Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee
NCT: NCT06138548 · ENROLLING_BY_INVITATION
Brief 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). The 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. This use is not considered off-label because the TFNs are being used in the way they are intended to be used via FDA approval.
Frequently Asked Questions
What is Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee?
Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee is a clinical trial registered under NCT06138548. Current status: ENROLLING_BY_INVITATION.
What is the status of NCT06138548?
The current status of NCT06138548 (Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee) is: ENROLLING_BY_INVITATION.
When did Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee start?
Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee started on 2025-10-31.
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Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.