IMPORTANCEThe 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 PARTICIPANTSIn 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.

Background: Mechanical failure of intramedullary nails is rare. This investigation was prompted by a series of cases of observed breakage of the recently introduced TFNA Proximal Femoral Nailing System (TFN [Trochanteric Fixation Nail]-Advanced; DePuy Synthes) in our region. Laboratory analysis and case data are presented, in contribution to post-market surveillance. Methods: Medical and imaging records from the 3 public tertiary orthopaedic trauma hospitals in Western Australia were reviewed. Relevant data of patients in whom breakage of the TFNA implant occurred between 2016 and 2018 were collected and analyzed. Laboratory review of retrieved implants was conducted at the Centre for Implant Technology and Retrieval Analysis (CITRA) in Western Australia. Results: A total of 16 cases of TFNA implant breakage were recorded and analyzed. The predominant OTA/AO fracture classification was 31A3 (12 cases, 75%). The reduction quality was good in 10 cases, acceptable in 4 cases, and poor in 2 cases. The mean time to failure (and standard deviation) was 5.0 ± 2.2 months (range, 2.2 to 9.8 months). The treatment modality for the breakage was revision nailing in 11 cases, arthroplasty in 3, and nonoperative management in 2. All nails broke at the proximal screw aperture, with 1 nail additionally breaking at the distal aperture. Of 8 patients treated with a second TFNA implant for nail breakage, 3 (38%) returned with breakage of the revision implant. Laboratory analysis of the broken nails demonstrated a unique fracture pattern, with a stepped propagation pathway. Conclusions: This study represents the largest series, to our knowledge, of proximal femoral nail breakages in the published English literature and is the first that we are aware of to involve laboratory analysis of the TFNA implant. Changes to the nail design and/or alloy may have contributed to the observed cases of breakage, and this study will be followed by an evaluation of breakage rates in comparison with those of previous generations of nailing systems. We advise close clinical and radiographic surveillance of patients with unstable hip fracture patterns who undergo osteosynthesis with use of a TFNA implant. Level of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

This study showed excellent mid-term survival and good clinical and radiographic outcomes in patients who had undergone revision THA with a modular uncemented, tapered, straight design.

Background: We are performing a combined randomised and observational study comparing internal fixation to nonsurgical 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 astreated 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.

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 analysisThis 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 disseminationCROSSFIRE(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.RegistrationCROSSFIRE has been registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR: ACTRN12616000969460).