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BACKGROUND: The clinical application of the second-generation tissue-engineering approach for the treatment of cartilage lesions has been documented for different types of scaffolds, but systematic information on clinical efficacy and long-term results is not available. PURPOSE: To analyze and assess the quality of clinical studies on different products in the emerging field of matrix-assisted autologous chondrocyte transplantation. The secondary purpose of this review was to improve the quality assessment of studies by modifying the Coleman methodology score (CMS). STUDY DESIGN: Systematic review. METHODS: For this review, a literature search was performed to identify all published and unpublished clinical studies of matrix-assisted (second-generation) autologous chondrocyte transplantation using the following medical electronic databases: MEDLINE, MEDLINE preprints, EMBASE, CINAHL, Life Science Citations, and British National Library of Health, including the Cochrane Central Register of Controlled Trials (CENTRAL). The search period was January 1, 1995, to July 1, 2008. To better assess cartilage-related studies, a modification of the CMS was proposed. RESULTS: Eighteen studies were included in the analysis, reporting on 731 patients with an average follow-up of 27.3 months (6.5-60.0 months). Of the 18 studies, 2 were randomized controlled studies, 3 were prospective comparative studies, 11 were prospective cohort studies or prospective case series, and 2 were retrospective case series. Original CMSs for these studies (55.1 +/- 1.6) were significantly higher than those of cartilage repair studies in general (43.5 +/- 1.6, P < .0001) reported in 2005. The statistical analysis indicated that the modified CMS showed higher correlations and lower variability of correlations among 3 reviewers. CONCLUSION: The quality of the currently available data on second-generation autologous chondrocyte transplantation is still limited by study designs. The modified CMS has demonstrated better sensitivity and reproducibility with respect to the original score, so it can be recommended for cartilage clinical studies evaluation.
Kon et al. (Tue,) studied this question.