This is a first-in-human clinical, open label, non-randomized, prospective investigation to assess the initial safety and performance of the COPLA® cartilage implant. In the investigation, the patients will receive COPLA® device during normal clinical practice for cartilage repair surgery with bone marrow stimulation.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Single contained symptomatic chondral or osteochondral defect located on the femoral condyle graded as ICRS III or IV observed in the preoperative MRI;
✓. Minimum defect size 1 cm2 post-debridement;
✓. Aged between 18 and 50 at the time of enrollment;
✓. Osteoarthritis of the index knee graded 0 or I according to the Kellgren-Lawrence Grading in posterior-anterior knee radiography with full weight bearing;
✓. Subject is able and willing to give informed consent; AND
✓. Subject is physically and mentally willing and able to comply with the post-operative rehabilitation protocol, questionnaires, and scheduled clinical and radiographic visits
Exclusion criteria
✕. Defect size over 4 cm2 according to arthroscopy during operation;
✕. Subchondral defect depth over 4 mm according to pre-operative MRI;
✕. Osteoarthritis of the index knee grades II or above according to the Kellgren-Lawrence Grading;
✕. History of allergic reaction or intolerance of materials containing polylactide and/or bovine collagen;
✕. Presence of an additional articular cartilage lesions in the femur, tibia or the patella, ICRS grades III or above observed in the preoperative MRI or during the final intraoperative arthroscopic evaluation;
What they're measuring
1
Number of Serious Adverse Events (SAE)
Timeframe: From pre-operative baseline up to 24-month follow-up visit
. Any known systemic cartilage and/or bone disorder, such as but not limited to, osteochondrosis, osteoporosis, chondrodysplasia or osteogenesis imperfecta;
✕. Any previous surgical treatment in the index knee in the past 12 months;
✕. Any previous intra-articular injections in the index knee in the past 3 months;