COPLA® Cartilage Implant Pilot Clinical Trial

Inclusion Criteria:

1. Single contained symptomatic chondral or osteochondral defect located on the femoralcondyle graded as ICRS III or IV observed in the preoperative MRI;

2. Minimum defect size 1 cm2 post-debridement;

3. Aged between 18 and 50 at the time of enrollment;

4. Osteoarthritis of the index knee graded 0 or I according to the Kellgren-LawrenceGrading in posterior-anterior knee radiography with full weight bearing;

5. Subject is able and willing to give informed consent; AND

6. Subject is physically and mentally willing and able to comply with thepost-operative rehabilitation protocol, questionnaires, and scheduled clinical andradiographic visits

Exclusion Criteria:

1. Defect size over 4 cm2 according to arthroscopy during operation;

2. Subchondral defect depth over 4 mm according to pre-operative MRI;

3. Osteoarthritis of the index knee grades II or above according to theKellgren-Lawrence Grading;

4. History of allergic reaction or intolerance of materials containing polylactideand/or bovine collagen;

5. Presence of an additional articular cartilage lesions in the femur, tibia or thepatella, ICRS grades III or above observed in the preoperative MRI or during thefinal intraoperative arthroscopic evaluation;

6. Any known systemic cartilage and/or bone disorder, such as but not limited to,osteochondrosis, osteoporosis, chondrodysplasia or osteogenesis imperfecta;

7. Any previous surgical treatment in the index knee in the past 12 months;

8. Any previous intra-articular injections in the index knee in the past 3 months;

9. Systemic corticosteroid therapy in the past 1 month;

10. Presence of an untreated clinically significant meniscal tear;

11. Lack of functional remaining meniscus, at least 5mm rim at the end of the procedure;

12. Prior meniscal resection > 50%;

13. Untreated Anterior cruciate ligament (ACL) and/or Posterior cruciate ligament (PCL)deficiency: collateral and rotational;

14. Anteroposterior and/or varus/valgus instability on clinical testing;

15. Asymmetrical collateral stability in full extension and 20-degree flexion onclinical testing;

16. Need for any concomitant surgical intervention with the cartilage repair;

17. Inflammatory joint disease of the index or contralateral knee;

18. Any known history of inflammatory arthropathy or crystal-deposition arthropathy;

19. Active acute or chronic intra-articular or osseous infection of the index knee;

20. Any evidence of active infection anywhere in the body;

21. Inflammatory joint disease;

22. Body Mass Index (BMI) ≥ 30;

23. History of any significant systemic disease, such as but not limited to: humanimmunodeficiency virus (HIV), hepatitis, human T-lymphotropic virus (HTLV),syphilis, and coagulopathies;

24. Use of anticoagulation medication or antiaggregant medication; however up to 100 mgAcetylsalicylic acid (ASA) daily is allowed;

25. Chemotherapy in the past 12 months;

26. Any known tumor of the index knee;

27. Subject known to be pregnant or lactating;

28. Participation in other clinical trials within 60 days prior to this trial orconcurrent with this trial;

29. Prisoners;

30. Known substance or alcohol abuse; OR

31. Current nicotine users