Demographics in Patients Receiving Matrix-Assisted Chondrocyte Implantation (MACI) in the Ankle.

Objective. To compare demographics and cartilage lesion characteristics of patients enrolled in clinical trials investigating autologous chondrocyte implantation (ACI) in the ankle joint with those actually scheduled for matrix-assisted chondrocyte implantation (MACI) using database records. Design. Anonymized data from patients scheduled for MACI treatment in the ankle in Australia/Asia and Europe were obtained from the Genzyme/Sanofi database. Average age, defect size, and male-female ratio were analyzed and compared by country. A literature search was performed on PubMed and Google Scholar and clinical cohort studies and prospective comparative trials using ACI and related treatments in the ankle joint were identified. Weighted average age, weighted defect size, and male-female ratio were analyzed and compared with database data. Results. The 167 patients included from the databases from Europe and Australia had a mean age of 33.4 years (range 14-64 years) and a mean defect size of 2.27 cm2 (range 0.25-16 cm2). Male-female ratio was 4:3. Patients from European countries were significantly younger and had significantly larger defects compared with patients from Australia. From the literature search a total of 472 patients were included from 28 studies. The mean age was 32.2 years (range 15-62 years). Male-female ratio was 3:2. Weighted mean size was 1.94cm2 (range 0.3-16). There were no significant differences between previous studies and databases. Conclusion. No differences in sizes and age were found between patients enrolled in clinical trials and patients scheduled for MACI outside clinical trials. The sizes of treated defects followed the general recommendations. There were, however, significant differences between countries.