Focal Chondral Defect in Femoro-tibial Compartment of the Knee Joint Clinical Trial
Official title:
Safety and Efficacy of a Novel, Cell-free Cartilage Repair Construct in the Treatment of Focal Chondral Defects Involving the Femoro-tibial Compartment of the Knee Joint.
The two-layer bioresorbable HYTOP® matrix consists of an upper layer of highly purified
porcine splint-skin which contains natural pores, and a lower layer of highly purified
collagen fleece containing hyaluronan (HA).
In this study, the medical device will be used and evaluated in a one-step procedure
combining microfracturing with surgical implantation of HYTOP®. HYTOP® will support
haemostasis in the articular cartilage defect, act as a support for cell growth and as a
three-dimensional scaffold for cell differentiation. HYTOP® will protect the underlying
tissue after cartilage debridement and/or microfracturing of the subchondral bone.
The primary working hypothesis is that HYTOP® is safe and suitable as a cell-free matrix to
support haemostasis, as a cover for the cartilage lesion and eventually to enhance cartilage
regeneration in a one-step surgical procedure.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment