Multilayered biomimetic scaffolds for cartilage repair of the talus. A systematic review of the literature

The aim of the present review was to analyze the available evidence in the literature on the clinical and radiological outcomes of multilayered biomimetic scaffolds in the treatment of osteochondral lesions of the talus (OLTs).A systematic search was performed in three databases to identify clinical trials, where the multilayered biomimetic scaffolds were used for the treatment of OLTs. The PRISMA guidelines were followed. Qualitative analysis of the relevant data of the included studies was executed. The methodological quality of the analyzed studies was assessed with a modified Coleman Methodology Score (CMS).A total of 10 studies with 87 patients were included in the analysis. Only three multilayered biomimetic scaffolds have been investigated in clinical trials for the treatment of OLTs. The worst clinical and radiological outcomes, as well as safety profile were observed for the TruFit scaffold (Smith & Nephew, Andover, MA, USA), which had already been withdrawn from the market. The other two scaffolds (MaioRegen, Finceramica, Italy; Agili-C, Cartiheal, Israel) performed significantly better in the majority of the reviewed studies, especially in the clinical aspect. The radiological findings, the improvements of MOCART scores, the completeness of lesions' fill, and the structure of regenerated tissue were much more inconsistent.Two of the multilayered biomimetic scaffolds demonstrated an adequate potential in the treatment of complex OLTs. However, limited studies availability and their low level of medical evidence request further high-level investigations before the clinical decision making for such scaffolds in the treatment of OLTs can be defined.