AIR: Ankle injury rehabilitatio

Not Applicable

Completed

• Conditions: Topic: Musculoskeletal disorders; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal; Musculoskeletal Diseases; Ankle fracture

• Registration Number: ISRCTN17809322
• Lead Sponsor: niversity of Warwick

Brief Summary

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28265461 2019 results in https://pubmed.ncbi.nlm.nih.gov/31019736/ (added 25/02/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-05
• Study Completion: 2017-05-31
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Aged 16 years or over
2. Ankle fracture for which the treating clinician would consider plaster cast a reasonable management option

Exclusion Criteria

1. Lack of capacity to consent
2. Unable to walk prior to injury
3. Previous ankle fracture randomisation in the present trial
4. Open fracture
5. Pathological fractures, i.e. known metastatic disease
6. Evidence that the patient would be unable to adhere to trial procedures or complete postal questionnaires
7. Any other lower limb injury (including bilateral ankle fractures and syndesmosis injury requiring surgery, contraindication to cast application) that will affect the primary outcome measure
8. In the opinion of the surgeon the patient would require Close Contact Casting

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health outcomes are determined using the Manchester–Oxford Foot Questionnaire (MOxFQ) at baseline and 6 months.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Complications are recorded using Complications CRF (created in house, not a validated questionnaire) at baseline, post-treatment, 6 weeks, 3 months and 6 months<br> 2. Health outcomes measured using the EQ-5D questionnaire, the Manchester–Oxford Foot Questionnaire (MOXFQ) and the Olerud-Molander Ankle Score (OMAS) at baseline, post-treatment, 6 weeks, 3 months and 6 months<br> 3. Healing is determined by viewing copies of routine pre- and post-operative x-rays taken at baseline, 6 weeks and 6 months<br>