DRAFT3-CASP: Distal Radius Acute Fracture Trial 3 – 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

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.

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.

Study design. A multi-centre, randomised non-inferiority trial with internal pilot and embedded process and economic evaluations.

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.

Comparison. Standard care plaster cast.

Intervention. A removable splint applied from below the elbow to the knuckles.

Primary outcome: the Patient Reported Wrist Evaluation at 3 months post randomisation.

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.