The search for volunteers for the on-going COPLA® Pilot Trial has ended. The maximum number of enrolled patients (20) will continue to come in for their scheduled follow-up visits and the interim results from these visits are analyzed as they come in.
The COPLA® cartilage implant and its safety are being studied in a clinical investigation in Finland, Estonia and Sweden. The purpose of this study is to determine the safety and effectiveness of COPLA® for the treatment of cartilage defects in the knee. In this study, volunteers receive COPLA® during normal cartilage repair surgery of the knee. This is the first study of the COPLA® device in humans. In addition, the safety and efficacy of the COPLA®-specific rehabilitation program is being studied. Visits may include clinical examination, questionnaires about pain and movement, and imaging such as magnetic resonance (MRI). The safety and well-being of participants are followed up for 2 years after the surgery.
COPLA® is an investigational device and is not approved for commercial use in any country.
The participating investigators and hospitals for the pilot clinical trial to evaluate the preliminary safety and performance of COPLA® for the treatment of cartilage defects are the following:
- Terveystalo, Finland, Teemu Paatela, MD
- Mehiläinen, Finland, Mikko Kirjavainen, MD, PhD
- Central Finland Health Care District, Hospital Nova Jyväskylä, Finland, Heikki Nurmi, MD
- Tartu University Hospital, Estonia, Kaspar Tootsi, MD, PhD
- Sahlgrenska University Hospital – Mölndal, Sweden, Sebastian Concaro, MD, PhD
Askel Healthcare is planning a new clinical trial that is anticipated to start enrolment by the end of 2025 in selected European countries.
