Actively Recruiting

Age: 18Years +
All Genders
NCT07227493

Open Pilon With FIBERGRAFT AERIDYAN Matrix Bioactive Glass

Led by University of Missouri-Columbia · Updated on 2025-11-12

45

Participants Needed

1

Research Sites

62 weeks

Total Duration

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Sponsors

U

University of Missouri-Columbia

Lead Sponsor

D

DePuy Orthopaedics

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Open Pilon With FIBERGRAFT AERIDYAN Matrix Bioactive Glass

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Open pilon fracture requiring bone grafting
  • Able to provide informed consent for the study prior to definitive care
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Missouri - Columbia

Columbia, Missouri, United States, 65201

Actively Recruiting

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Research Team

V

Vicki L Jones, MEd

CONTACT

N

Nash Kolb

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Open Pilon With FIBERGRAFT AERIDYAN Matrix Bioactive Glass | DecenTrialz