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

ABSTRACT: 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

SUBMITTER: Lawson A

PROVIDER: S-EPMC7364640 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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

Lawson Andrew A Naylor Justine J Buchbinder Rachelle R Ivers Rebecca R Balogh Zsolt Z Smith Paul P Mittal Rajat R Xuan Wei W Howard Kirsten K Vafa Arezoo A Yates Piers P Rieger Bertram B Smith Geoff G Elkinson Ilia I Kim Woosung W Sungaran Jai J Latendresse Kim K Wong James J Viswanathan Sameer S Landale Keith K Drobetz Herwig H Tran Phong P Page Richard R Hau Raphael R Mulford Jonathan J Incoll Ian I Kale Michael M Schick Bernard B Higgs Andrew A Oppy Andrew A Perriman Diana D Harris Ian I

Trials 20200715 1

<h4>Background</h4>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.<h4>Methods/design</h4>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 ...[more]

PMID: 32669121

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Project description: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).

Project description:BackgroundPercutaneous pinning fixation (PCP) has been used for the treatment of distal radius fractures for decades, especially in the elderly with fragile soft tissue. However, achieving and maintaining a sound anatomic reduction before PCP is difficult if we use the manipulative reduction method alone. Our study innovatively applied the Steinmann pin retractor for closed reduction combined with PCP, to provide a new protocol for the treatment of distal radius fractures.MethodsFrom March 2017 to July 2018, 49 patients out of 57 that met the inclusion criteria but not the exclusion criteria were included in our retrospective cohort study. Sixteen patients were treated with Steinmann pin retractor-assisted closed reduction combined with PCP (S-PCP), and 19 patients were treated with the manipulative reduction combined with PCP (M-PCP), and 14 patients were treated with the manipulative reduction combined with cast splint (M-C). All these patients received a positive postoperative radiological and clinical evaluation.ResultsAll the patients were followed up for a minimum of 2 years. The radiological parameters in each group improved significantly postoperative (posttreatment). In the S-PCP group, the values of radial height (postoperative, 13.33±1.74 mm; the first follow-up, 13.27±1.81mm; last follow-up, 13.16±1.76mm) and ulnar variance (postoperative, -0.10±1.29mm; the first follow-up, -0.05±1.27mm; last follow-up, -0.12±1.09mm) significantly improved as compared to the M-PCP and M-C groups. While the patients in the M-C group experienced significant re-displacement at the first and last follow-ups, in the S-PCP group, the range of wrist motion including extension (89.94±5.21%), radial deviation (90.69±6.01%), and supination (90.25±5.87%); ulnar deviation (89.81±5.82%) and QuickDASH score (2.70±3.64); and grip strength (92.50±5.59%), pronation (90.50±6.04%), and modified Mayo wrist score (90.94±4.17, the excellent rate reached up to 75%) also improved as compared to the M-PCP group, M-C group, or both groups at the last follow-up.ConclusionS-PCP improves fracture reduction and wrist function and can serve as an effective method for A2(AO/OTA) and A3 type of distal radius fractures in the elderly with limited dorsal comminution, including intra-articular fractures with displacement less than 2mm.

Project description:Of all distal radius fractures, 25 % are complete articular fractures (AO/OTA type C fractures). Two thirds of those fractures are displaced and require reduction. According to several International Guidelines, adequately reduced intra-articular distal radius fractures are best treated non-operatively with plaster immobilisation, while surgical fixation is suggested only when the articular step exceeds 2 mm after reduction. However, these recommendations are based on studies that did not differentiate between intra- and extra-articular distal radius fractures. Thus, no clear consensus about the best treatment for patients with displaced intra-articular distal radius fractures can be reached. Despite the lack of evidence, an increase in internal fixation of intra-articular distal radius fractures has been observed over the last decade. The aim of this study is to determine the difference in functional outcome following open reduction and plate fixation compared with non-operative treatment with closed reduction and plaster immobilisation in patients with a displaced intra articular distal radius fracture.This multicentre randomised controlled trial will randomise between open reduction and internal plate fixation (intervention group) and closed reduction and plaster immobilisation (control group). All consecutive adult patients from 18 to 65 years with a displaced intra-articular distal radius fracture (AO/OTA type C), which has been adequately reduced at the Emergency Department according to the Dutch National Guidelines, are eligible for inclusion in this study. The primary outcome is function and pain of the wrist assessed with the Patient-Rated Wrist Evaluation score (PRWE). Secondary outcomes are the Disability of the Arm, Shoulder and Hand score (DASH), pain, quality of life (SF-36), range of motion, grip strength, radiological parameters, complications, crossovers and cost-effectiveness of both treatments. A total of 90 patients will be included in this study.Although displaced intra-articular distal radius fractures are common, there is still no evidence on the optimal treatment for these fractures in patients aged 18 to 65 years. Therefore we aim to determine the difference in functional outcome between open reduction and plate fixation and closed reduction and plaster immobilisation.This study is registered at ClinicalTrials.gov ( NCT02651779 ) on January 4(th) 2016.

Project description:IntroductionRecently, the Cobra prostheses were introduced in the treatment of distal radius fractures (DRF) of elderly patients. Fracture prostheses provide an alternative treatment option for complex fractures where conservative therapy seems not acceptable and osteosynthesis seems not possible. Data reporting the feasibility of the Cobra prosthesis are sparse. Therefore, this retrospective follow-up study investigated the clinical and radiological mid-term outcome of the Cobra implant in complex DRFs of elderly patients.Materials and methodsThirteen patients (mean age 73.5 years, range 65-87 years) were retrospectively evaluated with at least a 1-year follow-up after surgery. Objective and subjective clinical parameters as well as the radiological outcome and complications were analyzed.ResultsThe mean follow-up period was 31.2 months. Seven cases required a cemented prosthesis. The mean relative range-of-motion compared to the healthy side was 72.3% and 51.8% for extension and flexion, respectively, and 87.9% and 85.7% for pronation and supination, respectively. The mean grip strength was 78.3% compared to the non-operated side. Eight patients were very satisfied, five patients were partly satisfied with the result. The DASH, PRWE, MHQ and Lyon-Scores averaged 39.1, 36.2, 64.9 and 63.3 points, respectively. The mean VAS-Score for pain was 1.1 at rest and 3.2 during activities. Perioperative complications included one dissection of the extensor pollicis longus tendon, one heterotopic ossification, one radiocarpal dislocation and two cases of an ulnar impaction syndrome due to implant subsidence.ConclusionThe prosthetic treatment of complex DRFs in elderly patients with the Cobra implant led to clinically and radiologically satisfactory mid-term results. The Cobra prosthesis still does not represent a gold standard but can be regarded as a feasible salvage option for complex DRFs when osteosyntheses may not be possible and non-operative treatment will lead to further functional restrictions and wrist pain during performing activities of daily life in high functional demand patients.

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

Publications

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

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