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

PHASE2RecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

March 5, 2025

Primary Completion Date

March 5, 2026

Study Completion Date

December 5, 2026

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"

Trial Locations (1)

37232

RECRUITING

Vanderbilt University Medical Center, Nashville

All Listed Sponsors
lead

Vanderbilt University Medical Center

OTHER