Original Research

ABSTRACT

Injuries to the distal biceps occur at the tendinous insertion at the radial tuberosity. Distal biceps injuries range from tendinosis to partial tears to non-retracted and retracted complete tears. Acute and chronic complete tears result from a tendinous avulsion at the radial tuberosity. Acute tears result from a strong force exerted on an eccentric biceps contraction, leading to tendon injury.

Distal biceps tendon injuries are uncommon (1.2 per 100,000 patients in one study).¹ An underlying degenerative component is involved in all distal biceps tendon tears and tendinosis.² Partial tears can be caused by the same mechanism or by no particular inciting event.³ Magnetic resonance imaging (MRI) is the optimal imaging modality for distal tendon tears because of its excellent specificity and sensitivity in the detection of complete tears.^4,5 Imaging also accurately diagnoses and characterizes partial tears and tendinosis.⁵ On MRI, fast spin-echo intermediate-weighted and T2-weighted or short tau inversion recovery (STIR) sequences are normally obtained to assess tendon integrity. Along with standard axial and sagittal views, the FABS (flexed elbow, abducted shoulder, supinated forearm) view is an important tool in the diagnosis of distal biceps tendon tears.⁶ The FABS view is obtained with the patient prone with the shoulder abducted 180° (above the head), with the elbow flexed to 90°, and the forearm supinated. This position allows a longitudinal view of along the entire length of the distal tendon.

Complete distal biceps tears can usually be diagnosed by history and physical examinations. However, imaging can be helpful when intact brachialis function can compensate for a completely torn tendon. MRI is also useful in the setting of a complete tear to locate the torn tendon stump, and assess the degree of retraction for tendon retrieval^7,8 and quality of the tendon stump for repair. For associated rupture of the lacertus, the degree of proximal tendon retraction can be significant (Figures 1A, 1B). 

Continue to: Partial distal bicep tears...

MRI is useful in assessing the distal biceps tendon in the postoperative setting to evaluate the integrity of a repaired tendon. Cortical fixation button technique for repair creates minimal susceptibility artifacts on MRI. Postoperative MRI typically demonstrates a transverse hole drilled through the proximal radius at the site of the tuberosity with a cortical fixation button flush against the posterior radial cortex (Figures 8A-8D). 

ABSTRACT

Injuries to the distal biceps occur at the tendinous insertion at the radial tuberosity. Distal biceps injuries range from tendinosis to partial tears to non-retracted and retracted complete tears. Acute and chronic complete tears result from a tendinous avulsion at the radial tuberosity. Acute tears result from a strong force exerted on an eccentric biceps contraction, leading to tendon injury.

Distal biceps tendon injuries are uncommon (1.2 per 100,000 patients in one study).¹ An underlying degenerative component is involved in all distal biceps tendon tears and tendinosis.² Partial tears can be caused by the same mechanism or by no particular inciting event.³ Magnetic resonance imaging (MRI) is the optimal imaging modality for distal tendon tears because of its excellent specificity and sensitivity in the detection of complete tears.^4,5 Imaging also accurately diagnoses and characterizes partial tears and tendinosis.⁵ On MRI, fast spin-echo intermediate-weighted and T2-weighted or short tau inversion recovery (STIR) sequences are normally obtained to assess tendon integrity. Along with standard axial and sagittal views, the FABS (flexed elbow, abducted shoulder, supinated forearm) view is an important tool in the diagnosis of distal biceps tendon tears.⁶ The FABS view is obtained with the patient prone with the shoulder abducted 180° (above the head), with the elbow flexed to 90°, and the forearm supinated. This position allows a longitudinal view of along the entire length of the distal tendon.

Complete distal biceps tears can usually be diagnosed by history and physical examinations. However, imaging can be helpful when intact brachialis function can compensate for a completely torn tendon. MRI is also useful in the setting of a complete tear to locate the torn tendon stump, and assess the degree of retraction for tendon retrieval^7,8 and quality of the tendon stump for repair. For associated rupture of the lacertus, the degree of proximal tendon retraction can be significant (Figures 1A, 1B). 

Continue to: Partial distal bicep tears...

MRI is useful in assessing the distal biceps tendon in the postoperative setting to evaluate the integrity of a repaired tendon. Cortical fixation button technique for repair creates minimal susceptibility artifacts on MRI. Postoperative MRI typically demonstrates a transverse hole drilled through the proximal radius at the site of the tuberosity with a cortical fixation button flush against the posterior radial cortex (Figures 8A-8D). 

ABSTRACT

Injuries to the distal biceps occur at the tendinous insertion at the radial tuberosity. Distal biceps injuries range from tendinosis to partial tears to non-retracted and retracted complete tears. Acute and chronic complete tears result from a tendinous avulsion at the radial tuberosity. Acute tears result from a strong force exerted on an eccentric biceps contraction, leading to tendon injury.

Distal biceps tendon injuries are uncommon (1.2 per 100,000 patients in one study).¹ An underlying degenerative component is involved in all distal biceps tendon tears and tendinosis.² Partial tears can be caused by the same mechanism or by no particular inciting event.³ Magnetic resonance imaging (MRI) is the optimal imaging modality for distal tendon tears because of its excellent specificity and sensitivity in the detection of complete tears.^4,5 Imaging also accurately diagnoses and characterizes partial tears and tendinosis.⁵ On MRI, fast spin-echo intermediate-weighted and T2-weighted or short tau inversion recovery (STIR) sequences are normally obtained to assess tendon integrity. Along with standard axial and sagittal views, the FABS (flexed elbow, abducted shoulder, supinated forearm) view is an important tool in the diagnosis of distal biceps tendon tears.⁶ The FABS view is obtained with the patient prone with the shoulder abducted 180° (above the head), with the elbow flexed to 90°, and the forearm supinated. This position allows a longitudinal view of along the entire length of the distal tendon.

Complete distal biceps tears can usually be diagnosed by history and physical examinations. However, imaging can be helpful when intact brachialis function can compensate for a completely torn tendon. MRI is also useful in the setting of a complete tear to locate the torn tendon stump, and assess the degree of retraction for tendon retrieval^7,8 and quality of the tendon stump for repair. For associated rupture of the lacertus, the degree of proximal tendon retraction can be significant (Figures 1A, 1B). 

Continue to: Partial distal bicep tears...

MRI is useful in assessing the distal biceps tendon in the postoperative setting to evaluate the integrity of a repaired tendon. Cortical fixation button technique for repair creates minimal susceptibility artifacts on MRI. Postoperative MRI typically demonstrates a transverse hole drilled through the proximal radius at the site of the tuberosity with a cortical fixation button flush against the posterior radial cortex (Figures 8A-8D). 

ABSTRACT

Lesser tuberosity osteotomy (LTO) and subscapularis tenotomy (ST) are used for takedown of the subscapularis during shoulder arthroplasty. LTO offers the theoretical but unproven benefit of improved healing and function of the subscapularis. However, humeral stem subsidence and loosening may be greater when osteotomy is performed, which may compromise functional outcomes. Our hypothesis is that no difference in proximal collar press-fit humeral stem subsidence or loosening exists, with no impairment of functional outcomes using the LTO technique.

During the surgical approach for total shoulder arthroplasty (TSA), the subscapularis is taken down for adequate exposure to the glenohumeral joint. Various methods are available for taking down the subscapularis, including lesser tuberosity osteotomy (LTO) and a subscapularis tenotomy (ST). LTO offers the theoretical but unproven benefit of improved healing and function of the subscapularis secondary to bone-to-bone healing. One concern, however, is that humeral stem subsidence may be greater when an osteotomy is performed owing to compromise of metaphyseal cortical bone, which may compromise functional outcomes. The humeral stem design may also influence subsidence when metaphyseal bone proximally is compromised. This is a concern in both metaphyseal and diaphyseal fitting stems. Metaphyseal collars on diaphyseal fitting stems rely on adequate bone stock in the metaphysis to provide the additional support needed. Also, posterior subluxation remains a challenge in shoulder arthroplasty. The integrity of the subscapularis is important in prevention of posterior subluxation.¹ To our knowledge, no study to date has directly compared differences in humeral stem subsidence, loosening, or posterior subluxation between LTO and ST techniques with any humeral stem design. Our hypothesis is that no difference in proximal collar press-fit humeral stem subsidence or loosening exists, with no impairment of functional outcomes using the LTO technique. We also hypothesize that no difference in posterior subluxation exists between LTO and ST techniques.

MATERIALS AND METHODS

INCLUSION CRITERIA

Consecutive patients with a minimum of 12 months of radiographic follow-up were selected from 2007 to 2010 after TSA was performed by 1 of the senior authors (Dr. Miller and Dr. Voloshin). Study patients underwent primary TSA for primary osteoarthritis or rheumatoid arthritis.

EXCLUSION CRITERIA

Patients were excluded if they underwent TSA for posttraumatic glenohumeral arthritis, hemiarthroplasty, or osteonecrosis. Patients were also excluded if a rotator cuff tear was discovered intraoperatively or if they had a history of a rotator cuff repair. Additional exclusion criteria included postoperative trauma to the operative shoulder, postoperative infection, extensive documentation of chronic pain, and underlying neurologic disorder (eg, Parkinson disease, dystonia). Patients with a history of diabetes mellitus were not excluded.

SURGICAL TECHNIQUE

All patients underwent TSA via a deltopectoral approach in a modified beach chair position. Biceps tendons were tenodesed at the level of the pectoralis major. All patients received the same proximal collar press-fit implant (Bigliani-Flatow; Zimmer Biomet). These stems provide rotational stability in the metaphyseal segment via fins, vertical stability with the proximal collar, and distal fixation via an interference fit. All parts of the procedure were performed in similar fashion with the exception of ST vs LTO (Figures 1A-1D). 

Continue to: LTO was performed as the primary...

LESSER TUBEROSITY OSTEOTOMY

LTO was performed as the primary or preferred technique of 1 surgeon. After completion of the biceps tenodesis, the lesser tuberosity is reflected off with the subscapularis intact using an osteotome. After placement of the press-fit humeral stem, the LTO is repaired using No. 5 Ethibond Excel sutures (Ethicon) passed through previously created bone tunnels in the greater tuberosity. These sutures are tied over metal buttons over the lateral cortex of the greater tuberosity. Last, the lateral corner of the rotator interval is repaired using a single No. 2 FiberWire (Arthrex).²

SUBSCAPULARIS TENOTOMY

ST is the preferred surgical technique of the second surgeon. After a biceps tenodesis, the subscapularis tendon is released from the lesser tuberosity at the margin of the bicipital groove. Through careful dissection, a single flap including the underlying capsule is created and reflected medially to the level of the coracoid. After placement of the press-fit humeral stem and humeral head, the subscapularis is repaired back in place through previous bone tunnels and with a No. 5 Ethibond Excel suture under the appropriate tension. Then, the lateral corner of the rotator interval is closed using a single No. 2 Ethibond Excel suture in a figure-of-eight fashion.²

RADIOGRAPHIC ANALYSIS

The primary variables analyzed were subsidence and loosening. Additional variables, including humeral-acromial distance (HAD) and subluxation index, were also analyzed to assess for any additional impact caused by subsidence or loosening.³ All radiographic measurements were taken from the Grashey (true anteroposterior) view, except subluxation index, which was calculated using the axillary view. All radiographic measurements were completed by 3 independent reviewers. All radiographs were completed in a consistent manner according to postoperative protocols.

HAD was measured preoperatively, immediately postoperatively, and at final follow-up at a minimum of 1 year. The HAD was measured from the lowest point on the acromion to the humerus using a perpendicular line (Figure 2).

Subsidence of the prosthesis was calculated by determining the difference between immediate postoperative heights of the prosthesis in comparison to the value of the final follow-up films. To calculate the height, 2 lines were drawn, 1 line was drawn perpendicular to the top of the prosthetic head and 1 perpendicular to the top of the greater tuberosity (Figure 3). 

Continue to: Posterior subluxation is indicated...

The humeral stems were evaluated for loosening by assessing for lucency on final radiographic follow-up films. These were evaluated in a zonal fashion as demonstrated by Sanchez-Sotelo and colleagues⁴ and in Figure 5. 

FUNCTIONAL OUTCOME EVALUATION

Before clinical evaluation, each study patient completed the Western Ontario Osteoarthritis of the Shoulder (WOOS) index; the Disabilities of the Hand, Arm and Shoulder (DASH) questionnaire, and the pain and function sections of the Constant score. The functional outcomes scores were captured postoperatively from October to November 2011. The WOOS is a validated outcome measure specific to osteoarthritis of the shoulder and has been used in prior studies evaluating outcomes of TSA.^5-7 Previous studies have determined that the minimal clinically important difference for the WOOS score is 15 on a normalized 0 to 100 scale (100 being the best). The DASH score is a validated outcome measure for disorders of the upper extremity but is not specific to osteoarthritis of the shoulder.⁸ The Constant score is a validated outcome measure for a number of shoulder disorders, including TSA.^9,10

STATISTICAL ANALYSIS

Statistical analyses were completed by a trained biostatistician. A power analysis was calculated using the noninferiority test to determine if adequate data had been obtained for this study. This was calculated by using previously accepted data demonstrating a statistically significant difference for subsidence and HAD. The data from these studies were used to make assumptions regarding accepted standard deviations and noninferiority margins, as calculated from the mean values of the 2 groups analyzed in each respective study.^4,11 This analysis demonstrated power of 0.97 and 0.85 for the subsidence and HAD, respectively, given the current sample sizes. Intraclass coefficients were calculated to evaluate the measurements obtained during the radiographic analysis to determine the interrater agreement. Two samples’ t tests were calculated for the variables analyzed, along with P values and means.

RESULTS

DEMOGRAPHICS

A total of 51 consecutive patients were retrospectively selected for analysis. Of these, 16 patients were excluded from the study because they had <9 months of radiographic follow-up and were unavailable for further follow-up evaluation. Of the remaining 35 patients available for analysis, 4 patients had bilateral TSA, providing 39 shoulders for evaluation. Demographic characteristics of the study cohort are reported in Table 1.

  Fifteen patients underwent LTO, and 24 underwent ST. One patient underwent a tenotomy of the right shoulder and LTO of the left shoulder. Three LTOs were performed by the surgeon who primarily performed ST, owing to potential benefits of LTO. He eventually returned to his preferred technique of ST because of surgeon preference. Three ST procedures were completed by the surgeon who typically performed LTO at the start of the series prior to establishing LTO as his preferred technique. There was no significant difference between the study populations in terms of age, follow-up, male-to-female ratio, hand dominance, and primary diagnosis of osteoarthritis vs rheumatoid arthritis.

Continue to: There was no significant difference...

RADIOGRAPHIC DATA

There was no significant difference in preoperative HAD between the LTO and ST groups (9.5 ± 2.4 mm vs 10.9 ± 2.7 mm, P = .11). The immediate postoperative HAD was statistically significant between the LTO and ST groups (11.9 ± 3.7 mm vs 15.9 ± 4.5 mm, P = .005). There was as statistically significant difference noted in the final follow-up films between the LTO and ST groups (11.8 ± 3.2 mm vs 14.5 ± 3.9 mm, P = .025) (Table 2). 

Abbreviations: LTO, lesser tuberosity osteotomy; ST, subscapularis tenotomy.

There were no statistically significant differences found in subsidence between LTO and ST groups at final follow-up (2.8 mm ± 3.1 mm vs 2.5 mm ± 3.1 mm, P = .72) (Table 2). No statistically significant difference was noted in the subluxation index between the LTO and ST groups (0.55% ± .06% vs 0.54% ± 0.07%, P = .45), but there was a statistically significant difference noted postoperatively between the LTO and ST groups (0.55% ± 0.09% vs .48% ± 0.05%, P = .015) (Table 2).

Two stems were noted to have lucent lines >2 mm, both within the ST cohort. Each had 1 stem zone >2 mm, 1 in zone 7, and 1 in zone 4. No statistically significant difference was identified between the LTO and ST groups (0/15 vs 2/24, P = .51) (Table 2).

FUNCTIONAL OUTCOMES

Study patients were evaluated using functional outcome scores, including the Constant, WOOS, and DASH scores (Table 3). 

Abbreviations: DASH, disabilities of the arm, shoulder and hand; WOOS, Western Ontario Osteoarthritis of the Shoulder.

No statistically significant differences were noted in the DASH scores (8.4 ± 6.6 vs 13.8 ± 4.9, P = .13) or Constant scores (83.3 ± 9.1 vs 81.8 ± 10.1, P = .64) between the LTO and ST cohorts. There was a statistically significant difference between the WOOS scores (93.3 ± 5.3 vs 81.5 ± 20.8, P = .013). Because separate radiographic reviews were done by 3 independent personnel at 3 different times, it was important to ensure agreement among the reviewers. This was compared using the intraclass correlation coefficients. In the statistical analysis completed, the intraclass coefficients showed the 3 reviewers agreed with each other throughout the radiographic analysis (Table 4).

Abbreviations: CI, confidence interval; HAD, humeral acromial distance; ICC, intraclass correlation coefficient; SI, subluxation index.

DISCUSSION

At final follow-up, we identified no statistically significant difference between the LTO and ST patients in subsidence, lucent lines >2 mm, or functional outcomes (Constant and DASH scores) in patients who underwent TSA with the same proximal collar press-fit humeral stem. In regard to the functional outcome scores, although the WOOS score was statistically significant (P = .013) between the LTO and ST cohorts, we do not feel that this is clinically relevant because it does not reach the minimal clinically important difference threshold of 15 points.⁸

A statistically significant difference was noted in postoperative subluxation index but was not clinically relevant, because the values between the LTO and ST groups (0.55 vs 0.48) still showed a centered humeral head. Gerber and colleagues³ discussed using a value of 0.65 as a measure of posterior humeral head subluxation, whereas Walch and colleagues¹² defined posterior humeral head subluxation as a value >0.55. On the basis of these numbers, the values obtained in this study demonstrated that the postoperative values were still centered on the glenoid, and therefore were not clinically significant.^3,12

Continue to: In regard to HAD, there...

Studies have shown a concern regarding the integrity of the subscapularis after tenotomy or peel used in TSA with abnormal subscapularis function.^14,15 Miller and colleagues¹⁵ reported 41 patients, nearly two-thirds, of whom described subscapularis dysfunction. Those authors’ response to the poor clinical outcomes was to remove a fleck of bone with the tendon to achieve “bone-to-bone” healing.¹⁴ Gerber and colleagues¹⁶ reported on a series of patients using LTO and repair in TSA with 75% and 89% intact subscapularis function on clinical testing.¹⁶ Studies by Qureshi and colleagues¹⁷ and Scalise and colleagues¹⁸ showed similar results after LTO. Biomechanical studies have shown mixed results. Ponce and colleagues¹⁹ showed biomechanically superior results for LTO in comparison to the various repair techniques for ST. In another study, Giuseffi and colleagues²⁰ showed no difference in LTO vs ST during biomechanical testing. In response to the increased concern regarding subscapularis integrity, Caplan and colleagues²¹ reported on 45 arthroplasties in 43 patients with improved postoperative testing with intact subscapularis testing in 90% to 100% of patients. A level 1 randomized control trial conducted by Lapner and colleagues²² did not demonstrate any clear clinical advantage of LTO vs ST. Controversy still exists regarding which is the preferred technique for TSA.

Sanchez-Sotelo and colleagues⁴ evaluated uncemented humeral components in 72 patients who underwent TSA. They found a humeral component was at risk for loosening if a radiolucent line ≥2 mm was present in at least 3 radiographic zones. They also evaluated tilt or subsidence by measurement and whether the components were observed to have changed. Their measured values correlated with their observed values. That study provided a benchmark for evaluation of loosening and subsidence used during this study.⁴ Although radiographic follow-up is limited in this study, we feel that any potential subsidence secondary to use of the LTO technique would be radiographically apparent at 1 year. There were 16 patients without adequate radiographic follow-up included in the study. However, we feel that this was not a large concern, because the study was adequately powered with the patients available to determine a difference based on subsidence.

CONCLUSION

We found no difference in subsidence, lucent lines >2 mm, posterior subluxation, and the Constant and DASH functional outcome scores when we compared TSA performed by a LTO with an ST technique with proximal collar press-fit humeral stem. These data cannot be extrapolated to metaphyseal fit stems, which may exhibit different settling characteristics in the setting of the LTO technique.

This paper will be judged for the Resident Writer’s Award.

ABSTRACT

Lesser tuberosity osteotomy (LTO) and subscapularis tenotomy (ST) are used for takedown of the subscapularis during shoulder arthroplasty. LTO offers the theoretical but unproven benefit of improved healing and function of the subscapularis. However, humeral stem subsidence and loosening may be greater when osteotomy is performed, which may compromise functional outcomes. Our hypothesis is that no difference in proximal collar press-fit humeral stem subsidence or loosening exists, with no impairment of functional outcomes using the LTO technique.

During the surgical approach for total shoulder arthroplasty (TSA), the subscapularis is taken down for adequate exposure to the glenohumeral joint. Various methods are available for taking down the subscapularis, including lesser tuberosity osteotomy (LTO) and a subscapularis tenotomy (ST). LTO offers the theoretical but unproven benefit of improved healing and function of the subscapularis secondary to bone-to-bone healing. One concern, however, is that humeral stem subsidence may be greater when an osteotomy is performed owing to compromise of metaphyseal cortical bone, which may compromise functional outcomes. The humeral stem design may also influence subsidence when metaphyseal bone proximally is compromised. This is a concern in both metaphyseal and diaphyseal fitting stems. Metaphyseal collars on diaphyseal fitting stems rely on adequate bone stock in the metaphysis to provide the additional support needed. Also, posterior subluxation remains a challenge in shoulder arthroplasty. The integrity of the subscapularis is important in prevention of posterior subluxation.¹ To our knowledge, no study to date has directly compared differences in humeral stem subsidence, loosening, or posterior subluxation between LTO and ST techniques with any humeral stem design. Our hypothesis is that no difference in proximal collar press-fit humeral stem subsidence or loosening exists, with no impairment of functional outcomes using the LTO technique. We also hypothesize that no difference in posterior subluxation exists between LTO and ST techniques.

MATERIALS AND METHODS

INCLUSION CRITERIA

Consecutive patients with a minimum of 12 months of radiographic follow-up were selected from 2007 to 2010 after TSA was performed by 1 of the senior authors (Dr. Miller and Dr. Voloshin). Study patients underwent primary TSA for primary osteoarthritis or rheumatoid arthritis.

EXCLUSION CRITERIA

Patients were excluded if they underwent TSA for posttraumatic glenohumeral arthritis, hemiarthroplasty, or osteonecrosis. Patients were also excluded if a rotator cuff tear was discovered intraoperatively or if they had a history of a rotator cuff repair. Additional exclusion criteria included postoperative trauma to the operative shoulder, postoperative infection, extensive documentation of chronic pain, and underlying neurologic disorder (eg, Parkinson disease, dystonia). Patients with a history of diabetes mellitus were not excluded.

SURGICAL TECHNIQUE

All patients underwent TSA via a deltopectoral approach in a modified beach chair position. Biceps tendons were tenodesed at the level of the pectoralis major. All patients received the same proximal collar press-fit implant (Bigliani-Flatow; Zimmer Biomet). These stems provide rotational stability in the metaphyseal segment via fins, vertical stability with the proximal collar, and distal fixation via an interference fit. All parts of the procedure were performed in similar fashion with the exception of ST vs LTO (Figures 1A-1D). 

Continue to: LTO was performed as the primary...

LESSER TUBEROSITY OSTEOTOMY

LTO was performed as the primary or preferred technique of 1 surgeon. After completion of the biceps tenodesis, the lesser tuberosity is reflected off with the subscapularis intact using an osteotome. After placement of the press-fit humeral stem, the LTO is repaired using No. 5 Ethibond Excel sutures (Ethicon) passed through previously created bone tunnels in the greater tuberosity. These sutures are tied over metal buttons over the lateral cortex of the greater tuberosity. Last, the lateral corner of the rotator interval is repaired using a single No. 2 FiberWire (Arthrex).²

SUBSCAPULARIS TENOTOMY

ST is the preferred surgical technique of the second surgeon. After a biceps tenodesis, the subscapularis tendon is released from the lesser tuberosity at the margin of the bicipital groove. Through careful dissection, a single flap including the underlying capsule is created and reflected medially to the level of the coracoid. After placement of the press-fit humeral stem and humeral head, the subscapularis is repaired back in place through previous bone tunnels and with a No. 5 Ethibond Excel suture under the appropriate tension. Then, the lateral corner of the rotator interval is closed using a single No. 2 Ethibond Excel suture in a figure-of-eight fashion.²

RADIOGRAPHIC ANALYSIS

The primary variables analyzed were subsidence and loosening. Additional variables, including humeral-acromial distance (HAD) and subluxation index, were also analyzed to assess for any additional impact caused by subsidence or loosening.³ All radiographic measurements were taken from the Grashey (true anteroposterior) view, except subluxation index, which was calculated using the axillary view. All radiographic measurements were completed by 3 independent reviewers. All radiographs were completed in a consistent manner according to postoperative protocols.

HAD was measured preoperatively, immediately postoperatively, and at final follow-up at a minimum of 1 year. The HAD was measured from the lowest point on the acromion to the humerus using a perpendicular line (Figure 2).

Subsidence of the prosthesis was calculated by determining the difference between immediate postoperative heights of the prosthesis in comparison to the value of the final follow-up films. To calculate the height, 2 lines were drawn, 1 line was drawn perpendicular to the top of the prosthetic head and 1 perpendicular to the top of the greater tuberosity (Figure 3). 

Continue to: Posterior subluxation is indicated...

The humeral stems were evaluated for loosening by assessing for lucency on final radiographic follow-up films. These were evaluated in a zonal fashion as demonstrated by Sanchez-Sotelo and colleagues⁴ and in Figure 5. 

FUNCTIONAL OUTCOME EVALUATION

Before clinical evaluation, each study patient completed the Western Ontario Osteoarthritis of the Shoulder (WOOS) index; the Disabilities of the Hand, Arm and Shoulder (DASH) questionnaire, and the pain and function sections of the Constant score. The functional outcomes scores were captured postoperatively from October to November 2011. The WOOS is a validated outcome measure specific to osteoarthritis of the shoulder and has been used in prior studies evaluating outcomes of TSA.^5-7 Previous studies have determined that the minimal clinically important difference for the WOOS score is 15 on a normalized 0 to 100 scale (100 being the best). The DASH score is a validated outcome measure for disorders of the upper extremity but is not specific to osteoarthritis of the shoulder.⁸ The Constant score is a validated outcome measure for a number of shoulder disorders, including TSA.^9,10

STATISTICAL ANALYSIS

Statistical analyses were completed by a trained biostatistician. A power analysis was calculated using the noninferiority test to determine if adequate data had been obtained for this study. This was calculated by using previously accepted data demonstrating a statistically significant difference for subsidence and HAD. The data from these studies were used to make assumptions regarding accepted standard deviations and noninferiority margins, as calculated from the mean values of the 2 groups analyzed in each respective study.^4,11 This analysis demonstrated power of 0.97 and 0.85 for the subsidence and HAD, respectively, given the current sample sizes. Intraclass coefficients were calculated to evaluate the measurements obtained during the radiographic analysis to determine the interrater agreement. Two samples’ t tests were calculated for the variables analyzed, along with P values and means.

RESULTS

DEMOGRAPHICS

A total of 51 consecutive patients were retrospectively selected for analysis. Of these, 16 patients were excluded from the study because they had <9 months of radiographic follow-up and were unavailable for further follow-up evaluation. Of the remaining 35 patients available for analysis, 4 patients had bilateral TSA, providing 39 shoulders for evaluation. Demographic characteristics of the study cohort are reported in Table 1.

  Fifteen patients underwent LTO, and 24 underwent ST. One patient underwent a tenotomy of the right shoulder and LTO of the left shoulder. Three LTOs were performed by the surgeon who primarily performed ST, owing to potential benefits of LTO. He eventually returned to his preferred technique of ST because of surgeon preference. Three ST procedures were completed by the surgeon who typically performed LTO at the start of the series prior to establishing LTO as his preferred technique. There was no significant difference between the study populations in terms of age, follow-up, male-to-female ratio, hand dominance, and primary diagnosis of osteoarthritis vs rheumatoid arthritis.

Continue to: There was no significant difference...

RADIOGRAPHIC DATA

There was no significant difference in preoperative HAD between the LTO and ST groups (9.5 ± 2.4 mm vs 10.9 ± 2.7 mm, P = .11). The immediate postoperative HAD was statistically significant between the LTO and ST groups (11.9 ± 3.7 mm vs 15.9 ± 4.5 mm, P = .005). There was as statistically significant difference noted in the final follow-up films between the LTO and ST groups (11.8 ± 3.2 mm vs 14.5 ± 3.9 mm, P = .025) (Table 2). 

Abbreviations: LTO, lesser tuberosity osteotomy; ST, subscapularis tenotomy.

There were no statistically significant differences found in subsidence between LTO and ST groups at final follow-up (2.8 mm ± 3.1 mm vs 2.5 mm ± 3.1 mm, P = .72) (Table 2). No statistically significant difference was noted in the subluxation index between the LTO and ST groups (0.55% ± .06% vs 0.54% ± 0.07%, P = .45), but there was a statistically significant difference noted postoperatively between the LTO and ST groups (0.55% ± 0.09% vs .48% ± 0.05%, P = .015) (Table 2).

Two stems were noted to have lucent lines >2 mm, both within the ST cohort. Each had 1 stem zone >2 mm, 1 in zone 7, and 1 in zone 4. No statistically significant difference was identified between the LTO and ST groups (0/15 vs 2/24, P = .51) (Table 2).

FUNCTIONAL OUTCOMES

Study patients were evaluated using functional outcome scores, including the Constant, WOOS, and DASH scores (Table 3). 

Abbreviations: DASH, disabilities of the arm, shoulder and hand; WOOS, Western Ontario Osteoarthritis of the Shoulder.

No statistically significant differences were noted in the DASH scores (8.4 ± 6.6 vs 13.8 ± 4.9, P = .13) or Constant scores (83.3 ± 9.1 vs 81.8 ± 10.1, P = .64) between the LTO and ST cohorts. There was a statistically significant difference between the WOOS scores (93.3 ± 5.3 vs 81.5 ± 20.8, P = .013). Because separate radiographic reviews were done by 3 independent personnel at 3 different times, it was important to ensure agreement among the reviewers. This was compared using the intraclass correlation coefficients. In the statistical analysis completed, the intraclass coefficients showed the 3 reviewers agreed with each other throughout the radiographic analysis (Table 4).

Abbreviations: CI, confidence interval; HAD, humeral acromial distance; ICC, intraclass correlation coefficient; SI, subluxation index.

DISCUSSION

At final follow-up, we identified no statistically significant difference between the LTO and ST patients in subsidence, lucent lines >2 mm, or functional outcomes (Constant and DASH scores) in patients who underwent TSA with the same proximal collar press-fit humeral stem. In regard to the functional outcome scores, although the WOOS score was statistically significant (P = .013) between the LTO and ST cohorts, we do not feel that this is clinically relevant because it does not reach the minimal clinically important difference threshold of 15 points.⁸

A statistically significant difference was noted in postoperative subluxation index but was not clinically relevant, because the values between the LTO and ST groups (0.55 vs 0.48) still showed a centered humeral head. Gerber and colleagues³ discussed using a value of 0.65 as a measure of posterior humeral head subluxation, whereas Walch and colleagues¹² defined posterior humeral head subluxation as a value >0.55. On the basis of these numbers, the values obtained in this study demonstrated that the postoperative values were still centered on the glenoid, and therefore were not clinically significant.^3,12

Continue to: In regard to HAD, there...

Studies have shown a concern regarding the integrity of the subscapularis after tenotomy or peel used in TSA with abnormal subscapularis function.^14,15 Miller and colleagues¹⁵ reported 41 patients, nearly two-thirds, of whom described subscapularis dysfunction. Those authors’ response to the poor clinical outcomes was to remove a fleck of bone with the tendon to achieve “bone-to-bone” healing.¹⁴ Gerber and colleagues¹⁶ reported on a series of patients using LTO and repair in TSA with 75% and 89% intact subscapularis function on clinical testing.¹⁶ Studies by Qureshi and colleagues¹⁷ and Scalise and colleagues¹⁸ showed similar results after LTO. Biomechanical studies have shown mixed results. Ponce and colleagues¹⁹ showed biomechanically superior results for LTO in comparison to the various repair techniques for ST. In another study, Giuseffi and colleagues²⁰ showed no difference in LTO vs ST during biomechanical testing. In response to the increased concern regarding subscapularis integrity, Caplan and colleagues²¹ reported on 45 arthroplasties in 43 patients with improved postoperative testing with intact subscapularis testing in 90% to 100% of patients. A level 1 randomized control trial conducted by Lapner and colleagues²² did not demonstrate any clear clinical advantage of LTO vs ST. Controversy still exists regarding which is the preferred technique for TSA.

Sanchez-Sotelo and colleagues⁴ evaluated uncemented humeral components in 72 patients who underwent TSA. They found a humeral component was at risk for loosening if a radiolucent line ≥2 mm was present in at least 3 radiographic zones. They also evaluated tilt or subsidence by measurement and whether the components were observed to have changed. Their measured values correlated with their observed values. That study provided a benchmark for evaluation of loosening and subsidence used during this study.⁴ Although radiographic follow-up is limited in this study, we feel that any potential subsidence secondary to use of the LTO technique would be radiographically apparent at 1 year. There were 16 patients without adequate radiographic follow-up included in the study. However, we feel that this was not a large concern, because the study was adequately powered with the patients available to determine a difference based on subsidence.

CONCLUSION

We found no difference in subsidence, lucent lines >2 mm, posterior subluxation, and the Constant and DASH functional outcome scores when we compared TSA performed by a LTO with an ST technique with proximal collar press-fit humeral stem. These data cannot be extrapolated to metaphyseal fit stems, which may exhibit different settling characteristics in the setting of the LTO technique.

This paper will be judged for the Resident Writer’s Award.

ABSTRACT

Lesser tuberosity osteotomy (LTO) and subscapularis tenotomy (ST) are used for takedown of the subscapularis during shoulder arthroplasty. LTO offers the theoretical but unproven benefit of improved healing and function of the subscapularis. However, humeral stem subsidence and loosening may be greater when osteotomy is performed, which may compromise functional outcomes. Our hypothesis is that no difference in proximal collar press-fit humeral stem subsidence or loosening exists, with no impairment of functional outcomes using the LTO technique.

During the surgical approach for total shoulder arthroplasty (TSA), the subscapularis is taken down for adequate exposure to the glenohumeral joint. Various methods are available for taking down the subscapularis, including lesser tuberosity osteotomy (LTO) and a subscapularis tenotomy (ST). LTO offers the theoretical but unproven benefit of improved healing and function of the subscapularis secondary to bone-to-bone healing. One concern, however, is that humeral stem subsidence may be greater when an osteotomy is performed owing to compromise of metaphyseal cortical bone, which may compromise functional outcomes. The humeral stem design may also influence subsidence when metaphyseal bone proximally is compromised. This is a concern in both metaphyseal and diaphyseal fitting stems. Metaphyseal collars on diaphyseal fitting stems rely on adequate bone stock in the metaphysis to provide the additional support needed. Also, posterior subluxation remains a challenge in shoulder arthroplasty. The integrity of the subscapularis is important in prevention of posterior subluxation.¹ To our knowledge, no study to date has directly compared differences in humeral stem subsidence, loosening, or posterior subluxation between LTO and ST techniques with any humeral stem design. Our hypothesis is that no difference in proximal collar press-fit humeral stem subsidence or loosening exists, with no impairment of functional outcomes using the LTO technique. We also hypothesize that no difference in posterior subluxation exists between LTO and ST techniques.

MATERIALS AND METHODS

INCLUSION CRITERIA

Consecutive patients with a minimum of 12 months of radiographic follow-up were selected from 2007 to 2010 after TSA was performed by 1 of the senior authors (Dr. Miller and Dr. Voloshin). Study patients underwent primary TSA for primary osteoarthritis or rheumatoid arthritis.

EXCLUSION CRITERIA

Patients were excluded if they underwent TSA for posttraumatic glenohumeral arthritis, hemiarthroplasty, or osteonecrosis. Patients were also excluded if a rotator cuff tear was discovered intraoperatively or if they had a history of a rotator cuff repair. Additional exclusion criteria included postoperative trauma to the operative shoulder, postoperative infection, extensive documentation of chronic pain, and underlying neurologic disorder (eg, Parkinson disease, dystonia). Patients with a history of diabetes mellitus were not excluded.

SURGICAL TECHNIQUE

All patients underwent TSA via a deltopectoral approach in a modified beach chair position. Biceps tendons were tenodesed at the level of the pectoralis major. All patients received the same proximal collar press-fit implant (Bigliani-Flatow; Zimmer Biomet). These stems provide rotational stability in the metaphyseal segment via fins, vertical stability with the proximal collar, and distal fixation via an interference fit. All parts of the procedure were performed in similar fashion with the exception of ST vs LTO (Figures 1A-1D). 

Continue to: LTO was performed as the primary...

LESSER TUBEROSITY OSTEOTOMY

LTO was performed as the primary or preferred technique of 1 surgeon. After completion of the biceps tenodesis, the lesser tuberosity is reflected off with the subscapularis intact using an osteotome. After placement of the press-fit humeral stem, the LTO is repaired using No. 5 Ethibond Excel sutures (Ethicon) passed through previously created bone tunnels in the greater tuberosity. These sutures are tied over metal buttons over the lateral cortex of the greater tuberosity. Last, the lateral corner of the rotator interval is repaired using a single No. 2 FiberWire (Arthrex).²

SUBSCAPULARIS TENOTOMY

ST is the preferred surgical technique of the second surgeon. After a biceps tenodesis, the subscapularis tendon is released from the lesser tuberosity at the margin of the bicipital groove. Through careful dissection, a single flap including the underlying capsule is created and reflected medially to the level of the coracoid. After placement of the press-fit humeral stem and humeral head, the subscapularis is repaired back in place through previous bone tunnels and with a No. 5 Ethibond Excel suture under the appropriate tension. Then, the lateral corner of the rotator interval is closed using a single No. 2 Ethibond Excel suture in a figure-of-eight fashion.²

RADIOGRAPHIC ANALYSIS

The primary variables analyzed were subsidence and loosening. Additional variables, including humeral-acromial distance (HAD) and subluxation index, were also analyzed to assess for any additional impact caused by subsidence or loosening.³ All radiographic measurements were taken from the Grashey (true anteroposterior) view, except subluxation index, which was calculated using the axillary view. All radiographic measurements were completed by 3 independent reviewers. All radiographs were completed in a consistent manner according to postoperative protocols.

HAD was measured preoperatively, immediately postoperatively, and at final follow-up at a minimum of 1 year. The HAD was measured from the lowest point on the acromion to the humerus using a perpendicular line (Figure 2).

Subsidence of the prosthesis was calculated by determining the difference between immediate postoperative heights of the prosthesis in comparison to the value of the final follow-up films. To calculate the height, 2 lines were drawn, 1 line was drawn perpendicular to the top of the prosthetic head and 1 perpendicular to the top of the greater tuberosity (Figure 3). 

Continue to: Posterior subluxation is indicated...

The humeral stems were evaluated for loosening by assessing for lucency on final radiographic follow-up films. These were evaluated in a zonal fashion as demonstrated by Sanchez-Sotelo and colleagues⁴ and in Figure 5. 

FUNCTIONAL OUTCOME EVALUATION

Before clinical evaluation, each study patient completed the Western Ontario Osteoarthritis of the Shoulder (WOOS) index; the Disabilities of the Hand, Arm and Shoulder (DASH) questionnaire, and the pain and function sections of the Constant score. The functional outcomes scores were captured postoperatively from October to November 2011. The WOOS is a validated outcome measure specific to osteoarthritis of the shoulder and has been used in prior studies evaluating outcomes of TSA.^5-7 Previous studies have determined that the minimal clinically important difference for the WOOS score is 15 on a normalized 0 to 100 scale (100 being the best). The DASH score is a validated outcome measure for disorders of the upper extremity but is not specific to osteoarthritis of the shoulder.⁸ The Constant score is a validated outcome measure for a number of shoulder disorders, including TSA.^9,10

STATISTICAL ANALYSIS

Statistical analyses were completed by a trained biostatistician. A power analysis was calculated using the noninferiority test to determine if adequate data had been obtained for this study. This was calculated by using previously accepted data demonstrating a statistically significant difference for subsidence and HAD. The data from these studies were used to make assumptions regarding accepted standard deviations and noninferiority margins, as calculated from the mean values of the 2 groups analyzed in each respective study.^4,11 This analysis demonstrated power of 0.97 and 0.85 for the subsidence and HAD, respectively, given the current sample sizes. Intraclass coefficients were calculated to evaluate the measurements obtained during the radiographic analysis to determine the interrater agreement. Two samples’ t tests were calculated for the variables analyzed, along with P values and means.

RESULTS

DEMOGRAPHICS

A total of 51 consecutive patients were retrospectively selected for analysis. Of these, 16 patients were excluded from the study because they had <9 months of radiographic follow-up and were unavailable for further follow-up evaluation. Of the remaining 35 patients available for analysis, 4 patients had bilateral TSA, providing 39 shoulders for evaluation. Demographic characteristics of the study cohort are reported in Table 1.

  Fifteen patients underwent LTO, and 24 underwent ST. One patient underwent a tenotomy of the right shoulder and LTO of the left shoulder. Three LTOs were performed by the surgeon who primarily performed ST, owing to potential benefits of LTO. He eventually returned to his preferred technique of ST because of surgeon preference. Three ST procedures were completed by the surgeon who typically performed LTO at the start of the series prior to establishing LTO as his preferred technique. There was no significant difference between the study populations in terms of age, follow-up, male-to-female ratio, hand dominance, and primary diagnosis of osteoarthritis vs rheumatoid arthritis.

Continue to: There was no significant difference...

RADIOGRAPHIC DATA

There was no significant difference in preoperative HAD between the LTO and ST groups (9.5 ± 2.4 mm vs 10.9 ± 2.7 mm, P = .11). The immediate postoperative HAD was statistically significant between the LTO and ST groups (11.9 ± 3.7 mm vs 15.9 ± 4.5 mm, P = .005). There was as statistically significant difference noted in the final follow-up films between the LTO and ST groups (11.8 ± 3.2 mm vs 14.5 ± 3.9 mm, P = .025) (Table 2). 

Abbreviations: LTO, lesser tuberosity osteotomy; ST, subscapularis tenotomy.

There were no statistically significant differences found in subsidence between LTO and ST groups at final follow-up (2.8 mm ± 3.1 mm vs 2.5 mm ± 3.1 mm, P = .72) (Table 2). No statistically significant difference was noted in the subluxation index between the LTO and ST groups (0.55% ± .06% vs 0.54% ± 0.07%, P = .45), but there was a statistically significant difference noted postoperatively between the LTO and ST groups (0.55% ± 0.09% vs .48% ± 0.05%, P = .015) (Table 2).

Two stems were noted to have lucent lines >2 mm, both within the ST cohort. Each had 1 stem zone >2 mm, 1 in zone 7, and 1 in zone 4. No statistically significant difference was identified between the LTO and ST groups (0/15 vs 2/24, P = .51) (Table 2).

FUNCTIONAL OUTCOMES

Study patients were evaluated using functional outcome scores, including the Constant, WOOS, and DASH scores (Table 3). 

Abbreviations: DASH, disabilities of the arm, shoulder and hand; WOOS, Western Ontario Osteoarthritis of the Shoulder.

No statistically significant differences were noted in the DASH scores (8.4 ± 6.6 vs 13.8 ± 4.9, P = .13) or Constant scores (83.3 ± 9.1 vs 81.8 ± 10.1, P = .64) between the LTO and ST cohorts. There was a statistically significant difference between the WOOS scores (93.3 ± 5.3 vs 81.5 ± 20.8, P = .013). Because separate radiographic reviews were done by 3 independent personnel at 3 different times, it was important to ensure agreement among the reviewers. This was compared using the intraclass correlation coefficients. In the statistical analysis completed, the intraclass coefficients showed the 3 reviewers agreed with each other throughout the radiographic analysis (Table 4).

Abbreviations: CI, confidence interval; HAD, humeral acromial distance; ICC, intraclass correlation coefficient; SI, subluxation index.

DISCUSSION

At final follow-up, we identified no statistically significant difference between the LTO and ST patients in subsidence, lucent lines >2 mm, or functional outcomes (Constant and DASH scores) in patients who underwent TSA with the same proximal collar press-fit humeral stem. In regard to the functional outcome scores, although the WOOS score was statistically significant (P = .013) between the LTO and ST cohorts, we do not feel that this is clinically relevant because it does not reach the minimal clinically important difference threshold of 15 points.⁸

A statistically significant difference was noted in postoperative subluxation index but was not clinically relevant, because the values between the LTO and ST groups (0.55 vs 0.48) still showed a centered humeral head. Gerber and colleagues³ discussed using a value of 0.65 as a measure of posterior humeral head subluxation, whereas Walch and colleagues¹² defined posterior humeral head subluxation as a value >0.55. On the basis of these numbers, the values obtained in this study demonstrated that the postoperative values were still centered on the glenoid, and therefore were not clinically significant.^3,12

Continue to: In regard to HAD, there...

Studies have shown a concern regarding the integrity of the subscapularis after tenotomy or peel used in TSA with abnormal subscapularis function.^14,15 Miller and colleagues¹⁵ reported 41 patients, nearly two-thirds, of whom described subscapularis dysfunction. Those authors’ response to the poor clinical outcomes was to remove a fleck of bone with the tendon to achieve “bone-to-bone” healing.¹⁴ Gerber and colleagues¹⁶ reported on a series of patients using LTO and repair in TSA with 75% and 89% intact subscapularis function on clinical testing.¹⁶ Studies by Qureshi and colleagues¹⁷ and Scalise and colleagues¹⁸ showed similar results after LTO. Biomechanical studies have shown mixed results. Ponce and colleagues¹⁹ showed biomechanically superior results for LTO in comparison to the various repair techniques for ST. In another study, Giuseffi and colleagues²⁰ showed no difference in LTO vs ST during biomechanical testing. In response to the increased concern regarding subscapularis integrity, Caplan and colleagues²¹ reported on 45 arthroplasties in 43 patients with improved postoperative testing with intact subscapularis testing in 90% to 100% of patients. A level 1 randomized control trial conducted by Lapner and colleagues²² did not demonstrate any clear clinical advantage of LTO vs ST. Controversy still exists regarding which is the preferred technique for TSA.

Sanchez-Sotelo and colleagues⁴ evaluated uncemented humeral components in 72 patients who underwent TSA. They found a humeral component was at risk for loosening if a radiolucent line ≥2 mm was present in at least 3 radiographic zones. They also evaluated tilt or subsidence by measurement and whether the components were observed to have changed. Their measured values correlated with their observed values. That study provided a benchmark for evaluation of loosening and subsidence used during this study.⁴ Although radiographic follow-up is limited in this study, we feel that any potential subsidence secondary to use of the LTO technique would be radiographically apparent at 1 year. There were 16 patients without adequate radiographic follow-up included in the study. However, we feel that this was not a large concern, because the study was adequately powered with the patients available to determine a difference based on subsidence.

CONCLUSION

We found no difference in subsidence, lucent lines >2 mm, posterior subluxation, and the Constant and DASH functional outcome scores when we compared TSA performed by a LTO with an ST technique with proximal collar press-fit humeral stem. These data cannot be extrapolated to metaphyseal fit stems, which may exhibit different settling characteristics in the setting of the LTO technique.

This paper will be judged for the Resident Writer’s Award.

ABSTRACT

The purpose of this study is to determine the effectiveness of tranexamic acid (TXA) alone and in conjunction with a bipolar sealer in reducing postoperative transfusions during direct anterior (DA) total hip arthroplasty (THA).

In this retrospective review, we analyzed 173 consecutive patients who underwent primary unilateral DA THA performed by 2 surgeons during a 1-year period. Subjects were divided into 3 groups based on TXA use: 63 patients received TXA alone (TXA group), 49 patients received TXA in addition to a bipolar sealer (TXA + bipolar sealer group), and 61 patients received neither TXA nor a bipolar sealer (control group). Primary end points were the transfusion rate and estimated blood loss. Secondary end points were length of stay, postoperative drop in hemoglobin, and postoperative drain output.

Two patients in the TXA group and 10 patients in the control group were transfused (P = .02). In the TXA + bipolar sealer group, 1 patient was transfused (P = .02). No significant difference in the rate of transfusion was found between the TXA group and the TXA + bipolar sealer group (P = .99). Estimated blood loss was 310.3 mL ± 182.5 mL in the TXA group (P = .004), 292.9 mL ± 130.8 mL in the TXA + bipolar sealer group (P = .003), and 404.9 mL ± 201.2 mL in the control group. 

The use of TXA, with and without the concomitant use of a bipolar sealer, decreases intraoperative blood loss and postoperative transfusion requirements. The addition of a bipolar sealer, however, does not appear to provide any additional decrease in blood loss.

Historically, patients undergoing total hip arthroplasty (THA) have significant blood loss and required blood transfusions.^1-3 Blood transfusions increase not only the risk of complications but also the cost of the procedure.^4-9 Although less invasive techniques in hip surgery may decrease blood loss,^10-12 intraoperative blood loss remains a concern. Optimization of anemia and blood conservation techniques include preoperative autologous blood donation, perioperative hemodilution, meticulous surgical hemostasis, and the use of antifibrinolytic agents.^4,5,7,13,14 Antifibrinolytics are inexpensive and have been shown to reduce blood loss during THA and total knee arthroplasty (TKA).^7,15-17

Continue to: Tranexamic acid (TXA), a synthetic analog...

Although many studies have analyzed the use of TXA and a bipolar sealer with the posterior and lateral approaches to hip arthroplasty, there is a paucity of research analyzing its use in the DA approach. This study retrospectively reviews the effectiveness of TXA alone and in conjunction with a bipolar sealer in reducing allogeneic blood transfusions in DA THA.

METHODS

This is a retrospective, comparative study evaluating the efficacy of TXA with and without a bipolar sealer in unilateral DA THA. The study included 173 patients who underwent standard DA THA performed by 2 surgeons in the period April 2013 to April 2014. Patient demographic information is summarized in Table 1.

Table 1. Demographic Data

^aResult values are expressed as mean ± standard deviation (range). ^bResult values are expressed as number of cases (percentage of column header population).

Abbreviations: BMI, body mass index; TXA, tranexamic acid.

Three cohorts were created based on intraoperative blood loss management practices at the surgeon’s discretion. The first group included 63 patients who underwent DA THA with TXA but not a bipolar sealer. The second group included 49 patients who underwent DA THA with TXA and a bipolar sealer. The third (control) group included 61 patients who underwent DA THA without TXA or a bipolar sealer. Data for the control group were collected prospectively as a part of a randomized trial, which demonstrated a reduction in transfusion requirements and blood loss with the use of a bipolar sealer in DA THA.²⁸ All patients received a surgical hemovac suction drain, which was removed at 24 hours after surgery. All patients received 40 mg of enoxaparin daily for 2 weeks for venous thromboembolism prophylaxis starting the day after surgery.

All patients in the first 2 groups received 2 g of TXA administered intravenously in 2 doses: the first dose was given preoperatively, and the second dose was given immediately postoperatively in the recovery room. The bipolar sealer was utilized as needed perioperatively according to the manufacturer’s instructions to address specific bleeding targets. The common sites and steps of a DA THA, in which bleeding typically occurs, are:

• The medial femoral circumflex artery during the approach to the capsule;
• The anterior hip capsule vessels prior to capsulotomy;
• The deep branch of the medial femoral circumflex artery and the nutrient vessels to the lesser trochanter encountered while exposing the medial neck and releasing the medial capsule;
• The posterior-superior retinacular arteries encountered after femoral neck osteotomy and removal of the femoral head along the posterior capsule; and
• The branch of the obturator artery encountered during exposure of the acetabular fovea.^29-31

At the time of this study, the transfusion criteria included hemoglobin <8 g/dL in the presence of clinical symptoms.

Continue to: Primary outcome measures...

OUTCOME MEASURES AND DATA ANALYSIS

Primary outcome measures were transfusion requirements and estimated blood loss. Secondary outcome measures were postoperative decrease in hemoglobin, length of stay, and postoperative drain output. Demographic and operative data were compared between groups to ensure that there were no statistically significant differences in blood loss and transfusion requirements. All data were recorded in a password encrypted file and subsequently transferred to the REDCap system (Research Electronic Data Capture, Vanderbilt University).

STATISTICAL ANALYSIS

A priori sample size calculation was performed on the basis of a prior study ²⁸, which evaluated surgical blood loss reduction utilizing a bipolar sealer. This study suggested a sample size of 20 per group to detect the minimal clinically important difference of 1.5 (standard deviation (SD) = 1.5, α = 0.05, β = 0.20). Additionally, a general estimate for detecting a 1-unit change on an ordinal scale of 136 (SD = 1.0, α = 0.05, β = 0.20) resulted in the same number. We conservatively chose to include at least 24 patients in each study arm in the event of greater true variance. The Wilcoxon rank-sum test was used for comparison of continuous data between groups. Differences between means were analyzed using 2-sided t tests. Comparison of categorical data was performed using Pearson’s chi-square or Fisher’s exact probability test as indicated. Ordinal ranking scores were compared using the Mantel-Haenszel test.

RESULTS

There were no statistically significant differences between groups with respect to sex, age, body mass index, or preoperative hemoglobin level (Table 1). Two patients in the TXA group and 10 patients in the control group were transfused (P = .02). In the TXA + bipolar sealer group, 1 patient was transfused (P = .02). A comparison of the transfusion rate between the TXA group and the TXA + bipolar sealer group yielded no significant difference (P = .99). The estimated blood loss was 310.3 mL ± 182.5 mL in the TXA group (P = .004), 292.9 mL ± 130.8 mL in the TXA + bipolar sealer group (P = .003), and 404.9 mL ± 201.2 mL in the control group (P = .71) (Table 2).

Table 2. Patient-Related Outcomes

^aResult values are expressed as mean ± standard deviation (range). ^bResult values are expressed as number of cases (percentage of column header population).

Abbreviation: TXA, tranexamic acid.

The total drain output was 326.3 mL ± 197.5 mL in the TXA group (P < .001 for comparison with the control group), 309.8 mL ± 196.3 mL in the TXA + bipolar sealer group (P < .001 for comparison with the control group), and 473.6 mL ± 199.7 mL in the control group (P = .58). The decrease in hemoglobin was 3.5 g/dL ± 0.8 g/dL in the TXA group (P < .001), 3.5 g/dL ± 1.1 g/dL in the TXA + bipolar sealer group (P < .001), and 4.3 g/dL ± 1.2 g/dL in the control group (Table 2). The length of stay was 2.2 ± 0.6 days for the TXA group (P = .004) and 2.2 ± 0.9 days (P = .03) for the TXA + bipolar sealer group, and 2.6 ± 0.8 days in the control group (P = .78) (Table 2).

DISCUSSION

This study shows that the use of TXA alone provides a significant decrease in transfusion rates and estimated blood loss, a benefit which was not further increased with the addition of a bipolar sealer (Table 2). Many studies have demonstrated that TXA reduces blood loss and transfusion rates in patients undergoing THA and TKA.²⁹ However, TXA’s acceptance as a more readily used hemostatic medication has been hindered by the theoretically increased risk of thromboembolism in susceptible, high-risk patients.^32-35 In a 2012 meta-analysis conducted by Yang and colleagues,³⁶ the use of TXA led to significantly less blood loss per patient and fewer transfusions without leading to an increased risk of thromboembolic events.

Continue to: Similarly, the bipolar sealer...

Although the results of our research are in line with those of previous publications, it is important to address 3 limitations within this study. First, only the control group in this study was enrolled prospectively; the remaining groups were reviewed retrospectively. Second, our adoption of TXA was recent; therefore, a confounding factor is that our surgeons had more experience in the anterior approach when using TXA. Third, the established transfusion threshold of <8 g/dl for this study led to more liberal use of transfusions. Since the conclusion of this study, we have adopted stricter transfusion criteria (hemoglobin <7.0 g/dL with clinical symptoms) which has led to even lower transfusion requirements.

CONCLUSION

In the reviewed patient population, TXA decreased blood loss and transfusion requirements following DA THA. However, the addition of a bipolar sealer did not provide an advantage. The results of this study do not support the routine use of a bipolar sealer in DA THA.

ABSTRACT

The purpose of this study is to determine the effectiveness of tranexamic acid (TXA) alone and in conjunction with a bipolar sealer in reducing postoperative transfusions during direct anterior (DA) total hip arthroplasty (THA).

In this retrospective review, we analyzed 173 consecutive patients who underwent primary unilateral DA THA performed by 2 surgeons during a 1-year period. Subjects were divided into 3 groups based on TXA use: 63 patients received TXA alone (TXA group), 49 patients received TXA in addition to a bipolar sealer (TXA + bipolar sealer group), and 61 patients received neither TXA nor a bipolar sealer (control group). Primary end points were the transfusion rate and estimated blood loss. Secondary end points were length of stay, postoperative drop in hemoglobin, and postoperative drain output.

Two patients in the TXA group and 10 patients in the control group were transfused (P = .02). In the TXA + bipolar sealer group, 1 patient was transfused (P = .02). No significant difference in the rate of transfusion was found between the TXA group and the TXA + bipolar sealer group (P = .99). Estimated blood loss was 310.3 mL ± 182.5 mL in the TXA group (P = .004), 292.9 mL ± 130.8 mL in the TXA + bipolar sealer group (P = .003), and 404.9 mL ± 201.2 mL in the control group. 

The use of TXA, with and without the concomitant use of a bipolar sealer, decreases intraoperative blood loss and postoperative transfusion requirements. The addition of a bipolar sealer, however, does not appear to provide any additional decrease in blood loss.

Historically, patients undergoing total hip arthroplasty (THA) have significant blood loss and required blood transfusions.^1-3 Blood transfusions increase not only the risk of complications but also the cost of the procedure.^4-9 Although less invasive techniques in hip surgery may decrease blood loss,^10-12 intraoperative blood loss remains a concern. Optimization of anemia and blood conservation techniques include preoperative autologous blood donation, perioperative hemodilution, meticulous surgical hemostasis, and the use of antifibrinolytic agents.^4,5,7,13,14 Antifibrinolytics are inexpensive and have been shown to reduce blood loss during THA and total knee arthroplasty (TKA).^7,15-17

Continue to: Tranexamic acid (TXA), a synthetic analog...

Although many studies have analyzed the use of TXA and a bipolar sealer with the posterior and lateral approaches to hip arthroplasty, there is a paucity of research analyzing its use in the DA approach. This study retrospectively reviews the effectiveness of TXA alone and in conjunction with a bipolar sealer in reducing allogeneic blood transfusions in DA THA.

METHODS

This is a retrospective, comparative study evaluating the efficacy of TXA with and without a bipolar sealer in unilateral DA THA. The study included 173 patients who underwent standard DA THA performed by 2 surgeons in the period April 2013 to April 2014. Patient demographic information is summarized in Table 1.

Table 1. Demographic Data

^aResult values are expressed as mean ± standard deviation (range). ^bResult values are expressed as number of cases (percentage of column header population).

Abbreviations: BMI, body mass index; TXA, tranexamic acid.

Three cohorts were created based on intraoperative blood loss management practices at the surgeon’s discretion. The first group included 63 patients who underwent DA THA with TXA but not a bipolar sealer. The second group included 49 patients who underwent DA THA with TXA and a bipolar sealer. The third (control) group included 61 patients who underwent DA THA without TXA or a bipolar sealer. Data for the control group were collected prospectively as a part of a randomized trial, which demonstrated a reduction in transfusion requirements and blood loss with the use of a bipolar sealer in DA THA.²⁸ All patients received a surgical hemovac suction drain, which was removed at 24 hours after surgery. All patients received 40 mg of enoxaparin daily for 2 weeks for venous thromboembolism prophylaxis starting the day after surgery.

All patients in the first 2 groups received 2 g of TXA administered intravenously in 2 doses: the first dose was given preoperatively, and the second dose was given immediately postoperatively in the recovery room. The bipolar sealer was utilized as needed perioperatively according to the manufacturer’s instructions to address specific bleeding targets. The common sites and steps of a DA THA, in which bleeding typically occurs, are:

• The medial femoral circumflex artery during the approach to the capsule;
• The anterior hip capsule vessels prior to capsulotomy;
• The deep branch of the medial femoral circumflex artery and the nutrient vessels to the lesser trochanter encountered while exposing the medial neck and releasing the medial capsule;
• The posterior-superior retinacular arteries encountered after femoral neck osteotomy and removal of the femoral head along the posterior capsule; and
• The branch of the obturator artery encountered during exposure of the acetabular fovea.^29-31

At the time of this study, the transfusion criteria included hemoglobin <8 g/dL in the presence of clinical symptoms.

Continue to: Primary outcome measures...

OUTCOME MEASURES AND DATA ANALYSIS

Primary outcome measures were transfusion requirements and estimated blood loss. Secondary outcome measures were postoperative decrease in hemoglobin, length of stay, and postoperative drain output. Demographic and operative data were compared between groups to ensure that there were no statistically significant differences in blood loss and transfusion requirements. All data were recorded in a password encrypted file and subsequently transferred to the REDCap system (Research Electronic Data Capture, Vanderbilt University).

STATISTICAL ANALYSIS

A priori sample size calculation was performed on the basis of a prior study ²⁸, which evaluated surgical blood loss reduction utilizing a bipolar sealer. This study suggested a sample size of 20 per group to detect the minimal clinically important difference of 1.5 (standard deviation (SD) = 1.5, α = 0.05, β = 0.20). Additionally, a general estimate for detecting a 1-unit change on an ordinal scale of 136 (SD = 1.0, α = 0.05, β = 0.20) resulted in the same number. We conservatively chose to include at least 24 patients in each study arm in the event of greater true variance. The Wilcoxon rank-sum test was used for comparison of continuous data between groups. Differences between means were analyzed using 2-sided t tests. Comparison of categorical data was performed using Pearson’s chi-square or Fisher’s exact probability test as indicated. Ordinal ranking scores were compared using the Mantel-Haenszel test.

RESULTS

There were no statistically significant differences between groups with respect to sex, age, body mass index, or preoperative hemoglobin level (Table 1). Two patients in the TXA group and 10 patients in the control group were transfused (P = .02). In the TXA + bipolar sealer group, 1 patient was transfused (P = .02). A comparison of the transfusion rate between the TXA group and the TXA + bipolar sealer group yielded no significant difference (P = .99). The estimated blood loss was 310.3 mL ± 182.5 mL in the TXA group (P = .004), 292.9 mL ± 130.8 mL in the TXA + bipolar sealer group (P = .003), and 404.9 mL ± 201.2 mL in the control group (P = .71) (Table 2).

Table 2. Patient-Related Outcomes

^aResult values are expressed as mean ± standard deviation (range). ^bResult values are expressed as number of cases (percentage of column header population).

Abbreviation: TXA, tranexamic acid.

The total drain output was 326.3 mL ± 197.5 mL in the TXA group (P < .001 for comparison with the control group), 309.8 mL ± 196.3 mL in the TXA + bipolar sealer group (P < .001 for comparison with the control group), and 473.6 mL ± 199.7 mL in the control group (P = .58). The decrease in hemoglobin was 3.5 g/dL ± 0.8 g/dL in the TXA group (P < .001), 3.5 g/dL ± 1.1 g/dL in the TXA + bipolar sealer group (P < .001), and 4.3 g/dL ± 1.2 g/dL in the control group (Table 2). The length of stay was 2.2 ± 0.6 days for the TXA group (P = .004) and 2.2 ± 0.9 days (P = .03) for the TXA + bipolar sealer group, and 2.6 ± 0.8 days in the control group (P = .78) (Table 2).

DISCUSSION

This study shows that the use of TXA alone provides a significant decrease in transfusion rates and estimated blood loss, a benefit which was not further increased with the addition of a bipolar sealer (Table 2). Many studies have demonstrated that TXA reduces blood loss and transfusion rates in patients undergoing THA and TKA.²⁹ However, TXA’s acceptance as a more readily used hemostatic medication has been hindered by the theoretically increased risk of thromboembolism in susceptible, high-risk patients.^32-35 In a 2012 meta-analysis conducted by Yang and colleagues,³⁶ the use of TXA led to significantly less blood loss per patient and fewer transfusions without leading to an increased risk of thromboembolic events.

Continue to: Similarly, the bipolar sealer...

Although the results of our research are in line with those of previous publications, it is important to address 3 limitations within this study. First, only the control group in this study was enrolled prospectively; the remaining groups were reviewed retrospectively. Second, our adoption of TXA was recent; therefore, a confounding factor is that our surgeons had more experience in the anterior approach when using TXA. Third, the established transfusion threshold of <8 g/dl for this study led to more liberal use of transfusions. Since the conclusion of this study, we have adopted stricter transfusion criteria (hemoglobin <7.0 g/dL with clinical symptoms) which has led to even lower transfusion requirements.

CONCLUSION

In the reviewed patient population, TXA decreased blood loss and transfusion requirements following DA THA. However, the addition of a bipolar sealer did not provide an advantage. The results of this study do not support the routine use of a bipolar sealer in DA THA.

ABSTRACT

The purpose of this study is to determine the effectiveness of tranexamic acid (TXA) alone and in conjunction with a bipolar sealer in reducing postoperative transfusions during direct anterior (DA) total hip arthroplasty (THA).

In this retrospective review, we analyzed 173 consecutive patients who underwent primary unilateral DA THA performed by 2 surgeons during a 1-year period. Subjects were divided into 3 groups based on TXA use: 63 patients received TXA alone (TXA group), 49 patients received TXA in addition to a bipolar sealer (TXA + bipolar sealer group), and 61 patients received neither TXA nor a bipolar sealer (control group). Primary end points were the transfusion rate and estimated blood loss. Secondary end points were length of stay, postoperative drop in hemoglobin, and postoperative drain output.

Two patients in the TXA group and 10 patients in the control group were transfused (P = .02). In the TXA + bipolar sealer group, 1 patient was transfused (P = .02). No significant difference in the rate of transfusion was found between the TXA group and the TXA + bipolar sealer group (P = .99). Estimated blood loss was 310.3 mL ± 182.5 mL in the TXA group (P = .004), 292.9 mL ± 130.8 mL in the TXA + bipolar sealer group (P = .003), and 404.9 mL ± 201.2 mL in the control group. 

The use of TXA, with and without the concomitant use of a bipolar sealer, decreases intraoperative blood loss and postoperative transfusion requirements. The addition of a bipolar sealer, however, does not appear to provide any additional decrease in blood loss.

Historically, patients undergoing total hip arthroplasty (THA) have significant blood loss and required blood transfusions.^1-3 Blood transfusions increase not only the risk of complications but also the cost of the procedure.^4-9 Although less invasive techniques in hip surgery may decrease blood loss,^10-12 intraoperative blood loss remains a concern. Optimization of anemia and blood conservation techniques include preoperative autologous blood donation, perioperative hemodilution, meticulous surgical hemostasis, and the use of antifibrinolytic agents.^4,5,7,13,14 Antifibrinolytics are inexpensive and have been shown to reduce blood loss during THA and total knee arthroplasty (TKA).^7,15-17

Continue to: Tranexamic acid (TXA), a synthetic analog...

Although many studies have analyzed the use of TXA and a bipolar sealer with the posterior and lateral approaches to hip arthroplasty, there is a paucity of research analyzing its use in the DA approach. This study retrospectively reviews the effectiveness of TXA alone and in conjunction with a bipolar sealer in reducing allogeneic blood transfusions in DA THA.

METHODS

This is a retrospective, comparative study evaluating the efficacy of TXA with and without a bipolar sealer in unilateral DA THA. The study included 173 patients who underwent standard DA THA performed by 2 surgeons in the period April 2013 to April 2014. Patient demographic information is summarized in Table 1.

Table 1. Demographic Data

^aResult values are expressed as mean ± standard deviation (range). ^bResult values are expressed as number of cases (percentage of column header population).

Abbreviations: BMI, body mass index; TXA, tranexamic acid.

Three cohorts were created based on intraoperative blood loss management practices at the surgeon’s discretion. The first group included 63 patients who underwent DA THA with TXA but not a bipolar sealer. The second group included 49 patients who underwent DA THA with TXA and a bipolar sealer. The third (control) group included 61 patients who underwent DA THA without TXA or a bipolar sealer. Data for the control group were collected prospectively as a part of a randomized trial, which demonstrated a reduction in transfusion requirements and blood loss with the use of a bipolar sealer in DA THA.²⁸ All patients received a surgical hemovac suction drain, which was removed at 24 hours after surgery. All patients received 40 mg of enoxaparin daily for 2 weeks for venous thromboembolism prophylaxis starting the day after surgery.

All patients in the first 2 groups received 2 g of TXA administered intravenously in 2 doses: the first dose was given preoperatively, and the second dose was given immediately postoperatively in the recovery room. The bipolar sealer was utilized as needed perioperatively according to the manufacturer’s instructions to address specific bleeding targets. The common sites and steps of a DA THA, in which bleeding typically occurs, are:

• The medial femoral circumflex artery during the approach to the capsule;
• The anterior hip capsule vessels prior to capsulotomy;
• The deep branch of the medial femoral circumflex artery and the nutrient vessels to the lesser trochanter encountered while exposing the medial neck and releasing the medial capsule;
• The posterior-superior retinacular arteries encountered after femoral neck osteotomy and removal of the femoral head along the posterior capsule; and
• The branch of the obturator artery encountered during exposure of the acetabular fovea.^29-31

At the time of this study, the transfusion criteria included hemoglobin <8 g/dL in the presence of clinical symptoms.

Continue to: Primary outcome measures...

OUTCOME MEASURES AND DATA ANALYSIS

Primary outcome measures were transfusion requirements and estimated blood loss. Secondary outcome measures were postoperative decrease in hemoglobin, length of stay, and postoperative drain output. Demographic and operative data were compared between groups to ensure that there were no statistically significant differences in blood loss and transfusion requirements. All data were recorded in a password encrypted file and subsequently transferred to the REDCap system (Research Electronic Data Capture, Vanderbilt University).

STATISTICAL ANALYSIS

A priori sample size calculation was performed on the basis of a prior study ²⁸, which evaluated surgical blood loss reduction utilizing a bipolar sealer. This study suggested a sample size of 20 per group to detect the minimal clinically important difference of 1.5 (standard deviation (SD) = 1.5, α = 0.05, β = 0.20). Additionally, a general estimate for detecting a 1-unit change on an ordinal scale of 136 (SD = 1.0, α = 0.05, β = 0.20) resulted in the same number. We conservatively chose to include at least 24 patients in each study arm in the event of greater true variance. The Wilcoxon rank-sum test was used for comparison of continuous data between groups. Differences between means were analyzed using 2-sided t tests. Comparison of categorical data was performed using Pearson’s chi-square or Fisher’s exact probability test as indicated. Ordinal ranking scores were compared using the Mantel-Haenszel test.

RESULTS

There were no statistically significant differences between groups with respect to sex, age, body mass index, or preoperative hemoglobin level (Table 1). Two patients in the TXA group and 10 patients in the control group were transfused (P = .02). In the TXA + bipolar sealer group, 1 patient was transfused (P = .02). A comparison of the transfusion rate between the TXA group and the TXA + bipolar sealer group yielded no significant difference (P = .99). The estimated blood loss was 310.3 mL ± 182.5 mL in the TXA group (P = .004), 292.9 mL ± 130.8 mL in the TXA + bipolar sealer group (P = .003), and 404.9 mL ± 201.2 mL in the control group (P = .71) (Table 2).

Table 2. Patient-Related Outcomes

^aResult values are expressed as mean ± standard deviation (range). ^bResult values are expressed as number of cases (percentage of column header population).

Abbreviation: TXA, tranexamic acid.

The total drain output was 326.3 mL ± 197.5 mL in the TXA group (P < .001 for comparison with the control group), 309.8 mL ± 196.3 mL in the TXA + bipolar sealer group (P < .001 for comparison with the control group), and 473.6 mL ± 199.7 mL in the control group (P = .58). The decrease in hemoglobin was 3.5 g/dL ± 0.8 g/dL in the TXA group (P < .001), 3.5 g/dL ± 1.1 g/dL in the TXA + bipolar sealer group (P < .001), and 4.3 g/dL ± 1.2 g/dL in the control group (Table 2). The length of stay was 2.2 ± 0.6 days for the TXA group (P = .004) and 2.2 ± 0.9 days (P = .03) for the TXA + bipolar sealer group, and 2.6 ± 0.8 days in the control group (P = .78) (Table 2).

DISCUSSION

This study shows that the use of TXA alone provides a significant decrease in transfusion rates and estimated blood loss, a benefit which was not further increased with the addition of a bipolar sealer (Table 2). Many studies have demonstrated that TXA reduces blood loss and transfusion rates in patients undergoing THA and TKA.²⁹ However, TXA’s acceptance as a more readily used hemostatic medication has been hindered by the theoretically increased risk of thromboembolism in susceptible, high-risk patients.^32-35 In a 2012 meta-analysis conducted by Yang and colleagues,³⁶ the use of TXA led to significantly less blood loss per patient and fewer transfusions without leading to an increased risk of thromboembolic events.

Continue to: Similarly, the bipolar sealer...

Although the results of our research are in line with those of previous publications, it is important to address 3 limitations within this study. First, only the control group in this study was enrolled prospectively; the remaining groups were reviewed retrospectively. Second, our adoption of TXA was recent; therefore, a confounding factor is that our surgeons had more experience in the anterior approach when using TXA. Third, the established transfusion threshold of <8 g/dl for this study led to more liberal use of transfusions. Since the conclusion of this study, we have adopted stricter transfusion criteria (hemoglobin <7.0 g/dL with clinical symptoms) which has led to even lower transfusion requirements.

CONCLUSION

In the reviewed patient population, TXA decreased blood loss and transfusion requirements following DA THA. However, the addition of a bipolar sealer did not provide an advantage. The results of this study do not support the routine use of a bipolar sealer in DA THA.

ABSTRACT

Diaphyseal fractures of the distal humerus have a high rate of union when treated with a functional brace or an above-elbow cast (AEC). This study compares alignment of the humerus and motion of the elbow after functional brace or AEC treatment.

One-hundred and five consecutive patients with a closed, extra-articular fracture of the distal humeral diaphysis were identified in the orthopedic trauma databases of 3 hospitals between 2003 and 2012. Seventy-five patients with a follow-up of at least 6 months or with radiographic and clinical evidence of fracture union were included (51 treated with functional bracing and 24 treated with an AEC).

All of the fractures healed. The average arc of elbow flexion was 130° ± 9° in braced patients vs 127° ± 12° in casted patients. Four patients (8%) in the bracing group and 4 (17%) in the casting group lost >20° of elbow motion. The average varus angulation on radiographs was 17° ± 8° in braced and 13° ± 8° in casted patients, while the average posterior angulation was 9° ± 6° vs 7° ± 7°, respectively.

Closed extra-articular distal diaphyseal humerus fractures heal with both bracing and casting and there are no differences in average elbow motion or radiographic alignment.

Nonoperative treatment of closed fractures of the humeral shaft (AO/OTA [Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association] type 12) with a functional brace or above-elbow cast (AEC) is associated with a high union rate, good motion, and good function. Advocates of casting believe that a brace cannot control fracture alignment as well as a cast that allows for immobilization and molding. Advocates of brace treatment are concerned that immobilization in a cast will cause elbow stiffness.^1-11

Continue to: In our differing institutions...

MATERIALS AND METHODS

Between 2003 and 2012, consecutive adult patients treated for a nonpathological fracture of the diaphysis of the distal humerus at the orthopedic trauma service of 3 level 1 academic trauma centers were identified from prospectively collected trauma injury databases. Patients with vascular injury, ipsilateral upper extremity fracture, and periprosthetic fractures were excluded. The attending orthopedic surgeon chose the treatment method and evaluated the range of motion (ROM) of the elbow and radiographic union at the final ambulatory visit. We included patients followed to clinical and radiographic union with a minimum of 6 months of follow-up. We also included patients with <6 months’ follow-up who demonstrated union and had elbow ROM within 10° of the uninjured arm.

We identified 105 consecutive adult patients with a closed nonpathological extra-articular distal humeral shaft fracture (fracture of the distal humeral shaft with an AO/OTA type-12.A, 12.B, or 12.C pattern) treated with an AEC or a brace in our databases.¹² Two patients in the brace group chose surgery to improve alignment within 3 weeks of injury and were excluded from the analysis. Twenty-eight patients had inadequate follow-up.

A total of 75 patients were included in the study. At the first and second institutions, 51 patients were treated with functional bracing with an average follow-up of 7 months. At the third institution, 24 patients were treated with an AEC with an average follow-up of 4 months. Seventeen out of 24 patients in the long arm casting group and 19 out of 51 patients in the bracing group, who were included since they had <6 months of follow-up, demonstrated union and had elbow ROM within 10° of the uninjured arm. Differing methods of closed immobilization were the result of differing treatment algorithms at each institution.

The patients who were treated with a functional brace averaged 34 years of age (range, 18-90 years) and included 27 men and 24 women. The brace was removed at an average of 11.5 weeks (range, 8-18 weeks) after initial injury. Six patients had an injury-associated radial nerve palsy, all of which fully recovered within an average of 4 months (range, 0.5-7 months). Sixteen patients were injured due to a fall from standing height, 2 due to a fall from a greater height than standing, 16 in a motor-vehicle accident, 15 during a sport activity, and 2 were not specifically documented.

Continue to: Four patients had concomitant...

The patients who were treated with an AEC had an average age of 32 years (range,18-82 years) and included 14 men and 10 women. The cast was removed at an average of 4.2 weeks (range, 3-7 weeks) after the initial injury. Two patients had an injury-associated radial nerve palsy, both of which fully recovered. Five patients were injured due to a fall from standing height, 1 due to a fall from a height greater than standing, 7 during a motor-vehicle accident, 5 during a sport activity, and 6 were not documented. Two patients sustained concomitant injuries: one patient sustained a tibia-fibula fracture, and another patient sustained facial trauma.

The 2 groups were comparable in age and gender, as well as the injury mechanism (Table).

Table. Patient Demographics and Outcome Data

FUNCTIONAL BRACING TECHNIQUE

Upon presentation after injury, patients were immobilized in a coaptation splint (Figure 1A). Within 10 days, the arm was placed in a pre-manufactured polyethylene functional brace (Corflex) and the arm was supported with a simple sling. Patients were allowed to use the hand for light tasks and move the elbow, but most patients were not capable of active elbow flexion exercises until early healing was established 4 to 6 weeks after injury. Shoulder motion was discouraged until radiographic union. Patients started active, self-assisted elbow and shoulder stretching exercises, and weaned from the brace once radiographic union was confirmed between 6 and 10 weeks after injury (Figures 1B, 1C).

ABOVE-ELBOW CASE

Patients were also initially immobilized in a coaptation splint upon initial presentation. Within 7 days, an above-elbow fiberglass cast with neutral forearm rotation and 90° of elbow flexion was applied with a supracondylar mold, followed by radiographic imaging (Figure 2A). With the fractured arm dependent, a valgus mold was applied as the material hardened in order to align the fracture site and limit varus angulation.

Continue to: There were no shoulder...

STATISTICAL ANALYSIS

Alignment of the humerus (including varus-valgus alignment and apex anterior-posterior alignment) was measured on anteroposterior and lateral radiographs as the angle between lines bisecting the humeral diaphysis proximal and distal to the fracture. The normality of the data was tested using the Kolmogorov-Smirnov test. To statistically compare continuous variables with a normal distribution, t-tests were used; otherwise the Wilcoxon t-test was applied. The Pearson’s Chi-Square test was used to statistically compare dichotomous variables, except when expected cell frequency was <5, in which case the Fisher exact test was used. The level of significance was set at P < .05.

RESULTS

RANGE OF MOTION AND RADIOGRAPHIC ALIGNMENT

The average range of elbow motion was 130° ± 9° after brace treatment and 127° ± 12° after cast treatment (P = .26). Four patients (8%) treated with a brace and 3 (12%) treated with a cast lost >20° of elbow motion.

All the fractures healed. The average varus angulation on the anteroposterior radiograph was 17° (range, 2°-26°) in braced patients and 13 (range, 5°-31°) in casted patients (P = .11). The average posterior angulation on the lateral radiograph was 9° (range, 0°-28°) in braced patients vs 7° (range, 2°-33°) in casted patients (P = .54).

Continue to: Two weeks after initiating brace...

COMPLICATIONS

Two weeks after initiating brace treatment, an obese patient suffered a rash with desquamation that necessitated discontinuation of the brace. However, the skin and fracture ultimately healed with a coaptation splint and sling support without additional complications. In the casting cohort, 2 patients returned to the emergency department after AEC placement because of swelling of the hand and pain in the cast. Both casts were removed and reapplied.

DISCUSSION

Fractures of the distal third of the humeral diaphysis heal without surgery. Fracture angulation and elbow stiffness are the concerns that lead to variations in nonoperative treatment.^1-3 Advocates of casting believe they can get better alignment without losing elbow motion, and advocates of bracing feel that the brace is less cumbersome.^1-3,5-8 We compared these treatments retrospectively and found them comparable.

This study should be considered in light of its limitations. Many patients were lost to follow-up in our urban trauma centers. We do not know if these patients did better, worse, or the same as the patients we were able to evaluate, but our opinion is that patients having problems were more likely to return. The evaluation time was relatively short, but motion can only improve in the longer-term. Two patients that were initially braced chose surgery, probably because either they or their surgeon were nervous about the radiographic appearance of the fracture. In our opinion, continued nonoperative treatment of these patients would not affect the findings.

Cast treatment of distal diaphyseal humerus fractures does not cause permanent elbow stiffness. This is confirmed by our results; as casted patients did not lose final ROM compared to the bracing cohort. These injuries are extra-articular and casted patients are transitioned to bracing once humeri have significant union demonstrated by the arm moving as a unit. To our knowledge, there is no other study that has evaluated casting for these fractures, but it may be that evidence of permanent stiffness with nonoperative treatment of distal metaphyseal fractures of the humerus [AO/OTA type 13] is misapplied to distal humeral shaft fractures [AO/OTA type 12].^3,9,10,12 For brace treatment, Sarmiento and colleagues⁹ showed no significant elbow stiffness in a consecutive cohort of 69 patients, while Jawa and colleagues⁵ showed no increased elbow stiffness compared to plate fixation. Given the accumulated data,^3,5,6,8,13 advocates of operative treatment for distal third diaphyseal humerus fractures¹² can no longer site elbow stiffness as a disadvantage of nonoperative treatment, whether with cast or brace.

As shown in this study, patients that choose nonoperative treatment can expect their fracture to heal with an average of approximately 15° of varus angulation, as well as 2 others evaluating brace treatment.^5,9 Some will heal with as much as 30° of varus angulation.^5,9 The arm may look a little different, particularly in thin patients, but there is no evidence that this angulation affects function. The risks, discomforts, and inconveniences of surgery can be balanced with the ability of surgery to improve alignment and allow elbow motion a few weeks earlier. The aesthetics of the scar after surgery may not be better than the deformity after nonoperative treatment. Patients should be involved in these decisions.

Continue to: No cost comparison...

There is a passive implication that operative treatment of distal third diaphyseal humerus fractures affords better results and union for patients in the discussed literature. Our results demonstrate that the distal diaphyseal humerus has a natural anatomic and biologic propensity to heal with closed immobilization. Patients should be made aware that while operative treatments exist for this fracture pattern, nonoperative treatment modalities have proven to be efficacious using a variety of immobilization methods. Thus, patients that prefer nonoperative treatment of a distal third diaphyseal humerus fracture can choose between a cast or a brace with confidence of the efficacy of the nonoperative treatment.

ABSTRACT

Diaphyseal fractures of the distal humerus have a high rate of union when treated with a functional brace or an above-elbow cast (AEC). This study compares alignment of the humerus and motion of the elbow after functional brace or AEC treatment.

One-hundred and five consecutive patients with a closed, extra-articular fracture of the distal humeral diaphysis were identified in the orthopedic trauma databases of 3 hospitals between 2003 and 2012. Seventy-five patients with a follow-up of at least 6 months or with radiographic and clinical evidence of fracture union were included (51 treated with functional bracing and 24 treated with an AEC).

All of the fractures healed. The average arc of elbow flexion was 130° ± 9° in braced patients vs 127° ± 12° in casted patients. Four patients (8%) in the bracing group and 4 (17%) in the casting group lost >20° of elbow motion. The average varus angulation on radiographs was 17° ± 8° in braced and 13° ± 8° in casted patients, while the average posterior angulation was 9° ± 6° vs 7° ± 7°, respectively.

Closed extra-articular distal diaphyseal humerus fractures heal with both bracing and casting and there are no differences in average elbow motion or radiographic alignment.

Nonoperative treatment of closed fractures of the humeral shaft (AO/OTA [Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association] type 12) with a functional brace or above-elbow cast (AEC) is associated with a high union rate, good motion, and good function. Advocates of casting believe that a brace cannot control fracture alignment as well as a cast that allows for immobilization and molding. Advocates of brace treatment are concerned that immobilization in a cast will cause elbow stiffness.^1-11

Continue to: In our differing institutions...

MATERIALS AND METHODS

Between 2003 and 2012, consecutive adult patients treated for a nonpathological fracture of the diaphysis of the distal humerus at the orthopedic trauma service of 3 level 1 academic trauma centers were identified from prospectively collected trauma injury databases. Patients with vascular injury, ipsilateral upper extremity fracture, and periprosthetic fractures were excluded. The attending orthopedic surgeon chose the treatment method and evaluated the range of motion (ROM) of the elbow and radiographic union at the final ambulatory visit. We included patients followed to clinical and radiographic union with a minimum of 6 months of follow-up. We also included patients with <6 months’ follow-up who demonstrated union and had elbow ROM within 10° of the uninjured arm.

We identified 105 consecutive adult patients with a closed nonpathological extra-articular distal humeral shaft fracture (fracture of the distal humeral shaft with an AO/OTA type-12.A, 12.B, or 12.C pattern) treated with an AEC or a brace in our databases.¹² Two patients in the brace group chose surgery to improve alignment within 3 weeks of injury and were excluded from the analysis. Twenty-eight patients had inadequate follow-up.

A total of 75 patients were included in the study. At the first and second institutions, 51 patients were treated with functional bracing with an average follow-up of 7 months. At the third institution, 24 patients were treated with an AEC with an average follow-up of 4 months. Seventeen out of 24 patients in the long arm casting group and 19 out of 51 patients in the bracing group, who were included since they had <6 months of follow-up, demonstrated union and had elbow ROM within 10° of the uninjured arm. Differing methods of closed immobilization were the result of differing treatment algorithms at each institution.

The patients who were treated with a functional brace averaged 34 years of age (range, 18-90 years) and included 27 men and 24 women. The brace was removed at an average of 11.5 weeks (range, 8-18 weeks) after initial injury. Six patients had an injury-associated radial nerve palsy, all of which fully recovered within an average of 4 months (range, 0.5-7 months). Sixteen patients were injured due to a fall from standing height, 2 due to a fall from a greater height than standing, 16 in a motor-vehicle accident, 15 during a sport activity, and 2 were not specifically documented.

Continue to: Four patients had concomitant...

The patients who were treated with an AEC had an average age of 32 years (range,18-82 years) and included 14 men and 10 women. The cast was removed at an average of 4.2 weeks (range, 3-7 weeks) after the initial injury. Two patients had an injury-associated radial nerve palsy, both of which fully recovered. Five patients were injured due to a fall from standing height, 1 due to a fall from a height greater than standing, 7 during a motor-vehicle accident, 5 during a sport activity, and 6 were not documented. Two patients sustained concomitant injuries: one patient sustained a tibia-fibula fracture, and another patient sustained facial trauma.

The 2 groups were comparable in age and gender, as well as the injury mechanism (Table).

Table. Patient Demographics and Outcome Data

FUNCTIONAL BRACING TECHNIQUE

Upon presentation after injury, patients were immobilized in a coaptation splint (Figure 1A). Within 10 days, the arm was placed in a pre-manufactured polyethylene functional brace (Corflex) and the arm was supported with a simple sling. Patients were allowed to use the hand for light tasks and move the elbow, but most patients were not capable of active elbow flexion exercises until early healing was established 4 to 6 weeks after injury. Shoulder motion was discouraged until radiographic union. Patients started active, self-assisted elbow and shoulder stretching exercises, and weaned from the brace once radiographic union was confirmed between 6 and 10 weeks after injury (Figures 1B, 1C).

ABOVE-ELBOW CASE

Patients were also initially immobilized in a coaptation splint upon initial presentation. Within 7 days, an above-elbow fiberglass cast with neutral forearm rotation and 90° of elbow flexion was applied with a supracondylar mold, followed by radiographic imaging (Figure 2A). With the fractured arm dependent, a valgus mold was applied as the material hardened in order to align the fracture site and limit varus angulation.

Continue to: There were no shoulder...

STATISTICAL ANALYSIS

Alignment of the humerus (including varus-valgus alignment and apex anterior-posterior alignment) was measured on anteroposterior and lateral radiographs as the angle between lines bisecting the humeral diaphysis proximal and distal to the fracture. The normality of the data was tested using the Kolmogorov-Smirnov test. To statistically compare continuous variables with a normal distribution, t-tests were used; otherwise the Wilcoxon t-test was applied. The Pearson’s Chi-Square test was used to statistically compare dichotomous variables, except when expected cell frequency was <5, in which case the Fisher exact test was used. The level of significance was set at P < .05.

RESULTS

RANGE OF MOTION AND RADIOGRAPHIC ALIGNMENT

The average range of elbow motion was 130° ± 9° after brace treatment and 127° ± 12° after cast treatment (P = .26). Four patients (8%) treated with a brace and 3 (12%) treated with a cast lost >20° of elbow motion.

All the fractures healed. The average varus angulation on the anteroposterior radiograph was 17° (range, 2°-26°) in braced patients and 13 (range, 5°-31°) in casted patients (P = .11). The average posterior angulation on the lateral radiograph was 9° (range, 0°-28°) in braced patients vs 7° (range, 2°-33°) in casted patients (P = .54).

Continue to: Two weeks after initiating brace...

COMPLICATIONS

Two weeks after initiating brace treatment, an obese patient suffered a rash with desquamation that necessitated discontinuation of the brace. However, the skin and fracture ultimately healed with a coaptation splint and sling support without additional complications. In the casting cohort, 2 patients returned to the emergency department after AEC placement because of swelling of the hand and pain in the cast. Both casts were removed and reapplied.

DISCUSSION

Fractures of the distal third of the humeral diaphysis heal without surgery. Fracture angulation and elbow stiffness are the concerns that lead to variations in nonoperative treatment.^1-3 Advocates of casting believe they can get better alignment without losing elbow motion, and advocates of bracing feel that the brace is less cumbersome.^1-3,5-8 We compared these treatments retrospectively and found them comparable.

This study should be considered in light of its limitations. Many patients were lost to follow-up in our urban trauma centers. We do not know if these patients did better, worse, or the same as the patients we were able to evaluate, but our opinion is that patients having problems were more likely to return. The evaluation time was relatively short, but motion can only improve in the longer-term. Two patients that were initially braced chose surgery, probably because either they or their surgeon were nervous about the radiographic appearance of the fracture. In our opinion, continued nonoperative treatment of these patients would not affect the findings.

Cast treatment of distal diaphyseal humerus fractures does not cause permanent elbow stiffness. This is confirmed by our results; as casted patients did not lose final ROM compared to the bracing cohort. These injuries are extra-articular and casted patients are transitioned to bracing once humeri have significant union demonstrated by the arm moving as a unit. To our knowledge, there is no other study that has evaluated casting for these fractures, but it may be that evidence of permanent stiffness with nonoperative treatment of distal metaphyseal fractures of the humerus [AO/OTA type 13] is misapplied to distal humeral shaft fractures [AO/OTA type 12].^3,9,10,12 For brace treatment, Sarmiento and colleagues⁹ showed no significant elbow stiffness in a consecutive cohort of 69 patients, while Jawa and colleagues⁵ showed no increased elbow stiffness compared to plate fixation. Given the accumulated data,^3,5,6,8,13 advocates of operative treatment for distal third diaphyseal humerus fractures¹² can no longer site elbow stiffness as a disadvantage of nonoperative treatment, whether with cast or brace.

As shown in this study, patients that choose nonoperative treatment can expect their fracture to heal with an average of approximately 15° of varus angulation, as well as 2 others evaluating brace treatment.^5,9 Some will heal with as much as 30° of varus angulation.^5,9 The arm may look a little different, particularly in thin patients, but there is no evidence that this angulation affects function. The risks, discomforts, and inconveniences of surgery can be balanced with the ability of surgery to improve alignment and allow elbow motion a few weeks earlier. The aesthetics of the scar after surgery may not be better than the deformity after nonoperative treatment. Patients should be involved in these decisions.

Continue to: No cost comparison...

There is a passive implication that operative treatment of distal third diaphyseal humerus fractures affords better results and union for patients in the discussed literature. Our results demonstrate that the distal diaphyseal humerus has a natural anatomic and biologic propensity to heal with closed immobilization. Patients should be made aware that while operative treatments exist for this fracture pattern, nonoperative treatment modalities have proven to be efficacious using a variety of immobilization methods. Thus, patients that prefer nonoperative treatment of a distal third diaphyseal humerus fracture can choose between a cast or a brace with confidence of the efficacy of the nonoperative treatment.

ABSTRACT

Diaphyseal fractures of the distal humerus have a high rate of union when treated with a functional brace or an above-elbow cast (AEC). This study compares alignment of the humerus and motion of the elbow after functional brace or AEC treatment.

One-hundred and five consecutive patients with a closed, extra-articular fracture of the distal humeral diaphysis were identified in the orthopedic trauma databases of 3 hospitals between 2003 and 2012. Seventy-five patients with a follow-up of at least 6 months or with radiographic and clinical evidence of fracture union were included (51 treated with functional bracing and 24 treated with an AEC).

All of the fractures healed. The average arc of elbow flexion was 130° ± 9° in braced patients vs 127° ± 12° in casted patients. Four patients (8%) in the bracing group and 4 (17%) in the casting group lost >20° of elbow motion. The average varus angulation on radiographs was 17° ± 8° in braced and 13° ± 8° in casted patients, while the average posterior angulation was 9° ± 6° vs 7° ± 7°, respectively.

Closed extra-articular distal diaphyseal humerus fractures heal with both bracing and casting and there are no differences in average elbow motion or radiographic alignment.

Nonoperative treatment of closed fractures of the humeral shaft (AO/OTA [Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association] type 12) with a functional brace or above-elbow cast (AEC) is associated with a high union rate, good motion, and good function. Advocates of casting believe that a brace cannot control fracture alignment as well as a cast that allows for immobilization and molding. Advocates of brace treatment are concerned that immobilization in a cast will cause elbow stiffness.^1-11

Continue to: In our differing institutions...

MATERIALS AND METHODS

Between 2003 and 2012, consecutive adult patients treated for a nonpathological fracture of the diaphysis of the distal humerus at the orthopedic trauma service of 3 level 1 academic trauma centers were identified from prospectively collected trauma injury databases. Patients with vascular injury, ipsilateral upper extremity fracture, and periprosthetic fractures were excluded. The attending orthopedic surgeon chose the treatment method and evaluated the range of motion (ROM) of the elbow and radiographic union at the final ambulatory visit. We included patients followed to clinical and radiographic union with a minimum of 6 months of follow-up. We also included patients with <6 months’ follow-up who demonstrated union and had elbow ROM within 10° of the uninjured arm.

We identified 105 consecutive adult patients with a closed nonpathological extra-articular distal humeral shaft fracture (fracture of the distal humeral shaft with an AO/OTA type-12.A, 12.B, or 12.C pattern) treated with an AEC or a brace in our databases.¹² Two patients in the brace group chose surgery to improve alignment within 3 weeks of injury and were excluded from the analysis. Twenty-eight patients had inadequate follow-up.

A total of 75 patients were included in the study. At the first and second institutions, 51 patients were treated with functional bracing with an average follow-up of 7 months. At the third institution, 24 patients were treated with an AEC with an average follow-up of 4 months. Seventeen out of 24 patients in the long arm casting group and 19 out of 51 patients in the bracing group, who were included since they had <6 months of follow-up, demonstrated union and had elbow ROM within 10° of the uninjured arm. Differing methods of closed immobilization were the result of differing treatment algorithms at each institution.

The patients who were treated with a functional brace averaged 34 years of age (range, 18-90 years) and included 27 men and 24 women. The brace was removed at an average of 11.5 weeks (range, 8-18 weeks) after initial injury. Six patients had an injury-associated radial nerve palsy, all of which fully recovered within an average of 4 months (range, 0.5-7 months). Sixteen patients were injured due to a fall from standing height, 2 due to a fall from a greater height than standing, 16 in a motor-vehicle accident, 15 during a sport activity, and 2 were not specifically documented.

Continue to: Four patients had concomitant...

The patients who were treated with an AEC had an average age of 32 years (range,18-82 years) and included 14 men and 10 women. The cast was removed at an average of 4.2 weeks (range, 3-7 weeks) after the initial injury. Two patients had an injury-associated radial nerve palsy, both of which fully recovered. Five patients were injured due to a fall from standing height, 1 due to a fall from a height greater than standing, 7 during a motor-vehicle accident, 5 during a sport activity, and 6 were not documented. Two patients sustained concomitant injuries: one patient sustained a tibia-fibula fracture, and another patient sustained facial trauma.

The 2 groups were comparable in age and gender, as well as the injury mechanism (Table).

Table. Patient Demographics and Outcome Data

FUNCTIONAL BRACING TECHNIQUE

Upon presentation after injury, patients were immobilized in a coaptation splint (Figure 1A). Within 10 days, the arm was placed in a pre-manufactured polyethylene functional brace (Corflex) and the arm was supported with a simple sling. Patients were allowed to use the hand for light tasks and move the elbow, but most patients were not capable of active elbow flexion exercises until early healing was established 4 to 6 weeks after injury. Shoulder motion was discouraged until radiographic union. Patients started active, self-assisted elbow and shoulder stretching exercises, and weaned from the brace once radiographic union was confirmed between 6 and 10 weeks after injury (Figures 1B, 1C).

ABOVE-ELBOW CASE

Patients were also initially immobilized in a coaptation splint upon initial presentation. Within 7 days, an above-elbow fiberglass cast with neutral forearm rotation and 90° of elbow flexion was applied with a supracondylar mold, followed by radiographic imaging (Figure 2A). With the fractured arm dependent, a valgus mold was applied as the material hardened in order to align the fracture site and limit varus angulation.

Continue to: There were no shoulder...

STATISTICAL ANALYSIS

Alignment of the humerus (including varus-valgus alignment and apex anterior-posterior alignment) was measured on anteroposterior and lateral radiographs as the angle between lines bisecting the humeral diaphysis proximal and distal to the fracture. The normality of the data was tested using the Kolmogorov-Smirnov test. To statistically compare continuous variables with a normal distribution, t-tests were used; otherwise the Wilcoxon t-test was applied. The Pearson’s Chi-Square test was used to statistically compare dichotomous variables, except when expected cell frequency was <5, in which case the Fisher exact test was used. The level of significance was set at P < .05.

RESULTS

RANGE OF MOTION AND RADIOGRAPHIC ALIGNMENT

The average range of elbow motion was 130° ± 9° after brace treatment and 127° ± 12° after cast treatment (P = .26). Four patients (8%) treated with a brace and 3 (12%) treated with a cast lost >20° of elbow motion.

All the fractures healed. The average varus angulation on the anteroposterior radiograph was 17° (range, 2°-26°) in braced patients and 13 (range, 5°-31°) in casted patients (P = .11). The average posterior angulation on the lateral radiograph was 9° (range, 0°-28°) in braced patients vs 7° (range, 2°-33°) in casted patients (P = .54).

Continue to: Two weeks after initiating brace...

COMPLICATIONS

Two weeks after initiating brace treatment, an obese patient suffered a rash with desquamation that necessitated discontinuation of the brace. However, the skin and fracture ultimately healed with a coaptation splint and sling support without additional complications. In the casting cohort, 2 patients returned to the emergency department after AEC placement because of swelling of the hand and pain in the cast. Both casts were removed and reapplied.

DISCUSSION

Fractures of the distal third of the humeral diaphysis heal without surgery. Fracture angulation and elbow stiffness are the concerns that lead to variations in nonoperative treatment.^1-3 Advocates of casting believe they can get better alignment without losing elbow motion, and advocates of bracing feel that the brace is less cumbersome.^1-3,5-8 We compared these treatments retrospectively and found them comparable.

This study should be considered in light of its limitations. Many patients were lost to follow-up in our urban trauma centers. We do not know if these patients did better, worse, or the same as the patients we were able to evaluate, but our opinion is that patients having problems were more likely to return. The evaluation time was relatively short, but motion can only improve in the longer-term. Two patients that were initially braced chose surgery, probably because either they or their surgeon were nervous about the radiographic appearance of the fracture. In our opinion, continued nonoperative treatment of these patients would not affect the findings.

Cast treatment of distal diaphyseal humerus fractures does not cause permanent elbow stiffness. This is confirmed by our results; as casted patients did not lose final ROM compared to the bracing cohort. These injuries are extra-articular and casted patients are transitioned to bracing once humeri have significant union demonstrated by the arm moving as a unit. To our knowledge, there is no other study that has evaluated casting for these fractures, but it may be that evidence of permanent stiffness with nonoperative treatment of distal metaphyseal fractures of the humerus [AO/OTA type 13] is misapplied to distal humeral shaft fractures [AO/OTA type 12].^3,9,10,12 For brace treatment, Sarmiento and colleagues⁹ showed no significant elbow stiffness in a consecutive cohort of 69 patients, while Jawa and colleagues⁵ showed no increased elbow stiffness compared to plate fixation. Given the accumulated data,^3,5,6,8,13 advocates of operative treatment for distal third diaphyseal humerus fractures¹² can no longer site elbow stiffness as a disadvantage of nonoperative treatment, whether with cast or brace.

As shown in this study, patients that choose nonoperative treatment can expect their fracture to heal with an average of approximately 15° of varus angulation, as well as 2 others evaluating brace treatment.^5,9 Some will heal with as much as 30° of varus angulation.^5,9 The arm may look a little different, particularly in thin patients, but there is no evidence that this angulation affects function. The risks, discomforts, and inconveniences of surgery can be balanced with the ability of surgery to improve alignment and allow elbow motion a few weeks earlier. The aesthetics of the scar after surgery may not be better than the deformity after nonoperative treatment. Patients should be involved in these decisions.

Continue to: No cost comparison...

There is a passive implication that operative treatment of distal third diaphyseal humerus fractures affords better results and union for patients in the discussed literature. Our results demonstrate that the distal diaphyseal humerus has a natural anatomic and biologic propensity to heal with closed immobilization. Patients should be made aware that while operative treatments exist for this fracture pattern, nonoperative treatment modalities have proven to be efficacious using a variety of immobilization methods. Thus, patients that prefer nonoperative treatment of a distal third diaphyseal humerus fracture can choose between a cast or a brace with confidence of the efficacy of the nonoperative treatment.

Diabetes mellitus (DM) is a risk factor for cardiovascular disease(CVD).^1-4 Death rates from heart disease are 2- to 4-times higher among adults with DM compared with those of adults without DM. In the US, it is estimated that 21.1 million adults have diagnosed DM, 8.1 million adults have undiagnosed DM, and 80.8 million adults have prediabetes.³ The American Heart Association has identified an untreated fasting blood glucose level < 100 mg/dL as a component of ideal cardiovascular health.³

Although the use of antidiabetic agents has been shown to reduce the risks of microvascular complications among patients with DM, a cardiovascular benefit has not been consistently demonstrated with all available agents, and some used in the treatment of DM are associated with cardiovascular harm.⁵ In addition, some cardiovascular medications may contribute to the development of DM or may mask the symptoms of hypoglycemia.⁶ Given the risk for CVD among patients with DM, a medication with utility in both DM and CVD could be beneficial.

Evidence for Use of Ranolazine

Ranolazine is indicated for the treatment of chronic angina.⁷ In clinical trials, ranolazine also was found to decrease hemoglobin A_1c (HbA_1c).^8-15 The possible mechanisms for lowering HbA_1c with ranolazine include preservation of pancreatic β-cells and an increase in glucose-dependent insulin secretion.⁶ The most common adverse effects associated with ranolazine include dizziness, headache, constipation, and nausea.⁷

Ranolazine has been shown to be efficacious and safe in the reduction of angina symptoms among patients with and without DM.^8-12 In addition to improving symptoms of angina, studies have demonstrated a reduction in HbA_1c among patients taking ranolazine.^9,13-15 In an open-label extension of the Combination Assessment of Ranolazine in Stable Angina (CARISA) trial, ranolazine 750 mg twice daily and 1,000 mg twice daily led to a greater reduction in HbA_1c when each was compared with placebo (-0.48% HbA_1c, P = .008; and -0.70% HbA_1c, P = .001, respectively).⁹

Among the 5,576 patients enrolled in the Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST-Elevation Acute Coronary Syndromes—Thrombolysis in Myocardial Infarction 36 (MERLIN-TIMI 36) trial with a baseline HbA_1c, ranolazine significantly reduced HbA_1c at 4 months when compared with placebo among patients with and without DM.¹³ In addition, patients with DM who were treated with ranolazine were more likely to achieve a HbA_1c < 7% at 4 months when compared with placebo (59% vs 49%; P < .001). Ranolazine was not found to increase the incidence of hypoglycemia.