NCT01791062

Safety and Efficacy Study of HYTOP® in the Treatment of Focal Chondral Defects.

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: TRB Chemedica AG · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Focal Chondral Defect in Femoro-tibial Compartment of the Knee Joint

Interventions

Type	Name	Description
DEVICE	HYTOP®	HYTOP® will be implanted once during surgery.

Timeline

• Start date: 2014-02-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2013-02-13
• Last updated: 2016-11-21

Locations

1 site across 1 country: Germany