Status:
COMPLETED
Medial Malleolus: Operative Or Non-operative
Lead Sponsor:
Royal Infirmary of Edinburgh
Conditions:
Ankle Fracture - Medial Malleolus
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
Medial malleolus: Operative Or Non-operative (MOON study) Ankle fractures are a common Orthopaedic trauma presentation, accounting for approximately 10% of the workload. There has been debate regardin...
Detailed Description
This trial will include adult patients (16 years) presenting to the single centre; Edinburgh Orthopaedic Trauma Unit, Royal Infirmary of Edinburgh, with an isolated unstable fracture of the ankle join...
Eligibility Criteria
Inclusion
- Age ≥16 years
- Able to consent to treatment
- Unstable fracture dislocation of the ankle joint requiring operative intervention as defined in section 3.1
- Closed injury
- Weber B \& Weber C fractures
- Surgery date within two weeks of date of fracture
Exclusion
- Patients unable to comply with post-operative data gathering including completing questionnaires in English language
- Additional lower limb injury, which may impact on patient rehabilitation
- Open fracture
- Confirmed severe associated neurovascular injuries
- Distal tibial intra-articular fractures/ pilon type injuries
- Supination-adduction type 2 (SAD-2) fracture configurations with a medial malleolus vertical shear fracture
- Patients medically unfit for surgery
- Patients declining operative management
- Non-residents, unable to return to the unit for follow-up for a period of 1-year
- Current engagement in a pharmaceutical/drug trial
- Where the treating surgeon does not feel that inclusion in the trial is in the patients' best interest either due to the fracture pattern or patient factors
Key Trial Info
Start Date :
October 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT03362229
Start Date
October 24 2017
End Date
August 1 2021
Last Update
August 26 2021
Active Locations (1)
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1
Edinburgh Orthopaedic Trauma Unit, Edinburgh Royal Infirmary
Edinburgh, United Kingdom, EH16 4SA