Comparison of Microfracture Treatment and CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00945399|
Recruitment Status : Terminated (Manufacturing stopped)
First Posted : July 24, 2009
Last Update Posted : April 28, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Knee Chondral Osteochondral Defect||Procedure: CARTIPATCH® procedure Procedure: Microfracture||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase III Protocol Comparing a Microfracture Treatment to a CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||September 2014|
|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.
- Clinical evaluation scoring system: IKDC [ Time Frame: 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945399
|Gent University Hospital, Dept of Orthopaedic Surgery|
|Gent, Belgium, 9000|