Pilot Clinical Trial to Evaluate the Preliminary Safety and Performance of COPLA® for Treatment of Cartilage Defects
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cartilage or Osteochondral Defects in the Knee
- Sponsor
- Askel Healthcare Ltd
- Enrollment
- 20
- Locations
- 5
- Primary Endpoint
- Number of Serious Adverse Events (SAE)
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
Included subjects will be symptomatic patients between the ages 18 and 50 years with a single contained chondral or osteochondral defect located on the femoral condyle and graded as III or IV according to the International Cartilage Repair Society (ICRS) grading system. Subjects with known health related risks or certain recent surgical or medical interventions will be excluded. The primary objective of the investigation is to confirm that COPLA® device is safe for humans. The secondary objectives relate to the performance of the device after it is placed into the knee joint during surgery. Focus points of secondary objectives will be facilitation of mobility and non-restricted weight-bearing of the operated leg as well as the identification of repair tissue growth at the lesion site. Post-operative follow-up is planned for 24 months after surgery. Subject will come for scheduled visits at 6-week, 3-month, 6-month, 12-month, and 24-month timepoints.
Investigators
Eligibility Criteria
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;
- •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;
- •Systemic corticosteroid therapy in the past 1 month;
- •Presence of an untreated clinically significant meniscal tear;
Outcomes
Primary Outcomes
Number of Serious Adverse Events (SAE)
Time Frame: From pre-operative baseline up to 24-month follow-up visit
Safety - Measured by number of SAE and evaluated over the course of the clinical investigation
Secondary Outcomes
- Defect filling(From pre-operative baseline up to 24-month follow-up visit)
- Change in pain score(From pre-operative baseline up to 24-month follow-up visit)
- Change in Quality of life(From pre-operative baseline up to 24-month follow-up visit)
- Functional outcome(From pre-operative baseline up to 24-month follow-up visit)