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 surgical treatment of chondral and osteochondral lesions in the knee joints of adult patients. It is a porous biodegradable implant that enables new tissue formation to lesion site. Immediate full weight-bearing of the operated leg is allowed after COPLA® surgery, resulting in early rehabilitation.
Healthcare professionals
COPLA® has entered the first in-human clinical trial phase
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. In the trial, patients 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 porous biodegradable implant that enables new tissue formation to the lesion site. Immediate weight-bearing of the operated leg is allowed after COPLA® surgery. The intended clinical benefit of COPLA® to the patient is to allow full immediate weight-bearing of the operated leg after the knee cartilage repair surgery, resulting in early rehabilitation and recovery to their normal activity after the surgery.
The subjects included are 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 are 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 are 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 are scheduled visits at 6 weeks, 3 months, 6 months, 12 months and 24 months after the operation.
Recruitment has been completed for the pilot clinical trial. Trial continues with the follow-up of the operated patients and final results are expected by the end of 2026.
Askel Healthcare is planning a new clinical trial that is anticipated to start enrolment by the end of 2025 in selected European countries.
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.
Participating investigators and hospitals
Teemu Paatela, MD, is the Coordinating Investigator for the multicenter trial and Principal Investigator for Terveystalo, Finland.
- Terveystalo, Finland
Teemu Paatela, MD, Principal Investigator (Kamppi and Ruoholahti)
Heikki Nurmi, MD, Sub-Investigator (Jyväskylä) - Mehiläinen, Finland
Mikko Kirjavainen, MD, PhD, Principal Investigator (Töölö) - Central Finland Health Care District, Hospital Nova, Finland
Heikki Nurmi, MD, Principal Investigator (Jyväskylä) - Tartu University Hospital, Estonia
Kaspar Tootsi, MD, PhD, Principal Investigator
Sub-investigators:
Prof. Aare Märtson, MD, PhD
Egon Puuorg, MD
Reedik Pääsuke, MD - Sahlgrenska University Hospital – Mölndal, Sweden
Sebastian Concaro, MD, PhD, Principal Investigator
Sub-investigators:
Prof. Mats Brittberg, MD, PhD
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.
