Acute Bone Grafting of Open Pilon Fractures With FIBERGRAFT AERIDYAN Matrix Bioactive Glass
University of Missouri-Columbia
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.
Description
Tibial plafond, or pilon fractures are complicated, rare, challenging fractures representing less than 1% of all lower extremity fractures and 1-10% of all tibial fractures.1 A quarter of these pilon fractures are open and involve soft tissue complications and could lead to amputation if not treated properly.1-3 The AO/OTA classifies these pilon fractures as 43A-C,1-34; and are often open fractures characterized by the Gustilo Anderson (GA) scale.5 These high energy traumatic injuries are often susceptible to multiple complications such as superficial infection, fracture related infection, an…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DeviceFibergraft 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.
Location
- University of Missouri - ColumbiaColumbia, Missouri