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The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 978 - 985
1 Sep 2024
Savoie III FH Delvadia BP Tate JP Winter JE Williams GH Sherman WF O’Brien MJ

Rotator cuff tears are common in middle-aged and elderly patients. Despite advances in the surgical repair of rotator cuff tears, the rates of recurrent tear remain high. This may be due to the complexity of the tendons of the rotator cuff, which contributes to an inherently hostile healing environment. During the past 20 years, there has been an increased interest in the use of biologics to complement the healing environment in the shoulder, in order to improve rotator cuff healing and reduce the rate of recurrent tears. The aim of this review is to provide a summary of the current evidence for the use of forms of biological augmentation when repairing rotator cuff tears.

Cite this article: Bone Joint J 2024;106-B(9):978–985.


The Bone & Joint Journal
Vol. 105-B, Issue 5 | Pages 534 - 542
1 May 2023
Makaram NS Khan LAK Jenkins PJ Robinson CM

Aims. The outcomes following nonoperative management of minimally displaced greater tuberosity (GT) fractures, and the factors which influence patient experience, remain poorly defined. We assessed the early patient-derived outcomes following these injuries and examined the effect of a range of demographic- and injury-related variables on these outcomes. Methods. In total, 101 patients (53 female, 48 male) with a mean age of 50.9 years (19 to 76) with minimally displaced GT fractures were recruited to a prospective observational cohort study. During the first year after injury, patients underwent experiential assessment using the Disabilities of the Arm, Shoulder and Hand (DASH) score and assessment of associated injuries using MRI performed within two weeks of injury. The primary outcome was the one-year DASH score. Multivariate analysis was used to assess the effect of patient demographic factors, complications, and associated injuries, on outcome. Results. The mean DASH score improved from 42.3 (SD 9.6) at six weeks post-injury, to 19.5 (SD 14.3) at one-year follow-up (p < 0.001), but outcomes were mixed, with 30 patients having a DASH score > 30 at one year. MRI revealed a range of associated injuries, with a full-thickness rotator cuff tear present in 19 patients (19%). Overall, 11 patients (11%) developed complications requiring further operative intervention; 20 patients (21%) developed post-traumatic secondary shoulder stiffness. Multivariate analysis revealed a high-energy mechanism (p = 0.009), tobacco consumption (p = 0.033), use of mobility aids (p = 0.047), a full-thickness rotator cuff tear (p = 0.002), and the development of post-traumatic secondary shoulder stiffness (p = 0.035) were independent predictors of poorer outcome. Conclusion. The results of nonoperative management of minimally displaced GT fractures are heterogeneous. While many patients have satisfactory early outcomes, a substantial subgroup fare much worse. There is a high prevalence of rotator cuff injuries and post-traumatic shoulder stiffness, and their presence is associated with poorer patient experience. Furthermore, patients who have a high-energy injury, smoke, or use walking aids, have worse outcomes. Cite this article: Bone Joint J 2023;105-B(5):534–542


The Bone & Joint Journal
Vol. 105-B, Issue 4 | Pages 389 - 399
15 Mar 2023
Makaram NS Nicholson JA Yapp LZ Gillespie M Shah CP Robinson CM

Aims. The open Latarjet procedure is a widely used treatment for recurrent anterior instability of the shoulder. Although satisfactory outcomes are reported, factors which influence a patient’s experience are poorly quantified. The aim of this study was to evaluate the effect of a range of demographic factors and measures of the severity of instability on patient-reported outcome measures in patients who underwent an open Latarjet procedure at a minimum follow-up of two years. Methods. A total of 350 patients with anterior instability of the shoulder who underwent an open Latarjet procedure between 2005 and 2018 were reviewed prospectively, with the collection of demographic and psychosocial data, preoperative CT, and complications during follow-up of two years. The primary outcome measure was the Western Ontario Shoulder Instability Index (WOSI), assessed preoperatively, at two years postoperatively, and at mid-term follow-up at a mean of 50.6 months (SD 24.8) postoperatively. The secondary outcome measure was the abbreviated version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH) score. The influence of the demographic details of the patients, measurements of the severity of instability, and the complications of surgery were assessed in a multivariate analysis. Results. The mean age of the patients was 25.5 years (22 to 32) and 27 (7.7%) were female. The median time to surgery after injury was 19 months (interquartile range (IQR) 13 to 39). Seven patients developed clinically significant complications requiring further intervention within two years of surgery. The median percentage WOSI deficiency was 8.0% (IQR 4 to 20) and median QuickDASH was 3.0 (IQR 0 to 9) at mid-term assessment. A minority of patients reported a poorer experience, and 22 (6.3%) had a > 50% deficiency in WOSI score. Multivariate analysis revealed that consumption of ≥ 20 units of alcohol/week, a pre-existing affective disorder or epilepsy, medicolegal litigation, increasing time to surgery, and residing in a more socioeconomically deprived area were independently predictive of a poorer WOSI score. Conclusion. Although most patients treated by an open Latarjet procedure have excellent outcomes at mid-term follow-up, a minority have poorer outcomes, which are mainly predictable from pre-existing demographic factors, rather than measures of the severity of instability. Cite this article: Bone Joint J 2023;105-B(4):389–399


The Bone & Joint Journal
Vol. 104-B, Issue 5 | Pages 620 - 626
1 May 2022
Stadecker M Gu A Ramamurti P Fassihi SC Wei C Agarwal AR Bovonratwet P Srikumaran U

Aims. Corticosteroid injections are often used to manage glenohumeral arthritis in patients who may be candidates for future total shoulder arthroplasty (TSA) or reverse shoulder arthroplasty (rTSA). In the conservative management of these patients, corticosteroid injections are often provided for symptomatic relief. The purpose of this study was to determine if the timing of corticosteroid injections prior to TSA or rTSA is associated with changes in rates of revision and periprosthetic joint infection (PJI) following these procedures. Methods. Data were collected from a national insurance database from January 2006 to December 2017. Patients who underwent shoulder corticosteroid injection within one year prior to ipsilateral TSA or rTSA were identified and stratified into the following cohorts: < three months, three to six months, six to nine months, and nine to 12 months from time of corticosteroid injection to TSA or rTSA. A control cohort with no corticosteroid injection within one year prior to TSA or rTSA was used for comparison. Univariate and multivariate analyses were conducted to determine the association between specific time intervals and outcomes. Results. In total, 4,252 patients were included in this study. Among those, 1,632 patients (38.4%) received corticosteroid injection(s) within one year prior to TSA or rTSA and 2,620 patients (61.6%) did not. On multivariate analysis, patients who received corticosteroid injection < three months prior to TSA or rTSA were at significantly increased risk for revision (odds ratio (OR) 2.61 (95% confidence interval (CI) 1.77 to 3.28); p < 0.001) when compared with the control cohort. However, there was no significant increase in revision risk for all other timing interval cohorts. Notably, Charlson Comorbidity Index ≥ 3 was a significant independent risk factor for all-cause revision (OR 4.00 (95% CI 1.40 to 8.92); p = 0.036). Conclusion. There is a time-dependent relationship between the preoperative timing of corticosteroid injection and the incidence of all-cause revision surgery following TSA or rTSA. This analysis suggests that an interval of at least three months should be maintained between corticosteroid injection and TSA or rTSA to minimize risks of subsequent revision surgery. Cite this article: Bone Joint J 2022;104-B(5):620–626


The Bone & Joint Journal
Vol. 103-B, Issue 7 | Pages 1284 - 1291
1 Jul 2021
Carter TH Karunaratne BJ Oliver WM Murray IR White TO Reid JT Duckworth AD

Aims

Acute distal biceps tendon repair reduces fatigue-related pain and minimizes loss of supination of the forearm and strength of flexion of the elbow. We report the short- and long-term outcome following repair using fixation with a cortical button techqniue.

Methods

Between October 2010 and July 2018, 102 patients with a mean age of 43 years (19 to 67), including 101 males, underwent distal biceps tendon repair less than six weeks after the injury, using cortical button fixation. The primary short-term outcome measure was the rate of complications. The primary long-term outcome measure was the abbreviated Disabilities of the Arm, Shoulder and Hand (QuickDASH) score. Secondary outcomes included the Oxford Elbow Score (OES), EuroQol five-dimension three-level score (EQ-5D-3L), satisfaction, and return to function.


The Bone & Joint Journal
Vol. 103-B, Issue 4 | Pages 718 - 724
1 Apr 2021
Cavalier M Johnston TR Tran L Gauci M Boileau P

Aims

The aim of this study was to identify risk factors for recurrent instability of the shoulder and assess the ability to return to sport in patients with engaging Hill-Sachs lesions treated with arthroscopic Bankart repair and Hill-Sachs remplissage (ABR-HSR).

Methods

This retrospective study included 133 consecutive patients with a mean age of 30 years (14 to 69) who underwent ABR-HSR; 103 (77%) practiced sports before the instability of the shoulder. All had large/deep, engaging Hill-Sachs lesions (Calandra III). Patients were divided into two groups: A (n = 102) with minimal or no (< 10%) glenoid bone loss, and B (n = 31) with subcritical (10% to 20%) glenoid loss. A total of 19 patients (14%) had undergone a previous stabilization, which failed. The primary endpoint was recurrent instability, with a secondary outcome of the ability to return to sport.


The Bone & Joint Journal
Vol. 103-B, Issue 2 | Pages 366 - 372
1 Feb 2021
Sun Z Li J Luo G Wang F Hu Y Fan C

Aims

This study aimed to determine the minimal detectable change (MDC), minimal clinically important difference (MCID), and substantial clinical benefit (SCB) under distribution- and anchor-based methods for the Mayo Elbow Performance Index (MEPI) and range of movement (ROM) after open elbow arthrolysis (OEA). We also assessed the proportion of patients who achieved MCID and SCB; and identified the factors associated with achieving MCID.

Methods

A cohort of 265 patients treated by OEA were included. The MEPI and ROM were evaluated at baseline and at two-year follow-up. Distribution-based MDC was calculated with confidence intervals (CIs) reflecting 80% (MDC 80), 90% (MDC 90), and 95% (MDC 95) certainty, and MCID with changes from baseline to follow-up. Anchor-based MCID (anchored to somewhat satisfied) and SCB (very satisfied) were calculated using a five-level Likert satisfaction scale. Multivariate logistic regression of factors affecting MCID achievement was performed.


The Bone & Joint Journal
Vol. 102-B, Issue 12 | Pages 1629 - 1635
1 Dec 2020
Wang Q Sheng N Rui B Chen Y

Aims

The aim of this study was to explore why some calcar screws are malpositioned when a proximal humeral fracture is treated by internal fixation with a locking plate, and to identify risk factors for this phenomenon. Some suggestions can be made of ways to avoid this error.

Methods

We retrospectively identified all proximal humeral fractures treated in our institution between October 2016 and October 2018 using the hospital information system. The patients’ medical and radiological data were collected, and we divided potential risk factors into two groups: preoperative factors and intraoperative factors. Preoperative factors included age, sex, height, weight, body mass index, proximal humeral bone mineral density, type of fracture, the condition of the medial hinge, and medial metaphyseal head extension. Intraoperative factors included the grade of surgeon, neck-shaft angle after reduction, humeral head height, restoration of medial support, and quality of reduction. Adjusted binary logistic regression and multivariate logistic regression models were used to identify pre- and intraoperative risk factors. Area under the curve (AUC) analysis was used to evaluate the discriminative ability of the multivariable model.


The Bone & Joint Journal
Vol. 102-B, Issue 11 | Pages 1549 - 1554
1 Nov 2020
Schwartz AM Farley KX Boden SH Wilson JM Daly CA Gottschalk MB Wagner ER

Aims. The impact of tobacco use on readmission and medical and surgical complications has been documented in hip and knee arthroplasty. However, there remains little information about the effect of smoking on the outcome after total shoulder arthroplasty (TSA). We hypothesized that active smokers are at an increased risk of poor medical and surgial outcomes after TSA. Methods. Data for patients who underwent arthroplasty of the shoulder in the USA between January 2011 and December 2015 were obtained from the National Readmission Database, and 90-day readmissions and complications were documented using validated coding methods. Multivariate regression analysis was performed to quantify the risk of smoking on the outcome after TSA, while controlling for patient demographics, comorbidities, and hospital-level confounding factors. Results. A total of 196,325 non-smokers (93.1%) and 14,461 smokers (6.9%) underwent TSA during the five-year study period. Smokers had significantly increased rates of 30- and 90-day readmission (p = 0.025 and 0.001, respectively), revision within 90 days (p < 0.001), infection (p < 0.001), wound complications (p < 0.001), and instability of the prosthesis (p < 0.001). They were also at significantly greater risk of suffering from pneumonia (p < 0.001), sepsis (p = 0.001), and myocardial infarction (p < 0.001), postoperatively. Conclusion. Smokers have an increased risk of readmission and medical and surgical complications after TSA. These risks are similar to those found for smokers after hip and knee arthroplasty. Many surgeons choose to avoid these elective procedures in patients who smoke. The increased risks should be considered when counselling patients who smoke before undertaking TSA. Cite this article: Bone Joint J 2020;102-B(11):1549–1554


The Bone & Joint Journal
Vol. 102-B, Issue 9 | Pages 1194 - 1199
14 Sep 2020
Lee H Kim E Kim Y

Aims. The purpose of this study was to identify the changes in untreated long head of the biceps brachii tendon (LHBT) after a rotator cuff tear and to evaluate the factors related to the changes. Methods. A cohort of 162 patients who underwent isolated supraspinatus with the preservation of LHBT was enrolled and evaluated. The cross-sectional area (CSA) of the LHBT on MRI was measured in the bicipital groove, and preoperative to postoperative difference was calculated at least 12 months postoperatively. Second, postoperative changes in the LHBT including intratendinous signal change, rupture, dislocation, or superior labral lesions were evaluated with seeking of factors that were correlated with the changes or newly developed lesions after rotator cuff repair. Results. The postoperative CSA (12.5 mm. 2. (SD 8.3) was significantly larger than preoperative CSA (11.5 mm. 2. (SD 7.5); p = 0.005). In total, 32 patients (19.8%) showed morphological changes in the untreated LHBT 24 months after rotator cuff repair. Univariate regression analysis revealed that the factor chiefly related to the change in LHBT status was an eccentric LHBT position within the groove found on preoperative MRI (p = 0.011). Multivariate analysis using logistic regression also revealed that an eccentric LHBT position was a factor related to postoperative change in untreated LHBTs (p = 0.011). Conclusion. The CSA of the LHBT inside the biceps groove increased after rotator cuff repair. The preoperative presence of an eccentrically positioned LHBT was associated with further changes of the tendon itself after rotator cuff repair. Cite this article: Bone Joint J 2020;102-B(9):1194–1199


The Bone & Joint Journal
Vol. 102-B, Issue 4 | Pages 539 - 544
1 Apr 2020
Cirino CM Chan JJ Patterson DC Jia R Poeran J Parsons BO Cagle PJ

Aims

Heterotopic ossification (HO) is a potentially devastating complication of the surgical treatment of a proximal humeral fracture. The literature on the rate and risk factors for the development of HO under these circumstances is lacking. The aim of this study was to determine the incidence and risk factors for the development of HO in these patients.

Methods

A retrospective analysis of 170 patients who underwent operative treatment for a proximal humeral fracture between 2005 and 2016, in a single institution, was undertaken. The mean follow-up was 18.2 months (1.5 to 140). The presence of HO was identified on follow-up radiographs.


The Bone & Joint Journal
Vol. 101-B, Issue 2 | Pages 147 - 153
1 Feb 2019
Mai DH Oh C Doany ME Rokito AS Kwon YW Zuckerman JD Virk MS

Aims

The aim of this study was to investigate the effects of preoperative bisphosphonate treatment on the intra- and postoperative outcomes of arthroplasty of the shoulder. The hypothesis was that previous bisphosphonate treatment would adversely affect both intra- and postoperative outcomes.

Patients and Methods

A retrospective cohort study was conducted involving patients undergoing arthroplasty of the shoulder, at a single institution. Two patients with no previous bisphosphonate treatment were matched to each patient who had received this treatment preoperatively by gender, age, race, ethnicity, body mass index (BMI), and type of arthroplasty. Previous bisphosphonate treatment was defined as treatment occurring during the three-year period before the arthroplasty. The primary outcome measure was the incidence of intraoperative complications and those occurring at one and two years postoperatively. A total of 87 patients were included: 29 in the bisphosphonates-exposed (BP+) group and 58 in the non-exposed (BP-) group. In the BP+ group, there were 26 female and three male patients, with a mean age of 71.4 years (51 to 87). In the BP- group, there were 52 female and six male patients, with a mean age of 72.1 years (53 to 88).


The Bone & Joint Journal
Vol. 100-B, Issue 4 | Pages 485 - 492
1 Apr 2018
Gauci MO Bonnevialle N Moineau G Baba M Walch G Boileau P

Aims

Controversy about the use of an anatomical total shoulder arthroplasty (aTSA) in young arthritic patients relates to which is the ideal form of fixation for the glenoid component: cemented or cementless. This study aimed to evaluate implant survival of aTSA when used in patients aged < 60 years with primary glenohumeral osteoarthritis (OA), and to compare the survival of cemented all-polyethylene and cementless metal-backed glenoid components.

Materials and Methods

A total of 69 consecutive aTSAs were performed in 67 patients aged < 60 years with primary glenohumeral OA. Their mean age at the time of surgery was 54 years (35 to 60). Of these aTSAs, 46 were undertaken using a cemented polyethylene component and 23 were undertaken using a cementless metal-backed component. The age, gender, preoperative function, mobility, premorbid glenoid erosion, and length of follow-up were comparable in the two groups. The patients were reviewed clinically and radiographically at a mean of 10.3 years (5 to 12, sd 26) postoperatively. Kaplan–Meier survivorship analysis was performed with revision as the endpoint.


The Bone & Joint Journal
Vol. 100-B, Issue 3 | Pages 324 - 330
1 Mar 2018
Mahure SA Mollon B Capogna BM Zuckerman JD Kwon YW Rokito AS

Aims. The factors that predispose to recurrent instability and revision stabilization procedures after arthroscopic Bankart repair for anterior glenohumeral instability remain unclear. We sought to determine the rate and risk factors associated with ongoing instability in patients undergoing arthroscopic Bankart repair for instability of the shoulder. Materials and Methods. We used the Statewide Planning and Research Cooperative System (SPARCS) database to identify patients with a diagnosis of anterior instability of the shoulder undergoing arthroscopic Bankart repair between 2003 and 2011. Patients were followed for a minimum of three years. Baseline demographics and subsequent further surgery to the ipsilateral shoulder were analyzed. Multivariate analysis was used to identify independent risk factors for recurrent instability. Results. A total of 5719 patients were analyzed. Their mean age was 24.9 years (. sd.  9.3); 4013 (70.2%) were male. A total of 461 (8.1%) underwent a further procedure involving the ipsilateral shoulder at a mean of 31.5 months (. sd.  23.8) postoperatively; 117 (2.1%) had a closed reduction and 344 (6.0%) had further surgery. Revision arthroscopic Bankart repair was the most common subsequent surgical procedure (223; 65.4%). Independent risk factors for recurrent instability were: age < 19 years (odds ratio 1.86), Caucasian ethnicity (hazard ratio 1.42), bilateral instability of the shoulder (hazard ratio 2.17), and a history of closed reduction(s) prior to the initial repair (hazard ratio 2.45). Revision arthroscopic Bankart repair was associated with significantly higher rates of ongoing persistent instability than revision open stabilization (12.4% vs 5.1%, p = 0.041). Conclusion. The incidence of a further procedure being required in patients undergoing arthroscopic Bankart repair for anterior glenohumeral instability was 8.1%. Younger age, Caucasian race, bilateral instability, and closed reduction prior to the initial repair were independent risk factors for recurrent instability, while subsequent revision arthroscopic Bankart repair had significantly higher rates of persistent instability than subsequent open revision procedures. Cite this article: Bone Joint J 2018;100-B:324–30


The Bone & Joint Journal
Vol. 99-B, Issue 11 | Pages 1515 - 1519
1 Nov 2017
Saltzman BM Mayo BC Bohl DD Frank RM Cole BJ Verma NN Nicholson GP Romeo AA

Aims

To determine the incidence and timing of post-operative fevers following shoulder arthroplasty and the resulting investigations performed.

Patients and Methods

A retrospective review was conducted of all patients undergoing shoulder arthroplasty over a nine-year period. The charts of all patients with a post-operative fever (≥ 38.6°C) were reviewed and the results of all investigations were analysed.


The Bone & Joint Journal
Vol. 99-B, Issue 9 | Pages 1190 - 1196
1 Sep 2017
Swarup I Henn CM Nguyen JT Dines DM Craig EV Warren RF Gulotta LV Henn III RF

Aims

Few studies have evaluated the relationship between patients’ pre-operative expectations and the outcome of orthopaedic procedures. Our aim was to determine the effect of expectations on the outcome after primary anatomical total shoulder arthroplasty (TSA). We hypothesised that patients with greater expectations would have better outcomes.

Patients and Methods

Patients undergoing primary anatomical TSA completed the Hospital for Special Surgery’s Shoulder Expectations Survey pre-operatively. The American Shoulder and Elbow Surgeons (ASES), Shoulder Activity Scale (SAS), Short-Form-36 (SF-36), and visual analogue scale (VAS) for pain, fatigue, and general health scores were also collected pre-operatively and two years post-operatively. Pearson correlations were used to assess the relationship between the number of expectations and the outcomes. Differences in outcomes between those with higher and lower levels of expectations for each expectation were assessed by independent samples t-test. Multivariable linear regression analysis was used to control for potential confounding factors.


The Bone & Joint Journal
Vol. 98-B, Issue 12 | Pages 1656 - 1661
1 Dec 2016
Kim S Park J Lee K Lee B

Aims

The aim of the study was to develop a quantitative scoring system to predict whether a large-to-massive rotator cuff tear was arthroscopically reparable prior to surgery.

Patients and Methods

We conducted a retrospective review of the pre-operative MR imaging and surgical records of 87 patients (87 shoulders) who underwent arthroscopic repair of a large-to-massive rotator cuff tear. Patients were divided into two groups, based on the surgical outcome of the repair. Of the 87 patients, 53 underwent complete repair (Group I) and 34 an incomplete repair (Group II). Pre-operative MR images were reviewed to quantify several variables. Between-group differences were evaluated and multiple logistic regression analysis was used to calculate the predictive value of significant variables. The reparability index (RI) was constructed using the odds ratios of significant variables and a receiver operating characteristic curve analysis performed to identify the optimal RI cutoff to differentiate between the two groups.


The Bone & Joint Journal
Vol. 98-B, Issue 6 | Pages 818 - 824
1 Jun 2016
Mollon B Mahure SA Ding DY Zuckerman JD Kwon YW

Aims

Depression can significantly affect quality of life and is associated with higher rates of medical comorbidities and increased mortality following surgery. Although depression has been linked to poorer outcomes following orthopaedic trauma, total joint arthroplasty and spinal surgery, we wished to examine the impact of depression in elective total shoulder arthroplasty (TSA) as this has not been previously explored.

Patients and Methods

The United States Nationwide Inpatient Sample (NIS) was used to identify patients undergoing elective TSA over a ten-year period. Between 2002 and 2012, 224 060 patients underwent elective TSA.


The Bone & Joint Journal
Vol. 96-B, Issue 12 | Pages 1681 - 1687
1 Dec 2014
Foruria AM Lawrence TM Augustin S Morrey BF Sanchez-Sotelo J

We retrospectively reviewed 89 consecutive patients (45 men and 44 women) with a mean age at the time of injury of 58 years (18 to 97) who had undergone external fixation after sustaining a unilateral fracture of the distal humerus. Our objectives were to determine the incidence of heterotopic ossification (HO); identify risk factors associated with the development of HO; and characterise the location, severity and resultant functional impairment attributable to the presence of HO.

HO was identified in 37 elbows (42%), mostly around the humerus and along the course of the medial collateral ligament. HO was hazy immature in five elbows (13.5%), mature discrete in 20 (54%), extensive mature in 10 (27%), and complete bone bridges were present in two elbows (5.5%). Mild functional impairment occurred in eight patients, moderate in 27 and severe in two. HO was associated with less extension (p = 0.032) and less overall flexion-to-extension movement (p = 0.022); the flexion-to-extension arc was < 100º in 21 elbows (57%) with HO compared with 18 elbows (35%) without HO (p = 0.03). HO was removed surgically in seven elbows.

The development of HO was significantly associated with sustaining a head injury (p = 0.015), delayed internal fixation (p = 0.027), the method of fracture fixation (p = 0.039) and the use of bone graft or substitute (p = 0.02).HO continues to be a substantial complication after internal fixation for distal humerus fractures.

Cite this article: Bone Joint J 2014;96-B:1681–7.