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Phase III Protocol Comparing a Microfracture Treatment to a 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: 1. Arthroscopy to collect cartilage; 2. Implantation following arthrotomy about 6 weeks following arthroscopy. Both groups will follow the same rehabilitation program.
Age
18 - 45 years
Sex
ALL
Healthy Volunteers
No
Gent University Hospital, Dept of Orthopaedic Surgery
Ghent, Belgium
Start Date
October 1, 2008
Primary Completion Date
July 1, 2012
Completion Date
September 1, 2014
Last Updated
April 28, 2015
40
ACTUAL participants
CARTIPATCH® procedure
PROCEDURE
Microfracture
PROCEDURE
Lead Sponsor
TBF Genie Tissulaire
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03371121