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Orthopedic ambulatory surgery centers beat inpatient services on cost

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NATIONAL HARBOR, MD. – Hospital outpatient departments (HOPDs) and ambulatory surgery centers (ASC) are cheaper settings for orthopedic surgery than inpatient venues (IPs) with similar levels of postoperative opioid use, according to a new study.

Fanta Waterman, PhD, director of medical and health sciences at Pacira Pharmaceuticals, and colleagues retrospectively published the results of their investigation in the Journal of Managed Care & Specialty Pharmacy supplement for the annual meeting of the Academy of Managed Care Pharmacy.

Investigators evaluated data from 126,172 commercially insured patients who underwent one of six orthopedic surgical procedures between April 2012 and December 2017. Using the Optum Research Database, they pooled data from patients who had received total knee arthroplasty (TKA), partial knee arthroplasty, total hip arthroplasty (THA), rotator cuff repair (RCR), total shoulder arthroplasty, and lumbar spine fusion.

More than half (51%) of the patients were male, and the patients averaged 58 years of age. Most patients who underwent any of the six surgical interventions had the procedures performed at IPs (68%), while 18% had their operations at HOPDs and 14% were perfomed at ASCs.

TKA, RCR, and THA were the most common procedures performed (32%, 27%, and 20%, respectively). While no fluctuation was observed in the total number of IP procedures performed during 2012-2017, researchers noted a marked increase in ASCs (58%) and HOPDs (15%).

At the 30-day mark, the total all-cause postsurgical costs associated with IPs ($44,566) were more than double that of HOPDs ($20,468) and ASCs ($19,110; P less than .001). Moreover, multivariate adjustment showed that postsurgical costs accrued 30 days after surgery for HOPDs and ASCs were 14% and 27% lower than IPs (P less than .001), respectively.

Additionally, each group exhibited similar evidence of opioid use in the 12-month period prior to undergoing surgery, ranging from 63% to 65%. Postsurgical opioid use among opioid-naive patients was the highest in the HOPD group at 96% prevalence, with IPs and ASCs trailing with 91% and 90% (P less than .001), respectively. However, the postsurgical prevalence of opioid use in patients who had used opioids before surgery was 95% for IPs and HOPDs and 82% for ASCs (P less than .001).

SOURCE: Waterman F et al. AMCP NEXUS 2019, Abstract U12.

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NATIONAL HARBOR, MD. – Hospital outpatient departments (HOPDs) and ambulatory surgery centers (ASC) are cheaper settings for orthopedic surgery than inpatient venues (IPs) with similar levels of postoperative opioid use, according to a new study.

Fanta Waterman, PhD, director of medical and health sciences at Pacira Pharmaceuticals, and colleagues retrospectively published the results of their investigation in the Journal of Managed Care & Specialty Pharmacy supplement for the annual meeting of the Academy of Managed Care Pharmacy.

Investigators evaluated data from 126,172 commercially insured patients who underwent one of six orthopedic surgical procedures between April 2012 and December 2017. Using the Optum Research Database, they pooled data from patients who had received total knee arthroplasty (TKA), partial knee arthroplasty, total hip arthroplasty (THA), rotator cuff repair (RCR), total shoulder arthroplasty, and lumbar spine fusion.

More than half (51%) of the patients were male, and the patients averaged 58 years of age. Most patients who underwent any of the six surgical interventions had the procedures performed at IPs (68%), while 18% had their operations at HOPDs and 14% were perfomed at ASCs.

TKA, RCR, and THA were the most common procedures performed (32%, 27%, and 20%, respectively). While no fluctuation was observed in the total number of IP procedures performed during 2012-2017, researchers noted a marked increase in ASCs (58%) and HOPDs (15%).

At the 30-day mark, the total all-cause postsurgical costs associated with IPs ($44,566) were more than double that of HOPDs ($20,468) and ASCs ($19,110; P less than .001). Moreover, multivariate adjustment showed that postsurgical costs accrued 30 days after surgery for HOPDs and ASCs were 14% and 27% lower than IPs (P less than .001), respectively.

Additionally, each group exhibited similar evidence of opioid use in the 12-month period prior to undergoing surgery, ranging from 63% to 65%. Postsurgical opioid use among opioid-naive patients was the highest in the HOPD group at 96% prevalence, with IPs and ASCs trailing with 91% and 90% (P less than .001), respectively. However, the postsurgical prevalence of opioid use in patients who had used opioids before surgery was 95% for IPs and HOPDs and 82% for ASCs (P less than .001).

SOURCE: Waterman F et al. AMCP NEXUS 2019, Abstract U12.

 

NATIONAL HARBOR, MD. – Hospital outpatient departments (HOPDs) and ambulatory surgery centers (ASC) are cheaper settings for orthopedic surgery than inpatient venues (IPs) with similar levels of postoperative opioid use, according to a new study.

Fanta Waterman, PhD, director of medical and health sciences at Pacira Pharmaceuticals, and colleagues retrospectively published the results of their investigation in the Journal of Managed Care & Specialty Pharmacy supplement for the annual meeting of the Academy of Managed Care Pharmacy.

Investigators evaluated data from 126,172 commercially insured patients who underwent one of six orthopedic surgical procedures between April 2012 and December 2017. Using the Optum Research Database, they pooled data from patients who had received total knee arthroplasty (TKA), partial knee arthroplasty, total hip arthroplasty (THA), rotator cuff repair (RCR), total shoulder arthroplasty, and lumbar spine fusion.

More than half (51%) of the patients were male, and the patients averaged 58 years of age. Most patients who underwent any of the six surgical interventions had the procedures performed at IPs (68%), while 18% had their operations at HOPDs and 14% were perfomed at ASCs.

TKA, RCR, and THA were the most common procedures performed (32%, 27%, and 20%, respectively). While no fluctuation was observed in the total number of IP procedures performed during 2012-2017, researchers noted a marked increase in ASCs (58%) and HOPDs (15%).

At the 30-day mark, the total all-cause postsurgical costs associated with IPs ($44,566) were more than double that of HOPDs ($20,468) and ASCs ($19,110; P less than .001). Moreover, multivariate adjustment showed that postsurgical costs accrued 30 days after surgery for HOPDs and ASCs were 14% and 27% lower than IPs (P less than .001), respectively.

Additionally, each group exhibited similar evidence of opioid use in the 12-month period prior to undergoing surgery, ranging from 63% to 65%. Postsurgical opioid use among opioid-naive patients was the highest in the HOPD group at 96% prevalence, with IPs and ASCs trailing with 91% and 90% (P less than .001), respectively. However, the postsurgical prevalence of opioid use in patients who had used opioids before surgery was 95% for IPs and HOPDs and 82% for ASCs (P less than .001).

SOURCE: Waterman F et al. AMCP NEXUS 2019, Abstract U12.

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Two regenerative techniques prove comparable for repairing knee cartilage

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When it comes to repairing knee cartilage, a new study found no significant differences between autologous matrix-induced chondrogenesis (AMIC) and autologous chondrocyte implantation with a collagen membrane (ACI-C) as treatment options.

“If the conclusion of the present study stands and is confirmed by further clinical trials, AMIC could be considered an equal alternative to techniques based on chondrocyte transplantation for treatment of cartilage defects of the knee,” wrote Vegard Fossum, MD, of University Hospital of North Norway, Tromsø, and coauthors, adding that cost and comparative ease might actually make AMIC the preferred choice. The study was published in the Orthopaedic Journal of Sports Medicine.

To evaluate outcomes of the two procedures, the researchers initiated a clinical trial of 41 patients with at least one chondral or osteochondral defect of the distal femur or patella. They were split into two groups: those treated with ACI-C (n = 21) and those treated with AMIC (n = 20). At 1- and 2-year follow-up, patients were assessed via improvements in Knee Injury and Osteoarthritis Outcome Score (KOOS), compared with baseline, along with Lysholm and visual analog scale (VAS) pain scores.

After 1 and 2 years, both groups saw improvements from baseline. At 2 years, the AMIC group had an 18.1 change in KOOS, compared with 10.3 in the ACI-C group (P = .17). Two-year improvements on the Lysholm score (19.7 in AMIC, compared with 17.0 in ACI-C, P = .66) and VAS pain score (30.6 in AMIC versus 19.6 in ACI-C, P = .19) were not significantly different. Two patients in the AMIC group had undergone total knee replacement after 2 years, compared with zero in the ACI-C group.

The authors noted their study’s potential limitations, including the small number of patients in each group – the initial plan was to include 80 total – and its broad inclusion criteria. However, since the aim was to compare treatment results and not evaluate effectiveness, they did not consider the broad criteria “a major limitation.”

The authors reported no conflicts of interest.

SOURCE: Fossum V et al. Orthop J Sports Med. 2019 Sept 17. doi: 10.1177/2325967119868212.

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When it comes to repairing knee cartilage, a new study found no significant differences between autologous matrix-induced chondrogenesis (AMIC) and autologous chondrocyte implantation with a collagen membrane (ACI-C) as treatment options.

“If the conclusion of the present study stands and is confirmed by further clinical trials, AMIC could be considered an equal alternative to techniques based on chondrocyte transplantation for treatment of cartilage defects of the knee,” wrote Vegard Fossum, MD, of University Hospital of North Norway, Tromsø, and coauthors, adding that cost and comparative ease might actually make AMIC the preferred choice. The study was published in the Orthopaedic Journal of Sports Medicine.

To evaluate outcomes of the two procedures, the researchers initiated a clinical trial of 41 patients with at least one chondral or osteochondral defect of the distal femur or patella. They were split into two groups: those treated with ACI-C (n = 21) and those treated with AMIC (n = 20). At 1- and 2-year follow-up, patients were assessed via improvements in Knee Injury and Osteoarthritis Outcome Score (KOOS), compared with baseline, along with Lysholm and visual analog scale (VAS) pain scores.

After 1 and 2 years, both groups saw improvements from baseline. At 2 years, the AMIC group had an 18.1 change in KOOS, compared with 10.3 in the ACI-C group (P = .17). Two-year improvements on the Lysholm score (19.7 in AMIC, compared with 17.0 in ACI-C, P = .66) and VAS pain score (30.6 in AMIC versus 19.6 in ACI-C, P = .19) were not significantly different. Two patients in the AMIC group had undergone total knee replacement after 2 years, compared with zero in the ACI-C group.

The authors noted their study’s potential limitations, including the small number of patients in each group – the initial plan was to include 80 total – and its broad inclusion criteria. However, since the aim was to compare treatment results and not evaluate effectiveness, they did not consider the broad criteria “a major limitation.”

The authors reported no conflicts of interest.

SOURCE: Fossum V et al. Orthop J Sports Med. 2019 Sept 17. doi: 10.1177/2325967119868212.

When it comes to repairing knee cartilage, a new study found no significant differences between autologous matrix-induced chondrogenesis (AMIC) and autologous chondrocyte implantation with a collagen membrane (ACI-C) as treatment options.

“If the conclusion of the present study stands and is confirmed by further clinical trials, AMIC could be considered an equal alternative to techniques based on chondrocyte transplantation for treatment of cartilage defects of the knee,” wrote Vegard Fossum, MD, of University Hospital of North Norway, Tromsø, and coauthors, adding that cost and comparative ease might actually make AMIC the preferred choice. The study was published in the Orthopaedic Journal of Sports Medicine.

To evaluate outcomes of the two procedures, the researchers initiated a clinical trial of 41 patients with at least one chondral or osteochondral defect of the distal femur or patella. They were split into two groups: those treated with ACI-C (n = 21) and those treated with AMIC (n = 20). At 1- and 2-year follow-up, patients were assessed via improvements in Knee Injury and Osteoarthritis Outcome Score (KOOS), compared with baseline, along with Lysholm and visual analog scale (VAS) pain scores.

After 1 and 2 years, both groups saw improvements from baseline. At 2 years, the AMIC group had an 18.1 change in KOOS, compared with 10.3 in the ACI-C group (P = .17). Two-year improvements on the Lysholm score (19.7 in AMIC, compared with 17.0 in ACI-C, P = .66) and VAS pain score (30.6 in AMIC versus 19.6 in ACI-C, P = .19) were not significantly different. Two patients in the AMIC group had undergone total knee replacement after 2 years, compared with zero in the ACI-C group.

The authors noted their study’s potential limitations, including the small number of patients in each group – the initial plan was to include 80 total – and its broad inclusion criteria. However, since the aim was to compare treatment results and not evaluate effectiveness, they did not consider the broad criteria “a major limitation.”

The authors reported no conflicts of interest.

SOURCE: Fossum V et al. Orthop J Sports Med. 2019 Sept 17. doi: 10.1177/2325967119868212.

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FROM THE ORTHOPAEDIC JOURNAL OF SPORTS MEDICINE

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Diagnosis Is an Open Book

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Radiograph of openbook pelvic fracture

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There is evidence of significant widening of the pubic symphysis. This injury results in a disruption of the normal pelvic ring. Such fractures are typically referred to as open-book pelvic fractures. Usually the result of high-energy trauma, they can also be associated with bladder and/or vascular injuries.

Orthopedics was consulted for management of this injury. Prompt stabilization with an external binder may help reduce complications. The patient will ultimately require some form of external or internal fixation.

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Nandan R. Hichkad, PA-C, MMSc, practices at the Georgia Neurosurgical Institute in Macon and is a clinical instructor at the Mercer University School of Medicine, Macon.

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Nandan R. Hichkad, PA-C, MMSc, practices at the Georgia Neurosurgical Institute in Macon and is a clinical instructor at the Mercer University School of Medicine, Macon.

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Nandan R. Hichkad, PA-C, MMSc, practices at the Georgia Neurosurgical Institute in Macon and is a clinical instructor at the Mercer University School of Medicine, Macon.

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Radiograph of openbook pelvic fracture

ANSWER

There is evidence of significant widening of the pubic symphysis. This injury results in a disruption of the normal pelvic ring. Such fractures are typically referred to as open-book pelvic fractures. Usually the result of high-energy trauma, they can also be associated with bladder and/or vascular injuries.

Orthopedics was consulted for management of this injury. Prompt stabilization with an external binder may help reduce complications. The patient will ultimately require some form of external or internal fixation.

Radiograph of openbook pelvic fracture

ANSWER

There is evidence of significant widening of the pubic symphysis. This injury results in a disruption of the normal pelvic ring. Such fractures are typically referred to as open-book pelvic fractures. Usually the result of high-energy trauma, they can also be associated with bladder and/or vascular injuries.

Orthopedics was consulted for management of this injury. Prompt stabilization with an external binder may help reduce complications. The patient will ultimately require some form of external or internal fixation.

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Pelvis radiograph

A 50-year-old woman is airlifted to your facility from the scene of an accident. She was riding a motorcycle that was struck by a car at a presumed high rate of speed. There was reportedly a brief loss of consciousness, although when the first responders arrived, the patient was complaining of pain in both her hands and wrists, as well as severe hip pain.

The patient was hemodynamically stable during transport. Blood pressure on arrival is 130/78 mm Hg, with a heart rate of 90 beats/min. Her O2 saturation is 97% with supplemental oxygen administered by nasal cannula.

As you begin your primary survey, the patient responds appropriately to you: She tells you her name and where she is from. Her medical history is significant for migraines, and her surgical history is significant for a prior cholecystectomy and tubal ligation. Primary exam overall appears normal, except for obvious deformities in both wrists.

As you begin your secondary survey, the radiology technicians obtain portable chest and pelvis radiographs (latter shown). What is your impression?

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Tranexamic acid does not increase complications in high-risk joint replacement surgery patients

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A study has found that administering tranexamic acid (TXA) to high-risk patients undergoing total joint arthroplasty (TJA) does not increase their odds of adverse outcomes.

“The inclusion of high-risk patients in our study increases the generalizability of our findings and is consistent with the previous studies that showed no increase in complications when TXA is administered to TJA patients,” wrote Steven B. Porter, MD, of the Mayo Clinic in Jacksonville, Fla., and coauthors. The study was published in the Journal of Arthroplasty.

To determine the safety of TXA in patients at risk for thrombotic complications, the researchers investigated 38,220 patients who underwent total knee or total hip arthroplasty between 2011 and 2017 at the Mayo Clinic. Of those patients, 20,501 (54%) patients received TXA during their operation and 17,719 (46%) did not. Overall, 8,877 were classified as “high-risk” cases, which meant they had one or more cardiovascular disease or thromboembolic event before surgery.

After multivariable analysis, high risk-patients who received TXA had no significant difference in adverse outcome odds, compared with high-risk patients who did not receive TXA (odds ratio, 1.00; 95% confidence interval, 0.85-1.18). After 90 days, high-risk patients who did not receive TXA were more likely than those who received TXA to experience deep vein thrombosis (2.3% vs 0.8%, P less than .001), pulmonary embolism (1.7% vs 1.0%, P less than .001), cerebrovascular accident (0.8% vs. 0.4%, P less than .001), or death (0.5% vs. 0.4%, P less than .001).

The authors noted their study’s limitations, including a higher baseline incidence of risk factors in high-risk patients who did not receive TXA, compared with high-risk patients who did, which could have led to that group being “self-selected” to not receive TXA. In addition, all medical histories and rates of complications were based on ICD codes, which may have been inaccurate and therefore led to mischaracterized risk or miscoded postoperative complications.

The study was funded by the Mayo Clinic’s Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. No conflicts of interest were reported.

SOURCE: Porter SB et al. J Arthroplasty. 2019 Aug 17. doi: 10.1016/j.arth.2019.08.015.

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A study has found that administering tranexamic acid (TXA) to high-risk patients undergoing total joint arthroplasty (TJA) does not increase their odds of adverse outcomes.

“The inclusion of high-risk patients in our study increases the generalizability of our findings and is consistent with the previous studies that showed no increase in complications when TXA is administered to TJA patients,” wrote Steven B. Porter, MD, of the Mayo Clinic in Jacksonville, Fla., and coauthors. The study was published in the Journal of Arthroplasty.

To determine the safety of TXA in patients at risk for thrombotic complications, the researchers investigated 38,220 patients who underwent total knee or total hip arthroplasty between 2011 and 2017 at the Mayo Clinic. Of those patients, 20,501 (54%) patients received TXA during their operation and 17,719 (46%) did not. Overall, 8,877 were classified as “high-risk” cases, which meant they had one or more cardiovascular disease or thromboembolic event before surgery.

After multivariable analysis, high risk-patients who received TXA had no significant difference in adverse outcome odds, compared with high-risk patients who did not receive TXA (odds ratio, 1.00; 95% confidence interval, 0.85-1.18). After 90 days, high-risk patients who did not receive TXA were more likely than those who received TXA to experience deep vein thrombosis (2.3% vs 0.8%, P less than .001), pulmonary embolism (1.7% vs 1.0%, P less than .001), cerebrovascular accident (0.8% vs. 0.4%, P less than .001), or death (0.5% vs. 0.4%, P less than .001).

The authors noted their study’s limitations, including a higher baseline incidence of risk factors in high-risk patients who did not receive TXA, compared with high-risk patients who did, which could have led to that group being “self-selected” to not receive TXA. In addition, all medical histories and rates of complications were based on ICD codes, which may have been inaccurate and therefore led to mischaracterized risk or miscoded postoperative complications.

The study was funded by the Mayo Clinic’s Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. No conflicts of interest were reported.

SOURCE: Porter SB et al. J Arthroplasty. 2019 Aug 17. doi: 10.1016/j.arth.2019.08.015.

 

A study has found that administering tranexamic acid (TXA) to high-risk patients undergoing total joint arthroplasty (TJA) does not increase their odds of adverse outcomes.

“The inclusion of high-risk patients in our study increases the generalizability of our findings and is consistent with the previous studies that showed no increase in complications when TXA is administered to TJA patients,” wrote Steven B. Porter, MD, of the Mayo Clinic in Jacksonville, Fla., and coauthors. The study was published in the Journal of Arthroplasty.

To determine the safety of TXA in patients at risk for thrombotic complications, the researchers investigated 38,220 patients who underwent total knee or total hip arthroplasty between 2011 and 2017 at the Mayo Clinic. Of those patients, 20,501 (54%) patients received TXA during their operation and 17,719 (46%) did not. Overall, 8,877 were classified as “high-risk” cases, which meant they had one or more cardiovascular disease or thromboembolic event before surgery.

After multivariable analysis, high risk-patients who received TXA had no significant difference in adverse outcome odds, compared with high-risk patients who did not receive TXA (odds ratio, 1.00; 95% confidence interval, 0.85-1.18). After 90 days, high-risk patients who did not receive TXA were more likely than those who received TXA to experience deep vein thrombosis (2.3% vs 0.8%, P less than .001), pulmonary embolism (1.7% vs 1.0%, P less than .001), cerebrovascular accident (0.8% vs. 0.4%, P less than .001), or death (0.5% vs. 0.4%, P less than .001).

The authors noted their study’s limitations, including a higher baseline incidence of risk factors in high-risk patients who did not receive TXA, compared with high-risk patients who did, which could have led to that group being “self-selected” to not receive TXA. In addition, all medical histories and rates of complications were based on ICD codes, which may have been inaccurate and therefore led to mischaracterized risk or miscoded postoperative complications.

The study was funded by the Mayo Clinic’s Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. No conflicts of interest were reported.

SOURCE: Porter SB et al. J Arthroplasty. 2019 Aug 17. doi: 10.1016/j.arth.2019.08.015.

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Key clinical point: Administering tranexamic acid to high-risk patients undergoing joint replacement surgery does not increase the odds of adverse outcomes.

Major finding: After multivariable analysis, high-risk patients who received tranexamic acid had no significant difference in adverse outcome odds, compared with high-risk patients who did not receive tranexamic acid (odd ratio, 1.00; 95% confidence interval, 0.85-1.18).

Study details: A retrospective case-control study of 38,220 patients who underwent primary total knee or total hip arthroplasty between 2011 and 2017.

Disclosures: The study was funded by the Mayo Clinic’s Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. No conflicts of interest were reported.

Source: Porter SB et al. J Arthroplasty. 2019 Aug 17. doi: 10.1016/j.arth.2019.08.015.

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Delaying revision knee replacement increases the odds of infection

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According to a study on patients undergoing revision knee replacement, a delay of more than 24 hours between hospital admission and total knee arthroplasty (TKA) for periprosthetic fracture (PPF) led to increased odds of complications such as surgical site and urinary tract infections.

gorodenkoff/iStock/Getty Images

“Although this association is an important finding, the confounding factors that cause delay to surgery must be elucidated in non-database studies,” wrote Venkat Boddapati, MD, of Columbia University Medical Center, New York, and coauthors. The study was published in Arthroplasty Today.

To assess the best time for revision TKA after PPF of the knee, the researchers analyzed data from 484 patients who underwent another TKA from 2005 to 2016. Of those patients, 377 (78%) had expedited surgery – defined as less than or equal to 24 hours from hospital admission – and 107 (22%) had non-expedited surgery. Non-expedited patients averaged 3.2 days from admission to surgery.

After multivariate analysis, non-expedited patients had more complications overall, compared with expedited patients (odds ratio 2.35, P = .037). They also had comparative increases in surgical site infections (OR 12.87, P = .029), urinary tract infections (OR 10.46, P = .048), non-home discharge (OR 4.27, P less than .001), and blood transfusions (OR 4.53, P less than .001). The two groups saw no statistical difference in mortality.

The authors noted their study’s limitations, including an inability to assess complications beyond 30 days after surgery, which may affect tracking longer-term outcomes such as mortality. In addition, they were only able to classify surgery as expedited or non-expedited based on when the patient was admitted to the hospital, not the time since their injury. Finally, they lacked “relevant variables that may have contributed to this analysis,” including the type of fracture and the revision implants used.

Three authors reported being paid consultants for, and receiving research support from, several medical companies. The others reported no conflicts of interest.

SOURCE: Boddapati V et al. Arthroplast Today. 2019 Sep 1. doi: 10.1016/j.artd.2019.05.002.

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According to a study on patients undergoing revision knee replacement, a delay of more than 24 hours between hospital admission and total knee arthroplasty (TKA) for periprosthetic fracture (PPF) led to increased odds of complications such as surgical site and urinary tract infections.

gorodenkoff/iStock/Getty Images

“Although this association is an important finding, the confounding factors that cause delay to surgery must be elucidated in non-database studies,” wrote Venkat Boddapati, MD, of Columbia University Medical Center, New York, and coauthors. The study was published in Arthroplasty Today.

To assess the best time for revision TKA after PPF of the knee, the researchers analyzed data from 484 patients who underwent another TKA from 2005 to 2016. Of those patients, 377 (78%) had expedited surgery – defined as less than or equal to 24 hours from hospital admission – and 107 (22%) had non-expedited surgery. Non-expedited patients averaged 3.2 days from admission to surgery.

After multivariate analysis, non-expedited patients had more complications overall, compared with expedited patients (odds ratio 2.35, P = .037). They also had comparative increases in surgical site infections (OR 12.87, P = .029), urinary tract infections (OR 10.46, P = .048), non-home discharge (OR 4.27, P less than .001), and blood transfusions (OR 4.53, P less than .001). The two groups saw no statistical difference in mortality.

The authors noted their study’s limitations, including an inability to assess complications beyond 30 days after surgery, which may affect tracking longer-term outcomes such as mortality. In addition, they were only able to classify surgery as expedited or non-expedited based on when the patient was admitted to the hospital, not the time since their injury. Finally, they lacked “relevant variables that may have contributed to this analysis,” including the type of fracture and the revision implants used.

Three authors reported being paid consultants for, and receiving research support from, several medical companies. The others reported no conflicts of interest.

SOURCE: Boddapati V et al. Arthroplast Today. 2019 Sep 1. doi: 10.1016/j.artd.2019.05.002.

 

According to a study on patients undergoing revision knee replacement, a delay of more than 24 hours between hospital admission and total knee arthroplasty (TKA) for periprosthetic fracture (PPF) led to increased odds of complications such as surgical site and urinary tract infections.

gorodenkoff/iStock/Getty Images

“Although this association is an important finding, the confounding factors that cause delay to surgery must be elucidated in non-database studies,” wrote Venkat Boddapati, MD, of Columbia University Medical Center, New York, and coauthors. The study was published in Arthroplasty Today.

To assess the best time for revision TKA after PPF of the knee, the researchers analyzed data from 484 patients who underwent another TKA from 2005 to 2016. Of those patients, 377 (78%) had expedited surgery – defined as less than or equal to 24 hours from hospital admission – and 107 (22%) had non-expedited surgery. Non-expedited patients averaged 3.2 days from admission to surgery.

After multivariate analysis, non-expedited patients had more complications overall, compared with expedited patients (odds ratio 2.35, P = .037). They also had comparative increases in surgical site infections (OR 12.87, P = .029), urinary tract infections (OR 10.46, P = .048), non-home discharge (OR 4.27, P less than .001), and blood transfusions (OR 4.53, P less than .001). The two groups saw no statistical difference in mortality.

The authors noted their study’s limitations, including an inability to assess complications beyond 30 days after surgery, which may affect tracking longer-term outcomes such as mortality. In addition, they were only able to classify surgery as expedited or non-expedited based on when the patient was admitted to the hospital, not the time since their injury. Finally, they lacked “relevant variables that may have contributed to this analysis,” including the type of fracture and the revision implants used.

Three authors reported being paid consultants for, and receiving research support from, several medical companies. The others reported no conflicts of interest.

SOURCE: Boddapati V et al. Arthroplast Today. 2019 Sep 1. doi: 10.1016/j.artd.2019.05.002.

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Radiograph of a man who was hit by a car

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Aside from the usual artifacts from placement on a backboard and from the presence of monitoring devices and wires, the radiograph shows a displaced fracture of the right clavicle. No other significant abnormalities are present.

The patient was ultimately diagnosed with multiple orthopedic injuries, and orthopedics was called to evaluate and manage accordingly.

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Radiograph of a man who was hit by a car

ANSWER

Aside from the usual artifacts from placement on a backboard and from the presence of monitoring devices and wires, the radiograph shows a displaced fracture of the right clavicle. No other significant abnormalities are present.

The patient was ultimately diagnosed with multiple orthopedic injuries, and orthopedics was called to evaluate and manage accordingly.

Radiograph of a man who was hit by a car

ANSWER

Aside from the usual artifacts from placement on a backboard and from the presence of monitoring devices and wires, the radiograph shows a displaced fracture of the right clavicle. No other significant abnormalities are present.

The patient was ultimately diagnosed with multiple orthopedic injuries, and orthopedics was called to evaluate and manage accordingly.

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Radiograph of a man who was hit by a car

A 25-year-old man is brought to your facility by EMS transport following an accident while riding a bicycle. Witnesses say he was hit by a car when he suddenly tried to cross a busy intersection. They also report that he was not wearing a helmet and that he was thrown off the bike, landing several feet away.

Initial survey reveals a male who is arousable but nonverbal, just moaning and groaning. There are obvious deformities in both lower extremities and the right upper extremity. The patient’s blood pressure is 100/50 mm Hg and his heart rate, 130 beats/min. Pulse oximetry shows his O2 saturation to be 95% with 100% oxygen via nonrebreather mask. His pupils are equal and reactive bilaterally. Heart and lungs sound clear. Abdomen is soft.

While you continue examining the patient and begin your secondary survey, a portable chest radiograph is obtained (shown). What is your impression?

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Be alert to deep SSI risk after knee surgery

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Deep surgical-site infections (SSIs) and septic arthritis are not uncommon after the surgeries for periarticular knee fractures, a meta-analysis of existing research found.

National Institute of Allergy and Infectious Diseases

According to an analysis of data on 11,432 patients who underwent surgery for periarticular knee fractures, 5.7% had deep postoperative SSIs. A smaller analysis of 1,567 patients found that 2.4% had septic arthritis. “Surgeons managing periarticular knee fractures should be vigilant when wounds are not pristine,” the investigators recommended.

The report, which appeared in JAMA Network Open, was led by premed student Grayson R. Norris of High Point (N.C.) University.

The researchers noted that there are widely variable statistics regarding SSI after surgery for periarticular knee fractures. A better understanding of the risk would help orthopedic surgeons, given the mortality risk and extra costs associated with postoperative deep SSIs.

For the analysis, the researchers reviewed 117 studies with 11,432 patients who had fractures in the tibial plateau (61% of studies), distal femur (14%), proximal tibia (11%), patella (9%), and multiple sites (6%). More than two-thirds of the studies were retrospective.

Overall, 5.7% of patients suffered deep SSIs, with the highest percentage in the proximal tibia group (6.4%).

A total of 20 studies examined septic arthritis and found that 2.4% of patients in those studies suffered from the condition. Of 182 cases of deep SSIs with bacterial culture results, methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-susceptible S. aureus were the most common bacteria.

“Considering that MRSA was the most common pathogen in our study and that this pathogen is increasing in prevalence, health care practitioners should revisit the use of specific and appropriate prophylactic antibiotics,” the researchers wrote. “Risk factors, such as open fractures, diabetes, smoking, and, most importantly, compartment syndrome, should alert the treating surgeon to an increased risk. Further work is needed to mitigate the association of these conditions with SSI risk in periarticular knee fractures.”

The researchers added that many of the studies in their analysis were of poor quality. “Authors in orthopedic traumatology should strive to conduct higher-quality research, such as randomized clinical trials and case-control or cohort studies,” they noted.

One author reported receiving grants from Zimmer Biomet and DePuy Synthes outside the submitted work. No other disclosures were reported. No study funding was reported.

SOURCE: Norris GR et al. JAMA Netw Open. 2019;2(8):e199951.

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Deep surgical-site infections (SSIs) and septic arthritis are not uncommon after the surgeries for periarticular knee fractures, a meta-analysis of existing research found.

National Institute of Allergy and Infectious Diseases

According to an analysis of data on 11,432 patients who underwent surgery for periarticular knee fractures, 5.7% had deep postoperative SSIs. A smaller analysis of 1,567 patients found that 2.4% had septic arthritis. “Surgeons managing periarticular knee fractures should be vigilant when wounds are not pristine,” the investigators recommended.

The report, which appeared in JAMA Network Open, was led by premed student Grayson R. Norris of High Point (N.C.) University.

The researchers noted that there are widely variable statistics regarding SSI after surgery for periarticular knee fractures. A better understanding of the risk would help orthopedic surgeons, given the mortality risk and extra costs associated with postoperative deep SSIs.

For the analysis, the researchers reviewed 117 studies with 11,432 patients who had fractures in the tibial plateau (61% of studies), distal femur (14%), proximal tibia (11%), patella (9%), and multiple sites (6%). More than two-thirds of the studies were retrospective.

Overall, 5.7% of patients suffered deep SSIs, with the highest percentage in the proximal tibia group (6.4%).

A total of 20 studies examined septic arthritis and found that 2.4% of patients in those studies suffered from the condition. Of 182 cases of deep SSIs with bacterial culture results, methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-susceptible S. aureus were the most common bacteria.

“Considering that MRSA was the most common pathogen in our study and that this pathogen is increasing in prevalence, health care practitioners should revisit the use of specific and appropriate prophylactic antibiotics,” the researchers wrote. “Risk factors, such as open fractures, diabetes, smoking, and, most importantly, compartment syndrome, should alert the treating surgeon to an increased risk. Further work is needed to mitigate the association of these conditions with SSI risk in periarticular knee fractures.”

The researchers added that many of the studies in their analysis were of poor quality. “Authors in orthopedic traumatology should strive to conduct higher-quality research, such as randomized clinical trials and case-control or cohort studies,” they noted.

One author reported receiving grants from Zimmer Biomet and DePuy Synthes outside the submitted work. No other disclosures were reported. No study funding was reported.

SOURCE: Norris GR et al. JAMA Netw Open. 2019;2(8):e199951.

 

Deep surgical-site infections (SSIs) and septic arthritis are not uncommon after the surgeries for periarticular knee fractures, a meta-analysis of existing research found.

National Institute of Allergy and Infectious Diseases

According to an analysis of data on 11,432 patients who underwent surgery for periarticular knee fractures, 5.7% had deep postoperative SSIs. A smaller analysis of 1,567 patients found that 2.4% had septic arthritis. “Surgeons managing periarticular knee fractures should be vigilant when wounds are not pristine,” the investigators recommended.

The report, which appeared in JAMA Network Open, was led by premed student Grayson R. Norris of High Point (N.C.) University.

The researchers noted that there are widely variable statistics regarding SSI after surgery for periarticular knee fractures. A better understanding of the risk would help orthopedic surgeons, given the mortality risk and extra costs associated with postoperative deep SSIs.

For the analysis, the researchers reviewed 117 studies with 11,432 patients who had fractures in the tibial plateau (61% of studies), distal femur (14%), proximal tibia (11%), patella (9%), and multiple sites (6%). More than two-thirds of the studies were retrospective.

Overall, 5.7% of patients suffered deep SSIs, with the highest percentage in the proximal tibia group (6.4%).

A total of 20 studies examined septic arthritis and found that 2.4% of patients in those studies suffered from the condition. Of 182 cases of deep SSIs with bacterial culture results, methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-susceptible S. aureus were the most common bacteria.

“Considering that MRSA was the most common pathogen in our study and that this pathogen is increasing in prevalence, health care practitioners should revisit the use of specific and appropriate prophylactic antibiotics,” the researchers wrote. “Risk factors, such as open fractures, diabetes, smoking, and, most importantly, compartment syndrome, should alert the treating surgeon to an increased risk. Further work is needed to mitigate the association of these conditions with SSI risk in periarticular knee fractures.”

The researchers added that many of the studies in their analysis were of poor quality. “Authors in orthopedic traumatology should strive to conduct higher-quality research, such as randomized clinical trials and case-control or cohort studies,” they noted.

One author reported receiving grants from Zimmer Biomet and DePuy Synthes outside the submitted work. No other disclosures were reported. No study funding was reported.

SOURCE: Norris GR et al. JAMA Netw Open. 2019;2(8):e199951.

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New Method Helps Restore Respiratory Muscle Function in Patients with Spinal Cord Injury

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A VA research collaboration finds a new way to improve quality of life and reduce major causes of morbidity and mortality in patients with spinal cord injury.

Many patients with spinal cord injury (SCI) need mechanical ventilatory support. One type of support is diaphragm pacing, which stimulates the diaphragm, helping the person breathe. A minimally invasive form of diaphragm pacing via laparoscopically placed intramuscular diaphragm electrodes has “liberated thousands of patients from mechanical ventilation,” says Anthony DiMarco, MD. He and VA colleague Krzysztof Kowalski, PhD, have found a way to completely restore respiratory muscle function in patients with SCI safely and effectively.

In mid-thoracic and higher level SCIs, the expiratory muscles are paralyzed, putting patients at risk for respiratory tract infections and atelectasis, a major cause of morbidity and mortality in that population. The research team, led by DiMarco and Kowalski, combined diaphragm pacing with a minimally invasive system that allows the patient—simply with the press of a button—to cough effectively, reducing the risk of aspiration and infections. It is the first method in the world, says Dr. Kowalski, that activates abdominal and lower rib cage muscles to produce an effective cough.

An interventional clinical trial in 3 patients demonstrated that using the 2 systems in tandem was safe. The new system was implanted surgically, with disc electrodes placed on the dorsal surface of the spinal cord via laminectomy. Participants in the study used a stimulator to produce several different cough efforts from light to strong.

Mean peak expiratory airflow and airway pressure generation during spontaneous efforts were 1.7 ± 0.2 L/s and 31 ± 7 cmH2O, respectively. After the spinal cord stimulation was applied, peak expiratory airflow was 9.0 ± 1.9 L/s and airway pressure generation was 90 ± 6 cmH2O. In other words, results “characteristic of a normal cough,” the researchers concluded. Moreover, each patient raised secretions much more easily.

The research is being done at the Cleveland Functional Electrical Stimulation Center, a consortium of MetroHealth Medical Center, Case Western Reserve University, and Louis Stokes Cleveland VA Medical Center.

Army veteran David Powers, one of the study participants, in an interview with the VAntage Point blog, says, “Being a part of this research trial has made me feel great. For not only my own health but helping to improve the lives of others as well.”

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A VA research collaboration finds a new way to improve quality of life and reduce major causes of morbidity and mortality in patients with spinal cord injury.
A VA research collaboration finds a new way to improve quality of life and reduce major causes of morbidity and mortality in patients with spinal cord injury.

Many patients with spinal cord injury (SCI) need mechanical ventilatory support. One type of support is diaphragm pacing, which stimulates the diaphragm, helping the person breathe. A minimally invasive form of diaphragm pacing via laparoscopically placed intramuscular diaphragm electrodes has “liberated thousands of patients from mechanical ventilation,” says Anthony DiMarco, MD. He and VA colleague Krzysztof Kowalski, PhD, have found a way to completely restore respiratory muscle function in patients with SCI safely and effectively.

In mid-thoracic and higher level SCIs, the expiratory muscles are paralyzed, putting patients at risk for respiratory tract infections and atelectasis, a major cause of morbidity and mortality in that population. The research team, led by DiMarco and Kowalski, combined diaphragm pacing with a minimally invasive system that allows the patient—simply with the press of a button—to cough effectively, reducing the risk of aspiration and infections. It is the first method in the world, says Dr. Kowalski, that activates abdominal and lower rib cage muscles to produce an effective cough.

An interventional clinical trial in 3 patients demonstrated that using the 2 systems in tandem was safe. The new system was implanted surgically, with disc electrodes placed on the dorsal surface of the spinal cord via laminectomy. Participants in the study used a stimulator to produce several different cough efforts from light to strong.

Mean peak expiratory airflow and airway pressure generation during spontaneous efforts were 1.7 ± 0.2 L/s and 31 ± 7 cmH2O, respectively. After the spinal cord stimulation was applied, peak expiratory airflow was 9.0 ± 1.9 L/s and airway pressure generation was 90 ± 6 cmH2O. In other words, results “characteristic of a normal cough,” the researchers concluded. Moreover, each patient raised secretions much more easily.

The research is being done at the Cleveland Functional Electrical Stimulation Center, a consortium of MetroHealth Medical Center, Case Western Reserve University, and Louis Stokes Cleveland VA Medical Center.

Army veteran David Powers, one of the study participants, in an interview with the VAntage Point blog, says, “Being a part of this research trial has made me feel great. For not only my own health but helping to improve the lives of others as well.”

Many patients with spinal cord injury (SCI) need mechanical ventilatory support. One type of support is diaphragm pacing, which stimulates the diaphragm, helping the person breathe. A minimally invasive form of diaphragm pacing via laparoscopically placed intramuscular diaphragm electrodes has “liberated thousands of patients from mechanical ventilation,” says Anthony DiMarco, MD. He and VA colleague Krzysztof Kowalski, PhD, have found a way to completely restore respiratory muscle function in patients with SCI safely and effectively.

In mid-thoracic and higher level SCIs, the expiratory muscles are paralyzed, putting patients at risk for respiratory tract infections and atelectasis, a major cause of morbidity and mortality in that population. The research team, led by DiMarco and Kowalski, combined diaphragm pacing with a minimally invasive system that allows the patient—simply with the press of a button—to cough effectively, reducing the risk of aspiration and infections. It is the first method in the world, says Dr. Kowalski, that activates abdominal and lower rib cage muscles to produce an effective cough.

An interventional clinical trial in 3 patients demonstrated that using the 2 systems in tandem was safe. The new system was implanted surgically, with disc electrodes placed on the dorsal surface of the spinal cord via laminectomy. Participants in the study used a stimulator to produce several different cough efforts from light to strong.

Mean peak expiratory airflow and airway pressure generation during spontaneous efforts were 1.7 ± 0.2 L/s and 31 ± 7 cmH2O, respectively. After the spinal cord stimulation was applied, peak expiratory airflow was 9.0 ± 1.9 L/s and airway pressure generation was 90 ± 6 cmH2O. In other words, results “characteristic of a normal cough,” the researchers concluded. Moreover, each patient raised secretions much more easily.

The research is being done at the Cleveland Functional Electrical Stimulation Center, a consortium of MetroHealth Medical Center, Case Western Reserve University, and Louis Stokes Cleveland VA Medical Center.

Army veteran David Powers, one of the study participants, in an interview with the VAntage Point blog, says, “Being a part of this research trial has made me feel great. For not only my own health but helping to improve the lives of others as well.”

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Preoperative tramadol fails to improve function after knee surgery

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Tramadol given prior to knee surgery was associated with less postoperative improvement than other opiates or no opiates, according to findings of a study based on pre- and postsurgery data.

Tramadol has become a popular choice for nonoperative knee pain relief because of its low potential for abuse and favorable safety profile, but its impact on postoperative outcomes when given before knee surgery has not been well studied, wrote Adam Driesman, MD, of the New York University Langone Orthopedic Hospital and colleagues.

In a study published in the Journal of Arthroplasty, the researchers compared patient-reported outcomes (PRO) after total knee arthroplasty among 136 patients who received no opiates, 21 who received tramadol, and 42 who received other opiates. All patients who did not have preoperative and postoperative PRO scores were excluded

All patients received the same multimodal perioperative pain protocol, and all were placed on oxycodone postoperatively for maintenance and breakthrough pain as needed, with discharge prescriptions for acetaminophen/oxycodone combination (Percocet) for breakthrough pain.

Patients preoperative assessment using the Knee Disability and Osteoarthritis Outcome Score Jr. (KOOS, JR.) were similar among the groups prior to surgery; baseline scores for the groups receiving either tramadol, no opiates, or other opiates were 49.95, 50.4, and 48.0, respectively. Demographics also were not significantly different among the groups.

At 3 months, the average KOOS, JR., score for the tramadol group (62.4) was significantly lower, compared with the other-opiate group (67.1) and treatment-naive group (70.1). In addition, patients in the tramadol group had the least change in scores on KOOS, JR., with an average of 12.5 points, compared with 19.1-point and 20.1-point improvements, respectively, in the alternate-opiate group and opiate-naive group.

The data expand on previous findings that patients given preoperative opioids had proportionally less postoperative pain relief than those not on opioids, the researchers said, but noted that they were surprised by the worse outcomes in the tramadol group given its demonstrated side-effect profile.

The study findings were limited by several factors including the retrospective design and relatively short follow-up period, as well as the inability to accurately determine outpatient medication use, not only of opioids, but of nonopioid postoperative pain medications that could have affected the results, the researchers said.

“However, given the conflicting evidence presented in this study and despite the 2013 American Academy of Orthopedic Surgeons Clinical Practice Guidelines, it is recommended providers remain very conservative in their administration of outpatient narcotics including tramadol prior to surgery,” they concluded.

SOURCE: Driesman A et al. J Arthroplasty. 2019;34(8):1662-66.

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Tramadol given prior to knee surgery was associated with less postoperative improvement than other opiates or no opiates, according to findings of a study based on pre- and postsurgery data.

Tramadol has become a popular choice for nonoperative knee pain relief because of its low potential for abuse and favorable safety profile, but its impact on postoperative outcomes when given before knee surgery has not been well studied, wrote Adam Driesman, MD, of the New York University Langone Orthopedic Hospital and colleagues.

In a study published in the Journal of Arthroplasty, the researchers compared patient-reported outcomes (PRO) after total knee arthroplasty among 136 patients who received no opiates, 21 who received tramadol, and 42 who received other opiates. All patients who did not have preoperative and postoperative PRO scores were excluded

All patients received the same multimodal perioperative pain protocol, and all were placed on oxycodone postoperatively for maintenance and breakthrough pain as needed, with discharge prescriptions for acetaminophen/oxycodone combination (Percocet) for breakthrough pain.

Patients preoperative assessment using the Knee Disability and Osteoarthritis Outcome Score Jr. (KOOS, JR.) were similar among the groups prior to surgery; baseline scores for the groups receiving either tramadol, no opiates, or other opiates were 49.95, 50.4, and 48.0, respectively. Demographics also were not significantly different among the groups.

At 3 months, the average KOOS, JR., score for the tramadol group (62.4) was significantly lower, compared with the other-opiate group (67.1) and treatment-naive group (70.1). In addition, patients in the tramadol group had the least change in scores on KOOS, JR., with an average of 12.5 points, compared with 19.1-point and 20.1-point improvements, respectively, in the alternate-opiate group and opiate-naive group.

The data expand on previous findings that patients given preoperative opioids had proportionally less postoperative pain relief than those not on opioids, the researchers said, but noted that they were surprised by the worse outcomes in the tramadol group given its demonstrated side-effect profile.

The study findings were limited by several factors including the retrospective design and relatively short follow-up period, as well as the inability to accurately determine outpatient medication use, not only of opioids, but of nonopioid postoperative pain medications that could have affected the results, the researchers said.

“However, given the conflicting evidence presented in this study and despite the 2013 American Academy of Orthopedic Surgeons Clinical Practice Guidelines, it is recommended providers remain very conservative in their administration of outpatient narcotics including tramadol prior to surgery,” they concluded.

SOURCE: Driesman A et al. J Arthroplasty. 2019;34(8):1662-66.

 

Tramadol given prior to knee surgery was associated with less postoperative improvement than other opiates or no opiates, according to findings of a study based on pre- and postsurgery data.

Tramadol has become a popular choice for nonoperative knee pain relief because of its low potential for abuse and favorable safety profile, but its impact on postoperative outcomes when given before knee surgery has not been well studied, wrote Adam Driesman, MD, of the New York University Langone Orthopedic Hospital and colleagues.

In a study published in the Journal of Arthroplasty, the researchers compared patient-reported outcomes (PRO) after total knee arthroplasty among 136 patients who received no opiates, 21 who received tramadol, and 42 who received other opiates. All patients who did not have preoperative and postoperative PRO scores were excluded

All patients received the same multimodal perioperative pain protocol, and all were placed on oxycodone postoperatively for maintenance and breakthrough pain as needed, with discharge prescriptions for acetaminophen/oxycodone combination (Percocet) for breakthrough pain.

Patients preoperative assessment using the Knee Disability and Osteoarthritis Outcome Score Jr. (KOOS, JR.) were similar among the groups prior to surgery; baseline scores for the groups receiving either tramadol, no opiates, or other opiates were 49.95, 50.4, and 48.0, respectively. Demographics also were not significantly different among the groups.

At 3 months, the average KOOS, JR., score for the tramadol group (62.4) was significantly lower, compared with the other-opiate group (67.1) and treatment-naive group (70.1). In addition, patients in the tramadol group had the least change in scores on KOOS, JR., with an average of 12.5 points, compared with 19.1-point and 20.1-point improvements, respectively, in the alternate-opiate group and opiate-naive group.

The data expand on previous findings that patients given preoperative opioids had proportionally less postoperative pain relief than those not on opioids, the researchers said, but noted that they were surprised by the worse outcomes in the tramadol group given its demonstrated side-effect profile.

The study findings were limited by several factors including the retrospective design and relatively short follow-up period, as well as the inability to accurately determine outpatient medication use, not only of opioids, but of nonopioid postoperative pain medications that could have affected the results, the researchers said.

“However, given the conflicting evidence presented in this study and despite the 2013 American Academy of Orthopedic Surgeons Clinical Practice Guidelines, it is recommended providers remain very conservative in their administration of outpatient narcotics including tramadol prior to surgery,” they concluded.

SOURCE: Driesman A et al. J Arthroplasty. 2019;34(8):1662-66.

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Shoulder Injury Related to Vaccine Administration: A Rare Reaction

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Awareness of shoulder injury related to vaccine administration and a high index of suspicion are necessary to evaluate patients with shoulder concerns postvaccination.

Localized reactions and transient pain at the site of vaccine administration are frequent and well-described occurrences that are typically short-lived and mild in nature. The most common findings at the injection site are soreness, erythema, and edema.1 Although less common, generalized shoulder dysfunction after vaccine administration also has been reported. Bodor and colleagues described a peri-articular inflammatory response that led to shoulder pain and weakness.2 A single case report by Kuether and colleagues described atraumatic osteonecrosis of the humeral head after H1N1 vaccine administration in the deltoid.3 In 2010, shoulder injury related to vaccine administration (SIRVA) was described by Atanasoff and colleagues as the rapid onset of shoulder pain and dysfunction persisting as a complication of deltoid muscle vaccination in a case series of 13 patients.4 In our report, we present a case of an active-duty male eventually diagnosed with SIRVA after influenza vaccination and discuss factors that may prevent vaccine-related shoulder injuries.

Case Presentation

A 31-year-old active-duty male presented to the Allergy clinic for evaluation of persistent left shoulder pain and decreased range of motion (ROM) following influenza vaccination 4 months prior. He reported a history of chronic low back and right shoulder pain. Although the patient had a traumatic injury to his right shoulder, which was corrected with surgery, he had no surgeries on the left shoulder. He reported no prior pain or known trauma to his left shoulder. He had no personal or family history of atopy or vaccine reactions.

The patient weighed 91 kg and received an intramuscular (IM) quadrivalent influenza vaccine with a 25-gauge, 1-inch needle during a mass influenza immunization. He recalled that the site of vaccination was slightly more than 3 cm below the top of the shoulder in a region correlating to the left deltoid. The vaccine was administered while he was standing with his arm extended, adducted, and internally rotated. The patient experienced intense pain immediately after the vaccination and noted decreased ROM. Initially, he dismissed the pain and decreased ROM as routine but sought medical attention when there was no improvement after 3 weeks.

Six weeks after the onset of symptoms, a magnetic resonance image (MRI) revealed tendinopathy of the left distal subscapularis, infraspinatus, supraspinatus, and teres minor tendon. These findings were suggestive of a small partial thickness tear of the supraspinatus (Figure 1), possible calcific tendinopathy of the distal teres minor (Figure 2), and underlying humeral head edema (Figure 3). The patient was evaluated by Orthopedics and experienced no relief from ibuprofen, celecoxib, and a steroid/lidocaine intra-articular injection. Laboratory studies included an unremarkable complete blood count and erythrocyte sedimentation rate. He was diagnosed with SIRVA and continued in physical therapy with incomplete resolution of symptoms 6 months postvaccination.

 

Discussion

According to a 2018 report issued by the Centers for Disease Control and Prevention, local reactions following immunizations are seen in up to 80% of administered vaccine doses.1 While most of these reactions are mild, transient, cutaneous reactions, rarely these also may persist and impact quality of life significantly. SIRVA is one such process that can lead to persistent musculoskeletal dysfunction. SIRVA presents as shoulder pain and limited ROM that occurs after the administration of an injectable vaccine. In 2011, the Institute of Medicine determined that evidence supported a causal relationship between vaccine administration and deltoid bursitis.5

 

 

In 2017, SIRVA was included in the Vaccine Injury Compensation Program (VICP), a federal program that can provide compensation to individuals injured by certain vaccines.6 A diagnosis of SIRVA can be considered in patients who experience pain within 48 hours of vaccination, have no prior history of pain or dysfunction of the affected shoulder prior to vaccine administration, and have symptoms limited to the shoulder in which the vaccine was administered where no other abnormality is present to explain these symptoms (eg, brachial neuritis, other neuropathy). Currently, patients with back pain or musculoskeletal complaints that do not include the shoulder following deltoid vaccination do not meet the reporting criteria for SIRVA in the VICP.6

The exact prevalence or incidence of SIRVA is unknown. In a 2017 systematic review of the literature and the Spanish Pharmacovigilance System database, Martín Arias and colleagues found 45 cases of new onset, unilateral shoulder dysfunction without associated neuropathy or autoimmune conditions following vaccine administration. They noted a female to male predominance (71.1% vs 28.9%) with a mean age of 53.6 years (range 22-89 y). Most of the cases occurred following influenza vaccine (62%); pneumococcal vaccine was the next most common (13%).7 Shoulder injury also has been reported after tetanus-diphtheria toxoids, human papilloma virus, and hepatitis A virus vaccines.4,7 The review noted that all patients had onset of pain within the first week following vaccination with the majority (81%) having pain in the first 24 hours. Two cases found in the Spanish database had pain onset 2 months postvaccination.7 Atanasoff and colleagues found that 93% of patients had pain onset within 24 hours of vaccination with 54% reporting immediate pain.4

The Vaccine Adverse Event Reporting System (VAERS) tracks reports of shoulder dysfunction following certain vaccinations, but the system is unable to establish causality. According to VAERS reporting, between 2010 and 2016, there were 1006 possible reports of shoulder dysfunction following inactivated influenza vaccination (IIV) compared with an estimated 130 million doses of IIV given each influenza season in the US.8

Bodor and Montalvo postulated that vaccine antigen was being over penetrated into the synovial space of the shoulder, as the subdeltoid/subacromial bursa is located a mere 0.8 to 1.6 cm below the skin surface in patients with healthy body mass index.2 Atanasoff and colleagues expounded that antibodies from previous vaccination or natural infection may then form antigen-antibody complexes, creating prolonged local immune and inflammatory responses leading to bursitis or tendonitis.4 Martín Arias and colleagues hypothesized that improper injection technique, including wrong insertion angle, incorrect needle type/size, and failure to account for the patient’s physical characteristics were the most likely causes of SIRVA.7

Proper vaccine administration ensures that vaccinations are delivered in a safe and efficacious manner. Safe vaccination practices include the use of trained personnel who receive comprehensive, competency-based training regarding vaccine administration.1 Aspiration prior to an injection is a practice that has not been evaluated fully. Given that the 2 routinely recommended locations for IM vaccines (deltoid muscle in adults or vastus lateralis muscle in infants) lack large blood vessels, the practice of aspiration prior to an IM vaccine is not currently deemed necessary.1 Additional safe vaccine practices include the selection of appropriate needle length for muscle penetration and that anatomic landmarks determine the location of vaccination.1 Despite this, in a survey of 100 medical professionals, half could not name any structure at risk from improper deltoid vaccination technique.9

Cook and colleagues used anthropomorphic data to evaluate the potential for injury to the subdeltoid/subacromial bursa and/or the axillary nerve.10 Based on these data, they recommended safe IM vaccine administration can be assured by using the midpoint of the deltoid muscle located midway between the acromion and deltoid tuberosity with the arm abducted to 60°.10,11 In 46% of SIRVA cases described by Atanasoff and colleagues, patients reported that the vaccine was administered “too high.”4 The study also recommended that the clinician and the patient be in the seated position to ensure proper needle angle and location of administration.4 For most adults, a 1-inch needle is appropriate for vaccine administration in the deltoid; however, in females weighing < 70 kg and males < 75 kg, a 5/8-inch needle is recommended to avoid injury.7

Our 91-kg patient was appropriately administered his vaccine with a 1-inch needle. As he experienced immediate pain, it is unlikely that his symptoms were due to an immune-mediated process, as this would not be expected to occur immediately. Improper location of vaccine administration is a proposed mechanism of injury for our patient, though this cannot be confirmed by history alone. His prior history of traumatic injury to the opposite shoulder could represent a confounding factor as no prior imaging was available for the vaccine-affected shoulder. A preexisting shoulder abnormality or injury cannot be completely excluded, and it is possible that an underlying prior shoulder injury was aggravated postvaccination.

 

 

Evaluation and Treatment

There is no standardized approach for the evaluation of SIRVA to date. Awareness of SIRVA and a high index of suspicion are necessary to evaluate patients with shoulder concerns postvaccination. Laboratory evaluation should be considered to evaluate for other potential diagnoses (eg, infection, rheumatologic concerns). Routine X-rays are not helpful in cases of SIRVA. Ultrasound may be considered as it can show bursa abnormalities consistent with bursitis.2 MRI of the affected shoulder may provide improved diagnostic capability if SIRVA is suspected. MRI findings vary but include intraosseous edema, bursitis, tendonitis, and rotator cuff tears.4,12 Complete rotator cuff tears were found in 15% of cases reviewed by Atanasoff and colleagues.4 While there is no recommended timing for MRI, 63% of MRIs were performed within 3 months of symptom onset.4 As SIRVA is not a neurologic injury, nerve conduction, electromyographic studies, and neurologic evaluation or testing are expected to be normal.

Treatment of SIRVA and other vaccine-related shoulder injuries typically have involved pain management (eg, nonsteroidal anti-inflammatory agents), intra-articular steroid injections, and physical therapy, though some patients never experience complete resolution of symptoms.2,4,7 Both patients with vaccination-related shoulder dysfunction described by Bodor and colleagues improved after intra-articular triamcinolone injections, with up to 3 injections before complete resolution of pain in one patient.2 Orthopedics evaluation may need to be considered for persistent symptoms. According to Atanasoff and colleagues, most patients were symptomatic for at least 6 months, and complete recovery was seen in less than one-third of patients.4 Although the development of SIRVA is not a contraindication to future doses of the presumed causative vaccine, subsequent vaccination should include careful consideration of other administration sites if possible (eg, vastus lateralis may be used for IM injections in adults) (Figure 4).

Reporting

A diagnosis or concern for SIRVA also should be reported to the VAERS, the national database established in order to detect possible safety problems with US-licensed vaccines. VAERS reports can be submitted by anyone with concerns for vaccine adverse reactions, including patients, caregivers, and health care professionals at vaers.hhs.gov/reportevent.html. Additional information regarding VICP can be obtained at www.hrsa.gov/vaccine-compensation/index.html.

 

Military-Specific Issues

The military values readiness, which includes ensuring that active-duty members remain up-to-date on life-saving vaccinations. Immunization is of critical importance to mobility and success of the overall mission. Mobility processing lines where immunizations can be provided to multiple active-duty members can be a successful strategy for mass immunizations. Although the quick administration of immunizations maintains readiness and provides a medically necessary service, it also may increase the chances of incorrect vaccine placement in the deltoid, causing long-term shoulder immobility that may impact a service member’s retainability. The benefits of mobility processing lines can continue to outweigh the risks of immunization administration by ensuring proper staff training, seating both the administrator and recipient of vaccination, and selecting a proper needle length and site of administration specific to each recipient.

Conclusion

Correct administration of vaccines is of utmost importance in preventing SIRVA and other vaccine-related shoulder dysfunctions. Proper staff training and refresher training can help prevent vaccine-related shoulder injuries. Additionally, clinicians should be aware of this potential complication and maintain a high index of suspicion when evaluating patients with postvaccination shoulder complaints.

References

1. Centers for Disease Control and Prevention. Epidemiology and prevention of vaccine-preventable diseases. https://www.cdc.gov/vaccines/pubs/pinkbook/vac-admin.html. Published 2015. Accessed June 3, 2019.

2. Bodor M, Montalvo E. Vaccination-related shoulder dysfunction. Vaccine. 2007;25(4):585-587.

3. Kuether G, Dietrich B, Smith T, Peter C, Gruessner S. Atraumatic osteonecrosis of the humeral head after influenza A-(H1N1) v-2009 vaccination. Vaccine. 2011;29(40):6830-6833.

4. Atanasoff S, Ryan T, Lightfoot R, Johann-Liang R. Shoulder injury related to vaccine administration (SIRVA). Vaccine. 2010;28(51):8049-8052.

5. Institute of Medicine. Adverse effects of vaccines: evidence and causality. http://www.nationalacademies.org/hmd/~/media/Files/Report%20Files/2011/Adverse-Effects-of-Vaccines-Evidence-and-Causality/Vaccine-report-brief-FINAL.pdf. Published August 2011. Accessed June 3, 2019.

6. Health Resources and Services Administration, Health and Human Services Administration. National vaccine injury compensation program: revisions to the vaccine injury table. https://www.federalregister.gov/documents/2017/01/19/2017-00701/national-vaccine-injury-compensation-program-revisions-to-the-vaccine-injury-table. Published January 19, 2017. Accessed June 3, 2019.

7. Martín Arias LH, Sanz Fadrique R, Sáinz Gil M, Salgueiro-Vazquez ME. Risk of bursitis and other injuries and dysfunctions of the shoulder following vaccinations. Vaccine. 2017;35(37):4870-4876.

8. Centers for Disease Control and Prevention. Reports of shoulder dysfunction following inactivated influenza vaccine in the Vaccine Adverse Event Reporting System (VAERS), 2010-2016. https://stacks.cdc.gov/view/cdc/57624. Published January 4, 2018. Accessed June 3, 2019.

9. McGarvey MA, Hooper AC. The deltoid intramuscular injection site in the adult. Current practice among general practitioners and practice nurses. Ir Med J. 2005;98(4):105-107.

10. Cook IF. An evidence based protocol for the prevention of upper arm injury related to vaccine administration (UAIRVA). Hum Vaccin. 2011;7(8):845-848.

11. Cook IF. Best vaccination practice and medically attended injection site events following deltoid intramuscular injection. Hum Vaccin Immunother. 2015;11(5):1184-1191.

12. Okur G, Chaney KA, Lomasney LM. Magnetic resonance imaging of abnormal shoulder pain following influenza vaccination. Skeletal Radiol. 2014;43(9):1325-1331.

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Correspondence: Sofia Szari (sofia.m.szari [email protected])

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The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

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Maj Szari is an Allergy/ Immunology Fellow, Lt Col Adams and Col Freiler are Staff Allergists; all at Lackland Air Force Base in Texas. Capt Belgard is a Staff Pediatrician at Eglin Air Force Base in Florida.
Correspondence: Sofia Szari (sofia.m.szari [email protected])

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Author and Disclosure Information

Maj Szari is an Allergy/ Immunology Fellow, Lt Col Adams and Col Freiler are Staff Allergists; all at Lackland Air Force Base in Texas. Capt Belgard is a Staff Pediatrician at Eglin Air Force Base in Florida.
Correspondence: Sofia Szari (sofia.m.szari [email protected])

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

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Awareness of shoulder injury related to vaccine administration and a high index of suspicion are necessary to evaluate patients with shoulder concerns postvaccination.
Awareness of shoulder injury related to vaccine administration and a high index of suspicion are necessary to evaluate patients with shoulder concerns postvaccination.

Localized reactions and transient pain at the site of vaccine administration are frequent and well-described occurrences that are typically short-lived and mild in nature. The most common findings at the injection site are soreness, erythema, and edema.1 Although less common, generalized shoulder dysfunction after vaccine administration also has been reported. Bodor and colleagues described a peri-articular inflammatory response that led to shoulder pain and weakness.2 A single case report by Kuether and colleagues described atraumatic osteonecrosis of the humeral head after H1N1 vaccine administration in the deltoid.3 In 2010, shoulder injury related to vaccine administration (SIRVA) was described by Atanasoff and colleagues as the rapid onset of shoulder pain and dysfunction persisting as a complication of deltoid muscle vaccination in a case series of 13 patients.4 In our report, we present a case of an active-duty male eventually diagnosed with SIRVA after influenza vaccination and discuss factors that may prevent vaccine-related shoulder injuries.

Case Presentation

A 31-year-old active-duty male presented to the Allergy clinic for evaluation of persistent left shoulder pain and decreased range of motion (ROM) following influenza vaccination 4 months prior. He reported a history of chronic low back and right shoulder pain. Although the patient had a traumatic injury to his right shoulder, which was corrected with surgery, he had no surgeries on the left shoulder. He reported no prior pain or known trauma to his left shoulder. He had no personal or family history of atopy or vaccine reactions.

The patient weighed 91 kg and received an intramuscular (IM) quadrivalent influenza vaccine with a 25-gauge, 1-inch needle during a mass influenza immunization. He recalled that the site of vaccination was slightly more than 3 cm below the top of the shoulder in a region correlating to the left deltoid. The vaccine was administered while he was standing with his arm extended, adducted, and internally rotated. The patient experienced intense pain immediately after the vaccination and noted decreased ROM. Initially, he dismissed the pain and decreased ROM as routine but sought medical attention when there was no improvement after 3 weeks.

Six weeks after the onset of symptoms, a magnetic resonance image (MRI) revealed tendinopathy of the left distal subscapularis, infraspinatus, supraspinatus, and teres minor tendon. These findings were suggestive of a small partial thickness tear of the supraspinatus (Figure 1), possible calcific tendinopathy of the distal teres minor (Figure 2), and underlying humeral head edema (Figure 3). The patient was evaluated by Orthopedics and experienced no relief from ibuprofen, celecoxib, and a steroid/lidocaine intra-articular injection. Laboratory studies included an unremarkable complete blood count and erythrocyte sedimentation rate. He was diagnosed with SIRVA and continued in physical therapy with incomplete resolution of symptoms 6 months postvaccination.

 

Discussion

According to a 2018 report issued by the Centers for Disease Control and Prevention, local reactions following immunizations are seen in up to 80% of administered vaccine doses.1 While most of these reactions are mild, transient, cutaneous reactions, rarely these also may persist and impact quality of life significantly. SIRVA is one such process that can lead to persistent musculoskeletal dysfunction. SIRVA presents as shoulder pain and limited ROM that occurs after the administration of an injectable vaccine. In 2011, the Institute of Medicine determined that evidence supported a causal relationship between vaccine administration and deltoid bursitis.5

 

 

In 2017, SIRVA was included in the Vaccine Injury Compensation Program (VICP), a federal program that can provide compensation to individuals injured by certain vaccines.6 A diagnosis of SIRVA can be considered in patients who experience pain within 48 hours of vaccination, have no prior history of pain or dysfunction of the affected shoulder prior to vaccine administration, and have symptoms limited to the shoulder in which the vaccine was administered where no other abnormality is present to explain these symptoms (eg, brachial neuritis, other neuropathy). Currently, patients with back pain or musculoskeletal complaints that do not include the shoulder following deltoid vaccination do not meet the reporting criteria for SIRVA in the VICP.6

The exact prevalence or incidence of SIRVA is unknown. In a 2017 systematic review of the literature and the Spanish Pharmacovigilance System database, Martín Arias and colleagues found 45 cases of new onset, unilateral shoulder dysfunction without associated neuropathy or autoimmune conditions following vaccine administration. They noted a female to male predominance (71.1% vs 28.9%) with a mean age of 53.6 years (range 22-89 y). Most of the cases occurred following influenza vaccine (62%); pneumococcal vaccine was the next most common (13%).7 Shoulder injury also has been reported after tetanus-diphtheria toxoids, human papilloma virus, and hepatitis A virus vaccines.4,7 The review noted that all patients had onset of pain within the first week following vaccination with the majority (81%) having pain in the first 24 hours. Two cases found in the Spanish database had pain onset 2 months postvaccination.7 Atanasoff and colleagues found that 93% of patients had pain onset within 24 hours of vaccination with 54% reporting immediate pain.4

The Vaccine Adverse Event Reporting System (VAERS) tracks reports of shoulder dysfunction following certain vaccinations, but the system is unable to establish causality. According to VAERS reporting, between 2010 and 2016, there were 1006 possible reports of shoulder dysfunction following inactivated influenza vaccination (IIV) compared with an estimated 130 million doses of IIV given each influenza season in the US.8

Bodor and Montalvo postulated that vaccine antigen was being over penetrated into the synovial space of the shoulder, as the subdeltoid/subacromial bursa is located a mere 0.8 to 1.6 cm below the skin surface in patients with healthy body mass index.2 Atanasoff and colleagues expounded that antibodies from previous vaccination or natural infection may then form antigen-antibody complexes, creating prolonged local immune and inflammatory responses leading to bursitis or tendonitis.4 Martín Arias and colleagues hypothesized that improper injection technique, including wrong insertion angle, incorrect needle type/size, and failure to account for the patient’s physical characteristics were the most likely causes of SIRVA.7

Proper vaccine administration ensures that vaccinations are delivered in a safe and efficacious manner. Safe vaccination practices include the use of trained personnel who receive comprehensive, competency-based training regarding vaccine administration.1 Aspiration prior to an injection is a practice that has not been evaluated fully. Given that the 2 routinely recommended locations for IM vaccines (deltoid muscle in adults or vastus lateralis muscle in infants) lack large blood vessels, the practice of aspiration prior to an IM vaccine is not currently deemed necessary.1 Additional safe vaccine practices include the selection of appropriate needle length for muscle penetration and that anatomic landmarks determine the location of vaccination.1 Despite this, in a survey of 100 medical professionals, half could not name any structure at risk from improper deltoid vaccination technique.9

Cook and colleagues used anthropomorphic data to evaluate the potential for injury to the subdeltoid/subacromial bursa and/or the axillary nerve.10 Based on these data, they recommended safe IM vaccine administration can be assured by using the midpoint of the deltoid muscle located midway between the acromion and deltoid tuberosity with the arm abducted to 60°.10,11 In 46% of SIRVA cases described by Atanasoff and colleagues, patients reported that the vaccine was administered “too high.”4 The study also recommended that the clinician and the patient be in the seated position to ensure proper needle angle and location of administration.4 For most adults, a 1-inch needle is appropriate for vaccine administration in the deltoid; however, in females weighing < 70 kg and males < 75 kg, a 5/8-inch needle is recommended to avoid injury.7

Our 91-kg patient was appropriately administered his vaccine with a 1-inch needle. As he experienced immediate pain, it is unlikely that his symptoms were due to an immune-mediated process, as this would not be expected to occur immediately. Improper location of vaccine administration is a proposed mechanism of injury for our patient, though this cannot be confirmed by history alone. His prior history of traumatic injury to the opposite shoulder could represent a confounding factor as no prior imaging was available for the vaccine-affected shoulder. A preexisting shoulder abnormality or injury cannot be completely excluded, and it is possible that an underlying prior shoulder injury was aggravated postvaccination.

 

 

Evaluation and Treatment

There is no standardized approach for the evaluation of SIRVA to date. Awareness of SIRVA and a high index of suspicion are necessary to evaluate patients with shoulder concerns postvaccination. Laboratory evaluation should be considered to evaluate for other potential diagnoses (eg, infection, rheumatologic concerns). Routine X-rays are not helpful in cases of SIRVA. Ultrasound may be considered as it can show bursa abnormalities consistent with bursitis.2 MRI of the affected shoulder may provide improved diagnostic capability if SIRVA is suspected. MRI findings vary but include intraosseous edema, bursitis, tendonitis, and rotator cuff tears.4,12 Complete rotator cuff tears were found in 15% of cases reviewed by Atanasoff and colleagues.4 While there is no recommended timing for MRI, 63% of MRIs were performed within 3 months of symptom onset.4 As SIRVA is not a neurologic injury, nerve conduction, electromyographic studies, and neurologic evaluation or testing are expected to be normal.

Treatment of SIRVA and other vaccine-related shoulder injuries typically have involved pain management (eg, nonsteroidal anti-inflammatory agents), intra-articular steroid injections, and physical therapy, though some patients never experience complete resolution of symptoms.2,4,7 Both patients with vaccination-related shoulder dysfunction described by Bodor and colleagues improved after intra-articular triamcinolone injections, with up to 3 injections before complete resolution of pain in one patient.2 Orthopedics evaluation may need to be considered for persistent symptoms. According to Atanasoff and colleagues, most patients were symptomatic for at least 6 months, and complete recovery was seen in less than one-third of patients.4 Although the development of SIRVA is not a contraindication to future doses of the presumed causative vaccine, subsequent vaccination should include careful consideration of other administration sites if possible (eg, vastus lateralis may be used for IM injections in adults) (Figure 4).

Reporting

A diagnosis or concern for SIRVA also should be reported to the VAERS, the national database established in order to detect possible safety problems with US-licensed vaccines. VAERS reports can be submitted by anyone with concerns for vaccine adverse reactions, including patients, caregivers, and health care professionals at vaers.hhs.gov/reportevent.html. Additional information regarding VICP can be obtained at www.hrsa.gov/vaccine-compensation/index.html.

 

Military-Specific Issues

The military values readiness, which includes ensuring that active-duty members remain up-to-date on life-saving vaccinations. Immunization is of critical importance to mobility and success of the overall mission. Mobility processing lines where immunizations can be provided to multiple active-duty members can be a successful strategy for mass immunizations. Although the quick administration of immunizations maintains readiness and provides a medically necessary service, it also may increase the chances of incorrect vaccine placement in the deltoid, causing long-term shoulder immobility that may impact a service member’s retainability. The benefits of mobility processing lines can continue to outweigh the risks of immunization administration by ensuring proper staff training, seating both the administrator and recipient of vaccination, and selecting a proper needle length and site of administration specific to each recipient.

Conclusion

Correct administration of vaccines is of utmost importance in preventing SIRVA and other vaccine-related shoulder dysfunctions. Proper staff training and refresher training can help prevent vaccine-related shoulder injuries. Additionally, clinicians should be aware of this potential complication and maintain a high index of suspicion when evaluating patients with postvaccination shoulder complaints.

Localized reactions and transient pain at the site of vaccine administration are frequent and well-described occurrences that are typically short-lived and mild in nature. The most common findings at the injection site are soreness, erythema, and edema.1 Although less common, generalized shoulder dysfunction after vaccine administration also has been reported. Bodor and colleagues described a peri-articular inflammatory response that led to shoulder pain and weakness.2 A single case report by Kuether and colleagues described atraumatic osteonecrosis of the humeral head after H1N1 vaccine administration in the deltoid.3 In 2010, shoulder injury related to vaccine administration (SIRVA) was described by Atanasoff and colleagues as the rapid onset of shoulder pain and dysfunction persisting as a complication of deltoid muscle vaccination in a case series of 13 patients.4 In our report, we present a case of an active-duty male eventually diagnosed with SIRVA after influenza vaccination and discuss factors that may prevent vaccine-related shoulder injuries.

Case Presentation

A 31-year-old active-duty male presented to the Allergy clinic for evaluation of persistent left shoulder pain and decreased range of motion (ROM) following influenza vaccination 4 months prior. He reported a history of chronic low back and right shoulder pain. Although the patient had a traumatic injury to his right shoulder, which was corrected with surgery, he had no surgeries on the left shoulder. He reported no prior pain or known trauma to his left shoulder. He had no personal or family history of atopy or vaccine reactions.

The patient weighed 91 kg and received an intramuscular (IM) quadrivalent influenza vaccine with a 25-gauge, 1-inch needle during a mass influenza immunization. He recalled that the site of vaccination was slightly more than 3 cm below the top of the shoulder in a region correlating to the left deltoid. The vaccine was administered while he was standing with his arm extended, adducted, and internally rotated. The patient experienced intense pain immediately after the vaccination and noted decreased ROM. Initially, he dismissed the pain and decreased ROM as routine but sought medical attention when there was no improvement after 3 weeks.

Six weeks after the onset of symptoms, a magnetic resonance image (MRI) revealed tendinopathy of the left distal subscapularis, infraspinatus, supraspinatus, and teres minor tendon. These findings were suggestive of a small partial thickness tear of the supraspinatus (Figure 1), possible calcific tendinopathy of the distal teres minor (Figure 2), and underlying humeral head edema (Figure 3). The patient was evaluated by Orthopedics and experienced no relief from ibuprofen, celecoxib, and a steroid/lidocaine intra-articular injection. Laboratory studies included an unremarkable complete blood count and erythrocyte sedimentation rate. He was diagnosed with SIRVA and continued in physical therapy with incomplete resolution of symptoms 6 months postvaccination.

 

Discussion

According to a 2018 report issued by the Centers for Disease Control and Prevention, local reactions following immunizations are seen in up to 80% of administered vaccine doses.1 While most of these reactions are mild, transient, cutaneous reactions, rarely these also may persist and impact quality of life significantly. SIRVA is one such process that can lead to persistent musculoskeletal dysfunction. SIRVA presents as shoulder pain and limited ROM that occurs after the administration of an injectable vaccine. In 2011, the Institute of Medicine determined that evidence supported a causal relationship between vaccine administration and deltoid bursitis.5

 

 

In 2017, SIRVA was included in the Vaccine Injury Compensation Program (VICP), a federal program that can provide compensation to individuals injured by certain vaccines.6 A diagnosis of SIRVA can be considered in patients who experience pain within 48 hours of vaccination, have no prior history of pain or dysfunction of the affected shoulder prior to vaccine administration, and have symptoms limited to the shoulder in which the vaccine was administered where no other abnormality is present to explain these symptoms (eg, brachial neuritis, other neuropathy). Currently, patients with back pain or musculoskeletal complaints that do not include the shoulder following deltoid vaccination do not meet the reporting criteria for SIRVA in the VICP.6

The exact prevalence or incidence of SIRVA is unknown. In a 2017 systematic review of the literature and the Spanish Pharmacovigilance System database, Martín Arias and colleagues found 45 cases of new onset, unilateral shoulder dysfunction without associated neuropathy or autoimmune conditions following vaccine administration. They noted a female to male predominance (71.1% vs 28.9%) with a mean age of 53.6 years (range 22-89 y). Most of the cases occurred following influenza vaccine (62%); pneumococcal vaccine was the next most common (13%).7 Shoulder injury also has been reported after tetanus-diphtheria toxoids, human papilloma virus, and hepatitis A virus vaccines.4,7 The review noted that all patients had onset of pain within the first week following vaccination with the majority (81%) having pain in the first 24 hours. Two cases found in the Spanish database had pain onset 2 months postvaccination.7 Atanasoff and colleagues found that 93% of patients had pain onset within 24 hours of vaccination with 54% reporting immediate pain.4

The Vaccine Adverse Event Reporting System (VAERS) tracks reports of shoulder dysfunction following certain vaccinations, but the system is unable to establish causality. According to VAERS reporting, between 2010 and 2016, there were 1006 possible reports of shoulder dysfunction following inactivated influenza vaccination (IIV) compared with an estimated 130 million doses of IIV given each influenza season in the US.8

Bodor and Montalvo postulated that vaccine antigen was being over penetrated into the synovial space of the shoulder, as the subdeltoid/subacromial bursa is located a mere 0.8 to 1.6 cm below the skin surface in patients with healthy body mass index.2 Atanasoff and colleagues expounded that antibodies from previous vaccination or natural infection may then form antigen-antibody complexes, creating prolonged local immune and inflammatory responses leading to bursitis or tendonitis.4 Martín Arias and colleagues hypothesized that improper injection technique, including wrong insertion angle, incorrect needle type/size, and failure to account for the patient’s physical characteristics were the most likely causes of SIRVA.7

Proper vaccine administration ensures that vaccinations are delivered in a safe and efficacious manner. Safe vaccination practices include the use of trained personnel who receive comprehensive, competency-based training regarding vaccine administration.1 Aspiration prior to an injection is a practice that has not been evaluated fully. Given that the 2 routinely recommended locations for IM vaccines (deltoid muscle in adults or vastus lateralis muscle in infants) lack large blood vessels, the practice of aspiration prior to an IM vaccine is not currently deemed necessary.1 Additional safe vaccine practices include the selection of appropriate needle length for muscle penetration and that anatomic landmarks determine the location of vaccination.1 Despite this, in a survey of 100 medical professionals, half could not name any structure at risk from improper deltoid vaccination technique.9

Cook and colleagues used anthropomorphic data to evaluate the potential for injury to the subdeltoid/subacromial bursa and/or the axillary nerve.10 Based on these data, they recommended safe IM vaccine administration can be assured by using the midpoint of the deltoid muscle located midway between the acromion and deltoid tuberosity with the arm abducted to 60°.10,11 In 46% of SIRVA cases described by Atanasoff and colleagues, patients reported that the vaccine was administered “too high.”4 The study also recommended that the clinician and the patient be in the seated position to ensure proper needle angle and location of administration.4 For most adults, a 1-inch needle is appropriate for vaccine administration in the deltoid; however, in females weighing < 70 kg and males < 75 kg, a 5/8-inch needle is recommended to avoid injury.7

Our 91-kg patient was appropriately administered his vaccine with a 1-inch needle. As he experienced immediate pain, it is unlikely that his symptoms were due to an immune-mediated process, as this would not be expected to occur immediately. Improper location of vaccine administration is a proposed mechanism of injury for our patient, though this cannot be confirmed by history alone. His prior history of traumatic injury to the opposite shoulder could represent a confounding factor as no prior imaging was available for the vaccine-affected shoulder. A preexisting shoulder abnormality or injury cannot be completely excluded, and it is possible that an underlying prior shoulder injury was aggravated postvaccination.

 

 

Evaluation and Treatment

There is no standardized approach for the evaluation of SIRVA to date. Awareness of SIRVA and a high index of suspicion are necessary to evaluate patients with shoulder concerns postvaccination. Laboratory evaluation should be considered to evaluate for other potential diagnoses (eg, infection, rheumatologic concerns). Routine X-rays are not helpful in cases of SIRVA. Ultrasound may be considered as it can show bursa abnormalities consistent with bursitis.2 MRI of the affected shoulder may provide improved diagnostic capability if SIRVA is suspected. MRI findings vary but include intraosseous edema, bursitis, tendonitis, and rotator cuff tears.4,12 Complete rotator cuff tears were found in 15% of cases reviewed by Atanasoff and colleagues.4 While there is no recommended timing for MRI, 63% of MRIs were performed within 3 months of symptom onset.4 As SIRVA is not a neurologic injury, nerve conduction, electromyographic studies, and neurologic evaluation or testing are expected to be normal.

Treatment of SIRVA and other vaccine-related shoulder injuries typically have involved pain management (eg, nonsteroidal anti-inflammatory agents), intra-articular steroid injections, and physical therapy, though some patients never experience complete resolution of symptoms.2,4,7 Both patients with vaccination-related shoulder dysfunction described by Bodor and colleagues improved after intra-articular triamcinolone injections, with up to 3 injections before complete resolution of pain in one patient.2 Orthopedics evaluation may need to be considered for persistent symptoms. According to Atanasoff and colleagues, most patients were symptomatic for at least 6 months, and complete recovery was seen in less than one-third of patients.4 Although the development of SIRVA is not a contraindication to future doses of the presumed causative vaccine, subsequent vaccination should include careful consideration of other administration sites if possible (eg, vastus lateralis may be used for IM injections in adults) (Figure 4).

Reporting

A diagnosis or concern for SIRVA also should be reported to the VAERS, the national database established in order to detect possible safety problems with US-licensed vaccines. VAERS reports can be submitted by anyone with concerns for vaccine adverse reactions, including patients, caregivers, and health care professionals at vaers.hhs.gov/reportevent.html. Additional information regarding VICP can be obtained at www.hrsa.gov/vaccine-compensation/index.html.

 

Military-Specific Issues

The military values readiness, which includes ensuring that active-duty members remain up-to-date on life-saving vaccinations. Immunization is of critical importance to mobility and success of the overall mission. Mobility processing lines where immunizations can be provided to multiple active-duty members can be a successful strategy for mass immunizations. Although the quick administration of immunizations maintains readiness and provides a medically necessary service, it also may increase the chances of incorrect vaccine placement in the deltoid, causing long-term shoulder immobility that may impact a service member’s retainability. The benefits of mobility processing lines can continue to outweigh the risks of immunization administration by ensuring proper staff training, seating both the administrator and recipient of vaccination, and selecting a proper needle length and site of administration specific to each recipient.

Conclusion

Correct administration of vaccines is of utmost importance in preventing SIRVA and other vaccine-related shoulder dysfunctions. Proper staff training and refresher training can help prevent vaccine-related shoulder injuries. Additionally, clinicians should be aware of this potential complication and maintain a high index of suspicion when evaluating patients with postvaccination shoulder complaints.

References

1. Centers for Disease Control and Prevention. Epidemiology and prevention of vaccine-preventable diseases. https://www.cdc.gov/vaccines/pubs/pinkbook/vac-admin.html. Published 2015. Accessed June 3, 2019.

2. Bodor M, Montalvo E. Vaccination-related shoulder dysfunction. Vaccine. 2007;25(4):585-587.

3. Kuether G, Dietrich B, Smith T, Peter C, Gruessner S. Atraumatic osteonecrosis of the humeral head after influenza A-(H1N1) v-2009 vaccination. Vaccine. 2011;29(40):6830-6833.

4. Atanasoff S, Ryan T, Lightfoot R, Johann-Liang R. Shoulder injury related to vaccine administration (SIRVA). Vaccine. 2010;28(51):8049-8052.

5. Institute of Medicine. Adverse effects of vaccines: evidence and causality. http://www.nationalacademies.org/hmd/~/media/Files/Report%20Files/2011/Adverse-Effects-of-Vaccines-Evidence-and-Causality/Vaccine-report-brief-FINAL.pdf. Published August 2011. Accessed June 3, 2019.

6. Health Resources and Services Administration, Health and Human Services Administration. National vaccine injury compensation program: revisions to the vaccine injury table. https://www.federalregister.gov/documents/2017/01/19/2017-00701/national-vaccine-injury-compensation-program-revisions-to-the-vaccine-injury-table. Published January 19, 2017. Accessed June 3, 2019.

7. Martín Arias LH, Sanz Fadrique R, Sáinz Gil M, Salgueiro-Vazquez ME. Risk of bursitis and other injuries and dysfunctions of the shoulder following vaccinations. Vaccine. 2017;35(37):4870-4876.

8. Centers for Disease Control and Prevention. Reports of shoulder dysfunction following inactivated influenza vaccine in the Vaccine Adverse Event Reporting System (VAERS), 2010-2016. https://stacks.cdc.gov/view/cdc/57624. Published January 4, 2018. Accessed June 3, 2019.

9. McGarvey MA, Hooper AC. The deltoid intramuscular injection site in the adult. Current practice among general practitioners and practice nurses. Ir Med J. 2005;98(4):105-107.

10. Cook IF. An evidence based protocol for the prevention of upper arm injury related to vaccine administration (UAIRVA). Hum Vaccin. 2011;7(8):845-848.

11. Cook IF. Best vaccination practice and medically attended injection site events following deltoid intramuscular injection. Hum Vaccin Immunother. 2015;11(5):1184-1191.

12. Okur G, Chaney KA, Lomasney LM. Magnetic resonance imaging of abnormal shoulder pain following influenza vaccination. Skeletal Radiol. 2014;43(9):1325-1331.

References

1. Centers for Disease Control and Prevention. Epidemiology and prevention of vaccine-preventable diseases. https://www.cdc.gov/vaccines/pubs/pinkbook/vac-admin.html. Published 2015. Accessed June 3, 2019.

2. Bodor M, Montalvo E. Vaccination-related shoulder dysfunction. Vaccine. 2007;25(4):585-587.

3. Kuether G, Dietrich B, Smith T, Peter C, Gruessner S. Atraumatic osteonecrosis of the humeral head after influenza A-(H1N1) v-2009 vaccination. Vaccine. 2011;29(40):6830-6833.

4. Atanasoff S, Ryan T, Lightfoot R, Johann-Liang R. Shoulder injury related to vaccine administration (SIRVA). Vaccine. 2010;28(51):8049-8052.

5. Institute of Medicine. Adverse effects of vaccines: evidence and causality. http://www.nationalacademies.org/hmd/~/media/Files/Report%20Files/2011/Adverse-Effects-of-Vaccines-Evidence-and-Causality/Vaccine-report-brief-FINAL.pdf. Published August 2011. Accessed June 3, 2019.

6. Health Resources and Services Administration, Health and Human Services Administration. National vaccine injury compensation program: revisions to the vaccine injury table. https://www.federalregister.gov/documents/2017/01/19/2017-00701/national-vaccine-injury-compensation-program-revisions-to-the-vaccine-injury-table. Published January 19, 2017. Accessed June 3, 2019.

7. Martín Arias LH, Sanz Fadrique R, Sáinz Gil M, Salgueiro-Vazquez ME. Risk of bursitis and other injuries and dysfunctions of the shoulder following vaccinations. Vaccine. 2017;35(37):4870-4876.

8. Centers for Disease Control and Prevention. Reports of shoulder dysfunction following inactivated influenza vaccine in the Vaccine Adverse Event Reporting System (VAERS), 2010-2016. https://stacks.cdc.gov/view/cdc/57624. Published January 4, 2018. Accessed June 3, 2019.

9. McGarvey MA, Hooper AC. The deltoid intramuscular injection site in the adult. Current practice among general practitioners and practice nurses. Ir Med J. 2005;98(4):105-107.

10. Cook IF. An evidence based protocol for the prevention of upper arm injury related to vaccine administration (UAIRVA). Hum Vaccin. 2011;7(8):845-848.

11. Cook IF. Best vaccination practice and medically attended injection site events following deltoid intramuscular injection. Hum Vaccin Immunother. 2015;11(5):1184-1191.

12. Okur G, Chaney KA, Lomasney LM. Magnetic resonance imaging of abnormal shoulder pain following influenza vaccination. Skeletal Radiol. 2014;43(9):1325-1331.

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Federal Practitioner - 36(8)a
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Federal Practitioner - 36(8)a
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380-384
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