| Project/Area Number |
14571352
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Single-year Grants |
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| Section | 一般 |
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| Research Field |
Orthopaedic surgery
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| Research Institution | Hokkaido University |
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Principal Investigator |
KOTANI Yoshihisa Hokkaido Univ.Hospital, Inst., 病院, 助手 (40312368)
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| Co-Investigator(Kenkyū-buntansha) |
ABUMI Kuniyoshi Hokkaido Univ., Health Administration Center, Prof., 保健管理センター, 教授 (00159419)
SHIKINAMI Yasuo Takiron Co., LTD, Medical Division, Chief, メディカル事業部, 研究室長
KADOSAWA Tsuyoshi Rakuno Gakuen Univ., School of Vet Surg., Prof., 獣医学部, 教授 (70214418)
ITO Manabu Hokkaido Univ.Hospital, Assistant Prof., 病院・講師 (00271677)
MINAMI Akio Hokkaido Univ., Grad.School of Med., Prof., 大学院・医学研究科, 教授 (20133738)
敷浪 保夫 タキロン株式会社, メディカル事業部, 研究室長
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| Project Period (FY) |
2002 – 2004
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| Project Status |
Completed (Fiscal Year 2004)
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| Budget Amount *help |
¥4,000,000 (Direct Cost: ¥4,000,000)
Fiscal Year 2004: ¥900,000 (Direct Cost: ¥900,000)
Fiscal Year 2003: ¥1,800,000 (Direct Cost: ¥1,800,000)
Fiscal Year 2002: ¥1,300,000 (Direct Cost: ¥1,300,000)
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| Keywords | Artificial intervertebral disc / Spinal reconstruction / Biomaterials / Hydroxyapatite / Poly-L-lactic acid / Bioresorbables / 生体活性セラミックス |
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| Research Abstract |
The objective of this study was to establish a novel artificial intervertebral disc design containing a vertebral body fixation mechanism in both cervical and lumbar spines. The anterior total disc replacement and posterior subtotal disc replacement design were developed. Using an ultrahigh strength bioresorbable material, the porous bioresorbable plate was created in conjunction with the use of bioresorbable pins providing the reliable fixation to the vertebral body. The anterior total disc replacement model in both cervical and lumbar spines as well as the posterior subtotal disc replacement model were fabricated. Using these models, the in vitro biomechanical evaluation was performed in a human cadaveric spine model, as well as the in vivo evaluation until twelve months period in a non-human primate model The in vitro study demonstrated that the replaced spinal segment at C5/6 level revealed biomechanical properties similar to normal spinal segments. The lumbar artificial disc did n
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ot show any device displacement or dislodgement during the testing. The replaced spinal segments demonstrated mechanical properties equivalent to the normal lumbar spinal segments. The in vivo study was conducted using forty-four mature baboons with anterior total and subtotal replacement procedures until twelve months period. The cervical replaced segment demonstrated 108%, 72%, and 65% of ROMs in flexion-extension, axial rotation, and lateral bending loading, respectively at postoperative six months. No neurologic disturbance or device failure was reported in all operated animals. Histologically, the interface between artificial disc and vertebral body demonstrated the direct bony contact and the stable environment. Based on the above experimental results, the clinical trial of human artificial disc replacement was submitted to the ministry of health in Japan, The multicenter study is planned with anterior cervical total disc replacement and posterior lumbar subtotal disc replacement designs. Less
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