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

Exclusion Criteria

• •Imaging evidence of the study knee that includes any of the following:
• •1. Kellgren-Lawrence grade 4 osteoarthritis.
• •2. Collapse of subchondral bone.
• •3. Avascular Necrosis (AVN).
• •4. Osteochondral defect overlying the BML
• •5. BML located at ACL or PCL insertions
• •Clinical evidence of the study knee that includes any of the following:
• •1. History of rheumatoid arthritis, septic arthritis, reactive arthritis, gout or pseudogout, secondary arthropathy (e.g., hemochromatosis, hemophilia, or psoriasis).
• •2. Osteochondritis dissecans.
• •3. Frank ligamentous instability.
• •4. Neuromuscular deficiency or other that would limit the ability to do a functional assessment.
• •Bi-cortical nail implantation cannot be achieved, including where the required nail length is not yet available.
• •Current tobacco use or has quit within 3 months of study enrolment.
• •Substance abuse history.
• •Diabetes mellitus, HbA1c\>8
• •High surgical risk due to pre-existing conditions.
• •Currently pregnant or has plans to become pregnant prior to surgery.
• •Active infection or history of chronic infection in study knee.
• •Will require concomitant procedures within study knee, including but not limited to ligament reconstruction, tendon repair, meniscus repair, microfracture, osteotomy, or osteochondral transplantation (Meniscal tears, including chronic, are acceptable if no repair is required)
• •Significant malalignment (varus or valgus) of the knee (\>8°)
• •Use of augmentation or concomitant biologic therapy during surgery.
• •Contraindications to magnetic resonance imaging.
• •Any condition which in the view of the treating physician makes it inadvisable for the subject to participate in the study.