NCT05798741

Hardware Removal After ORIF of Ankle Fractures

Hardware Removal After ORIF of Ankle Fractures: A Randomized Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Hôpital Fribourgeois · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Ankle Fractures

Interventions

Type	Name	Description
PROCEDURE	Hardware removal	The surgery of hardware removal after an ORIF of an ankle fracture

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-06-01
• Completion: 2026-03-01
• First posted: 2023-04-05
• Last updated: 2023-04-06