Recruiting

Fibergraft Aeridyan

Sponsor:

University of Missouri-Columbia

Code:

NCT07227493

Conditions

Open Pilon Fractures

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fibergraft Aeridyan Matrix

Study Details

Brief 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

Study ID

NCT07227493

Start date

Oct 24, 2025

Status verified date

Nov, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

45 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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 and Locations

Locations

University of Missouri - Columbia

Recruiting

Columbia, Missouri, United States, 65201

Contacts

Principal Investigator:

Kyle M Schweser, MD

More Information

Sponsor

University of Missouri-Columbia

Last update posted

Nov 12, 2025

Last verified

Nov, 2025

Keywords

  • pilon
  • bone graft
  • open pilon
  • fibergraft
  • fibergraft aeridyan

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri-Columbia on 2025-11-12.