Clinical Trial

Osteosynthesis of Fibula Fractures With a Locked Thin Plate

Study acronym: OFFPAV
Not Yet Recruiting
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Summary
Ankle fractures represent about 10% of all fractures and are common in both elderly patients with comorbidities and younger polytraumatized individuals. Traditional fibular osteosynthesis uses open plating, which carries up to a 20% complication rate, mainly due to skin issues. These complications are more frequent in patients with diabetes, vascular or neurological disease, obesity, or tobacco/alcohol use, as well as in open fractures or fracture-dislocations. Standard plates can also cause long-term discomfort due to their thickness, often requiring removal. Recent meta-analyses show that fibular nailing and thin one-third tubular plates result in fewer complications than anatomical plates, while maintaining similar bone-healing rates (97-100%). New thinner locked plates (2.8 mm) have been developed to reduce skin risks and discomfort; biomechanical studies suggest superior strength. Clinical research is needed to confirm their effectiveness and tolerance.
Trial Details
NCT Number NCT07365202
Lead Sponsor University Hospital, Grenoble
Conditions Osteosynthesis of Fibula Fractures With a Locked Thin Plate
Enrollment 40 participants
Start Date 2026-01-15
Primary Completion 2026-12-15 (estimated)
Study Completion 2026-12-15 (estimated)
Updated on ClinicalTrials.gov 2026-01-26