Reconstruction of osteochondral defects with a collagen I hydrogel. Results of a prospective multicenter study

Study goals. The aim of the study was to evaluate the therapeutic benefit of CaReS (R), a type I collagen hydrogel-based autologous chondrocyte implantation technique, for the treatment of osteochondral defects of the knee (Outerbridge grades III and IV) within a prospective multicenter study. Material and methods. A total of 116 patients in 9 clinical centers were treated with CaReS between 2003 and 2008. The Cartilage Injury Evaluation Package 2000 of the International Cartilage Repair Society (ICRS) was employed for data acquisition and included the subjective International Knee Documentation Committee score (IKDC score), the pain level (visual analog scale, VAS), the physical and mental SF-36 score, the overall treatment satisfaction and the functional IKDC status of the indexed knee. Follow-up evaluation was performed 3, 6 and 12 months after surgery and annually thereafter. Results. The mean defect size treated was 5.4 +/- 2.7 cm(2) with 30% of the cartilage defects being <= 4 cm(2) and 70% >= 4 cm(2). The mean follow-up period was 30.2 +/- 17.4 months (minimum 12 months and maximum 60 months). The mean IKDC score significantly improved from 42.4 +/- 13.8 preoperatively to 70.5 +/- 18.7 (p < 0.01) in the mean follow-up period. Global pain level significantly decreased (p < 0.001) from 6.7 +/- 2.2 preoperatively to 3.2 +/- 3.1 at the latest follow-up. Both the physical and mental components of the SF-36 score significantly increased. At the latest follow-up 80% of the patients rated the overall treatment satisfaction as either good or very good. The functional IKDC knee status clearly improved from preoperative to the latest follow-up when 23.4% of the patients reported having no restriction of knee function (I), 56.3% had mild restriction (II), 17,2% had moderate restriction (III) and 3.1% revealed severe restriction (IV). Conclusions. The CaReS technique is a clinically effective and safe method for the reconstruction of isolated osteochondral defects of the knee joint and reveals promising clinical outcome up to 5 years after surgery. A longer follow-up period and larger patient cohorts are needed to evaluate the sustainability of CaReS treatment.