DRAFFT 2 - Distal Radius Acute Fracture Fixation Trial 2
Research type
Research Study
Full title
DRAFFT 2: Distal Radius Acute Fracture Fixation Trial - A Randomised Controlled Trial of Manipulation and surgical fixation with K-wires versus Manipulation and Casting in the Treatment of Adult Patients with a Dorsally Displaced Fracture of the Distal Radius
IRAS ID
208830
Contact name
Matthew Costa
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
3 years, 4 months, 1 days
Research summary
Research Summary
The proposed project is a two-phased study. Phase 1 will confirm the expected rate of recruitment in a large-scale multi-centre randomised controlled trial. Phase 2 will be the proposed RCT in a minimum of 24 trauma centres across the UK.
The main trial will be recruiting from 24 trauma centres across the UK.
All adult patients presenting at the trial centres with an acute fracture of the distal radius are potentially eligible to take part in the trial.
Prior to manipulation, baseline demographic data, radiographs and functional data using the Patient Rated Wrist Evaluation Score (PRWE) and health-related quality of life using the EuroQoL EQ-5D-5L will be collected.
A randomisation sequence, stratified by centre, intra-articular extension of the fracture and age of the patient (above or below 50 years), will be produced and administered independently. Each patient will be randomly allocated to either ‘manipulation and surgical fixation with K-wires’ or ‘manipulation and plaster casting’. Both of these interventions are widely used within the NHS and all of the surgeons will be familiar with both techniques.
A clinical assessment and a record of any early complications will be made at 6 weeks. Further routine radiographs will also be taken at 6 weeks. Functional status and quality of life will be assessed at 3 months, 6 months and 12 months post-operatively. The patients will also be asked to fill out a resource use questionnaire and provide details of any late complications or interventions related to their injury.Summary of Results
Many patients with a wrist fracture can be treated in a simple plaster cast or splint. However, if the broken bones have moved out of position, patients are frequently offered surgery to restore the position of the broken bones and then hold the bones in place with metal implants while they heal. A plaster cast, shaped to support the bones, is an alternative treatment which avoids metal implants, but there is little research to say which is the better treatment.
The DRAFFT2 study compared surgical fixation with metal wires versus a shaped plaster cast for patients with a broken wrist. Half of the patients had the surgical fixation and half the shaped plaster cast. The decision about which treatment patients had was made by chance using a computer to ensure a fair comparison. The patients described their own wrist function and quality of life in the first year after their injury.What did the study find?
Between January 2017 and March 2019, 500 patients took part at 36 NHS hospitals in the UK. The patients treated with a plaster cast reported very similar wrist function and quality of life as the patients treated with surgical fixation. However, 1 in 8 of the patients treated in the plaster cast later required surgery because their broken bones fell back out of position.
The DRAFFT2 study showed that a shaped plaster cast is as good as surgical fixation for patients with a broken wrist in terms of wrist function. However, a proportion of the patients treated with a plaster cast will require later surgery if the broken bones cannot be held in position by the cast alone.
Further research is required to find out the best type of splint or cast to use to hold the bones in position.REC name
South Central - Oxford B Research Ethics Committee
REC reference
16/SC/0462
Date of REC Opinion
6 Oct 2016
REC opinion
Further Information Favourable Opinion