Acute Knee Cartilage Injury Clinical Trial
Official title:
Evaluation of an Acellular Osteochondral Graft for Cartilage LEsions ("EAGLE") European Post Market Study
Prospective, multi-center, non-randomized, historical controlled, post-market study of patients requiring surgical repair of a focal articular cartilage lesion or osteochondral defect in the knee.
BioMatrix CRD is a CE marked device that is intended to repair focal articular cartilage
lesions or osteochondral defects in the knee. BioMatrix CRD™ is a sterile, biphasic,
bioresorbable scaffold designed to aid in the repair of cartilage and subchondral bone. The
device serves as a scaffold for cellular and extracellular matrix ingrowth supporting the
regeneration of cartilage and subchondral bone.
The purpose of this post-market study is to confirm the safety and performance of the
BioMatrix CRD for its intended use. Fifty (50) patients will be enrolled at up to 10
hospitals in Europe. Patients will be followed for 2 years post-operative to examine the rate
of adverse events associated with the device, track improvement in knee pain and knee
function over time, and assess the quality of repair tissue.
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