EPIC-Knee: Episealer® Knee System IDE Clinical Study (V 4.0)
Research type
Research Study
Full title
A Prospective, Randomized, Controlled, Multi-Center 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
IRAS ID
269545
Contact name
Timothy Spalding
Contact email
Sponsor organisation
Episurf Medical Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This research study is being conducted to explore the potential medical benefits and safety of an implant that is intended to be used as a cartilage and bone replacement for a knee joint, compared to microfracture.
Due to the high number of uncertain outcomes and high failure rates for knee cartilage pathologies for patients over 30-35 years of age, a treatment gap arises for a large group of patients: those who do not respond to biological interventions but who are still too young for partial or total knee arthroplasty (surgical reconstruction or replacement of a joint).
Episurf Medical Inc. (Episurf) are addressing this treatment gap with individualized (using a computerized model of an individual's knee) Episealer knee implants. The Episealer® knee implant is a knee resurfacing implant, classified as a Class IIb medical device, intended to be used as cartilage and bone replacement for a knee joint.
The Episealer Knee System obtained CE-mark in Europe in 2013. Recently, this device showed good results in a 24-month follow-up clinical investigation and in a 36-month follow-up case report. However, clinical, comparative data from a larger number of patients is needed, which is the scope of this investigation. The data from this study will be submitted to the FDA in the U.S. to obtain approval for use in the U.S.
This study intends to recruit 180 participants across 16-20 hospital sites in the US and Europe. The study is estimated to last 36 months, from first patient recruited to last subject follow-up, each study subject participating for 26-30 months.
Patients between age 30 and 70 with a focal femoral knee chondral or osteochondral lesion that is causing pain and/or disability and requires surgical treatment will be considered for the study.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
19/YH/0389
Date of REC Opinion
25 Feb 2020
REC opinion
Further Information Favourable Opinion