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Recruiting NCT05798741

Hardware Removal After ORIF of Ankle Fractures

Conditions: Ankle Fractures

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Hôpital Fribourgeois

Location: HFR Fribourg

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.

Eligibility Criteria

Inclusion Criteria: * \>18 y.o * Operative treatment of ankle/foot fractures at HFR or RHNe: * Ankle fractures: bi-malleolar and tri-malleolar fractures or equivalent * FAAM score \>5%, \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05798741). StuddyBuddy aggregates publicly available trial information.