Ankle fracture imaging of patients with a complex injury

Not Applicable

• Conditions: Complex and/or unstable ankle fracture; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN25963775
• Lead Sponsor: Mid Yorkshire Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-20
• Last Update Posted: 2 September 2024
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ankle symptoms measured using the Olerud- Molander Ankle Score (OMAS) at 6 months after the injury

Secondary Outcome Measures

Name	Time	Method
1.Ankle symptoms measured using the Olerud- Molander Ankle Score (OMAS) at 6 weeks, 3 months and 6 months after the injury<br>2.Health related quality of life measured using the EQ-5D-5L questionnaire at 6 weeks, 3 months and 6 months after the injury<br>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<br>4.Feasibility measured using screening and recruitment logs, and change of status forms (Withdrawals, loss to follow up) at study close out<br>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