reported implant dysfunction. In this study, we observed a similar rate of failure at 3 years (15.6%) for pain (11) and infection (1). The revision surgery successfully relieved all of these symptoms. One patient presented with heterotopic ossification and anterior hip pain after the original revision and required additional surgery with prosthesis retention. No patient in this series required repeat component revisions at a mean of 2.9 years after surgery. In all but 1 case, primary acetabular components were used in the revision, and in all cases except that with infection, the femoral component was retained. Replacement shells were 2 to 4 mm larger in diameter than the original ASR component.
Recently, concerns have arisen regarding the long-term effects of serum cobalt and chromium metal ions levels. Studies have shown increased serum metal ion levels,15 groin pain,16 pseudotumor formation,17 and metallosis18 after the implantation of MoM bearings. In a case study by Mao and colleagues,19 1 patient reported headaches, anorexia, continuous metallic taste in her mouth, and weight loss. A cerebrospinal fluid analysis revealed cobalt and chromium levels at 9 and 13 nmol/L, respectively, indicating that these metal ions can cross the blood-brain barrier. Another patient reported painful muscle fatigue, night cramps, fainting spells, cognitive decline, and an inability to climb stairs. His serum cobalt level reached 258 nmol/L (reference range, 0-20 nmol/L), and chromium level totaled 88 nmol/L (reference range, 0-100 nmol/L). At 8-week follow-up after revision surgery, the symptoms of the patient had resolved, with serum cobalt levels dropping to 42 nmol/L.19 None of the patients in this study presented with any signs or symptoms of metal toxicity. The upper limits of blood cobalt and chromium levels in our study population reached 18.9 and 15.9 µg/L for the revised group and 16.8 and 5.4 µg/L for the non-revised group, respectively. However, we noted a similar drop in post-revision blood cobalt (91% decrease) and chromium (78% decrease) levels.
In summary, our data showed a high revision rate of the DePuy Synthes ASR™ XL Acetabular hip system. Our findings are consistent with internationally published data. In the absence of reliable predictors of early failure, continued close clinical surveillance and laboratory monitoring of these patients are warranted.
CONCLUSION
This study demonstrates the high failure rate of the DePuy Synthes ASR™ XL Acetabular hip system used in THA at a minimum of 5 years of follow-up. No variable that was predictive of failure could be identified in this series. Close clinical surveillance of these patients is therefore required. Metal levels dropped quickly after revision, and the revision surgery can generally be performed with slightly larger primary components. Symptomatic patients with ASR hip replacements, regardless of blood metal-ion levels, were candidates for the revision surgery. Not all failed hips exhibited substantially elevated metal levels. Asymptomatic patients with high blood metal-ion levels should be closely followed-up and revision surgery should be strongly considered, consistent with recently published guidelines.20
- Bernthal NM, Celestre PC, Stavrakis AI, Ludington JC, Oakes DA. Disappointing short-term results with the DePuy ASR XL metal-on-metal total hip arthroplasty. J Arthroplasty. 2012;27(4):539. doi:10.1016/j.arth.2011.08.022.
- de Steiger RN, Hang JR, Miller LN, Graves SE, Davidson DC. Five-year results of the ASR XL acetabular system and the ASR hip resurfacing system: An analysis from the Australian Orthopaedic Association National Joint Replacement Registry. J Bone Joint Surg Am. 2011;93(24):2287. doi:10.2106/JBJS.J.01727.
- Langton DJ, Jameson SS, Joyce TJ, Hallab NJ, Natu S, Nargol AV. Early failure of metal-on-metal bearings in hip resurfacing and large-diameter total hip replacement: a consequence of excess wear. J Bone Joint Surg Br. 2010;92(1):38-46. doi:10.1302/0301-620X.92B1.22770.
- Siebel T, Maubach S, Morlock MM. Lessons learned from early clinical experience and results of 300 ASR hip resurfacing implantations. Proc Inst Mech Eng H. 2006;220(2):345-353. doi:10.1243/095441105X69079.
- Jameson SS, Langton DJ, Nargol AV. Articular surface replacement of the hip: a prospective single-surgeon series. J Bone Joint Surg Br. 2010;92(1):28-37. doi:10.1302/0301-620X.92B1.22769.
- Australian Orthopaedic Association National Joint Replacement Registry annual report 2010. Australian Orthopaedic Association Web site. https://aoanjrr.sahmri.com/annual-reports-2010. Accessed June 19, 2018.
- Wolford ML, Palso K, Bercovitz A. Hospitalization for total hip replacement among inpatients aged 45 and over: United States, 2000-2010. Centers for Disease Control and Prevention Web site. http://www.cdc.gov/nchs/data/databriefs/db186.pdf. Accessed July 13, 2015.
- Hodgkinson J, Skinner J, Kay P. Large diameter metal on metal bearing total hip replacements. British Hip Society Web site. https://www.britishhipsociety.com/uploaded/BHS_MOM_THR.pdf. Accessed August 6, 2015.
- Hart AJ, Ilo K, Underwood R, et al. The relationship between the angle of version and rate of wear of retrieved metal-on-metal resurfacings: a prospective, CT-based study. J Bone Joint Surg Br. 2011;93(3):315-320. doi:10.1302/0301-620X.93B3.25545.
- Langton DJ, Joyce TJ, Jameson SS, et al. Adverse reaction to metal debris following hip resurfacing: the influence of component type, orientation and volumetric wear. J Bone Joint Surg Br. 2011;93(2):164-171. doi:10.1302/0301-620X.93B2.25099.
- Steele GD, Fehring TK, Odum SM, Dennos AC, Nadaud MC. Early failure of articular surface replacement XL total hip arthroplasty. J Arthroplasty. 2011;26(6):14-18. doi:10.1016/j.arth.2011.03.027.
- De Haan R, Campbell PA, Su EP, De Smet KA. Revision of metal-on-metal resurfacing arthroplasty of the hip: the influence of malpositioning of the components. J Bone Joint Surg Br. 2008;90(9):1158-1163. doi:10.1302/0301-620X.90B9.19891.
- Griffin WL, Nanson CJ, Springer BD, Davies MA, Fehring TK. Reduced articular surface of one-piece cups: a cause of runaway wear and early failure. Clin Orthop Relat Res. 2010;468(9):2328-2332. doi:10.1007/s11999-010-1383-8.
- Grammatopolous G, Pandit H, Glyn-Jones S, et al. Optimal acetablular orientation for hip resurfacing. J Bone Joint Surg Br. 2010;92(8):1072-1078. doi:10.1302/0301-620X.92B8.24194.
- MacDonalad SJ, McCalden RW, Chess DG, et al. Meta-onmetal versus polyethylene in hip arthoplasty: a randomized clinical trial. Clin Orthop Relat Res. 2003;(406):282-296.
- Bin Nasser A, Beaule PE, O'Neill M, Kim PR, Fazekas A. Incidence of groin pain after metal-on-metal hip resurfacing. Clin Orthop Relat Res. 2010;468(2):392-399. doi:10.1007/s11999-009-1133-y.
- Mahendra G, Pandit H, Kliskey K, Murray D, Gill HS, Athanasou N. Necrotic and inflammatory changes in metal-on-metal resurfacing hip arthroplasties. Acta Orthop. 2009;80(6):653-659. doi:10.3109/17453670903473016.
- Neumann DRP, Thaler C, Hitzl W, Huber M, Hofstädter T, Dorn U. Long term results of a contemporary metal-on-metal total hip arthroplasty. J Arthroplasty. 2010;25(5):700-708. doi:10.1016/j.arth.2009.05.018.
- Mao X, Wong AA, Crawford RW. Cobalt toxicity--an emerging clinical problem in patients with metal-on-metal hip prostheses? Med J Aust. 2011;194(12):649-651.
- Information statement: current concerns with metal-on-metal hip arthroplasty. American Academy of Orthopaedic Surgeons Web site. https://aaos.org/uploadedFiles/PreProduction/About/Opinion_Statements/advistmt/1035%20Current%20Concerns%20with%20Metal-on-Metal%20Hip%20Arthroplasty.pdf. Accessed June 19, 2018.
ABSTRACT
The articular surface replacement (ASR) monoblock metal-on-metal acetabular component was recalled due to a higher than expected early failure rate. We evaluated the survivorship of the device and variables that may be predictive of failure at a minimum of 5-year follow-up. A single-center, single-surgeon retrospective review was conducted in patients who received the DePuy Synthes ASR™ XL Acetabular hip system from December 2005 to November 2009. Mean values and percentages were calculated and compared using the Fisher’s exact test, simple logistic regression, and Student’s t-test. The significance level was P ≤ .05. This study included 29 patients (24 males, 5 females) with 32 ASR™ XL acetabular hip systems. Mean age and body mass index (BMI) reached 55.2 years and 28.9 kg/m2, respectively. Mean postoperative follow-up was 6.2 years. A total of 2 patients (6.9%) died of an unrelated cause and 1 patient was lost to follow-up (3.4%), leaving 26 patients with 28 hip replacements, all of whom were available for follow-up. The 5-year revision rate was 34.4% (10 patients with 11 hip replacements). Mean time to revision was 3.1 years. Age (P = .76), gender (P = .49), BMI (P = .29), acetabular component abduction angle (P = .12), and acetabulum size (P = .59) were not associated with the increased rate for hip failure. Blood cobalt (7.6 vs 6.8 µg/L, P = .58) and chromium (5.0 vs 2.2 µg/L, P = .31) levels were not significantly higher in the revised group when compared with those of the unrevised group. In the revised group, a 91% decrease in cobalt and 78% decrease in chromium levels were observed at a mean of 6 months following the revision. This study demonstrates a high rate of failure of ASR acetabular components used in total hip arthroplasty at a minimum of 5 years of follow-up. No variable that was predictive of failure could be identified in this series. Close clinical surveillance of these patients is required.
Continue to: Metal-on-metal...
Metal-on-metal (MoM) articulations have been widely explored as an alternative to polyethylene bearings in total hip arthroplasty (THA), with proposed benefits including improved range of motion, lower dislocation rates, and enhanced durability.1 Comprising cobalt and chromium, these MoM bearings gained widespread popularity in the United States, particularly in younger and more active patients looking for longer lasting devices.
The articular surface replacement (ASR) acetabular system (DePuy Synthes) was approved for sale by the US Food and Drug Administration in 2003 and implanted in an estimated 93,000 cases.2 Since then, however, the early failure rate of the prosthesis has been well documented,3-5 leading to a formal global product recall in August 2010. The Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) was amongst the first to report a 6.4% rate of failure of the device at 3 years when inserted with a Corail stem.6 An acceptable upper rate of hip prosthesis failure is considered to reach 1% per year, with the majority of implants reporting well below this value. A 10.9% failure rate at 5 years was documented when the prosthesis was inserted for resurfacing. The National Joint Registry of England and Wales confirmed these findings and observed a 13% and 12% rate of failure at 5 years for the acetabular and resurfacing systems, respectively.2 With the notable failure of the ASR system, this study reports our single-center 5-year survivorship experience and evaluates any variable that might be predictive of an early failure to aid in patient counseling.
METHODS
A single-center, single-surgeon, retrospective review of a consecutive series of patients was performed from December 2005 to November 2009. This study included all patients who underwent a primary THA with a DePuy Synthes ASR™ XL Acetabular hip system. No patients were excluded. Institutional Review Board approval was obtained. Patient demographics comprising of age, gender, and body mass index (BMI) were recorded. The primary endpoint of this study was 5-year survivorship rates. Secondary endpoints included duration to revision surgery, blood cobalt and chromium levels, time interval of blood ion tests, acetabulum size, acetabular component abduction angle, and duration to follow-up.
Candidates for the ASR™ XL Acetabular hip system included young patients and/or those considered to be physically active. In a select few, ASR devices were implanted upon patient request.
All patients underwent primary total hip replacement with a DePuy Synthes ASR™ XL uncemented acetabular component and an uncemented femoral stem (DePuy Synthes, Summit, or Tri-Lock) inserted via a standard posterior approach (Figure 1). Acetabulum sizes ranged from 52 mm to 68 mm in diameter.
All patients were followed-up yearly in the outpatient setting. Routine (yearly) metal-ion level sampling (whole blood) was started in 2010 for all patients. Laboratory tests were conducted at a single laboratory (Lab Corp.). Abduction cup inclination angles were measured by the providing surgeon using digital radiology software (GE Centricity systems).
The Student’s t-test was used to compare mean values (such as age, BMI, and metal ion levels) between the failure and no-failure groups. The 2-sided Fisher’s exact test analyzed differences in gender. Simple logistic regression analyzed variables associated with the failure group. Significance was P ≤ .05.
Continue to: Results...
RESULTS
A total of 29 patients (24 males, 5 females) with 32 ASR hip replacements were included in this study. Indications for surgery comprised osteoarthritis (28 hips, 87.5%) and avascular necrosis of the hip (4 hips, 12.5%). Mean age and BMI were 55.2 years and 28.9 kg/m2, respectively. A total of 2 patients (6.9%) died of an unrelated cause (1 myocardial infarct, 1 suicide), and 1 patient was lost to follow-up (3.4%), leaving 26 patients with 28 hip replacements, all of whom finished a 5-year minimum follow-up.
No implant failures were noted in the first year. The 5-year revision rate reached 34.4% (10 patients with 11 hip replacements). Mean time to revision for this subgroup was 3.1 years. Overall, an implant failure was observed in 37.5% of patients (11 patients with 12 hip replacements) at a mean postoperative follow-up of 6.2 years (Figure 2). Indications for implant revision were pain in 11 (92.7%) cases and infection in 1 (8.3%).
Of the 11 hips revised due to pain, 9 were performed by the original surgeon (8 were completed with primary acetabular components, 1 with a revision shell). Figure 3 shows a bilateral revision performed with primary acetabular components and retained DePuy Synthes Pinnacle femoral stems. In all these cases except 1, the ASR component was grossly loose. One case presented with pseudotumor and impingement between the femoral prosthetic neck and acetabular component after migration of a loose component. After revision, the patient returned with substantial anterior hip pain and heterotopic ossification, and failed conservative treatment, requiring another surgery with prosthesis retention, removal of heterotopic ossification, and iliopsoas lengthening. The surgery successfully relieved the symptoms. No other patients required additional surgery after their revision. In comparison to the original ASR component, the revision shell was 2 to 4 mm larger in diameter. No patient required component revision at a mean of 2.9 years after the revision surgery.
The patient with secondary revision developed a hematogenous streptococcal infection after a dental procedure performed without prophylactic antibiotics. The patient was initially lost to follow-up after the primary surgery and reported no antecedent pain prior to the revision. A substantial metal fluid collection was identified in the hip at the time of débridement and without component loosening. After débridement, the patient developed persistent metal stained wound drainage, necessitating ultimate successful treatment with a 2-stage exchange procedure.
Age (P = .76), gender (P = .49), BMI (P = .29), acetabular component abduction angle (P = .12), and acetabulum size (P = .59) were not associated with an increased rate for hip failure (Table). Blood cobalt (7.6 vs 6.8 µg/L, P = .58) and chromium (5.0 vs 2.2 µg/L, P = .31) levels were not significantly higher in the revised group when compared with those of the unrevised group. The upper limits of blood cobalt and chromium levels reached 18.9 and 15.9 µg/L for the revised group and 16.8 and 5.4 µg/L for the non-revised group, respectively. In the revised group, a 91% decrease in cobalt and 78% decrease in chromium levels were observed at a mean of 6 months after the revision (Figure 4).
Table. Variables Not Associated with Early ASR Failure
|
| No Failure (n = 20) | Failure (n = 12) | P value |
Age (years) | 55.4 ± 6.4 | 54.7 ± 6.3 | .76 | |
BMI (kg/m2) | 29.7 ± 6.7 | 27.4 ± 4.0 | .29 | |
Gender | .49 | |||
Female | 3 (15%) | 3 (25%) | ||
Male | 17 (85%) | 9 (75%) | ||
Acetabulum size (mm) | 59.1 ± 3.9 | 58.3 ± 3.8 | .59 | |
Abduction angle (degrees) | 44.9 ± 4.5 | 42.3 ± 3.8 | .12 | |
Serum levels (µg/L) | ||||
Cobalt | 6.8 ± 6.0 | 7.6 ± 4.7 | .58 | |
| Chromium | 2.2 ± 1.7 | 5.0 ± 5.0 | .31 |
Continue to: Discussion...
DISCUSSION
According to the Center for Disease Control and Prevention, 310,800 total hip replacements were performed among inpatients aged 45 years and older in the US in 2010.7 Specifically, in the 55- to 64-year-old age group, the number of procedures performed tripled from 2000 through 2010. As younger and more active patients opt for hip replacements, a growing need for prosthesis with enhanced durability is observed.
Despite the early proposed advantages of large head MoM bearings, our retrospective study of the DePuy Synthes ASR™ XL Acetabular hip system yielded 15.6% and 34.4% failure rates at 3 and 5 years, respectively. These higher-than-expected rates of failure are consistent with published data. The British Hip Society reported a 21% to 35% revision rate at 4 years and 49% at 6 years for the ASR XL prosthesis.8 In comparison, other MoM prosthesis, on average, report a 12% to 15% rate of failure at 5 years.
Considerable controversy surrounds the causes of adverse wear failure in MoM bearings.9,10 The non-modular design of the ASR prostheses is frequently implicated as a cause of early failure. The lack of a central hole in the 1-piece component compromises the tactile feel of insertion, thereby reducing the surgeon’s ability to assess complete seating.11 This condition may potentially increase the abduction angle at the time of insertion. Screw fixation of the non-modular device is not possible. The ASR XL device (148° to 160°) is less than a hemisphere (180°) in size and hence features a diminished functional articular surface, further compromising implant fixation.11 The functional articular surface is defined as the optimal surface area (10 mm) needed for a MoM implant.12 Griffin and colleagues13 reported a 48 mm ASR XL component, when implanted at 45° of abduction, to function similar to an implant at 59° of abduction, leading to diminished lubrication, metallosis, and edge loading. The version of the acetabular component may similarly and adversely affect implant wear characteristics. Furthermore, the variable thickness of the implant, which is thicker at the dome and thinner at the rim, may further promote edge loading by shifting the center of rotation of the femoral head out from the center of the acetabular prosthesis.11 Studies have also shown that increased wear of the MoM articulation is associated with an acetabular component inclination angle in excess of 55°10,14 and a failure of fixation at time of implantation.15 This study, however, found no correlation between the abduction angle and risk of early implant failure for the ASR acetabular component. No correlation was also detected between the acetabulum size and revision surgery.
The AOANJRR reported loosening (44%), infection (20%), metal sensitivity (12%), fracture (9%), and dislocation of prosthesis (7%) as the indications for revision surgery for the ASR prosthesis.6 Furthermore, a single-center retrospective review of 70 consecutive MoM THAs with ultra-large diameter femoral head and monoblock acetabular components showed that 17.1% required revision within 3 years for loosening, pain, and squeaking.1 Overall, 28.6% of patients reported implant dysfunction. In this study, we observed a similar rate of failure at 3 years (15.6%) for pain (11) and infection (1). The revision surgery successfully relieved all of these symptoms. One patient presented with heterotopic ossification and anterior hip pain after the original revision and required additional surgery with prosthesis retention. No patient in this series required repeat component revisions at a mean of 2.9 years after surgery. In all but 1 case, primary acetabular components were used in the revision, and in all cases except that with infection, the femoral component was retained. Replacement shells were 2 to 4 mm larger in diameter than the original ASR component.
Recently, concerns have arisen regarding the long-term effects of serum cobalt and chromium metal ions levels. Studies have shown increased serum metal ion levels,15 groin pain,16 pseudotumor formation,17 and metallosis18 after the implantation of MoM bearings. In a case study by Mao and colleagues,19 1 patient reported headaches, anorexia, continuous metallic taste in her mouth, and weight loss. A cerebrospinal fluid analysis revealed cobalt and chromium levels at 9 and 13 nmol/L, respectively, indicating that these metal ions can cross the blood-brain barrier. Another patient reported painful muscle fatigue, night cramps, fainting spells, cognitive decline, and an inability to climb stairs. His serum cobalt level reached 258 nmol/L (reference range, 0-20 nmol/L), and chromium level totaled 88 nmol/L (reference range, 0-100 nmol/L). At 8-week follow-up after revision surgery, the symptoms of the patient had resolved, with serum cobalt levels dropping to 42 nmol/L.19 None of the patients in this study presented with any signs or symptoms of metal toxicity. The upper limits of blood cobalt and chromium levels in our study population reached 18.9 and 15.9 µg/L for the revised group and 16.8 and 5.4 µg/L for the non-revised group, respectively. However, we noted a similar drop in post-revision blood cobalt (91% decrease) and chromium (78% decrease) levels.
In summary, our data showed a high revision rate of the DePuy Synthes ASR™ XL Acetabular hip system. Our findings are consistent with internationally published data. In the absence of reliable predictors of early failure, continued close clinical surveillance and laboratory monitoring of these patients are warranted.
CONCLUSION
This study demonstrates the high failure rate of the DePuy Synthes ASR™ XL Acetabular hip system used in THA at a minimum of 5 years of follow-up. No variable that was predictive of failure could be identified in this series. Close clinical surveillance of these patients is therefore required. Metal levels dropped quickly after revision, and the revision surgery can generally be performed with slightly larger primary components. Symptomatic patients with ASR hip replacements, regardless of blood metal-ion levels, were candidates for the revision surgery. Not all failed hips exhibited substantially elevated metal levels. Asymptomatic patients with high blood metal-ion levels should be closely followed-up and revision surgery should be strongly considered, consistent with recently published guidelines.20
ABSTRACT
The articular surface replacement (ASR) monoblock metal-on-metal acetabular component was recalled due to a higher than expected early failure rate. We evaluated the survivorship of the device and variables that may be predictive of failure at a minimum of 5-year follow-up. A single-center, single-surgeon retrospective review was conducted in patients who received the DePuy Synthes ASR™ XL Acetabular hip system from December 2005 to November 2009. Mean values and percentages were calculated and compared using the Fisher’s exact test, simple logistic regression, and Student’s t-test. The significance level was P ≤ .05. This study included 29 patients (24 males, 5 females) with 32 ASR™ XL acetabular hip systems. Mean age and body mass index (BMI) reached 55.2 years and 28.9 kg/m2, respectively. Mean postoperative follow-up was 6.2 years. A total of 2 patients (6.9%) died of an unrelated cause and 1 patient was lost to follow-up (3.4%), leaving 26 patients with 28 hip replacements, all of whom were available for follow-up. The 5-year revision rate was 34.4% (10 patients with 11 hip replacements). Mean time to revision was 3.1 years. Age (P = .76), gender (P = .49), BMI (P = .29), acetabular component abduction angle (P = .12), and acetabulum size (P = .59) were not associated with the increased rate for hip failure. Blood cobalt (7.6 vs 6.8 µg/L, P = .58) and chromium (5.0 vs 2.2 µg/L, P = .31) levels were not significantly higher in the revised group when compared with those of the unrevised group. In the revised group, a 91% decrease in cobalt and 78% decrease in chromium levels were observed at a mean of 6 months following the revision. This study demonstrates a high rate of failure of ASR acetabular components used in total hip arthroplasty at a minimum of 5 years of follow-up. No variable that was predictive of failure could be identified in this series. Close clinical surveillance of these patients is required.
Continue to: Metal-on-metal...
Metal-on-metal (MoM) articulations have been widely explored as an alternative to polyethylene bearings in total hip arthroplasty (THA), with proposed benefits including improved range of motion, lower dislocation rates, and enhanced durability.1 Comprising cobalt and chromium, these MoM bearings gained widespread popularity in the United States, particularly in younger and more active patients looking for longer lasting devices.
The articular surface replacement (ASR) acetabular system (DePuy Synthes) was approved for sale by the US Food and Drug Administration in 2003 and implanted in an estimated 93,000 cases.2 Since then, however, the early failure rate of the prosthesis has been well documented,3-5 leading to a formal global product recall in August 2010. The Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) was amongst the first to report a 6.4% rate of failure of the device at 3 years when inserted with a Corail stem.6 An acceptable upper rate of hip prosthesis failure is considered to reach 1% per year, with the majority of implants reporting well below this value. A 10.9% failure rate at 5 years was documented when the prosthesis was inserted for resurfacing. The National Joint Registry of England and Wales confirmed these findings and observed a 13% and 12% rate of failure at 5 years for the acetabular and resurfacing systems, respectively.2 With the notable failure of the ASR system, this study reports our single-center 5-year survivorship experience and evaluates any variable that might be predictive of an early failure to aid in patient counseling.
METHODS
A single-center, single-surgeon, retrospective review of a consecutive series of patients was performed from December 2005 to November 2009. This study included all patients who underwent a primary THA with a DePuy Synthes ASR™ XL Acetabular hip system. No patients were excluded. Institutional Review Board approval was obtained. Patient demographics comprising of age, gender, and body mass index (BMI) were recorded. The primary endpoint of this study was 5-year survivorship rates. Secondary endpoints included duration to revision surgery, blood cobalt and chromium levels, time interval of blood ion tests, acetabulum size, acetabular component abduction angle, and duration to follow-up.
Candidates for the ASR™ XL Acetabular hip system included young patients and/or those considered to be physically active. In a select few, ASR devices were implanted upon patient request.
All patients underwent primary total hip replacement with a DePuy Synthes ASR™ XL uncemented acetabular component and an uncemented femoral stem (DePuy Synthes, Summit, or Tri-Lock) inserted via a standard posterior approach (Figure 1). Acetabulum sizes ranged from 52 mm to 68 mm in diameter.
All patients were followed-up yearly in the outpatient setting. Routine (yearly) metal-ion level sampling (whole blood) was started in 2010 for all patients. Laboratory tests were conducted at a single laboratory (Lab Corp.). Abduction cup inclination angles were measured by the providing surgeon using digital radiology software (GE Centricity systems).
The Student’s t-test was used to compare mean values (such as age, BMI, and metal ion levels) between the failure and no-failure groups. The 2-sided Fisher’s exact test analyzed differences in gender. Simple logistic regression analyzed variables associated with the failure group. Significance was P ≤ .05.
Continue to: Results...
RESULTS
A total of 29 patients (24 males, 5 females) with 32 ASR hip replacements were included in this study. Indications for surgery comprised osteoarthritis (28 hips, 87.5%) and avascular necrosis of the hip (4 hips, 12.5%). Mean age and BMI were 55.2 years and 28.9 kg/m2, respectively. A total of 2 patients (6.9%) died of an unrelated cause (1 myocardial infarct, 1 suicide), and 1 patient was lost to follow-up (3.4%), leaving 26 patients with 28 hip replacements, all of whom finished a 5-year minimum follow-up.
No implant failures were noted in the first year. The 5-year revision rate reached 34.4% (10 patients with 11 hip replacements). Mean time to revision for this subgroup was 3.1 years. Overall, an implant failure was observed in 37.5% of patients (11 patients with 12 hip replacements) at a mean postoperative follow-up of 6.2 years (Figure 2). Indications for implant revision were pain in 11 (92.7%) cases and infection in 1 (8.3%).
Of the 11 hips revised due to pain, 9 were performed by the original surgeon (8 were completed with primary acetabular components, 1 with a revision shell). Figure 3 shows a bilateral revision performed with primary acetabular components and retained DePuy Synthes Pinnacle femoral stems. In all these cases except 1, the ASR component was grossly loose. One case presented with pseudotumor and impingement between the femoral prosthetic neck and acetabular component after migration of a loose component. After revision, the patient returned with substantial anterior hip pain and heterotopic ossification, and failed conservative treatment, requiring another surgery with prosthesis retention, removal of heterotopic ossification, and iliopsoas lengthening. The surgery successfully relieved the symptoms. No other patients required additional surgery after their revision. In comparison to the original ASR component, the revision shell was 2 to 4 mm larger in diameter. No patient required component revision at a mean of 2.9 years after the revision surgery.
The patient with secondary revision developed a hematogenous streptococcal infection after a dental procedure performed without prophylactic antibiotics. The patient was initially lost to follow-up after the primary surgery and reported no antecedent pain prior to the revision. A substantial metal fluid collection was identified in the hip at the time of débridement and without component loosening. After débridement, the patient developed persistent metal stained wound drainage, necessitating ultimate successful treatment with a 2-stage exchange procedure.
Age (P = .76), gender (P = .49), BMI (P = .29), acetabular component abduction angle (P = .12), and acetabulum size (P = .59) were not associated with an increased rate for hip failure (Table). Blood cobalt (7.6 vs 6.8 µg/L, P = .58) and chromium (5.0 vs 2.2 µg/L, P = .31) levels were not significantly higher in the revised group when compared with those of the unrevised group. The upper limits of blood cobalt and chromium levels reached 18.9 and 15.9 µg/L for the revised group and 16.8 and 5.4 µg/L for the non-revised group, respectively. In the revised group, a 91% decrease in cobalt and 78% decrease in chromium levels were observed at a mean of 6 months after the revision (Figure 4).
Table. Variables Not Associated with Early ASR Failure
|
| No Failure (n = 20) | Failure (n = 12) | P value |
Age (years) | 55.4 ± 6.4 | 54.7 ± 6.3 | .76 | |
BMI (kg/m2) | 29.7 ± 6.7 | 27.4 ± 4.0 | .29 | |
Gender | .49 | |||
Female | 3 (15%) | 3 (25%) | ||
Male | 17 (85%) | 9 (75%) | ||
Acetabulum size (mm) | 59.1 ± 3.9 | 58.3 ± 3.8 | .59 | |
Abduction angle (degrees) | 44.9 ± 4.5 | 42.3 ± 3.8 | .12 | |
Serum levels (µg/L) | ||||
Cobalt | 6.8 ± 6.0 | 7.6 ± 4.7 | .58 | |
| Chromium | 2.2 ± 1.7 | 5.0 ± 5.0 | .31 |
Continue to: Discussion...
DISCUSSION
According to the Center for Disease Control and Prevention, 310,800 total hip replacements were performed among inpatients aged 45 years and older in the US in 2010.7 Specifically, in the 55- to 64-year-old age group, the number of procedures performed tripled from 2000 through 2010. As younger and more active patients opt for hip replacements, a growing need for prosthesis with enhanced durability is observed.
Despite the early proposed advantages of large head MoM bearings, our retrospective study of the DePuy Synthes ASR™ XL Acetabular hip system yielded 15.6% and 34.4% failure rates at 3 and 5 years, respectively. These higher-than-expected rates of failure are consistent with published data. The British Hip Society reported a 21% to 35% revision rate at 4 years and 49% at 6 years for the ASR XL prosthesis.8 In comparison, other MoM prosthesis, on average, report a 12% to 15% rate of failure at 5 years.
Considerable controversy surrounds the causes of adverse wear failure in MoM bearings.9,10 The non-modular design of the ASR prostheses is frequently implicated as a cause of early failure. The lack of a central hole in the 1-piece component compromises the tactile feel of insertion, thereby reducing the surgeon’s ability to assess complete seating.11 This condition may potentially increase the abduction angle at the time of insertion. Screw fixation of the non-modular device is not possible. The ASR XL device (148° to 160°) is less than a hemisphere (180°) in size and hence features a diminished functional articular surface, further compromising implant fixation.11 The functional articular surface is defined as the optimal surface area (10 mm) needed for a MoM implant.12 Griffin and colleagues13 reported a 48 mm ASR XL component, when implanted at 45° of abduction, to function similar to an implant at 59° of abduction, leading to diminished lubrication, metallosis, and edge loading. The version of the acetabular component may similarly and adversely affect implant wear characteristics. Furthermore, the variable thickness of the implant, which is thicker at the dome and thinner at the rim, may further promote edge loading by shifting the center of rotation of the femoral head out from the center of the acetabular prosthesis.11 Studies have also shown that increased wear of the MoM articulation is associated with an acetabular component inclination angle in excess of 55°10,14 and a failure of fixation at time of implantation.15 This study, however, found no correlation between the abduction angle and risk of early implant failure for the ASR acetabular component. No correlation was also detected between the acetabulum size and revision surgery.
The AOANJRR reported loosening (44%), infection (20%), metal sensitivity (12%), fracture (9%), and dislocation of prosthesis (7%) as the indications for revision surgery for the ASR prosthesis.6 Furthermore, a single-center retrospective review of 70 consecutive MoM THAs with ultra-large diameter femoral head and monoblock acetabular components showed that 17.1% required revision within 3 years for loosening, pain, and squeaking.1 Overall, 28.6% of patients reported implant dysfunction. In this study, we observed a similar rate of failure at 3 years (15.6%) for pain (11) and infection (1). The revision surgery successfully relieved all of these symptoms. One patient presented with heterotopic ossification and anterior hip pain after the original revision and required additional surgery with prosthesis retention. No patient in this series required repeat component revisions at a mean of 2.9 years after surgery. In all but 1 case, primary acetabular components were used in the revision, and in all cases except that with infection, the femoral component was retained. Replacement shells were 2 to 4 mm larger in diameter than the original ASR component.
Recently, concerns have arisen regarding the long-term effects of serum cobalt and chromium metal ions levels. Studies have shown increased serum metal ion levels,15 groin pain,16 pseudotumor formation,17 and metallosis18 after the implantation of MoM bearings. In a case study by Mao and colleagues,19 1 patient reported headaches, anorexia, continuous metallic taste in her mouth, and weight loss. A cerebrospinal fluid analysis revealed cobalt and chromium levels at 9 and 13 nmol/L, respectively, indicating that these metal ions can cross the blood-brain barrier. Another patient reported painful muscle fatigue, night cramps, fainting spells, cognitive decline, and an inability to climb stairs. His serum cobalt level reached 258 nmol/L (reference range, 0-20 nmol/L), and chromium level totaled 88 nmol/L (reference range, 0-100 nmol/L). At 8-week follow-up after revision surgery, the symptoms of the patient had resolved, with serum cobalt levels dropping to 42 nmol/L.19 None of the patients in this study presented with any signs or symptoms of metal toxicity. The upper limits of blood cobalt and chromium levels in our study population reached 18.9 and 15.9 µg/L for the revised group and 16.8 and 5.4 µg/L for the non-revised group, respectively. However, we noted a similar drop in post-revision blood cobalt (91% decrease) and chromium (78% decrease) levels.
In summary, our data showed a high revision rate of the DePuy Synthes ASR™ XL Acetabular hip system. Our findings are consistent with internationally published data. In the absence of reliable predictors of early failure, continued close clinical surveillance and laboratory monitoring of these patients are warranted.
CONCLUSION
This study demonstrates the high failure rate of the DePuy Synthes ASR™ XL Acetabular hip system used in THA at a minimum of 5 years of follow-up. No variable that was predictive of failure could be identified in this series. Close clinical surveillance of these patients is therefore required. Metal levels dropped quickly after revision, and the revision surgery can generally be performed with slightly larger primary components. Symptomatic patients with ASR hip replacements, regardless of blood metal-ion levels, were candidates for the revision surgery. Not all failed hips exhibited substantially elevated metal levels. Asymptomatic patients with high blood metal-ion levels should be closely followed-up and revision surgery should be strongly considered, consistent with recently published guidelines.20
- Bernthal NM, Celestre PC, Stavrakis AI, Ludington JC, Oakes DA. Disappointing short-term results with the DePuy ASR XL metal-on-metal total hip arthroplasty. J Arthroplasty. 2012;27(4):539. doi:10.1016/j.arth.2011.08.022.
- de Steiger RN, Hang JR, Miller LN, Graves SE, Davidson DC. Five-year results of the ASR XL acetabular system and the ASR hip resurfacing system: An analysis from the Australian Orthopaedic Association National Joint Replacement Registry. J Bone Joint Surg Am. 2011;93(24):2287. doi:10.2106/JBJS.J.01727.
- Langton DJ, Jameson SS, Joyce TJ, Hallab NJ, Natu S, Nargol AV. Early failure of metal-on-metal bearings in hip resurfacing and large-diameter total hip replacement: a consequence of excess wear. J Bone Joint Surg Br. 2010;92(1):38-46. doi:10.1302/0301-620X.92B1.22770.
- Siebel T, Maubach S, Morlock MM. Lessons learned from early clinical experience and results of 300 ASR hip resurfacing implantations. Proc Inst Mech Eng H. 2006;220(2):345-353. doi:10.1243/095441105X69079.
- Jameson SS, Langton DJ, Nargol AV. Articular surface replacement of the hip: a prospective single-surgeon series. J Bone Joint Surg Br. 2010;92(1):28-37. doi:10.1302/0301-620X.92B1.22769.
- Australian Orthopaedic Association National Joint Replacement Registry annual report 2010. Australian Orthopaedic Association Web site. https://aoanjrr.sahmri.com/annual-reports-2010. Accessed June 19, 2018.
- Wolford ML, Palso K, Bercovitz A. Hospitalization for total hip replacement among inpatients aged 45 and over: United States, 2000-2010. Centers for Disease Control and Prevention Web site. http://www.cdc.gov/nchs/data/databriefs/db186.pdf. Accessed July 13, 2015.
- Hodgkinson J, Skinner J, Kay P. Large diameter metal on metal bearing total hip replacements. British Hip Society Web site. https://www.britishhipsociety.com/uploaded/BHS_MOM_THR.pdf. Accessed August 6, 2015.
- Hart AJ, Ilo K, Underwood R, et al. The relationship between the angle of version and rate of wear of retrieved metal-on-metal resurfacings: a prospective, CT-based study. J Bone Joint Surg Br. 2011;93(3):315-320. doi:10.1302/0301-620X.93B3.25545.
- Langton DJ, Joyce TJ, Jameson SS, et al. Adverse reaction to metal debris following hip resurfacing: the influence of component type, orientation and volumetric wear. J Bone Joint Surg Br. 2011;93(2):164-171. doi:10.1302/0301-620X.93B2.25099.
- Steele GD, Fehring TK, Odum SM, Dennos AC, Nadaud MC. Early failure of articular surface replacement XL total hip arthroplasty. J Arthroplasty. 2011;26(6):14-18. doi:10.1016/j.arth.2011.03.027.
- De Haan R, Campbell PA, Su EP, De Smet KA. Revision of metal-on-metal resurfacing arthroplasty of the hip: the influence of malpositioning of the components. J Bone Joint Surg Br. 2008;90(9):1158-1163. doi:10.1302/0301-620X.90B9.19891.
- Griffin WL, Nanson CJ, Springer BD, Davies MA, Fehring TK. Reduced articular surface of one-piece cups: a cause of runaway wear and early failure. Clin Orthop Relat Res. 2010;468(9):2328-2332. doi:10.1007/s11999-010-1383-8.
- Grammatopolous G, Pandit H, Glyn-Jones S, et al. Optimal acetablular orientation for hip resurfacing. J Bone Joint Surg Br. 2010;92(8):1072-1078. doi:10.1302/0301-620X.92B8.24194.
- MacDonalad SJ, McCalden RW, Chess DG, et al. Meta-onmetal versus polyethylene in hip arthoplasty: a randomized clinical trial. Clin Orthop Relat Res. 2003;(406):282-296.
- Bin Nasser A, Beaule PE, O'Neill M, Kim PR, Fazekas A. Incidence of groin pain after metal-on-metal hip resurfacing. Clin Orthop Relat Res. 2010;468(2):392-399. doi:10.1007/s11999-009-1133-y.
- Mahendra G, Pandit H, Kliskey K, Murray D, Gill HS, Athanasou N. Necrotic and inflammatory changes in metal-on-metal resurfacing hip arthroplasties. Acta Orthop. 2009;80(6):653-659. doi:10.3109/17453670903473016.
- Neumann DRP, Thaler C, Hitzl W, Huber M, Hofstädter T, Dorn U. Long term results of a contemporary metal-on-metal total hip arthroplasty. J Arthroplasty. 2010;25(5):700-708. doi:10.1016/j.arth.2009.05.018.
- Mao X, Wong AA, Crawford RW. Cobalt toxicity--an emerging clinical problem in patients with metal-on-metal hip prostheses? Med J Aust. 2011;194(12):649-651.
- Information statement: current concerns with metal-on-metal hip arthroplasty. American Academy of Orthopaedic Surgeons Web site. https://aaos.org/uploadedFiles/PreProduction/About/Opinion_Statements/advistmt/1035%20Current%20Concerns%20with%20Metal-on-Metal%20Hip%20Arthroplasty.pdf. Accessed June 19, 2018.
- Bernthal NM, Celestre PC, Stavrakis AI, Ludington JC, Oakes DA. Disappointing short-term results with the DePuy ASR XL metal-on-metal total hip arthroplasty. J Arthroplasty. 2012;27(4):539. doi:10.1016/j.arth.2011.08.022.
- de Steiger RN, Hang JR, Miller LN, Graves SE, Davidson DC. Five-year results of the ASR XL acetabular system and the ASR hip resurfacing system: An analysis from the Australian Orthopaedic Association National Joint Replacement Registry. J Bone Joint Surg Am. 2011;93(24):2287. doi:10.2106/JBJS.J.01727.
- Langton DJ, Jameson SS, Joyce TJ, Hallab NJ, Natu S, Nargol AV. Early failure of metal-on-metal bearings in hip resurfacing and large-diameter total hip replacement: a consequence of excess wear. J Bone Joint Surg Br. 2010;92(1):38-46. doi:10.1302/0301-620X.92B1.22770.
- Siebel T, Maubach S, Morlock MM. Lessons learned from early clinical experience and results of 300 ASR hip resurfacing implantations. Proc Inst Mech Eng H. 2006;220(2):345-353. doi:10.1243/095441105X69079.
- Jameson SS, Langton DJ, Nargol AV. Articular surface replacement of the hip: a prospective single-surgeon series. J Bone Joint Surg Br. 2010;92(1):28-37. doi:10.1302/0301-620X.92B1.22769.
- Australian Orthopaedic Association National Joint Replacement Registry annual report 2010. Australian Orthopaedic Association Web site. https://aoanjrr.sahmri.com/annual-reports-2010. Accessed June 19, 2018.
- Wolford ML, Palso K, Bercovitz A. Hospitalization for total hip replacement among inpatients aged 45 and over: United States, 2000-2010. Centers for Disease Control and Prevention Web site. http://www.cdc.gov/nchs/data/databriefs/db186.pdf. Accessed July 13, 2015.
- Hodgkinson J, Skinner J, Kay P. Large diameter metal on metal bearing total hip replacements. British Hip Society Web site. https://www.britishhipsociety.com/uploaded/BHS_MOM_THR.pdf. Accessed August 6, 2015.
- Hart AJ, Ilo K, Underwood R, et al. The relationship between the angle of version and rate of wear of retrieved metal-on-metal resurfacings: a prospective, CT-based study. J Bone Joint Surg Br. 2011;93(3):315-320. doi:10.1302/0301-620X.93B3.25545.
- Langton DJ, Joyce TJ, Jameson SS, et al. Adverse reaction to metal debris following hip resurfacing: the influence of component type, orientation and volumetric wear. J Bone Joint Surg Br. 2011;93(2):164-171. doi:10.1302/0301-620X.93B2.25099.
- Steele GD, Fehring TK, Odum SM, Dennos AC, Nadaud MC. Early failure of articular surface replacement XL total hip arthroplasty. J Arthroplasty. 2011;26(6):14-18. doi:10.1016/j.arth.2011.03.027.
- De Haan R, Campbell PA, Su EP, De Smet KA. Revision of metal-on-metal resurfacing arthroplasty of the hip: the influence of malpositioning of the components. J Bone Joint Surg Br. 2008;90(9):1158-1163. doi:10.1302/0301-620X.90B9.19891.
- Griffin WL, Nanson CJ, Springer BD, Davies MA, Fehring TK. Reduced articular surface of one-piece cups: a cause of runaway wear and early failure. Clin Orthop Relat Res. 2010;468(9):2328-2332. doi:10.1007/s11999-010-1383-8.
- Grammatopolous G, Pandit H, Glyn-Jones S, et al. Optimal acetablular orientation for hip resurfacing. J Bone Joint Surg Br. 2010;92(8):1072-1078. doi:10.1302/0301-620X.92B8.24194.
- MacDonalad SJ, McCalden RW, Chess DG, et al. Meta-onmetal versus polyethylene in hip arthoplasty: a randomized clinical trial. Clin Orthop Relat Res. 2003;(406):282-296.
- Bin Nasser A, Beaule PE, O'Neill M, Kim PR, Fazekas A. Incidence of groin pain after metal-on-metal hip resurfacing. Clin Orthop Relat Res. 2010;468(2):392-399. doi:10.1007/s11999-009-1133-y.
- Mahendra G, Pandit H, Kliskey K, Murray D, Gill HS, Athanasou N. Necrotic and inflammatory changes in metal-on-metal resurfacing hip arthroplasties. Acta Orthop. 2009;80(6):653-659. doi:10.3109/17453670903473016.
- Neumann DRP, Thaler C, Hitzl W, Huber M, Hofstädter T, Dorn U. Long term results of a contemporary metal-on-metal total hip arthroplasty. J Arthroplasty. 2010;25(5):700-708. doi:10.1016/j.arth.2009.05.018.
- Mao X, Wong AA, Crawford RW. Cobalt toxicity--an emerging clinical problem in patients with metal-on-metal hip prostheses? Med J Aust. 2011;194(12):649-651.
- Information statement: current concerns with metal-on-metal hip arthroplasty. American Academy of Orthopaedic Surgeons Web site. https://aaos.org/uploadedFiles/PreProduction/About/Opinion_Statements/advistmt/1035%20Current%20Concerns%20with%20Metal-on-Metal%20Hip%20Arthroplasty.pdf. Accessed June 19, 2018.
TAKE-HOME POINTS
- High rate of failure of DePuy Synthes ASR™ XL Acetabular hip system used in THA, approaching 34.4% at 5 years.
- Mean time to revision was 3.1 years with pain being the most common indication for revision surgery.
- Age, gender, acetabular component abduction angle, acetabular size, and serum cobalt or chromium levels were not associated with increased rate of failure.
- Serum cobalt and chromium levels decreased significantly within 6 months of revision surgery.
- Close clinical surveillance and laboratory monitoring of patients is required.