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RECRUITING
NCT05798741
NA

Hardware Removal After ORIF of Ankle Fractures

Sponsor: Hôpital Fribourgeois

View on ClinicalTrials.gov

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

PROCEDURE

Hardware removal

The surgery of hardware removal after an ORIF of an ankle fracture

Locations (1)

HFR

Fribourg, Switzerland