Clinical application of cervical and lumbar artificial intervertebral disc consisting of composite material for the anterior and posterior replacement

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Our 3^<rd> model of artificial intervertebral disc prosthesis was accomplished based on the detailed in vitro experiment and the long-term animal study. This is the triaxial three-dimensional fabric consisting of ultra-high molecular weight polyethylene fiber and hydroxyapaite/ poly-L-lactic acid. According to the pretrial review with ministry of health in Japan, the randomized clinical trial was recommended for study design, however, the detailed condition of single-arm trial was also advised. This puts the emphasis on the segmental mobility as the originality of the new device based on meta-analysis of published data According to clinical 226 pts data which was retrieved by meta-analysis data, we determined the study population when considering the expected range of motion and the safety range. According to the collaborated study with Kurume biostatistical research center, the final statistical data was calculated and the final protocol for clinical trial was completed. Following the agreement with university medical ethical committee, the multicenter clinical trial is now prepared. We are designing the surgical instrument with US Medtronics Co.. Using the cadaveric spines, the actual modification procedures of surgical instruments were performed in both Memphis, USA and Soeul, Korea.