| Summary: | Abstract 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 Only three osteochondral scaffolds have been investigated in clinical trials: while TruFit® has been withdrawn from the market for the questionable results, the analysis of MaioRegen and Agili‐C™ provided clinical improvements at 1, 2, and ≥ 3 years of follow‐up (all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.
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