RecruitingNCT07227493

Open Pilon With FIBERGRAFT AERIDYAN Matrix Bioactive Glass

Acute Bone Grafting of Open Pilon Fractures With FIBERGRAFT AERIDYAN Matrix Bioactive Glass


Sponsor

University of Missouri-Columbia

Enrollment

45 participants

Start Date

Oct 24, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Fibergraft Aeridyan Matrix for people with open pilon fractures. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFibergraft Aeridyan Matrix

FIBERGRAFT™ Aeridyan™ Matrix is a resorbable porous bone graft substitute made from 45S5 bioactive glass, boron bioactive glass and type I collagen. The implantable material is provided as a premixed Matrix of bioactive granules and microspheres in a collagen carrier.


Locations(1)

University of Missouri - Columbia

Columbia, Missouri, United States

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NCT07227493