Hardware Removal After ORIF of Ankle Fractures

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

The study consists of a prospective multicentric parallel two-arm randomised non-blinded study, conducted at the HFR and RHNe (level of evidence II). The planned intervention is the following: after an ORIF of the ankle, patients have a follow-up. At the 12- month control, we ask eligible patients if they want to participate to the study. If they agree, they are randomised to treatment recommendations in one of two groups: conservative or surgical. The patients may follow or not the recommendations; not following the recommendations does not exclude them from the study. Patients of both groups will fill out FAAM and PDI questionnaires at 12 and 18 months after the 1st operation. Patients in the surgical group will have a hardware removal surgery. It is a very common operation consisting of hardware removal that is done ambulatory by the orthopaedic surgeons specialized in foot and ankle surgery. Operated patients will have the usual postoperative follow-up (6 weeks, 3 months and 6 months postoperative) and all complications will be recorded and classified according to the Ernst-sink classification ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05798741
Study type	Interventional
Source	Hôpital Fribourgeois
Contact
Status	Not yet recruiting
Phase	N/A
Start date	May 1, 2023
Completion date	March 1, 2026

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.