Fibergraft Aeridyan bone graft for open pilon fractures
Official title: Acute Bone Grafting of Open Pilon Fractures With FIBERGRAFT AERIDYAN Matrix Bioactive Glass
Run by University of Missouri-Columbia · NCT07227493 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | University of Missouri-Columbia Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Columbia, Missouri) |
| Status | Recruiting |
| Started | October 24, 2025 |
| Main results expected | January 2027 |
| Study ends | January 2027 |
| Registry record updated | November 12, 2025 |
| Trial ID | NCT07227493 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.