The COPLA® cartilage implant is not yet available for commercial use but has entered the first in-human clinical trial phase. COPLA® is intended for the treatment of symptomatic, full-thickness, cartilage and bone-cartilage lesions in the knee joints of adult patients. It is a biodegradable polymer scaffold that allows for immediate full weight-bearing after surgery.
The pilot clinical trial to evaluate the preliminary safety and performance of COPLA® in the treatment of cartilage defects 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, patients will receive the COPLA® device during normal clinical practice for cartilage repair surgery with bone marrow stimulation. The intended purpose of COPLA® is to treat symptomatic full-thickness chondral and osteochondral lesions in the knee joint with a biodegradable polymer scaffold that allows for immediate weight-bearing after surgery. The intended clinical benefit of using COPLA® is to enable cartilage lesions in the knee joints to heal and to allow immediate full weight-bearing and a recovery back to pain-free activity after surgery.
The subjects included will be symptomatic patients between the ages of 18 and 50 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 the COPLA® device is safe for humans. The secondary objectives relate to the performance of the device. The focus points of the secondary objectives will be the facilitation of mobility and non-restricted full weight-bearing of the operated leg as well as the identification of repair tissue growth at the lesion site.
A post-operative follow-up is planned for 24 months after surgery. Subjects will be scheduled visits at 6 weeks, 3 months, 6 months, 12 months and 24 months after the operation.
COPLA® is an investigational device and is not yet approved for commercial use in any country. The described design properties and intended purpose are subject to further validation.
Teemu Paatela, MD, is the Coordinating Investigator for the multicenter trial and Principal Investigator for Terveystalo, Finland.
In addition, Prof. Mats Brittberg, MD, PhD and Sebastian Concaro, MD, PhD from Sahlgrenska University Hospital-Mölndal, Sweden are included in the design and analysis of the clinical investigation.
COPLA® is an investigational device and is not yet approved for commercial use in any country. The described design properties and intended purpose are subject to further validation.
