EPIC-knee IDE clinical study

 

EPIC-Knee 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.

The study will be registered on the following link where details of the study can be found, and participating hospitals are listed: (Link)


Investigator-initiated clinical study

 

A new investigator-initiated clinical study conducted by Prof. H. Vandenneucker at the University hospital in Leuven, Belgium. The study will follow 30 Episealer® patients over 10 years and the goal is to evaluate the efficacy, safety and performance of the Episealer® device in a larger sample size and on the long term.