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Hardware Removal After ORIF of Ankle Fractures
Sponsor: Hôpital Fribourgeois
Summary
Ankle fractures account for 10 % of fractures in the adult population. A part of patients (40%) is treated surgically. After healing of the fractures, about one year after the operation, a surgery is often performed to remove the hardware in order to diminish pain. If this surgery is necessary is debated in the literature. The aim of our study is to evaluate the outcome of hardware removal surgery after a surgery of the ankle for a fracture. For that, we will perform do a controlled randomized trial with two arms: one arm includes the participants who will have a hardware removal and the other arm will not have a surgery. Outcome parameters are the patients reported outcome and pain related disability. They will be assessed by the questionnaires FAAM score (Foot and Ankle Ability Measure) and PDI (Pain Disability Index) at the beginning and at the end of the study, at six months. The third outcome parameter will be the complication rate after an anklehardware removal surgery, which will be assessed through the Ernst-Ssink classification.
Official title: Hardware Removal After ORIF of Ankle Fractures: A Randomized Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2023-10-01
Completion Date
2028-12-31
Last Updated
2026-10-23
Healthy Volunteers
No
Conditions
Interventions
Hardware removal
The surgery of hardware removal after an ORIF of an ankle fracture
Locations (1)
HFR
Fribourg, Switzerland