Distal Radius Acute Fracture Trial 3 – Cast versus Splint (DRAFT3-CASP): a randomised non-inferiority trial comparing clinical and cost-effectiveness of a standard care cast versus removable splint for adults with a distal radius fracture that does not require manipulation
Fractures in the distal radius that do not need manipulation
This trial is a pragmatic, randomised non-inferiority clinical trial with participant follow-up to 12 months post-randomisation. Participants will be randomised to either Plaster Cast or Removable Splint for treatment of their distal radius fracture; the randomisation will be on a 1:1 basis, stratified by centre and age (<50 vs ≥50 years). In a 6 month internal pilot phase, we expect to open 6 sites after which the Data Safety Management Committee (DSMC) will advise the Trial Steering Committee (TSC) on continuation of the trial. The TSC will evaluate this information and make a decision based on this and other information that they require for a decision. In the study as a whole, a total of 1894 participants will be recruited in a minimum of 36 Emergency departments within the UK. A member of the research team at each site will screen patients for eligibility and when this is confirmed by a clinician, a study trained member of the team will approach the patient to explain the study and gain informed consent. Participants will complete questionnaires at baseline, and will complete follow-up questionnaires on days 1,3,5,7,10 and 14 during the first 2 weeks. They will then complete further follow-up questionnaires at week 7, month 3, month 6 and month 12 after randomisation. Data will be collected via the clinical trial IT system REDCap, hosted by the University of Oxford, UK. Baseline demographic data will be entered directly by the site staff during the initial visit, and all baseline questionnaire data will be entered directly by the participant. Participants will then be contacted for follow-up using email and/or SMS text message prompts and invited to complete questionnaires through an online link. Telephone and postal follow-up will be conducted for those who require it. Follow-up will be conducted centrally by the trial team. A process evaluation will be conducted with up to 20 interviews with participants and up to 20 clinicians will be asked to participa
1. Participant is willing and able to give informed consent for participation in the study. 2. Aged 16 years or above. 3. Presenting with a fracture of the distal radius which, in the opinion of the treating clinician, does not require a manipulation of the fracture.
1. Present to research team more than 2 weeks post-injury 2. The fracture is open (Gustilo and Anderson > 1) 3. They are unable to adhere to trial procedures, e.g. patients with permanent cognitive impairment, or other concomitant severe injuries e.g. head injury.