RecruitingNCT07227493

Open Pilon With FIBERGRAFT AERIDYAN Matrix Bioactive Glass

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


Sponsor

University of Missouri-Columbia

Enrollment

45 participants

Start Date

Oct 24, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • years of age or older
  • Open pilon fracture requiring bone grafting
  • Able to provide informed consent for the study prior to definitive care

Exclusion Criteria8

  • 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

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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.


Locations(1)

University of Missouri - Columbia

Columbia, Missouri, United States

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NCT07227493