Specialty: Injuries and emergencies, Primary sub-specialty: Injuries and emergencies Musculoskeletal Diseases Ankle fractures
Conditions
Interventions
Participants receive identical care pre-operatively and in the first two post-operative weeks consisting of admission to hospital, consultant supervised surgery including management on a standard care
Sponsors
Nottingham University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 and over 2. Independently living 3. Isolated and closed Weber B ankle fractures which are stable following internally fixation
Exclusion criteria
Exclusion criteria: 1. Inability to provide informed consent 2. Diabetes 3. Non-healing leg/foot ulcers 4. Steroid users 5. Pre-existing ankle arthritis and concurrent or history of significant ipsilateral or contralateral lower limb injury/condition e.g. contralateral leg prosthesis 6. Neurological disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptoms and function, are measured by the Olerud and Molander ankle score (OMAS) patient reported outcome measure (PROM), recorded at 2 and 6-weeks post-surgery, as baseline and end-of-intervention respectively and at 12 (Primary timepoint) 24 and 52-weeks post-surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Symptoms and function, are measured using the Ankle Fracture Outcome of Rehabilitation Measure (A-FORM) PROM and use of walking aids at; 2, 6, 12, 24 and 52-weeks post-surgery 2. Generic quality of life is measurers using the EuroQoL EQ-5D-5L and level of activity PROMs at; 2, 6, 12, 24 and 52-weeks post-surgery 3. Health and social economic impact, are measured by ability and time to return to work and return to driving (where applicable), ankle related hospital attendance, quality adjusted life years (derived from the EQ-5D-5L), and complication rates are recorded through reviewing routine X-rays, hospital attendance and adverse events at; 2, 6, 12, 24 and 52-weeks post-surgery 4. Objective Ankle function is measured by non-weightbearing range-of-motion (dorsiflexion and plantar flexion) and tape measured ankle and calf sizes at; 2 and 6weeks post-surgery. Objective Ankle function measures are repeated with the addition of weightbearing dorsiflexion, walking speed, balance and isokinetic planter flexion strength at; 12, 24 and 52-weeks post-surgery To mitigate against bias, participants complete the 12-, 24- and 52-week PROMs, concealed from the researchers. A third party, blinded to the intervention group inputs the data, and analysis of the PROMs is completed by a Statistician, who is also blinded to the intervention group. | — |
Countries
England, United Kingdom
Contacts
Public ContactJess Nightingale
Outcome results
None listed