EPIC-Knee: Episealer® Knee System IDE Clinical Study is a prospective, randomised, controlled, multi-centre study to evaluate the safety and effectiveness of the Episealer® Knee System compared to microfracture for the treatment of focal femoral knee chondral or osteochondral lesions.
The study is performed at hospitals in the US and Europe and 180 total subjects are randomised at a 2:1 ratio to either the Episealer group (n=120) or the control group (n=60). All patients will be followed over a period of 2 years. The study is intended for patients in the age group 30-70 years with one single chondral or osteochondral lesion in the femoral knee joint.
More details about the EPIC-Knee study, as well as an overview of participating hospitals, can be found at ClinicalTrials.gov (ID: NCT04000659).