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NCT07227493 · ClinicalTrials.gov registry record
Open Pilon With FIBERGRAFT AERIDYAN Matrix Bioactive Glass
A clinical trial of Open Pilon Fractures, sponsored by University of Missouri-Columbia.
- Recruiting
- Registry status
- 45
- Enrollment target
- 1
- Study location
NCT07227493: Recruiting study of Open Pilon Fractures, sponsored by University of Missouri-Columbia.
NCT07227493 is a study of Open Pilon Fractures that is actively recruiting participants, run by University of Missouri-Columbia. The registered enrollment target is 45 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07227493, a study of Open Pilon Fractures, is actively recruiting participants, sponsored by University of Missouri-Columbia.
- RECRUITING
- Registry status
- 45 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 ma
Conditions Studied
Interventions
- DEVICE Fibergraft Aeridyan Matrix
Study Locations (1)
Missouri
- University of Missouri - Columbia - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2025-10-24 |
| Est. Completion | 2027-01 |
What NCT07227493 shows while recruiting
NCT07227493 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 45 participants, a relatively small participant target.
The record links to 1 condition, with Open Pilon Fractures appearing as the primary indexed condition, and to 1 intervention - of which Fibergraft Aeridyan Matrix is the first listed.
NCT07227493 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT07227493 about?
NCT07227493 is a clinical study titled "Open Pilon With FIBERGRAFT AERIDYAN Matrix Bioactive Glass". 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. Fibergra...
What is the current status of trial NCT07227493?
This trial is currently recruiting. The enrollment target is 45 participants. The study started on 2025-10-24. Estimated completion is 2027-01.
What conditions does trial NCT07227493 study?
This clinical trial studies the following conditions: Open Pilon Fractures.
What interventions are being tested in trial NCT07227493?
The interventions under investigation include: Fibergraft Aeridyan Matrix (DEVICE).
Who is sponsoring clinical trial NCT07227493?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07227493 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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