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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Cartilage was harvested, then transferred for cell isolation and culture. Cells are suspended in agarose and transferred to cylindrical molds and surgically implanted 4 weeks later.
Osteochondral patch are sampled and then implanted during the same surgical procedure
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
...and 2 more locations
Clinical evaluation scoring system
Time frame: IKDC
MRI
Time frame: at 2 years
Arthroscopy with biopsy
Time frame: at 2 years
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