About the study
This study will help us find out if a removable splint can provide the same support as a plaster cast for undisplaced distal radius fractures
Summary
Usual care for this population is to provide the patients with a temporary backslab plaster cast in the emergency department. The patient would then be referred to the fracture clinic where this cast is converted into a full, circumferential cast. The patient will then return at around 4-6 weeks to have this cast removed.
Some evidence has recently shown that a removable wrist splint may provide the same support as a cast whilst the fracture heals. The splint can be removed by the patient themselves and so would not require the patient to return to hospital and could save money for the NHS. However, if the splint does not provide patients the same support as a cast, the patient may have inferior function in their wrist.
This study aims to recruit a minimum of 1894 participants across 36 centres. The participants will be followed-up for 1 year following their recruitment to the trial and will complete a series of questionnaires in order to record their health related quality of life, wrist function and any costs incurred to them as a result of their injury.
Current enrolment curve
Locations
Information about the study
Study Design
Multi-centre, Randomised, Non-inferiority trial.
Sample Size
A minimum of 1894 participants.
Treatments
Standard care plaster cast or a removable splint applied from below the elbow to the knuckles.
Study Participants
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.
Study Duration
Study period: 01 May 2022 - 30 April 2026. Patients will be involved for up to 12 months post-randomisation.
Study Funders
NIHR Evaluation, Trials and Studies Coordinating Centre, University of Southampton Alpha House, Enterprise Road Southampton, SO16 7NS.
Study Team
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.
Matthew Costa
Chief Investigator
Matt was appointed Professor of Orthopaedic Trauma, University of Oxford in 2015. He was previously Professor of Trauma and Orthopaedics at University of Warwick. Matt is also Honorary Consultant Trauma Surgeon at the John Radcliffe Hospital, Oxford.
Heather Barnes
Clinical Trial Manager
Heather is a trial manager who has worked in research for over 5 years, she oversees the day to day running of multiple trials within the Oxford Trauma research team.
Elli Robertson
Clinical Trial Administrative Coordinator
Elli is a study administrator who works across multiple orthopaedic trials within NDORMS portfolio.