Musculoskeletal Musculoskeletal Diseases
Conditions
Interventions
This trial is a multi-centre, two-arm, parallel design, superiority, randomised controlled clinical study. Participants will be randomised to either buried K-wires or exposed K-wires for treatment of
the randomisation will be on a 1:1 basis, stratified by hand or wrist injury, research site and open or closed injury at presentation. A total of 470 participants will be recruited across a minimum of
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age 16 years and above 2. Open or closed hand/wrist fracture(s) which, in the opinion of the treating clinician, require manipulation under anaesthetic and fixation with K-wires
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 12/05/2026: 1. Insufficient soft tissue cover to bury the wire 2. Presence of overlying or adjacent skin infection/disorder 3. Injury is more than 2 weeks old at time of screening 4. Inability of participants to adhere to the trial procedures and/or follow-up procedures Previous exclusion criteria: 1. Insufficient soft tissue cover to bury the wire 2. Presence of overlying or adjacent skin infection/disorder 3. Injury is more than 2 weeks old 4. Inability of participants to adhere to the trial procedures and/or follow-up procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The risk of surgical site infection (SSI) will be measured using patient- and site-reported prescription of antibiotics for the presence of an SSI using data collected from REDCap by 90 days post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Upper extremity function and pain measured using PROMIS Upper Extremity at Baseline (pre- and post-injury), 90 days and 6 months 2. Health-Related Quality of Life will be measured using the EQ-5D-5L at Baseline (pre- and post-injury), 90 days and 6 months 3. Risk of complications will be measured using the site-reported complications at treatment and medical records check at 6 months 4. Assess costs and comparative cost-effectiveness will be measured using a bespoke participant resource use questionnaire at 90 days and 6 months | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed