New bone graft could cut infection in severe leg breaks
NCT ID NCT07227493
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at a new bone graft material called Fibergraft Aeridyan Matrix for treating open pilon fractures, which are severe breaks in the lower leg that often get infected or don't heal well. Researchers will follow 45 adults who need bone grafting as part of their standard care, using extra CT scans at 6 and 12 months to check healing. The goal is to see if this material reduces infection and helps bones heal better than current methods.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fibergraft Aeridyan Matrix (bioactive glass and collagen bone graft substitute)
- What this could lead to
- If successful, this could provide a better way to treat severe open leg fractures, reducing infection and helping bones heal without needing a second surgery.
- What could go wrong
- This is a small, early observational study with only 45 people, so results may not apply to everyone. The bone graft might not work as well as hoped, and infection or poor healing are still possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients presenting to our institution with an open pilon fracture that will undergo open reduction with internal fixation and will require bone grafting.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Get notified about this study
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Missouri - Columbia
RECRUITINGColumbia, Missouri, 65201, United States