DRAFT3-CASP
Research type
Research Study
Full title
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
IRAS ID
314712
Contact name
Matthew Costa
Contact email
ISRCTN Number
ISRCTN66692543
Duration of Study in the UK
3 years, 4 months, 30 days
Research summary
There are over 100,000 fractures of the wrist (distal radius) in the UK each year; 6% of all women will have sustained such a fracture by the age of 80 and 9% by the age of 90. Following a fracture of the distal radius, if the bone fragments have remained in their normal alignment, the fracture can be treated with a support for the injured wrist, which will provide pain relief and protects from further damage as the fracture heals. Over three quarters of all distal radius fractures in adults fall into this category and outcomes are generally good.\nFor those patients whose fracture remains aligned, usual care is to provide the patient with a temporary ‘backslab’ plaster cast in the emergency department. The patient is then referred to the orthopaedic fracture clinic where the backslab is converted to a full fibre-glass cast. The patient has to return to the fracture clinic 4-6 weeks later to have their cast removed.\nRecently, there has been some evidence that a removable wrist splint may provide the patient with the same support as a cast while their fracture heals. A splint can be removed by the patient themselves thereby avoiding additional visits to the hospital. This could be more convenient for patients and save money for the NHS.\n\nThis study will compare wrist function and pain in patients with a fracture of the distal radius treated with usual care in a cast with standard follow-up versus a removable wrist splint with discharge from the emergency department. \n\n1894 adult patients with a fracture of their distal radius will be invited to take part from hospitals across the UK. Half of these people will be treated in a cast and half in a removable splint. All of the patients will be given the same information and advice about their injury and their recovery. Which treatment a person gets will be decided by a computer to ensure a fair comparison. Everyone has an equal chance of getting either treatment. During the first two weeks, we will monitor the patients’ pain and after three, six and twelve months everyone will receive a questionnaire. The questions will ask about what activities they are able to do, their quality of life, any problems they might have and any costs that have been incurred because of the injury.\n\nOur research team includes people who have performed large trials before, including trials about wrist injuries. Each team member brings a different skill. These include physiotherapy, emergency medicine, orthopaedic surgery, statistics, health economics and patient and public involvement. \n\nThe research question and study design has been developed by clinicians, methodologists, patients and members of the public. Following this process, two patient and public representatives who have had wrist problems agreed to be part of the study team. This has been alongside consultation with an established patient group for existing studies in trauma care.\n\nWe will tell patients and the public the results of the study through presentations and videos. We will present the results at the annual NIHR trauma patient and public conference. We will work with health care professionals and planners to ensure the results help to shape future guidelines. We will publish the results in relevant academic journals and present at national meetings.\n
REC name
South West - Frenchay Research Ethics Committee
REC reference
22/SW/0177
Date of REC Opinion
21 Dec 2022
REC opinion
Favourable Opinion