In younger adults with unstable ankle fractures treated with close contact casting, is ankle function not worse than those treated with surgical intervention?

Not Applicable

• Conditions: nstable ankle fractures; Injury, Occupational Diseases, Poisoning; Fractures of other parts of lower leg

• Registration Number: ISRCTN67007305
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-01
• Last Update Posted: 23 October 2023
• Study Completion: 2028-09-05

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 891

Inclusion Criteria

1. Patients who are able and willing to give informed consent for participation in the trial
2. Patients aged 18 to 60 years inclusive with an unstable ankle fracture
3. Patients who in the opinion of the treating surgeon may benefit from surgical treatment with internal fixation

Exclusion Criteria

1. The fracture is open
2. The fracture is complicated by local tumour deposits
3. The injury is an isolated fracture of the medial malleolus
4. The index injury occurred more than 14 days prior to recruitment
5. They are unable to adhere to trial procedures
6. Previous randomisation in the current trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measure as of 16/12/2020:<br> Ankle functional outcomes measured by the Olerud and Molander ankle score (OMAS) at 4 months.<br><br> Previous primary outcome measure:<br> Ankle functional outcomes measured by the Olerud and Molander ankle score (OMAS) at baseline and 4 months.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. OMAS at 8 weeks and 12 months<br> 2. A-FORM (a specific ankle fracture questionnaire) at 8 weeks, 4 months and 12 months<br> 3. Work Productivity and Activity Impairment (WPAI) at 8 weeks, 4 months and 12 months<br> 4. Health-related quality of Life (EQ-5D-5L) at 8 weeks, 4 months and 12 months<br> 5. Resource use, costs and comparative cost-effectiveness at 8 weeks, 4 months and 12 months and up to 5 years<br> 6. OMAS, A-FORM, EQ-5D-5L and complications at all timepoints up to 5 years<br>