caa a22 4500 445831790 CHVBK 20180317145317.0 cr unu---uuuuu 170323e20110901xx s 000 0 eng 10.1007/s00586-011-1728-3 doi (NATIONALLICENCE)springer-10.1007/s00586-011-1728-3 A novel synthetic material for spinal fusion: a prospective clinical trial of porous bioactive titanium metal for lumbar interbody fusion [Elektronische Daten] [Shunsuke Fujibayashi, Mitsuru Takemoto, Masashi Neo, Tomiharu Matsushita, Tadashi Kokubo, Kenji Doi, Tatsuya Ito, Akira Shimizu, Takashi Nakamura] The objective of this study was to establish the efficacy and safety of porous bioactive titanium metal for use in a spinal fusion device, based on a prospective human clinical trial. A high-strength spinal interbody fusion device was manufactured from porous titanium metal. A bioactive surface was produced by simple chemical and thermal treatment. Five patients with unstable lumbar spine disease were treated surgically using this device in a clinical trial approved by our Ethics Review Committee and the University Hospital Medical Information Network. Clinical and radiological results were reported at the minimum follow-up period of 1year. The optimal mechanical strength and interconnected structure of the porous titanium metal were adjusted for the device. The whole surface of porous titanium metal was treated uniformly and its bioactive ability was confirmed before clinical use. Successful bony union was achieved in all cases within 6months without the need for autologous iliac crest bone grafting. Two specific findings including an anchoring effect and gap filling were evident radiologically. All clinical parameters improved significantly after the operation and no adverse effects were encountered during the follow-up period. Although a larger and longer-term follow-up clinical study is mandatory to reach any firm conclusions, the study results show that this porous bioactive titanium metal is promising material for a spinal fusion device. Springer-Verlag, 2011 Porous titanium metal nationallicence Spinal fusion nationallicence Biomaterial nationallicence Clinical trial nationallicence Fujibayashi Shunsuke Department of Orthopedic Surgery, Graduate School of Medicine, Kyoto University, 606-8507, Kyoto, Japan aut Takemoto Mitsuru Department of Orthopedic Surgery, Graduate School of Medicine, Kyoto University, 606-8507, Kyoto, Japan aut Neo Masashi Department of Orthopedic Surgery, Graduate School of Medicine, Kyoto University, 606-8507, Kyoto, Japan aut Matsushita Tomiharu Department of Biomedical Sciences, College of Life and Health Sciences, Chubu University, 487-8501, Kasugai, Japan aut Kokubo Tadashi Department of Biomedical Sciences, College of Life and Health Sciences, Chubu University, 487-8501, Kasugai, Japan aut Doi Kenji Osaka Yakin Kogyou Co.,Ltd, 673-0043, Miki, Japan aut Ito Tatsuya Department of Experimental Therapeutics, Translational Research Center, Kyoto University Hospital, 606-8507, Kyoto, Japan aut Shimizu Akira Department of Experimental Therapeutics, Translational Research Center, Kyoto University Hospital, 606-8507, Kyoto, Japan aut Nakamura Takashi Department of Orthopedic Surgery, Graduate School of Medicine, Kyoto University, 606-8507, Kyoto, Japan aut European Spine Journal Springer-Verlag 20/9(2011-09-01), 1486-1495 0940-6719 20:9<1486 2011 20 586 https://doi.org/10.1007/s00586-011-1728-3 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s00586-011-1728-3 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Fujibayashi Shunsuke Department of Orthopedic Surgery, Graduate School of Medicine, Kyoto University, 606-8507, Kyoto, Japan aut NATIONALLICENCE 700 1- Takemoto Mitsuru Department of Orthopedic Surgery, Graduate School of Medicine, Kyoto University, 606-8507, Kyoto, Japan aut NATIONALLICENCE 700 1- Neo Masashi Department of Orthopedic Surgery, Graduate School of Medicine, Kyoto University, 606-8507, Kyoto, Japan aut NATIONALLICENCE 700 1- Matsushita Tomiharu Department of Biomedical Sciences, College of Life and Health Sciences, Chubu University, 487-8501, Kasugai, Japan aut NATIONALLICENCE 700 1- Kokubo Tadashi Department of Biomedical Sciences, College of Life and Health Sciences, Chubu University, 487-8501, Kasugai, Japan aut NATIONALLICENCE 700 1- Doi Kenji Osaka Yakin Kogyou Co.,Ltd, 673-0043, Miki, Japan aut NATIONALLICENCE 700 1- Ito Tatsuya Department of Experimental Therapeutics, Translational Research Center, Kyoto University Hospital, 606-8507, Kyoto, Japan aut NATIONALLICENCE 700 1- Shimizu Akira Department of Experimental Therapeutics, Translational Research Center, Kyoto University Hospital, 606-8507, Kyoto, Japan aut NATIONALLICENCE 700 1- Nakamura Takashi Department of Orthopedic Surgery, Graduate School of Medicine, Kyoto University, 606-8507, Kyoto, Japan aut NATIONALLICENCE 773 0- European Spine Journal Springer-Verlag 20/9(2011-09-01), 1486-1495 0940-6719 20:9<1486 2011 20 586 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer