Back to search results

Observational Study of FIBERGRAFT AERIDYAN Matrix for Open Pilon Fractures

This study is looking at how well a product called FIBERGRAFT™ Aeridyan™ Matrix works for people with open pilon fractures. A pilon fracture is a serious break in the shin bone near the ankle. FIBERGRAFT™ Aeridyan™ Matrix is a special material made of bioactive glass and collagen that helps bone heal. Researchers want to see if this material helps these fractures heal well. You might be able to join if you are 18 or older, have an open pilon fracture that needs bone grafting, and can give your consent to participate. The main goal is to see how many participants show signs of healing on X-rays after 12 months. This is an observational study, meaning treatments are given as part of standard care, with two extra CT scans for research.

Study design
This is an observational study involving about 45 participants. It is not specified if it's blinded or randomized, but treatments are given as part of standard care.
What's involved
You would receive standard care for your open pilon fracture, plus two additional CT scans for research purposes. The study will assess healing at 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months to assess radiographic healing.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07227493

Open Pilon With FIBERGRAFT AERIDYAN Matrix Bioactive Glass

Recruiting
Not specifiedAges 18+Observational
University of Missouri-Columbia
~45 participants
Updated 2025-11-12 on ClinicalTrials.gov
What's tested:Fibergraft Aeridyan Matrix

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The number of participants that demonstrate radiographic healing at 12 months, as assessed by the mRUST
Measured over 12 months

Conditions

Open Pilon Fractures

Explore related trials

Pilon fracture

NCT07227493

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Missouri - Columbia

    Columbia, Missouristudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Kyle M Schweser, MD · PRINCIPAL_INVESTIGATOR · University of Missouri-Columbia

Who to contact

Vicki L Jones, MEd
[email protected]
573-882-7583
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • The number of participants that demonstrate radiographic healing at 12 months, as assessed by the mRUST12 months

    Participants will be assessed for radiographic healing through a modified radiographic union score for tibial fractures (mRUST), with an average grade of 6-8 per radiograph after application of FIBERGRAFT AERIDYAN Matrix bioactive glass and ORIF at 12 months. mRUST is scored on a scale of 1-4 for each cortex. 1: no callus is present, 2: callus is present, 3: bridging callus is present, 4: fracture line is no longer visible. 2 cortices are visible per radiographic image. Therefore, there is a max score of 8 per radiograph. Scores with an average of 6-8 in this study are deemed as demonstrating radiographic healing.