Ankle fracture Injury, Occupational Diseases, Poisoning Injuries and Accidents/ Injuries to the ankle and foot
Conditions
Interventions
All adults with a fractured ankle under the care of a clinician at any of the named recruiting sites are potentially eligible. New patients with an ankle fracture are reviewed each day by the trauma t
Sponsors
University of Warwick
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent 2. Aged 18 years or over 3. A closed ankle fracture for which the treating clinician would consider plaster cast a reasonable management option 4. Within 3 weeks of operative treatment or injury if non-operatively managed
Exclusion criteria
Exclusion criteria: 1. Ankle fracture secondary to known metastatic disease 2. Complex intra-articular fracture (e.g. Pilon fracture) 3. In the opinion of the surgeon the patient would require manipulation and close contact casting 4. In the opinion of the surgeon the patient would require manipulation and moulded cast 5. Wound complications following surgical management contraindicating Functional brace intervention 6. Previous ankle fracture randomised in the present trial 7. Evidence that the patient would be unable to adhere to trial procedures or complete postal questionnaires 8. Known pre-existing neuropathic joint disease contraindicating functional brace intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom evaluation is measured using Olerud Molander Ankle Score questionnaire (this will be collected using patient questionnaires sent via post) at 4 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Symptom evaluation is measured using Olerud Molander Ankle Score questionnaire at six weeks, 10 weeks, six months and 24 months 2. Surgical outcomes are measured using the Manchester-Oxford Foot and Ankle Questionnaire at four months 3. Health status is measured using EuroQol five dimensions questionnaire (EQ-5D) at “6 weeks, 10 weeks, 16 weeks, 24 weeks, 12 months, 18 months and 24 months. 4. Disability is measured using the disability rating index at “6 weeks, 10 weeks, 16 weeks, 24 weeks, 12 months, 18 months and 24 months 5. Cost is measured using a patient reported questionnaire at “6 weeks, 10 weeks, 16 weeks, 24 weeks, 12 months, 18 months and 24 months 6. Complication rate is measured using a patient reported questionnaire at “6 weeks, 10 weeks, 16 weeks, 24 weeks, 12 months, 18 months and 24 months | — |
Countries
England, United Kingdom
Contacts
Public ContactRebecca McKeown
Outcome results
None listed