Clinical Trial

Open Pilon With FIBERGRAFT AERIDYAN Matrix Bioactive Glass

Recruiting
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Summary
Open pilon fractures are challenging problems to manage. Infection rates vary from 6-30% and metaphyseal nonunion varies from 7-20%. The current recommendation for the management of open pilon fractures with bone loss is a staged approach, with internal fixation around an antibiotic spacer. Fibergraft Aeridyan Bone Graft Matrix is currently used along with other forms of allograft at our institution for filling bone voids in open pilon fractures. This is a prospective, observational study looking at the use of Fibergraft Aeridyan bone graft matrix and its efficacy in open pilon fractures. Everything in this study will be according to the standard of care at our institution other than two research only CT scans. One will be performed at the patient's 6-month visit and the other will be performed at the patient's 12-month visit. The investigators hypothesize that Fibergraft Aeridyan Bone Graft Matrix will lead to improved outcomes when compared to standard bone graft for patients by decreasing infection and nonunion rates.
Trial Details
NCT Number NCT07227493
Lead Sponsor University of Missouri-Columbia
Collaborators: DePuy Orthopaedics
Conditions Open Pilon Fractures
Enrollment 45 participants
Start Date 2025-10-24
Primary Completion 2027-01 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2025-11-12