Comparison of Microfracture Treatment and CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions

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.

Inclusion Criteria:

• isolated femoral osteochondral lesion
• aged 18 to 45
• grade 3 or 4 lesion (ICRS) sized 2,5 to 7,5cm2
• lesion depth under 10mm
• IKDC score below 55
• no prior surgical treatment

Exclusion Criteria:

• pregnancy or breastfeeding
• allergy
• arthrosis
• varus or valgus angle greater than 6°
• kissing lesion
• affection of the patella
• excessive laxity
• meniscal pathology history
• severe chronic disease
• BMI > 30
• HIV, Hepatitis B, C, HTLV, Syphilis