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NCT06423378 · ClinicalTrials.gov registry record · Phase 2
Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee
A Phase 2 study of Subchondral Insufficiency Fracture, sponsored by Vanderbilt University Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT06423378 is a Phase 2 study of Subchondral Insufficiency Fracture that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 10 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06423378, a Phase 2 study of Subchondral Insufficiency Fracture, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
The OSSIOfiber® Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis and bone grafts in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast, brace). Our hypothesis is that the use of OSSIOfiber® Trimmable Fixation Nails for treating subchondral insufficiency of the knee will result in improvement of patient-reported outcomes and imaging findings. The primary objective of this study is to evaluate the effectiveness of implanting bio-integrative OSSIOfiber® Trimmable Fixation Nails, organized in a bi-cortical rafter formation within the tibia or femur for the management of subchondral insufficiency. The OSSIOfiber® Trimmable Fixation Nails used in this study will be considered on-label.
Conditions Studied
Interventions
- DEVICE OSSIOfiber® Trimmable Fixation Nails
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2025-03-05 |
| Est. Completion | 2026-12-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06423378
The ClinicalTrials.gov registry entry for NCT06423378 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Subchondral Insufficiency Fracture appearing as the primary indexed condition, and to 1 intervention - of which OSSIOfiber® Trimmable Fixation Nails is the first listed.
NCT06423378 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT06423378 about?
NCT06423378 is a clinical study titled "Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee". The OSSIOfiber® Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis and bone grafts in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast, brace). Our hypothesis is that the use of OSSIOf...
What is the current status of trial NCT06423378?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2025-03-05. Estimated completion is 2026-12-05.
What conditions does trial NCT06423378 study?
This clinical trial studies the following conditions: Subchondral Insufficiency Fracture.
What interventions are being tested in trial NCT06423378?
The interventions under investigation include: OSSIOfiber® Trimmable Fixation Nails (DEVICE).
Who is sponsoring clinical trial NCT06423378?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06423378 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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