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Hardware Removal After ORIF of Ankle Fractures

RecruitingNAAges 18 Years - anyAllHôpital Fribourgeois
NCT05798741 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 t

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📋 Eligibility rules (as published)
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%, \<95% * Patient expected to complete length of study * Patient with sufficient cognitive and linguistic ability in order to participate in the study. * Operable patients (ASA score ≤3) Exclusion Criteria: * Absolute indications for HR: infection/malunion/allergy to metal/refracture * Ankle fractures that are not listed in the criteria above * Patient treated for a fracture at the same foot/ ankle before * Patient with fracture of two different regions of the foot/ankle * Patient treated for the fracture outside of HFR and RHNe * Patient non ambulating before time of injury * Patients having diabete, * immunocompromised under chemotherapy, * Peripheral artery disease stade IV * Pregnant patients
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What it tests

  • Hardware removal
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Where

1 site
HFR
Fribourg, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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