Dataset Information

Internal plate fixation versus plaster in displaced complete articular distal radius fractures, a randomised controlled trial.

ABSTRACT: 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.

SUBMITTER: Mulders MAM

PROVIDER: S-EPMC4748545 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature

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Internal plate fixation versus plaster in displaced complete articular distal radius fractures, a randomised controlled trial.

Mulders Marjolein A M MAM Walenkamp Monique M J MMJ Goslings J Carel JC Schep Niels W L NWL

BMC musculoskeletal disorders 20160209

<h4>Background</h4>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 t ...[more]

PMID: 26860090

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Project description:IntroductionOptimal management of distal radius fractures in adults remains controversial. Previous evidence and current clinical guidelines tell us that, if a closed reduction of a dorsally displaced fracture is possible, Kirschner wires (K-wires) are the preferred form of surgical fixation. However, the question remains whether there is any need to perform surgical fixation following a successful closed reduction, or is a simple plaster cast as effective? This is the protocol for a randomised controlled trial of manipulation and surgical fixation with K-wires versus manipulation and casting in the treatment of dorsally displaced distal radius fractures.Methods and analysisAdult patients with an acute dorsally displaced fracture of the distal radius are potentially eligible to take part. Prior to surgery, baseline demographic data, radiographs, data on pain/function using the Patient-Rated Wrist Evaluation Score (PRWE) and health-related quality of life (HRQoL) using the EuroQoL 5-dimension 5-level (EQ-5D-5L) will be collected. A randomisation sequence, stratified by centre, intra-articular extension of the fracture and age, will be administered via a secure web-based service. Each patient will be randomly allocated to either 'manipulation and surgical fixation with K-wires' or 'manipulation and plaster casting'. A clinical assessment, radiographs and records of early complications will be recorded at 6 weeks. PRWE and HRQoL outcome data will be collected at 3, 6 and 12 months post-randomisation. Further information will be requested with regard to healthcare resource use and any complications.Ethics and disseminationThe National Research Ethic Committee approved this study on 6 October 2016 (16/SC/0462).The National Institute for Health Research Health Technology Assessment monograph and a manuscript to a peer-reviewed journal will be submitted on completion of the trial. The results of this trial will substantially inform clinical practice on the clinical and cost-effectiveness of the treatment of this injury.Trial registration numberISRCTN11980540; Pre-results.

Project description:ObjectivesTo compare the clinical effectiveness of Kirschner wire fixation with locking plate fixation for patients with a dorsally displaced fracture of the distal radius.DesignA multicentre two arm parallel group assessor blind randomised controlled trial with 1:1 treatment allocation.Setting18 trauma centres in the United Kingdom.Participants461 adults with a dorsally displaced fracture of the distal radius within 3 cm of the radiocarpal joint that required surgical fixation. Patients were excluded if the surgeon thought that the surface of the wrist joint was so badly displaced it required open reduction.InterventionsKirschner wire fixation: wires are passed through the skin over the dorsal aspect of the distal radius and into the bone to hold the fracture in the correct anatomical position. Locking plate fixation: a locking plate is applied through an incision over the volar (palm) aspect of the wrist and secured to the bone with fixed angle locking screws.Main outcome measuresPrimary outcome measurevalidated patient rated wrist evaluation (PRWE). This rates wrist function in two (equally weighted) sections concerning the patient's experience of pain and disability to give a score out of 100.Secondary outcomesdisabilities of arm, shoulder, and hand (DASH) score, the EuroQol (EQ-5D), and complications related to the surgery.ResultsThe baseline characteristics of the two groups were well balanced, and over 90% of patients completed follow-up. The wrist function of both groups of patients improved by 12 months. There was no clinically relevant difference in the patient rated wrist score at three, six, or 12 months (difference in favour of the plate group was -1.3, 95% confidence interval -4.5 to 1.8; P=0.40). Nor was there a clinically relevant difference in health related quality of life or the number of complications in each group.ConclusionsContrary to the existing literature, and against the rapidly increasing use of locking plate fixation, this trial found no difference in functional outcome in patients with dorsally displaced fractures of the distal radius treated with Kirschner wires or volar locking plates. Kirschner wire fixation, however, is cheaper and quicker to perform.Trial registrationCurrent Controlled Trials ISCRTN 31379280. UKCRN 8956.

Project description:PURPOSE:Displaced distal radius fractures in children are common and often treated by reduction and cast immobilization. Redisplacement occurs frequently and may be prevented by additional treatment with K-wire fixation after initial reduction. This meta-analysis aims to summarize available literature on this topic and determine if primary K-wire fixation is the preferred treatment for displaced distal radius fractures in children. METHODS:A search in eight databases identified studies that compared cast immobilization alone to additional K-wire fixation as treatment for displaced paediatric distal radius fractures. The primary outcome was the redisplacement rate. Secondary outcomes were secondary reduction rate, range of motion and complications. This meta-analysis was performed according to the preferred reporting items for systematic reviews and meta-analysis (PRISMA) statement. RESULTS:Three RCTs and 3 cohort studies, analysing 197 patients treated with cast immobilization alone and 185 with additional K-wire fixation, were included in this meta-analysis. Redisplacement occurred less frequently after additional K-wire fixation than after cast alone (3.8 versus 45.7%; OR 0.07, 95% CI 0.03-0.15). Secondary reduction was performed in 59.8% of the redisplaced fractures. Complications, other than redisplacement, occurred more often after additional K-wire fixation than after cast alone (15.7 versus 3.6%). Range of motion did not differ after both treatments. CONCLUSIONS:Additional K-wire fixation is a suitable treatment to prevent redisplacement and secondary operations after initial reduction of displaced distal radius fractures in children, but is associated with post-procedural complications. Additional K-wire fixation does not result in a better range of motion than cast immobilization alone. More research is needed to identify those patients who will benefit the most from K-wire fixation as a treatment for displaced distal radius fractures in children.

Dataset Information

Internal plate fixation versus plaster in displaced complete articular distal radius fractures, a randomised controlled trial.

Publications

Internal plate fixation versus plaster in displaced complete articular distal radius fractures, a randomised controlled trial.

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