Fractures in the distal radius that do not need manipulation Musculoskeletal Diseases
Conditions
Interventions
This trial is a pragmatic, randomised non-inferiority clinical trial with participant follow-up to 12 months post-randomisation.
Participants will be randomised to either Plaster Cast or Removable Spl
the randomisation will be on a 1:1 basis, stratified by centre and age (<50 vs =50 years).
In a 6 month internal pilot phase, we expect to open 6 sites after which the Data Safety Management Committe
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
16 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study. 2. Aged 16 years or above. 3. Presenting with a fracture of the distal radius which, in the opinion of the treating clinician, does not require a manipulation of the fracture.
Exclusion criteria
Exclusion criteria: 1. Present to research team more than 2 weeks post-injury 2. The fracture is open (Gustilo and Anderson > 1) 3. They are unable to adhere to trial procedures, e.g. patients with permanent cognitive impairment, or other concomitant severe injuries e.g. head injury.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To quantify and draw inferences on observed differences in function between treatment groups, as measured by the Patient Rated Wrist Evaluation (PRWE) at 3 months post-randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To quantify and draw inferences on observed differences in pain related to the wrist fracture between treatment groups, as measured by the Visual Analogue Scale (VAS) pain score, on days 1, 3, 5, 7, 10 and 14 post-randomisation. 2. To quantify and draw inferences on observed differences in medium-term pain and function between treatment groups, as measured by the PRWE at Baseline, 7 weeks and 6 and 12 months post-randomisation and measured by the PROMIS Upper Limb Physical Function Score at Baseline, and 3, 6 and 12 months post-randomisation. 3. To quantify and draw inferences on observed differences in health-related quality of life between treatment groups, as measured by EQ-5D-5L at Baseline, 7 days and 3, 6, and 12 months post-randomisation. 4. To quantify and draw inferences on observed difference in the complication rate between treatment groups, including the need for subsequent manipulation or surgical fixation using the patient reported complications form at day 14, week 7 and 3, 6 and 12 months post-randomisation. 5. To investigate the healthcare and broader resource implications for both treatment groups using the Health Resource Questionnaire at 3, 6 and 12 months post-randomisation. 6. To quantify the comparative cost effectiveness of the trial treatments using the Health Research Questionnaire at 3, 6 and 12 months post-randomisation. | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed