Weight-bearing in ankle fractures

Not Applicable

Completed

Conditions: Surgically repaired unstable ankle fractures
Musculoskeletal Diseases
Fracture of ankle

Registration Number: ISRCTN12883981

Lead Sponsor: niversity of Oxford

Brief Summary: 2021 Protocol article in https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-021-04560-7 (added 12/10/2021) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38848738/ (added 11/06/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 562

Inclusion Criteria

1. Age 18 years and above
2. The patient has undergone operative fixation for an unstable ankle fracture
3. Surgery was performed within 14 days of the injury
4. In the opinion of the treating surgeon, the participant might benefit from early weight-bearing
5. Able and willing to give informed consent

Exclusion Criteria

1. A lack of protective sensation (e.g. peripheral neuropathy)
2. Inability to adhere to trial procedures
3. Bilateral operatively treated ankle fractures
4. Already in a trial for ankle fracture
5. The patient has received a hindfoot nail to treat index fracture

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ankle function outcomes measured by the Olerud and Molander Score (OMAS) at the 4 month follow-up time-point

Secondary Outcome Measures

Name	Time	Method
1. OMAS at 6 weeks and 12 months <br>2. Health related quality of life (EQ-5D-5L) at 6 weeks, 4 months and 12 months <br>3. Resource use, costs and comparative cost utility (The Work Productivity and Activity Impairment) at 6 weeks, 4 months and 12 months<br>4. Difference in risk of adverse events (adverse events)<br>5. Investigate generalisability, acceptability and mechanism of action of the trial and interventions (CRF's, patient and staff interviews) 6 weeks, 12 months