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Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee

NCT06138548 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2025-11-10

No results posted yet for this 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). 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.

Conditions

  • Subchondral Insufficiency Fracture

Interventions

DEVICE

Ossiofiber® Trimmable Fixation Nail

OSSIOfiber® Trimmable Fixation Nails are equally strong in the initial stability and fixation strength - and superior in rotational resistance to traditional metal cannulated headless compression screws.\*

Sponsors & Collaborators

Principal Investigators

  • Seth L Sherman, MD · Stanford University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2027-07-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06138548 on ClinicalTrials.gov