Abstract
Total ankle replacement (TAR) is a surgical treatment for the osteoarthritis or bone fracture of ankle joint. Total ankle prosthesis is classified according to fixed and mobile types of components, kind of material of bearing component. International standard for testing the durability and safety of each component in TAR suggests to adopt the test method for total knee and/or hip prostheses. Mechanical test conditions for commercial product of Hintegra (Lyon, SA, France) were determined by conducting finite element analyses with a foot, prosthesis components, and surgical models. Constraint test between talus and polyethylene bearing components adopted ASTM F1223 for total knee replacement, and the design of talus and polyethylene bearing components provided information about constraint force until dislocation occurred. Cyclic fatigue test of tibia component adopted ASTM F1800 for total knee replacement, and there was no fatigue failure of tibia component during 5,000,000 cycles. In vitro wear simulation test of polyethylene bearing component adopted ISO 14242-1 for total hip-joint prostheses and a wear rate of $0.44{\times}10^{-6}mg/cycles$ was observed during 1,000,000 cycles. In this study, mechanical test methods for evaluating total ankle joint prosthesis were developed on the base of international standard test methods of total hip and knee joint prostheses. However, this study was conducted on one commercial product. For the other products having different designs of total ankle prostheses, it is suggested to modify or adopt these test methods for their own products.