Multi-layer cell-free scaffolds for osteochondral defects of the knee: a systematic review and meta-analysis of clinical evidence

PURPOSE: The aim of this study was to analyze the clinical results provided by multi-layer cell-free scaffolds for the treatment of knee osteochondral defects. METHODS: A systematic review was performed on PubMed, Web of Science, and Cochrane to identify studies evaluating the clinical efficacy of cell-free osteochondral scaffolds for knee lesions. A meta-analysis was performed on articles reporting results of the International Knee Documentation Committee (IKDC) and Tegner scores. The scores were analyzed as improvement from baseline to 1, 2, and ≥ 3 years of follow-up. The modified Coleman Methodology Score was used to assess the study methodology. RESULTS: A total of 34 studies (1022 patients) with a mean follow-up of 35 months was included. Only three osteochondral scaffolds have been investigated in clinical trials: while TruFit® has been withdrawn from the market for the questionable results, the analysis of MaioRegen and Agili-C™ provided clinical improvements at 1, 2, and ≥ 3 years of follow-up (all significantly higher than the baseline, p < 0.05), although with a limited recovery of the sport-activity level. A low rate of adverse events and an overall failure rate of 7.0% were observed, but the overall evidence level of the available studies is limited. CONCLUSIONS: Multi-layer scaffolds may provide clinical benefits for the treatment of knee osteochondral lesions at short- and mid-term follow-up and with a low number of failures, although the sport-activity level obtained seems to be limited. Further research with high-level studies is needed to confirm the role of multi-layer scaffold for the treatment of knee osteochondral lesions.