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Statistical and health economic analysis plan for a randomized controlled trial of surgical fixation with K-wires versus plaster casting in the treatment of dorsally displaced distal radius fractures: DRAFFT2.

ABSTRACT: Aims:Describe a statistical and economic analysis plan for the Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT2) randomized controlled trial. Methods:DRAFFT2 is a multicentre, parallel, two-arm randomized controlled trial. It compares surgical fixation with K-wires versus plaster cast in adult patients who have sustained a dorsally displaced fracture of the distal radius. The primary outcome measure is the Patient-Rated Wrist Evaluation (PRWE, a validated assessment of wrist function and pain) at 12 months post-randomization. Secondary outcomes are measured at three, six, and 12 months after randomization and include the PWRE, EuroQoL EQ-5D-5L index and EQ-VAS (visual analogue scale), complication rate, and cost-effectiveness of the treatment. Results:This paper describes the full details of the planned methods of analysis and descriptive statistics. The DRAFFT2 study protocol has been published previously. Conclusion:The planned analysis strategy described records our intent to conduct statistical and within-trial cost-utility analyses.Cite this article: Bone Joint Open 2020;1-6:245-252.

SUBMITTER: Ooms AG

PROVIDER: S-EPMC7677726 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Statistical and health economic analysis plan for a randomized controlled trial of surgical fixation with K-wires versus plaster casting in the treatment of dorsally displaced distal radius fractures: DRAFFT2.

Ooms Alexander Gert AG Png May Ee ME Cook Jonathan A JA Dritsaki Melina M Dakin Helen A HA Costa Matthew L ML

Bone & joint open 20200611 6

<h4>Aims</h4>Describe a statistical and economic analysis plan for the Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT2) randomized controlled trial.<h4>Methods</h4>DRAFFT2 is a multicentre, parallel, two-arm randomized controlled trial. It compares surgical fixation with K-wires versus plaster cast in adult patients who have sustained a dorsally displaced fracture of the distal radius. The primary outcome measure is the Patient-Rated Wrist Evaluation (PRWE, a validated assessment of wrist ...[more]

PMID: 33225296

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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: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: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:IntroductionDistal radius is the most common site of fracture in children, comprising 23%-31% of all paediatric fractures. Approximately one-fifth of these fractures are displaced. Completely displaced distal metaphyseal radius fractures in children have traditionally been treated with closed reduction. Recent evidence suggests that correcting the shortening in over-riding distal metaphyseal radius fractures is not necessary in prepubertal children. To date, no published randomised controlled trial (RCT) has compared treatment of these fractures in children by casting the fracture in bayonet position to reduction and pin fixation.Methods and analysisWe will conduct an RCT to compare the outcomes of casting the fracture in bayonet position in children under 11 years of age to reduction and percutaneous pin fixation. 60 patients will be randomly assigned to casting or surgery groups. We have two primary outcomes. The first is ratio (injured side/non-injured side) in the total active forearm rotation and the second is ratio (injured side/non-injured side) in total active range of motion of the wrist in the flexion-extension plane at 6 months. The secondary outcomes will include axial radiographic alignment, passive extension of the wrists, grip strength and length of forearms and hands, patient-reported outcome QuickDASH and pain questionnaire PedsQL. Patients not willing to participate in the RCT will be asked to participate in a prospective cohort. Patients not eligible for randomisation will be asked to participate in a non-eligible cohort. These cohorts are included to enhance the external validity of the results of the RCT. Our null hypothesis is that the results of the primary outcome measures in the casting group are non-inferior to surgery group.Ethics and disseminationThe institutional review board of the Helsinki and Uusimaa Hospital District has approved the protocol. We will disseminate the findings through peer-reviewed publications.Trial registration numberNCT04323410.ProtocolV.1.1, 29 September 2020.

Project description:ObjectiveTo assess wrist function, quality of life, and complications in adult patients with a dorsally displaced fracture of the distal radius, treated with either a moulded cast or surgical fixation with K-wires.DesignMulticentre randomised clinical superiority trial, SETTING: 36 hospitals in the UK National Health Service (NHS).Participants500 adults aged 16 or over with a dorsally displaced fracture of the distal radius, randomised after manipulation of their fracture (255 to moulded cast; 245 to surgical fixation).InterventionsManipulation and moulded cast was compared with manipulation and surgical fixation with K-wires plus cast. Details of the application of the cast and the insertion of the K-wires were at the discretion of the treating surgeon, according to their normal clinical practice.Main outcome measuresThe primary outcome measure was the Patient Rated Wrist Evaluation (PRWE) score at 12 months (five questions about pain and 10 about function and disability; overall score out of 100 (best score=0 and worst score=100)). Secondary outcomes were PRWE score at three and six months, quality of life, and complications, including the need for surgery due to loss of fracture position in the first six weeks.ResultsThe mean age of participants was 60 years and 417 (83%) were women; 395 (79%) completed follow-up. No statistically significant difference in the PRWE score was seen at 12 months (cast group (n=200), mean 21.2 (SD 23.1); K-wire group (n=195), mean 20.7 (22.3); adjusted mean difference -0.34 (95% confidence interval -4.33 to 3.66), P=0.87). No difference was seen at earlier time points. In the cast group, 33 (13%) of participants needed surgical fixation for loss of fracture position in the first six weeks compared with one revision surgery in the K-wire group (odds ratio 0.02, 95% confidence interval 0.001 to 0.10).ConclusionsAmong patients with a dorsally displaced distal radius fracture that needed manipulation, surgical fixation with K-wires did not improve patients' wrist function at 12 months compared with a cast.Trial registrationISRCTN registry ISRCTN11980540.

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.

Project description:BackgroundSurgical treatment of displaced distal radius fractures (DRF) in older patients has increased, despite lacking evidence of its superiority over non-operative treatment. How treatment choice affects these patients after the initial 12-month period remains unknown. This study presents a clinical and radiographic follow up at an average of 3 years after treatment in the context of a randomized clinical trial comparing outcomes in patients aged ≥70 years, with a dorsally displaced distal radius fracture treated either surgically with volar locking plate or non-operatively.MethodsBetween 2009 and 2017, 140 patients aged ≥70 years with dorsally displaced DRF were randomized to surgery with volar locking plate (VLP) or non-operative treatment. At an average of 3 years after inclusion the participants were invited to an additional follow-up. The primary outcome was Patient Rated Wrist Evaluation (PRWE). Secondary outcomes included additional Patient Reported Outcome Measures (PROM), grip strength, range of motion, complications and radiological results.ResultsSixty six patients were available for a 3 year follow-up, 33 in the non-operatively treated group and 33 in the VLP-group. The mean age at injury was 77 years. At 3 years the median PRWE was better (0 points) in the VLP-group than in the non-operative treatment group (9 points) p-value: 0.027. No statistically significant difference was found in Disabilities of the Arm, Hand, and Shoulder (DASH), EuroQol 5 Dimensions (EQ-5D) or grip strength. Total arc of range of motion was larger in the operatively treated group. No significant difference in osteoarthritis was found. Both groups had regained grip strength. The complication rate was similar. Outcomes improved from the 1 year to the 3 year follow-up.ConclusionsSurgery with volar locking plate gave less long-term disability compared to non-operative treatment for severely displaced distal radius fractures in patients aged ≥70 years. Our findings were statistically significant but in the lower range of clinical importance.Trial registrationThe study was registered at : NCT02154620 03/06/2014 and NCT01268397 30/12/2010. Ethical approval was obtained from Ethical Committee in Stockholm, Sweden (2009/37-31/3, 2013/105-31/2, 2014/1041-32, 2017/611-32).

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Statistical and health economic analysis plan for a randomized controlled trial of surgical fixation with K-wires versus plaster casting in the treatment of dorsally displaced distal radius fractures: DRAFFT2.

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Statistical and health economic analysis plan for a randomized controlled trial of surgical fixation with K-wires versus plaster casting in the treatment of dorsally displaced distal radius fractures: DRAFFT2.

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