Comparison of Microfracture Treatment and CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions
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:
- Arthroscopy to collect cartilage;
- Implantation following arthrotomy about 6 weeks following arthroscopy.
Both groups will follow the same rehabilitation program.
|Knee Chondral Osteochondral Defect||Procedure: CARTIPATCH® procedure Procedure: Microfracture||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase III Protocol Comparing a Microfracture Treatment to a CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions|
- Clinical evaluation scoring system: IKDC [ Time Frame: 18 months ]
|Study Start Date:||October 2008|
|Study Completion Date:||September 2014|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
|Experimental: Autologous Chondrocytes Implantation||
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.
|Active Comparator: Microfracture||
Tiny fractures are created at the cartilage surface to stimulate cartilage growth.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00945399
|Gent University Hospital, Dept of Orthopaedic Surgery|
|Gent, Belgium, 9000|