Plating vs Closed Reduction for Fractures in the Distal Radius in Older Patients: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Distal radius fractures are common and are managed with or without surgery. Current evidence indicates surgical treatment is not superior to nonsurgical treatment at 12 months. Objective: Does surgical treatment for displaced distal radius fractures in patients 60 years or older provide better patient-reported wrist pain and function outcomes than nonsurgical treatment at 24 months? Design, Setting, and Participants: In this secondary analysis of a combined multicenter randomized clinical trial (RCT) and a parallel observational study, 300 patients were screened from 19 centers in Australia and New Zealand. Of these, 166 participants were randomized to surgical or nonsurgical treatment. Participants who declined randomization (n = 134) were included in the parallel observational group with the same treatment options and follow-up. Participants were followed up at 3, 12, and 24 months by a blinded assessor. The 24-month outcomes are reported herein. Data were collected from December 1, 2016, to December 31, 2020, and analyzed from February 4 to October 21, 2021. Interventions: Surgical treatment consisting of open reduction and internal fixation using a volar-locking plate (VLP group) and nonsurgical treatment consisting of closed reduction and cast immobilization (CR group). Main Outcomes and Measures: The primary outcome was patient-reported function using the Patient-Rated Wrist Evaluation (PRWE) questionnaire. Secondary outcomes included health-related quality of life, wrist pain, patient-reported treatment success, patient-rated bother with appearance, and posttreatment complications. Results: Among the 166 randomized and 134 observational participants (300 participants; mean [SD] age, 71.2 [7.5] years; 269 women [89.7%]), 151 (91.0%) randomized and 118 (88.1%) observational participants were followed up at 24 months. In the RCT, no clinically important difference occurred in mean PRWE scores at 24 months (13.6 [95% CI, 9.1-18.1] points for VLP fixation vs 15.8 [95% CI, 11.3-20.2] points for CR; mean difference, 2.1 [95% CI, -4.2 to 8.5]; P = .50). There were no between-group differences in all other outcomes except for patient-reported treatment success, which favored VLP fixation (33 of 74 [44.6%] in the CR group vs 54 of 72 [75.0%] in the VLP fixation group reported very successful treatment; P = .002). Rates of posttreatment complications were generally low and similar between treatment groups, including deep infection (1 of 76 [1.3%] in the CR group vs 0 of 75 in the VLP fixation group) and complex regional pain syndrome (2 of 76 [2.6%] in the CR group vs 1 of 75 [1.3%] in the VLP fixation group). The 24-month trial outcomes were consistent with 12-month outcomes and with outcomes from the observational group. Conclusions and Relevance: Consistent with previous reports, these findings suggest that VLP fixation may not be superior to CR for displaced distal radius fractures for patient-rated wrist function in persons 60 years or older during a 2-year period. Significantly higher patient-reported treatment success at 2 years in the VLP group may be attributable to other treatment outcomes not captured in this study. Trial Registration: ANZCTR.org Identifier: ACTRN12616000969460.

Surgical Plating vs Closed Reduction for Fractures in the Distal Radius in Older Patients: A Randomized Clinical Trial.

Importance: The burden of injury and costs of wrist fractures are substantial. Surgical treatment became popular without strong supporting evidence. Objective: To assess whether current surgical treatment for displaced distal radius fractures provided better patient-reported wrist pain and function than nonsurgical treatment in patients 60 years and older. Design, Setting, and Participants: In this multicenter randomized clinical trial and parallel observational study, 300 eligible patients were screened from 19 centers in Australia and New Zealand from December 1, 2016, until December 31, 2018. A total of 166 participants were randomized to surgical or nonsurgical treatment and followed up at 3 and 12 months by blinded assessors. Those 134 individuals who declined randomization were included in a parallel observational cohort with the same treatment options and follow-up. The primary analysis was intention to treat; sensitivity analyses included as-treated and per-protocol analyses. Intervention: Surgical treatment was open reduction and internal fixation using a volar-locking plate (VLP). Nonsurgical treatment was closed reduction and cast immobilization (CR). Main Outcomes and Measures: The primary outcome was the Patient-Rated Wrist Evaluation score at 12 months. Secondary outcomes were Disabilities of Arm, Shoulder, and Hand questionnaire score, health-related quality of life, pain, major complications, patient-reported treatment success, bother with appearance, and therapy use. Results: In the 300 study participants (mean [SD] age, 71.2 [7.5] years; 269 [90%] female; 166 [81 VLP and 85 CR] in the randomized clinical trial sample and 134 [32 VLP and 102 CR] in the observational sample), no clinically important between-group difference in 12-month Patient-Rated Wrist Evaluation scores (mean [SD] score of 19.8 [21.1] for VLP and 21.5 [24.3] for CR; mean difference, 1.7 points; 95% CI -5.4 to 8.8) was observed. No clinically important differences were found in quality of life, wrist pain, or bother at 3 and 12 months. No significant difference was found in total complications between groups (12 of 84 [14%] for the CR group vs 6 of 80 [8%] for the VLP group; risk ratio [RR], 0.53; 95% CI, 0.21-1.33). Patient-reported treatment success favored the VLP group at 12 months (very successful or successful: 70 [89%] vs 57 [70%]; RR, 1.26; 95% CI, 1.07-1.48; P = .005). There was greater use of postoperative physical therapy in the VLP group (56 [72%] vs 44 [54%]; RR, 1.32; 95% CI, 1.04-1.69; P = 0.02). Conclusions and Relevance: This randomized clinical trial found no between-group differences in improvement in wrist pain or function at 12 months from VLP fixation over CR for displaced distal radius fractures in older people. Trial Registration: http://anzctr.org.au identifier: ACTRN12616000969460.

A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE): a statistical analyses plan.

BACKGROUND: We are performing a combined randomised and observational study comparing internal fixation to non-surgical management for common wrist fractures in older patients. This paper describes the statistical analysis plan. METHODS/DESIGN: A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE) is a randomised controlled trial comparing two types of usual care for treating wrist fractures in older patients, surgical fixation using volar locking plates and non-surgical treatment using closed reduction and plaster immobilisation. The primary aim of this comparative-effectiveness study is to determine whether surgery is superior to non-surgical treatment with respect to patient-reported wrist function at 12 months post treatment. The secondary outcomes include radiographic outcomes, complication rates and patient-reported outcomes including quality of life, pain, treatment success and cosmesis. Primary analysis will use a two-sample t test and an intention-to-treat analysis using the randomised arm of the study. Statistical analyses will be two-tailed and significance will be determined by p < 0.05. Sensitivity analyses will be conducted to assess for differences in intention-to-treat, per-protocol and as-treated analyses. Sensitivity analyses will also be conducted to assess selection bias by evaluating differences in participants between the randomised and observational study arms, and for bias relating to any missing data. An economic analysis will be conducted separately if surgery is shown to provide superior outcomes to a level of clinical significance. DISCUSSION: This statistical analysis plan describes the analysis of the CROSSFIRE study which aims to provide evidence to aid clinical decision-making in the treatment of distal radius fractures in older patients. TRIAL REGISTRATION: CROSSFIRE was approved by The Hunter New England Human Research Ethics Committee (HNEHREC Reference No: 16/02/17/3.04). Registered on 22 July 2016 with The Australian and New Zealand Clinical Trials Registry (ANZCTR Number; ACTRN12616000969460 ). This manuscript is based on v.11 of the statistical analysis plan. A copy of v.11, signed by the chief investigator and the senior statistician is kept at the administering institution.

Benzoyl peroxide + chlorhexidine versus chlorhexidine alone skin preparation to reduce Propionibacterium acnes: a randomized controlled trial.

BACKGROUND: Traditional skin preparation for shoulder surgery is not specific for Propionibacterium acnes. Topical benzoyl peroxide for 48 h preoperatively has been shown to reduce the bacterial load of P. acnes on the skin. Our aim was to investigate whether skin preparation with a single application of benzoyl peroxide combined with 2% chlorhexidine/alcohol immediately prior to surgery was superior to 2% chlorhexidine/alcohol alone at inhibiting P. acnes. METHODS: We conducted a single-blinded interventional study. Each shoulder of the participant was assigned a different preparation through a randomization process. Two sites were assessed per shoulder. The intervention was the application of benzoyl peroxide followed by chlorhexidine/alcohol to the shoulder. The control was two applications of 2% chlorhexidine/alcohol. Superficial skin swabs for semi-quantitative culture were taken pre- and post-skin preparation. RESULTS: A total of 22 male participants were randomized. All participants were colonized with P. acnes on baseline swabs. We found complete inhibition of P. acnes at 14 days at 80% of sites prepared with benzoyl peroxide + chlorhexidine/alcohol compared with 86% inhibition at shoulder sites prepared with chlorhexidine alone. CONCLUSION: There was no reduction in the growth of P. acnes over 14 days with chlorhexidine/alcohol and benzoyl peroxide compared with chlorhexidine alone. On the basis of these results, the addition of benzoyl peroxide at the time of surgery does not appear to increase the efficacy of the surgical preparation for inhibiting P. acnes growth.

A combined randomised and observational study of surgery for fractures in the distal radius in the elderly (CROSSFIRE)-a study protocol.

Fractures of the distal radius are common and occur in all age groups. The incidence is high in older populations due to osteoporosis and increased falls risk. Considerable practice variation exists in the management of distal radius fractures in older patients ranging from closed reduction with cast immobilisation to open reduction with plate fixation. Plating is currently the most common surgical treatment. While there is evidence showing no significant advantage for some forms of surgical fixation over conservative treatment, and no difference between different surgical techniques, there is a lack of evidence comparing two of the most common treatments used: closed reduction and casting versus plating. Surgical management involves significant costs and risks compared with conservative management. High-level evidence is required to address practice variation, justify costs and to provide the best clinical outcomes for patients. METHODS AND ANALYSIS: This pragmatic, multicentre randomised comparative effectiveness trial aims to determine whether plating leads to better pain and function and is more cost-effective than closed reduction and casting of displaced distal radius fractures in adults aged 60 years and older. The trial will compare the two techniques but will also follow consenting patients who are unwilling to be randomised in a separate, observational cohort. Inclusion of non-randomised patients addresses selection bias, provides practice and outcome insights about standard care, and improves the generalisability of the results from the randomised trial. ETHICS AND DISSEMINATION: CROSSFIRE(Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly) was reviewed and approved by The Hunter New England HREC (HNEHREC Reference No: 16/02/17/3.04). The results of the trial will be published in a peer-reviewed journal and will be disseminated via various forms of media. Results will be incorporated in clinical recommendations and practice guidelines produced by professional bodies. REGISTRATION: CROSSFIRE has been registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR: ACTRN12616000969460).

Crista Supinatoris Fractures of the Proximal Part of the Ulna: Surgical Technique.

INTRODUCTION: Open reduction and internal fixation of crista supinatoris fractures is required when the elbow is unstable despite appropriate nonoperative management and when a patient is undergoing surgical treatment of a periarticular elbow fracture-dislocation. STEP 1 SKIN INCISION AND SURGICAL APPROACH: Use a posterior or lateral skin incision according to your preference and then utilize the Kocher interval to access the joint, lateral collateral ligament, and crista supinatoris or, in the setting of a proximal ulnar fracture, use the Boyd interval. STEP 2 MANAGEMENT OF ASSOCIATED INJURIES: Crista supinatoris fractures have not been identified in isolation; address associated injuries such as radial head/neck fractures, capitellar fractures, and coronoid fractures first. STEP 3 EVALUATION OF ELBOW STABILITY: If elbow instability persists after the concomitant injuries have been addressed, fix the crista supinatoris. STEP 4 EXPOSURE OF THE CRISTA SUPINATORIS: Expose the fracture fragment and base of the crista supinatoris. STEP 5 REDUCTION AND FIXATION OF THE CRISTA SUPINATORIS FRACTURE: Obtain an anatomic reduction and fixation of the crista supinatoris fracture to appropriately tension the lateral ulnar collateral ligament. STEP 6 REEVALUATION OF ELBOW STABILITY: Gently evaluate the stability of the elbow following repair of the crista supinatoris fracture. STEP 7 POSTOPERATIVE CARE: Initiate rehabilitation on the basis of intraoperative stability and concomitant injuries. RESULTS: We recently conducted a retrospective review of the outcomes of twelve patients with a fracture of the crista supinatoris.IndicationsContraindicationsPitfalls & Challenges.

Crista supinatoris fractures of the proximal part of the ulna.

BACKGROUND: The crista supinatoris is the insertion site of the lateral collateral ligament complex on the proximal part of the ulna. The purpose of this study was to report the presentation, management, and outcomes of patients with crista supinatoris fractures. METHODS: Twelve patients with fractures of the crista supinatoris were assessed clinically and radiographically and with validated outcomes at a mean of thirty-nine months after injury. Outcome measures included the Patient-Rated Elbow Evaluation (PREE), Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, American Shoulder and Elbow Surgeons elbow (ASES-e) score, and strength measured with a dynamometer. RESULTS: No crista supinatoris fracture occurred in isolation. Other associated injuries included radial head fracture in ten patients (83%), a radial neck fracture in one patient, and a capitellar fracture in one. At the time of presentation, all crista factures were difficult to identify on standard radiographs, but oblique radiographs and/or computed tomography (CT) allowed definitive fracture identification. Four patients were managed nonoperatively, and eight patients were managed surgically, with the indication for surgery being the associated injuries, not specifically the presence of a crista fracture. At the time of surgery, posterolateral rotatory elbow instability, if present, was due to the crista fracture. At the time of follow-up, all elbows were clinically stable and had radiographic concentric reductions. Elbow flexion and extension were a mean (and standard deviation) of 136° ± 6° and 5° ± 8°, respectively. The mean PREE score was 15 ± 20, and the mean DASH was 13.5 ± 18. CONCLUSIONS: Crista supinatoris fractures are difficult to identify on standard elbow radiographs. Fracture management is based on an assessment of elbow stability and on appropriate treatment of the associated injuries.

Classic versus congruent coracoid positioning during the Latarjet procedure: an in vitro biomechanical comparison.

PURPOSE: The purpose of this biomechanical study was to compare the classic Latarjet technique and congruent-arc modification with respect to glenohumeral stability, joint stiffness, translation, and range of motion. METHODS: Eight cadaveric forequarters were tested on a shoulder simulator that applied loads independently to the conjoint tendon, long head of biceps, rotator cuff, and deltoid. The test conditions included: intact, 30% glenoid defect, and reconstruction of the defect with the classic and congruent Latarjets. The Latarjet techniques were randomly ordered, with the outcome variables being anterior dislocation, glenohumeral translation, rotational range of motion, and joint stiffness. RESULTS: All 8 specimens dislocated after creation of a 30% glenoid defect. The classic Latarjet stabilized 7 of 8 specimens, whereas the congruent-arc modification stabilized all specimens (8/8). In abduction neutral rotation, there was no difference in joint translation between techniques (P = .613). In abduction external rotation, there was significantly greater anterior humeral head translation after the congruent technique than after the classic (9.9 and 6.5 mm, respectively, P = .013). Rotational range of motion was significantly reduced after classic (-25.8°) and congruent (-22.2°) transfers as compared with the 30% defect (P ≤ .041). Joint stiffness in the abducted, externally rotated position was significantly reduced in the 30% defect as compared with intact (P = .012), congruent (P = .015), and classic (P < .001) conditions. In all abduction positions, the intact was not significantly different from the Latarjet techniques, and the techniques did not significantly differ from each other (P ≥ .102). CONCLUSIONS: The classic and congruent-arc Latarjet techniques restore shoulder stability and motion in cases of considerable bone loss. The techniques do not substantially differ in rotational range of motion or joint stiffness. The congruent-arc technique, however, does result in significantly greater anterior humeral head translation, as compared with the classic technique, before reaching a stable non-dislocated endpoint. CLINICAL RELEVANCE: On the basis of this biomechanical model, both the classic and congruent-arc Latarjet techniques can be used to stabilize a shoulder with substantial glenoid bone loss. Further clinical and biomechanical studies are required to determine if particular clinical circumstances exist where 1 technique has an advantage over the other.

Does the dynamic sling effect of the Latarjet procedure improve shoulder stability? A biomechanical evaluation.

INTRODUCTION: Glenohumeral instability with glenoid bone loss is commonly treated with the Latarjet procedure. The procedure involves transfer of the coracoid and conjoint tendon, which is thought to provide a stabilizing sling effect; however, its significance is unknown. This study evaluated the effects of the Latarjet procedure, with and without conjoint tendon loading, on shoulder stability and range of motion (ROM). MATERIALS AND METHODS: A custom simulator was used to evaluate anterior shoulder stability and ROM in 8 cadaveric shoulders. Testing conditions included intact, 30% glenoid defect, and Latarjet with and without conjoint loading. Unloaded and 10-N loaded states were tested in adduction and 90° abduction. Outcome variables included dislocation, stiffness (neutral and 60° external rotation), and internal-external rotational ROM. RESULTS: All 30% defects dislocated in abduction external rotation. The loaded Latarjet prevented dislocation in all specimens, whereas the unloaded Latarjet stabilized 6 of 8 specimens. In abduction external rotation, there were no significant differences in stiffness between loaded and unloaded transfers (P = .176). In adduction, there were no significant differences between the intact and the loaded Latarjet (P ≥ .228); however, in neutral rotation, the unloaded Latarjet (P = .015) and the 30% defects (P = .011) were significantly less stiff. Rotational ROM in abduction was significantly reduced with the loaded Latarjet (P = .014) compared with unloaded Latarjet, and no differences were found in adduction. CONCLUSIONS: These findings indicate that glenohumeral stability is improved, but not fully restored to intact, with conjoint tendon loading. The results support the existence of the sling effect and its importance in augmenting stability provided by the transferred coracoid.

The effect of the remplissage procedure on shoulder stability and range of motion: an in vitro biomechanical assessment.

BACKGROUND: The remplissage procedure may be performed as an adjunct to Bankart repair to treat recurrent glenohumeral dislocation associated with an engaging Hill-Sachs humeral head defect. The purpose of this in vitro biomechanical study was to examine the effects of the remplissage procedure on glenohumeral joint motion and stability. METHODS: Cadaveric shoulders (n = 8) were mounted on a biomechanical testing apparatus that applies simulated loads to the rotator cuff and the anterior, middle, and posterior heads of the deltoid muscle. Testing was performed with the shoulder intact, after creation of the Bankart lesion, and after repair of the Bankart lesion. In addition, testing was performed after Bankart repair with and without remplissage in shoulders with 15% and 30% Hill-Sachs defects. Shoulder motion and glenohumeral translation were recorded with an optical tracking system. Outcomes measured included stability (joint stiffness and defect engagement) and internal-external glenohumeral rotational motion in adduction and in 90° of composite shoulder abduction. RESULTS: In specimens with a 15% Hill-Sachs defect, Bankart repair combined with remplissage resulted in a significant reduction in internal-external range of motion in adduction (15.1° ± 11.1°, p = 0.039), but not in abduction (7.7° ± 9.9, p = 0.38), compared with the intact condition. In specimens with a 30% Hill-Sachs defect, repair that included remplissage also significantly reduced internal-external range of motion in adduction (14.5° ± 11.3°, p = 0.049) but not in abduction (6.2° ± 9.3°, p = 0.60). In specimens with a 15% Hill-Sachs defect, addition of remplissage significantly increased joint stiffness compared with isolated Bankart repair (p = 0.038), with the stiffness trending toward surpassing the level in the intact condition (p = 0.060). In specimens with a 30% Hill-Sachs defect, addition of remplissage restored joint stiffness to approximately normal (p = 0.41 compared with the intact condition). All of the specimens with a 30% Hill-Sachs defect engaged and dislocated after Bankart repair alone. The addition of remplissage was effective in preventing engagement and dislocation in all specimens. None of the specimens with a 15% Hill-Sachs defect engaged or dislocated after Bankart repair. CONCLUSIONS: In this experimental model, addition of remplissage provided little additional benefit to a Bankart repair in specimens with a 15% Hill-Sachs defect, and it also reduced specific shoulder motions. However, Bankart repair alone was ineffective in preventing engagement and recurrent dislocation in specimens with a 30% Hill-Sachs defect. The addition of remplissage to the Bankart repair in these specimens prevented engagement and enhanced stability, although at the expense of some reduction in shoulder motion.

Moderate to large engaging Hill-Sachs defects: an in vitro biomechanical comparison of the remplissage procedure, allograft humeral head reconstruction, and partial resurfacing arthroplasty.

BACKGROUND: The management of engaging Hill-Sachs defects (HSD) is controversial. The purpose of this study was to biomechanically compare 3 treatment strategies. MATERIALS AND METHODS: Eight specimens were tested on a shoulder simulator. The protocol involved testing 2 unrepaired HSD (30% and 45%), which were then treated with remplissage, humeral head allograft (HHA), and partial resurfacing arthroplasty (PRA). Stability (defect engagement and glenohumeral stiffness) and range of motion (ROM) were measured. RESULTS: All 30% and 45% HSDs engaged and dislocated. Remplissage and HHA effectively prevented engagement in all specimens; however, 62% of PRA engaged. No repair exhibited stiffness significantly greater than intact, but 30% and 45% remplissage produced a 74% and 207% increase, respectively, and were significantly greater than the unrepaired states (P ≤ .047). Stiffness results for HHA and PRA closely matched those of intact. In adduction, remplissage reduced internal-external ROM compared with both defects (P ≤ .01), but only 30% remplissage caused a significant decrease compared with intact (P = .049). In abduction, all repairs reduced ROM compared with HSD (P ≤ .04), but none compared with intact (P ≥ 0.05). In extension, remplissage had significantly less ROM than either HHA or PRA (P ≤ .02). CONCLUSION: All procedures improved stability; however, unlike remplissage, results from HHA and PRA closely resembled intact. Remplissage (30% and 45%) improved stability and eliminated engagement but caused reductions in ROM. HHA and PRA re-established intact ROM, but PRA could not fully prevent engagement. The effects of each technique are not equivalent and further studies are required.

An anatomic, computed tomographic assessment of the coracoid process with special reference to the congruent-arc latarjet procedure.

PURPOSE: The purpose of this study was to determine the dimensions of the coracoid and to compare the radius of curvature (ROC) of the intact glenoid to the ROC of the coracoid undersurface, as oriented in the congruent-arc Latarjet procedure. The ROC of the coracoid undersurface was also compared with various glenoid bone loss scenarios. METHODS: Thirty-four computed tomography-based 3-dimensional models of the shoulder were examined by use of commercially available software. The mean dimensions of the coracoid were determined, and the ROC was calculated for the coracoid undersurface, the intact glenoid, and 20%, 35%, and 50% anterior glenoid bone loss scenarios. Intra-rater and inter-rater statistics were calculated. RESULTS: The mean length, width, and thickness of the coracoid were 16.8 mm (SD, 2.5 mm), 15.0 mm (SD, 2.2 mm), and 10.5 mm (SD, 1.7 mm), respectively. The mean ROC values were 13.6 mm (SD, 3.4 mm) for the coracoid, 13.8 mm (SD, 2.1 mm) for the intact glenoid, 27.6 mm (SD, 5.3 mm) for 20% anterior glenoid bone loss, 30.5 mm (SD, 5.2 mm) for 35% bone loss, and 33.3 mm (SD, 5.2 mm) for 50% bone loss. The coracoid ROC was not significantly different from the intact glenoid (P = .75); however, it was significantly less (P < .01) when compared with all glenoid bone loss scenarios. Intra-rater reliability and inter-rater reliability were good or excellent. A coracoid oriented in the congruent-arc manner can reconstitute a significantly greater glenoid bone defect than a coracoid oriented in the classic manner (P < .001). CONCLUSIONS: This image-based anatomic study found that the ROC of the coracoid undersurface matches the ROC of the intact anterior glenoid articular margin. In conditions with anterior glenoid bony deficiency, the radii of curvature differ significantly at the graft-native glenoid interface; however, the coracoid graft placed in the congruent-arc manner reconstitutes the ROC of the missing anterior glenoid rim. In addition, orienting the coracoid in the congruent-arc manner can reconstitute a greater glenoid bone defect than a coracoid placed in the original manner as described by Latarjet. CLINICAL RELEVANCE: The congruent-arc Latarjet procedure, a modification of the original procedure, is truly congruent in relation to the intact anterior glenoid rim. In addition, the congruent-arc modification can reconstitute a greater glenoid bone defect when compared with the original Latarjet procedure.