A biomechanical study of osseointegrated patient-matched additively manufactured implant for treatment of thumb amputees.

Thumb amputations leads to 50 % loss in hand functionality. To date, silicone vacuum prosthesis and autologous transplantation are the most adopted treatment solutions: nevertheless, vacuum prostheses lack in stability and cause skin issue and surgical treatment is not always accepted by patients. Osseointegrated implants were demonstrated to enhance stability, restore osseoperception and increase the time of prosthesis use. Thumb amputations present varying stump sizes: a standard size implant cannot address specificity of each patient, while a patient matched solution can meet surgeon requirements, by geometrical features of implant. The fixture presented in the current paper is the first additively manufactured patient matched osseointegrated implant for the treatment of thumb amputees. The current work aims to verify and validate a predictive finite element model (FEM) for mechanical strength of the presented fixture. FEM was demonstrated to correctly evaluate the mechanical strength of patient matched device. Minimum strength requirements were calculated in different core diameters: FEM were experimentally validated. Safety factor of 1.5 was guaranteed. Finally, considerations on performance of the prototype were carried out by means of insertion tests in Sawbones and axial pull-out force assessment. Cadaver tests to evaluate the entire procedure and production process are ongoing.