Distal Radius Acute Fracture Trial 3 - a randomised study to compare a plaster cast to a removable splint for patients with a broken wrist

Plain English Summary

Background and study aims
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.

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.

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.

This 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.

Who can participate?
Patients aged 16 years and older with an acute fracture of the distal radius who, in the opinion of the treating clinician, do not require a manipulation of the fracture. Patients presenting to the research team more than two weeks after they sustain their injury; those who have an open fracture; or patients who would be unable to follow trial procedures will be excluded.

What does the study involve?
1894 adult patients with a fracture of their distal radius will be invited to take part from hospitals across the UK. Half of those that agree to take part 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 questionnaires 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.

What are the possible benefits and risks of participating?
Both treatments in this study are used across the NHS at the moment. They are not new or experimental. We do not know whether there is a difference in recovery for patients who
get a cast or a splint. This is why we are doing the research. If patients join in, they will help us make treatment for future patients with similar injuries better. This study will also give us information about the best use of resources within the NHS. There are some standard risks of having a plaster cast or splint, such as rubbing on the skin, feelings of pins and needles, or numbness (temporary loss of feeling) and stiffness. These risks are the same for any patient having these treatments. They are not affected by whether patients join this research study or not.

Where is the study run from?
The Oxford Trauma and Emergency Care research team are responsible for the day-to-day running of the study as part of the Nuffield Department of Rheumatology, Orthopaedics and Musculoskeletal Sciences (NDORMS) and the Oxford Clinical Trials Research Unit (OCTRU).

When is the study starting and how long is it expected to run for?
May 2022 to April 2026

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).

Who is the main contact?
Trial Manager, Heather Barnes, draft3-casp@ndorms.ox.ac.uk

Study website

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom
• Wales

Study participating centres

Sponsor information

University of Oxford
University/education

University Offices
Oxford
OX1 2JD
England
United Kingdom

Email	ctrg@admin.ox.ac.uk
Website	http://www.ox.ac.uk/
"ROR"	https://ror.org/052gg0110

Funders

Funder type

Government

Results and Publications

Study outputs

Additional files

43115 DRAFT3-CASP_PIS_V2.0_06Jan2023.pdf

Editorial Notes

14/02/2024: The following changes were made:
1. The following study participating centres were removed: Cumberland Infirmary - Carlisle, Freeman Hospital, Great Western Hospital, Kings College Hospital, Luton and Dunstable University Hospital, Milton Keynes Hospital, Medway Maritime Hospital, North Tyneside General Hospital, Queens Medical Centre, St. Marys Hospital, University Hospital Llandough, University Hospital of North Durham, Darlington Memorial Hospital, Wythenshawe Hospital, Trafford General Hospital, Manchester Royal Hospital, and Ysbyty Gwynedd Hospital (yg NHS Trust).
2. The following study participating centres were added: Frimley Park Hospital, Wexham Park Hospital, The Royal Glamorgan Hospital, Airedale General, Derriford Hospital, Princess Alexandra Hospital, Queens Hospital, Sandwell General Hospital, Norfolk & Norwich University Hospital, and North West London Hospitals NHS Trust.
13/02/2023: The recruitment start date was changed from 13/02/2023 to 20/02/2023.
26/01/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).