Patients Scheduled for Chondrocyte Implantation Treatment with MACI Have Larger Defects than Those Enrolled in Clinical Trials.

Objective: To compare characteristics for patients scheduled for autologous chondrocyte implantation with matrix-assisted chondrocyte implantation (MACI) with those enrolled in clinical trials and to describe differences in patient selection between countries.

Design: Anonymized data from patients scheduled for MACI treatment in the knee in Europe and Australia/Asia were obtained from the Genzyme/Sanofi database. Average age, defect size, and male-female ratio were analyzed and compared by country. Clinical cohort studies and prospective comparative trials using autologous chondrocyte implantation and related treatments were identified and weighted average age, weighted defect size, and male-female ratio were analyzed and compared with data from the database.

Results: From the database 2,690 patients were included with mean age 33.7 years and male-female ratio of 67:33. Mean defect size was 5.64 cm(2) and 70% of the defects were 3 to 10 cm(2). There were significant differences between patients' mean defect sizes between countries. Sixty-nine studies (57 cohorts and 12 prospective comparative trials) with a total of 5,449 patients were identified. The combined weighted mean age was 34.2 years, and the combined weighted mean defect size was 4.89 cm(2). Patients scheduled for MACI had significantly larger defects that those included in clinical trials. There was no significant difference in age. No differences were found between cohorts and prospective comparative trials.

Conclusion: The vast majority of patients scheduled for autologous chondrocyte implantation with MACI have chondral defect comparable to that generally recommended, but differences exist between countries. Patients enrolled in clinical trials have significantly smaller defects than those undergoing treatment outside controlled trials.