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Phase 3 Study Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty
Numerous surgical techniques have been developped for the treatment of chondral and osteochondral defects of the knee. Among those techniques autologous chondrocyte transplantation (ACT) was promising but have potential drawbacks. A novel development by TBF is available. The aim of this randomized trial is to compared this new ACT technique to mosaicoplasty. Final outcomes were measured at 2 years using clinical evaluation scoring system (International Knee Documentation Committee), MRI and arthroscopy with biopsy. 64 patients are needed to detect a mean IKDC difference of at least 15 points with 90% power at a 5% alpha level. Twelve surgical centers in France are involved.
Age
18 - 50 years
Sex
ALL
Healthy Volunteers
No
CHU de Lyon
Lyon, Lyon, France
Orthopaedic surgery Departement Brest University Hospital
Brest, France
CHU de Caen
Caen, France
Centre médico chirurgical de Dracy-Le-Fort
Dracy-le-Fort, France
CHU de Grenoble
Grenoble, France
Ch Versailles
Le Chesnay, France
Clinique Chenieux
Limoges, France
CH Nord Mayenne
Mayenne, France
CHU de Nancy
Nancy, France
HIA Bégin
Saint-Mandé, France
Start Date
April 1, 2007
Primary Completion Date
October 1, 2012
Completion Date
August 1, 2013
Last Updated
December 3, 2025
58
ACTUAL participants
Autologous chondrocytes transplantation
PROCEDURE
Mosaicoplasty
PROCEDURE
Lead Sponsor
University Hospital, Brest
Collaborators
Data Source & Attribution
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