Clinical Trial

Osteosynthesis of High-Risk Ankle Fractures Using Locked Fibula Nails: What Results for Which Patients?

Study acronym: OFCCF
Unknown
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Record status
This record was last updated July 24, 2024 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.
Summary
Ankle fractures are among the most common injuries in orthopedic and trauma surgery, accounting for 9% of all fractures. They can be classified into isolated malleolar fractures (internal and/or external), pilon fractures, and distal tibia fractures, which affect the entire distal part of the tibia, depending on whether they are intra-articular or extra-articular. The aging of the population and the increase in survival of multiple trauma patients lead to an increase in ankle fractures with high skin risk, whether due to an open fracture, soft tissue injury (crush, dermabrasion, etc.). ) or a major risk of scarring (chronic venous insufficiency, lymphedema, unbalanced diabetes. The fibula nail is a recent, minimally invasive osteosynthesis method whose results seem at least equivalent to those of screwed plate osteosynthesis in numerous series in the literature. The most commonly used and most studied fibula nail in the literature is the Acumed fibula nail. In recent literature, the use of the fibula nail in the fixation of tibial pilon fractures and/or fractures of the distal quarter of the leg is associated with satisfactory results. The elements collected as part of this study could make it possible to validate the use of the fibula nail in the management strategy for these fractures and thus better codify and standardize practices in this restricted and complex area of traumatology.
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT06518265
Lead Sponsor University Hospital, Grenoble
Conditions Ankle Fractures:Osteosynthesis of High-Risk Ankle Fractures Using Locked Fibula Nails
Enrollment 15 participants
Start Date 2024-07-01
Primary Completion 2025-07 (estimated)
Study Completion 2025-07 (estimated)
Updated on ClinicalTrials.gov 2024-07-24