Complex and/or unstable ankle fracture Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Participants with a radiographically confirmed complex ankle fracture will be allocated 1:1 to a standard care arm where any imaging will be performed at the discretion of the Consultant Orthopaedic S
Sponsors
Mid Yorkshire Hospitals NHS Trust
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients aged 16 years and over 2. Radiographic evidence of a complex and/or unstable ankle fracture 3. The trial intervention (CT scan) can be provided within 24 hours of presentation 4. Able to provide informed consent
Exclusion criteria
Exclusion criteria: 1. The injury is more than 24 hours old 2. The patient is younger than 16 years old or they are pregnant 3. There are bilateral or additional fractures, or involvement of other body systems where treatment and rehabilitation would vary from normal expected procedures, and outcomes for the trial may be affected 4. Cases of open fracture with severe soft tissue compromise giving rise to additional complications affecting trial outcomes 5. Definitive emergent treatment has occurred or has been initiated 6. The patient would be unable to adhere to trial procedures or complete questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ankle symptoms measured using the Olerud- Molander Ankle Score (OMAS) at 6 months after the injury | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ankle symptoms measured using the Olerud- Molander Ankle Score (OMAS) at 6 weeks, 3 months and 6 months after the injury 2. Health related quality of life measured using the EQ-5D-5L questionnaire at 6 weeks, 3 months and 6 months after the injury 3. Healthcare resource use measured using patient questionnaire and routine hospital attendance data of planned and unplanned visits to hospital at study allocation, 6 weeks, 3 months and 6 months after the injury 4. Feasibility measured using screening and recruitment logs, and change of status forms (Withdrawals, loss to follow up) at study close out 5. Patient experience measured using semi structured qualitative interviews to explore the lived experience of a sub-set of participants in both study arms at 6 weeks and 6 months post allocation | — |
Countries
England, United Kingdom
Contacts
Public ContactMartine Mallinson
Outcome results
None listed