A SOLID IMPLANT FOR ACI: CARTIPATCH®
CLINICAL TRIAL PRELIMINARY REPORT

International Cartilage Repair Society, 2004, Gent

 

T. AIT SI SELMI*, Ch. BUSSIERE*, L. LAGANIER**, D. NOYER***, Ph. NEYRET*

 

^* : Centre Livet, Hôpital de la Croix-Rousse, 8 rue des Margnolles, 69300 Caluire, France

^** : TBF Tissue Bank of France, 7 Rue du Vinatier - 69500 Bron, France

*** : Cenre des Massues, 92, Rue E. Locard, 69005 Lyon - France

 

INTRODUCTION

A solid implant with autologous chondrocytes to repair chondral or osteochondral defect is the new challenge for the ACI. In order to make implantation easier and to promote redifferentiation, an agarose-alginate matrix was developed. It is evaluated in an ongoing phase II clinical trial.

 

METHOD

Following arthroscopic harvesting, chondrocytes are cultured in monolayer way and seeded in agarose and alginate. This mix is jellified and molded to provide cylinder grafts. After 45 days incubation, they are implanted as a mosaic in press-fit. According to pattern of the lesion, three sizes (10, 14 and 18 mm diameter) of graft are available and can be combined.

Exclusion criteria include asymptomatic patients, previous meniscectomy and age over 50. Nineteen patients, 16 to 42 years old, with a single femoral lesion and subjective IKDC score less than 55, are being evaluated. Clinical evaluation based in IKDC score is recorded at 3, 6, 12 and 24 months. Arthroscopic evaluation with a biopsy and MRI will be done at 24 month as well.

 

RESULTS

Patient age average is 28.9 years (15 males, 4 females) and grafted surface average is 3.1 cm². 11 osteochondritis and 8 posttraumatic lesions have been treated with Cartipatch®. Only 6 patients out of 19 have a knee surgery for the first time. Surgical time never exceeded 1 hour. An average of 2.5 chondrocytes grafts/patient (10 or 14 mm) was implanted. Lesions where fully covered. Clinical score are improving, no inflammation, adhesion or other adverse effect was noted.

 

CONCLUSION

First clinical results confirm the interest of a solid scaffold for the development of autologous chondrocytes grafts. There is no need for a periosteal flap and no leakage of the cells in the knee, the press fit method make the surgical technique easy with a well adapted implantation site.