Dataset Information

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

ABSTRACT: 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).

SUBMITTER: Harris IA

PROVIDER: S-EPMC5541521 | biostudies-literature | 2017 Jun

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 study protocol.

Harris Ian A IA Naylor Justine M JM Lawson Andrew A 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 Chehade Mellick M Sungaran Jai J Latendresse Kim K Wong James J Viswanathan Sameer S Richardson Martin M Shrestha Kush K Drobetz Herwig H Tran Phong P Loveridge Jeremy J Page Richard R Hau Raphael R Bingham Roger R Mulford Jonathan J Incoll Ian I

BMJ open 20170623 6

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 fix ...[more]

PMID: 28645976

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Project description: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.

Project description:BACKGROUND:In the past several years, an increase in open reduction and internal fixation (ORIF) for intra-articular distal radius fractures has been observed. This technique leads to a quicker recovery of function compared to non-operative treatment. However, some patients continue to have a painful and stiff wrist postoperatively. Arthroscopically assisted removal of intra-articular fracture haematoma and debris may improve the functional outcomes following operative treatment of intra-articular distal radius fractures. The purpose of this randomised controlled trial is to determine the difference in functional outcome, assessed with the Patient-Rated Wrist Evaluation (PRWE) score, after ORIF with and without an additional wrist arthroscopy in adult patients with displaced complete articular distal radius fractures. METHODS:In this multicentre trial, adult patients with a displaced complete articular distal radius fracture are randomised between ORIF with an additional wrist arthroscopy to remove fracture haematoma and debris (intervention group) and conventional fluoroscopic-assisted ORIF (control group). The primary outcome is functional outcome assessed with the PRWE score after three months. Secondary outcomes are wrist function assessed with the Disability of the Arm, Shoulder and Hand (DASH) score, postoperative pain, range of motion, grip strength, complications and cost-effectiveness. Additionally, in the intervention group, the quality of reduction, associated ligamentous injuries and cartilage damage will be assessed. A total of 50 patients will be included in this study. DISCUSSION:Although ORIF of intra-articular distal radius fractures leads to a quicker resume of function compared to non-operative treatment, some patients continue to have a painful and stiff wrist postoperatively. We hypothesise that, due to the removal of fracture haematoma and debris by an additional arthroscopy, functional outcomes will be better compared to the non-arthroscopically treated group. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02660515 . Registered on 13 January 2016.

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:IntroductionDistal radius fractures are among the most prevalent traumatic injuries worldwide. These injuries are associated with high healthcare-related and socioeconomic costs, mainly resulting from loss of productivity. To optimise recovery and return to work, wrist exercises are recommended. However, adherence to standard exercise regimens is low. Serious games provide a treatment platform for standardised postoperative care, uniting meaningful recovery with entertainment. Also, mobile serious games, for example, smartphone or tablet applications, are able to send practice reminders believed to improve self-efficacy.Methods and analysisTo test the effectiveness of a mobile serious game for distal radius fracture rehabilitation compared with standard care, a multicentre, randomised controlled clinical trial was designed. Primary outcome will be the Patient-Rated Wrist Evaluation (PRWE) score after 6 weeks of treatment. Secondary outcomes are range of motion, grip strength, pain scores, and self-reported treatment adherence after 2, 6 and 12 weeks of treatment.Adult patients with any type of closed distal radius fracture are included directly after non-operative or operative fracture treatment. Patients are recruited in the outpatient clinics of four teaching hospitals. The intended sample size is 92 patients, based on the minimal clinically important difference of the PRWE score at 6 weeks, using a superiority model.Patients are randomised between using the wearable-controlled mobile serious game ReValidate! (intervention group) and standard care consisting of unsupervised exercises and a referral for physiotherapy or exercise therapy upon request or recommendation by the treating clinician (control group).Ethics and disseminationThe protocol has been approved by the Medical Ethical Review Board of the Amsterdam University Medical Centres, location Academic Medical Centre in Amsterdam, the Netherlands. Results will be made available to involved healthcare providers, funders, and to the general public including patients via peer-reviewed academic journals and international conferences.Trial registration numberDutch Trial Registry (NTR), NL6140, protocol V.2.

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.

Project description:BackgroundDistal radial fractures are one of the most common orthopaedic cases that present to the A&E department. Surgical intervention is warranted in displaced intraarticular fractures and fractures with more than the recommended angulation or shortening, and is most commonly treated with volarly placed fixed angle locking plates. The aim of this study is to determine and compare the efficacy of two different plates for surgical treatment of distal radius fractures. The VRP 2.0 is a new plate produced by the Austofix company and this system will be compared against the VA-LP (Variable angle-locking plate) produced by Depuy-Synthes which has been used as the standard treatment device.Methods and designPatients between the ages of 18 and 80 presenting to the Royal Adelaide Hospital with isolated closed distal radial fractures will be invited to participate in this study. A total of 200 patients are required to provide 90% statistical power at a 5% alpha level to detect a difference of 11.5 points on the PRWE (Patient rated Wrist evaluation) score. The primary outcome measure will be the PRWE score while the secondary outcome measures will include the DASH score, EQ5D score, clinical range of movements, grip strength as well as patient perceived return of function at the wrist and time to resumption to work. These will be measured at 6 weeks, 3 months and 12 months. Radiographic indices including the radial tilt, length, volar inclination and plate prominence will also be measured. Complications will be recorded up to 12 months. Post hoc comparisons will be done using paired t tests. An intention to treat and a per protocol analysis will be done to compare the 2 groups.DiscussionDistal radial fractures are increasingly being treated by internal fixation using volar locking plates. However, there is no prospective study to date comparing one plate against another in terms of outcome and complications. This study could provide more information about the best way to treat these injuries surgically.Trial registrationThe trial is registered with the Australia New Zealand Clinical Trials Registry (ANZCTR). Trial registration date-17/11/2016. Trial registration number- ACTRN12616001590459 .

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.

Dataset Information

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

Methods and analysis

Ethics and dissemination

Registration

Publications

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

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