Primary fracture fixation surgery Surgery
Conditions
Interventions
Current interventions as of 11/02/2026:
This is a multi-centre feasibility RCT recruiting ankle fracture patients from University Hospitals Coventry and Warwickshire and Royal London Hospital with an
Sponsors
University of Warwick
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Feasibility RCT: 1. Aged 18 years and over 2. Patients undergoing primary fracture fixation surgery for a closed ankle fracture within 2 weeks of date of injury under general and/or regional anaesthetic 3. Capacity to give informed consent Embedded Qualitative Interview Study: 1. Aged 18 years and over 2.1. Consultant Trauma & Orthopaedic Surgeons who participated or declined to participate in the feasibility randomised controlled trial OR 2.2. Patients who participated or declined to participate in the feasibility randomised controlled trial 3. Ability to provide informed consent
Exclusion criteria
Exclusion criteria: Feasibility RCT: 1. Patients with a pilon fracture 2. Unable to understand and speak English (or does not have relative willing to translate) 3. Patients with a chronic musculoskeletal or neurological condition (excluding diabetes mellitus) affecting the operative limb, or a history of prior surgery on the affected limb Embedded Qualitative Interview Study: 1. Unable to understand and speak English (or does not have relative willing to translate)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment rates measured throughout the recruitment period using a study site tracker 2. Retention rates will be assessed at the end of the study by comparing the number of participants recruited and those who have completed the study 3. Data completeness will be assessed periodically using reports from the database 4. Blinding feasibility will be assessed based on reports of unblinding (up to 3 months post patient ankle fracture fixation) and explored during the surgeon qualitative interviews 5. Intervention adherence will be measured throughout the study recruitment and follow-up period, based on reported protocol deviations/violations | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Post-operative pain measured at baseline, 24 hours, 3 weeks and 3 months post-operatively using the painDETECT questionnaire and 11-point pain Numerical Rating Scale 2. Surgical field of view measured on the day of the procedure using a 5-point Likert scale 3. Blood loss and blood transfusions measured on the day of the procedure and up to 2 weeks post-procedure by measuring the weight of the surgical swabs, volume of blood collected and number of intraoperative and post-operative blood transfusions 4. Length of procedure measured on the day of the procedure 5. Skin assessment will be assessed pre-operatively and on the day of the procedure and collected from medical notes 6. Awareness of tourniquet use will be measured post-operatively using a self-completed questionnaire 7. Health-related quality of life will be measured at baseline, 3 weeks and 3 months post-operatively using a modified EQ5D5L questionnaire 8. Functional recovery after the ankle injury will be assessed using the Olerud-Molander Ankle Score at baseline, 3 weeks and 3 months post-operatively 9. Post-operative complications measured 3 months post-procedure will be captured using a patient self-reported questionnaire 10. Intra-operative complications will be captured on the day of the procedure through a surgeon-completed questionnaire | — |
Countries
England, United Kingdom
Contacts
Public ContactCristiana Huhulea
Outcome results
None listed