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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years of age or older

• Open pilon fracture requiring bone grafting

• Able to provide informed consent for the study prior to definitive care

Locations
United States
Missouri
University of Missouri - Columbia
RECRUITING
Columbia
Contact Information
Primary
Vicki L Jones, MEd
jonesvicki@health.missouri.edu
573-882-7583
Backup
Nash Kolb
kolbn@health.missouri.edu
573-884-8428
Time Frame
Start Date: 2025-10-24
Estimated Completion Date: 2027-01
Participants
Target number of participants: 45
Treatments
Fibergraft Aeridyan Bone Graft Matrix
Patients in this group will be those who present to our institution with an open pilon fracture who receive the Fibergraft Aeridyan Bone Graft Matrix as part of their treatment for their pilon fracture.
Related Therapeutic Areas
Sponsors
Collaborators: DePuy Orthopaedics
Leads: University of Missouri-Columbia

This content was sourced from clinicaltrials.gov