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

NCT06423378 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-04-13

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). 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

  • Subchondral Insufficiency Fracture

Interventions

DEVICE

OSSIOfiber® Trimmable Fixation Nails

Subjects will be treated with cannulated nails before or after arthroscopic management of their concomitant pathology at the discretion of the investigator. Technique described below. Following nail placement, tissue layers will be closed in standard fashion. 1. Preop MRI views used to estimate the proper depth \& location of nail placement on the femur and/or tibia 2. Exposure is gained to medial tibia 3. 1.4 mm K-Wire is placed through medial tibia parallel to the articular joint surface \~ 1 cm distal to the articular joint line 4. A depth gauge is placed over K-Wire to determine required length of cannulated nail 5. A 4.0 mm cannulated drill bit used over K-Wire to prepare the pilot hole 6. Tamp is used to insert pre-trimmed 4.0 mm cannulated nail into the pilot hole and K-Wire is subsequently removed 7. Intraop fluoroscopy can confirm adequate nail placement prior to removing K-wire 8. Repeat steps for additional nails

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-05
Primary Completion
2027-03-05
Completion
2027-12-05
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT06423378 on ClinicalTrials.gov