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AIR: Ankle injury rehabilitation

Ankle Injury Rehabilitation: Is it feasible to conduct a randomised controlled trial to assess the difference between functional bracing versus plaster cast for the treatment of fixed ankle fractures (AIR)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17809322
Enrollment
50
Registered
2015-11-05
Start date
2015-11-10
Completion date
Unknown
Last updated
2021-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Musculoskeletal disorders

Interventions

All participants who require ankle fixation will have this performed according to the preferred technique of the operating surgeon. The details of the surgery will be left to the discretion of the sur
the cast may be plaster of paris or fibreglass. Intervention Group – Functional Bracing: All participants in the intervention arm will be fitted with a removable funct

Sponsors

University of Warwick
Lead Sponsor
University Hospitals Coventry & Warwickshire NHS Trust
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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 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 3. Healing is determined by viewing copies of routine pre- and post-operative x-rays taken at baseline, 6 weeks and 6 months

Countries

United Kingdom

Contacts

Public ContactJoanne O'Beirne-Elliman

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 10, 2026