Open Pilon With FIBERGRAFT AERIDYAN Matrix Bioactive Glass

Conditions

• Open Pilon Fractures

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fibergraft Aeridyan Matrix — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Oct 24, 2025

Status verified

Nov 2025

Primary completion

Jan 31, 2027

Completion

Jan 31, 2027

Study Design

Enrollment

45 participants (estimated)

Arms

• Arm: 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.

Primary Outcome Measure

The number of participants that demonstrate radiographic healing at 12 months, as assessed by the mRUST [ Time Frame: 12 months ]

Central Contacts

• Vicki L Jones, MEd
  573-882-7583
  [email protected]
• Nash Kolb
  573-884-8428
  [email protected]

Locations (1)

Find similar trials in Columbia, MO