TKA Development in Japan: Future Knee

The “project to produce artificial joints tailored to individual patients” by Nakashima Propeller Co., Ltd. was certified in 2008 as a Super Special Zone (a Special Zone for Advanced Medical Development) by the Cabinet Office. The main focus of this project was the development of a series of technologies for designing and manufacturing joint prostheses optimized for each individual based on data on the patient’s joint morphology, which resulted in the development of materials and three-dimensional (3D) modeling technologies. In 2011, it was certified as a “Personalized Joint Prostheses Function and Safety Evaluation Project” as a part of the Asian Standards Certification Promotion Project by the Ministry of Economy, Trade and Industry (METI). The objectives of this project were: (1) standardization of technologies related to bone morphological extraction; (2) analysis of bone morphology of the Asian people and construction of a morphological database; (3) development of evaluation methods using surgical support technology; and (4) formulation of standardization proposals for functional and safety evaluation standards for personalized joint prostheses. This study was conducted in collaboration with research institutions in five countries: Japan, Thailand, Hong Kong, Taiwan, and Singapore. We measured and evaluated the 3D morphology of the lower limb using CT in groups of different races, sexes, and age groups, mainly with the development of artificial knee joints in mind. We concluded that there are clear racial and sex-based differences in knee joint morphology and that it is appropriate to use the standard postosteotomy surface as a measurement method on the premise of artificial joint replacement. Finally, we decided on the ISO 19233-1:2017 standard by Japan. The New Energy and Industrial Technology Development Organization (NEDO) certified the “NEDO International Demonstration: R&D and Demonstration of Construction of Artificial Joint and Surgical Support System” Project, which led to the development of “Future Knee.”