Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty: a Randomized Trial

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.

Inclusion Criteria:

• isolated femoral osteochondral lesion
• aged 18 to 50
• grade 3 or 4 lesion (ICRS) sized 2,5 cm2 to 7,5 cm2.
• IKDC score below 55

Exclusion Criteria:

• pregnancy
• allergy
• arthrosis
• varus or valgus angle greater than 10°
• ACL laxity
• Severe chronic disease
• BMI > 30 Kg/m2
• HIV, B or C Hepatitis