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Open Pilon With FIBERGRAFT AERIDYAN Matrix Bioactive Glass

NCT07227493 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2025-11-12

No results posted yet for this study

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.

Conditions

  • Open Pilon Fractures

Interventions

DEVICE

Fibergraft 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.

Sponsors & Collaborators

  • DePuy Orthopaedics

    collaborator INDUSTRY

  • University of Missouri-Columbia

    lead OTHER

Principal Investigators

  • Kyle M Schweser, MD · University of Missouri-Columbia

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-24
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07227493 on ClinicalTrials.gov