NCT00945399

Comparison of Microfracture Treatment and CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions

Phase III Protocol Comparing a Microfracture Treatment to a CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: TBF Genie Tissulaire · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

CARTIPATCH® is an Autologous Chondrocyte Implantation product including functional cells in a matrix, indicated for the treatment of isolated osteocartilaginous lesions. The submitted protocol is a Phase III multicentric, prospective, controlled and randomized clinical trial, sponsored by TBF Génie Tissulaire, France. The main objective of the protocol is to compare the clinical improvement of the IKDC subjective score between the microfracture-treated group and the CARTIPATCH® chondrocyte graft-treated group , 18 months following surgery. Several secondary objectives were determined. The microfracture procedure will be conducted in one operative step, during arthroscopy and CARTIPATCH® procedure will be conducted in two operative steps: 1. Arthroscopy to collect cartilage; 2. Implantation following arthrotomy about 6 weeks following arthroscopy. Both groups will follow the same rehabilitation program.

Conditions

• Knee Chondral
• Osteochondral Defect

Interventions

Type	Name	Description
PROCEDURE	CARTIPATCH® procedure	Cartilage is harvested and treated for chondrocytes isolation and culture. After multiplication, the chondrocytes are transferred into a biomaterial support and surgically implanted.
PROCEDURE	Microfracture	Tiny fractures are created at the cartilage surface to stimulate cartilage growth.

Timeline

• Start date: 2008-10-01
• Primary completion: 2012-07-01
• Completion: 2014-09-01
• First posted: 2009-07-24
• Last updated: 2015-04-28

Locations

1 site across 1 country: Belgium