Fibergraft Aeridyan bone graft for open pilon fractures
Acute Bone Grafting of Open Pilon Fractures With FIBERGRAFT AERIDYAN Matrix Bioactive Glass
This observational study will see if using Fibergraft Aeridyan bone graft matrix helps adults with open pilon fractures heal with fewer infections and nonunions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Missouri-Columbia Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Columbia, Missouri) |
| Trial ID | NCT07227493 on ClinicalTrials.gov |
What this trial studies
This is a prospective, observational, single-center study of adults with open pilon (tibial plafond) fractures who require bone grafting. Patients receive standard-of-care surgical management, with the addition of Fibergraft Aeridyan bone graft matrix used to fill metaphyseal bone voids alongside other allografts as indicated. Outcomes will be tracked clinically and radiographically, with two research-only CT scans performed at 6 and 12 months to document healing. The study will monitor infection rates, nonunion, and radiographic incorporation of the graft over the follow-up period.
Who should consider this trial
Good fit: Adults (18+) with an open pilon fracture requiring bone grafting who can provide informed consent and attend follow-up visits are ideal candidates.
Not a fit: Patients who do not require bone grafting, who have active infection at the time of definitive care, who receive definitive care elsewhere, or who cannot complete follow-up are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the graft matrix could reduce infection and nonunion rates and improve bone defect filling and healing in open pilon fractures.
How similar studies have performed: Prior work on acute allograft with bone morphogenetic proteins for large defects has shown variable success, and use of this specific Fibergraft Aeridyan matrix has limited published outcome data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age or older * Open pilon fracture requiring bone grafting * Able to provide informed consent for the study prior to definitive care Exclusion Criteria: * Under 18 years of age * Open pilon fracture not requiring bone grafting * Receiving definitive care at an outside facility * Unlikely to make follow-up appointments * Active infection at the time of definitive care * Unable to provide informed consent prior to definitive care * Prisoners * Pregnant patients
Where this trial is running
Columbia, Missouri
- University of Missouri - Columbia — Columbia, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Kyle M Schweser, MD — University of Missouri-Columbia
- Study coordinator: Vicki L Jones, MEd
- Email: jonesvicki@health.missouri.edu
- Phone: 573-882-7583
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.