A clinical trial comparing the effectiveness of a plaster cast to a functional brace in the treatment of adults with ankle fractures

INTERVENTION: 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 team. Participants are randomised to either receiving either the functional brace or the plaster cast. This process of randomisation is done via a computer generated sequence to determine the treatment to be given. The plaster cast or functional brace is usually worn from three to eight weeks, which is decided by the treating clinician. The clinician also decides how much weight can be put on the healing ankle. Participants who receive the functional brace are also be given an exercise sheet, outlining two very simple exercises to maintain and improve the movement in the ankle joint. It is recommended these are completed little and often, as pain allows. Participants are followed up in this study for a duration of two years and all trial follow up is completed by post. Participants will receive routine follow up by their treating clinician. CONDITION: Specialty: Injuries and emergencies, Primary sub‐specialty: Musculoskeletal Trauma; UKCRC code/ Disease: Injuries and Accidents/ Injuries to the ankle and foot ; Injury, Occupational Diseases, Poisoning ; Injuries and Accidents/ Injuries to the ankle and foot PRIMARY OUTCOME: Symptom evaluation is measured using Olerud Molander Ankle Score questionnaire (this will be collected using patient questionnaires sent via post) at 4 months SECONDARY OUTCOME: 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 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