Towards the development of a custom talus prosthesis produced by SLM: design rules and verification

Additive manufacturing (AM) is a promising technology for the personalized medicine industry, especially in the orthopedic field. It allows the production of prostheses that can fit complex anatomical sites and mimic bone morphology, featuring an external solid shell and an inner trabecular core. The new medical device regulation has recently outlined the need for safety assessment of these particular implants: to the best of the authors' knowledge, there are no defined methodologies to assess the quality of a custom product since each device is intended for single-time use. The goal of the current work is to propose a well-structured pipeline for designing and verifying an AM custom prosthesis: the exemplified case is that for the ankle joint treatment (i.e. talus resurfacing), whose standard solutions are affected by significant failure rates. A comprehensive characterization of the unique features of AM orthopedic implants will be presented, integrating finite element analyses and experiments.