NCT06423378

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-03-05
• Primary completion: 2027-03-05
• Completion: 2027-12-05
• First posted: 2024-05-21
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study