Title: DRAFT-CASP: Distal Radius Acute Fracture Trial – Cast versus Splint; 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
Funder: Department of Health and Social Care

Abstract: What is the problem?_x000D_ 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. _x000D_ Following a fracture of the distal radius, if the bone fragments remain in their normal alignment, the fracture can be treated with a support for the injured wrist. The support provides 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. _x000D_ For 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. _x000D_ Recently, 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._x000D_ What are we trying to find out?_x000D_ This study will compare wrist function and pain in patients with a fracture of the distal radius treated with usual care in a cast versus a removable wrist splint._x000D_ What will we do?_x000D_ 1894 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. Everyone has an equal chance of getting either treatment. _x000D_ After three months everyone will receive a questionnaire. The questions will ask about what activities they can do, if they have any problems, about their quality of life and any costs that have been incurred because of the injury. _x000D_ Who are we?_x000D_ Our research team includes people who have led 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. _x000D_ How have patients helped develop this research?_x000D_ The research question and study design has been co-produced with clinicians, methodologists, patients and members of the public. Following this process, two patient and public representatives who have lived experience of wrist injuries agreed to be part of the study team. This has been alongside consultation with an established patient group for existing studies in trauma care._x000D_ How will we tell people what we found out?_x000D_ We will tell patients and the public the results of the study through lay 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.

Lay abstract: Background. 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. As the population continues to age, an increasing burden for health and social care is expected. _x000D_ Aim. To compare the clinical and cost-effectiveness of a standard care cast versus removable splint for adults with a distal radius fracture that does not require manipulation._x000D_ Study design. A multi-centre, randomised non-inferiority trial with internal pilot and embedded process and economic evaluations._x000D_ Patients. 1894 adults with an acute fracture of the distal radius that does not require manipulation. Patients presenting more than two weeks after injury; with an open fracture; or with evidence that they would be unable to complete follow-up questionnaires will be excluded._x000D_ Comparison. Standard care plaster cast._x000D_ Intervention. A removable splint applied from below the elbow to the knuckles._x000D_ Primary outcome: the Patient Reported Wrist Evaluation at 3 months post randomisation. _x000D_ Secondary outcomes. Wrist function at other time-points, pain scores daily for the first two weeks, health-related quality of life, complications and resource use assessed up to 1 year.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: INJURIES AND ACCIDENTS