Agili-C™ Implant Performance Evaluation in the Repair of Cartilage and Osteochondral Defects

Exclusion Criteria

• •1. Bony defect depth deeper than 8mm, according to imaging Articular cartilage lesions in the tibia or the patella, ICRS grades IVa and IVb
• •2. Any previous ligamentous repair or malalignment correction in the index knee within the last 3 months
• •3. Significant instability of the index knee according to IKDC Knee Examination Form 2000, Grade C (abnormal) or D (severely abnormal)
• •4. Lack of functional remaining meniscus
• •5. Meniscal transplantation in the past 6 months
• •6. Malalignment more than 5 degrees varus OR 5 degrees valgus according to standing X-ray
• •7. Any known tumor of the index knee
• •8. Any know history of infection of the index knee
• •9. Any known history of inflammatory arthropathy or crystal-deposition arthropathy
• •10. Any known systemic cartilage and/or bone disorder such as but not limited to chondrodysplasia or osteogenesis imperfecta
• •11. Body mass index \>35
• •12. Osteoarthritis of the index knee graded as 4 according to the Kellgren- Lawrence scale
• •13. Chemotherapy treatment in the past 12 months
• •14. Any previous surgical cartilage treatment in the index knee within the last 6 months
• •15. History of allergic reaction or intolerance of materials containing calcium carbonate or hyaluronate
• •16. Patient who is pregnant or intends to become pregnant during the study
• •17. History of any significant systemic disease, such as but not limited to, HIV infection, hepatitis infection or HTLV infection; known coagulopathies, that might compromise the subject's welfare
• •18. Known substance abuse or alcohol abuse
• •19. Participation in other clinical trials within 30 days prior to the study or concurrent with the study
• •20. Known insulin dependent diabetes mellitus
• •21. Unable to undergo MRI or X-ray