OSSIOfiber® Nail Study

Study Overview

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

Sponsor

Rush University Medical Center, Department of Orthopedic Surgery

Research Type

Prospective Case Series

Candidate Criteria

Patients undergoing knee surgery with the OSSIOfiber® nail who have a meniscal tear, loose body, unstable cartilage, or mechanical symptoms.

Purpose

To evaluate the utility of implanting biointegrative cannulated nails, organized in a rafter like formation within the tibia or femoral cortex, for managing overload associated with meniscal or chondral deficiency, comparing baseline and postoperative KOOS Pain scores.

Study Design

A single-center, open-label case series with a six-month minimum follow-up. Two cohorts are enrolled: Group 1 preoperatively and Group 2 postoperatively. Patient-reported outcomes are collected preoperatively, and at three months and six months postoperatively.

Study Procedures

Preoperative knee evaluation and MRI are performed. Informed consent is signed through Patient IQ, up to three months post op.

1. Knee arthroscopy to evaluate pathology
2. Arthroscopic knee repair using the OSSIOfiber® nail in a rafter configuration
3. Office follow-ups at:
   • 1 week (Group 1 only)
   • 3 months (X-ray at visit)
   • 6 months (non-contrast MRI at visit)