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Establishment of novel artificial intervertebral disc design containing a vertebral body fixation mechanism and its clinical applications

Research Project

Project/Area Number 14571352
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeSingle-year Grants
Section一般
Research Field Orthopaedic surgery
Research InstitutionHokkaido University

Principal Investigator

KOTANI Yoshihisa  Hokkaido Univ.Hospital, Inst., 病院, 助手 (40312368)

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
Project Period (FY) 2002 – 2004
Project Status Completed (Fiscal Year 2004)
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)
KeywordsArtificial intervertebral disc / Spinal reconstruction / Biomaterials / Hydroxyapatite / Poly-L-lactic acid / Bioresorbables / 生体活性セラミックス
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 … More 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

Report

(4 results)
  • 2004 Annual Research Report   Final Research Report Summary
  • 2003 Annual Research Report
  • 2002 Annual Research Report
  • Research Products

    (27 results)

All 2005 2004 2003 2002 Other

All Journal Article (19 results) Publications (8 results)

  • [Journal Article] Multidirectional flexibility analysis of anterior and posterior lumbar artificial intervertebral disc replacement in human cadaveric spine model.2005

    • Author(s)
      Kotani Y
    • Journal Title

      European Spine J 14(In Press)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2004 Final Research Report Summary
  • [Journal Article] Multidirectional flexibility analysis of cervical artificial intervertebral disc replacement in human cadaveric spine model.2005

    • Author(s)
      Kotani Y
    • Journal Title

      J Neurosurg (Spine) 2

      Pages: 188-194

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2004 Final Research Report Summary
  • [Journal Article] Multidirectional flexibility analysis of anterior and posterior lumbar artificial intervertebral disc replacement in human cadaveric spine model.2005

    • Author(s)
      Kotani Y, Cunningham BW, Abumi K, et al.
    • Journal Title

      Eur Spine J (in press)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2004 Final Research Report Summary
  • [Journal Article] Multidirectional flexibility analysis of cervical artificial inter-vertebral disc replacement in human cadaveric spine model.2005

    • Author(s)
      Kotani Y, Cunningham BW, Abumi K, Dmitriev AE, Ito M, Hu N, Shikinami Y, McAfee PC, Minami A.
    • Journal Title

      J Neurosurg (Spine) 2

      Pages: 188-194

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2004 Final Research Report Summary
  • [Journal Article] A biomechanical and histological evaluation of bioresorbable lumbar interbody fusion cage.2005

    • Author(s)
      Hojo Y, Kotani Y, Ito M, Abumi K, Kadosawa T, Shikinami Y, Minami A.
    • Journal Title

      Biomaterials 26

      Pages: 2643-2651

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2004 Final Research Report Summary
  • [Journal Article] Multidirectional flexibility analysis of cervical artificial intervertebral disc replacement in human cadaveric spine model.2005

    • Author(s)
      Kotani Y, et al.
    • Journal Title

      J Neurosurg (Spine) 2

      Pages: 188-194

    • Related Report
      2004 Annual Research Report
  • [Journal Article] A biomechanical and histological evaluation of bioresorbable lumbar interbody fusion cage.2005

    • Author(s)
      Hojo Y, Kotani Y, et al.
    • Journal Title

      Biomaterials 26

      Pages: 2643-2651

    • Related Report
      2004 Annual Research Report
  • [Journal Article] Multidirectional flexibility analysis of anterior and posterior lumbar artificial intervertebral disc replacement in human cadaveric spine model.2005

    • Author(s)
      Kotani Y, et al.
    • Journal Title

      J Neurosurg (Spine) 2(In press)

    • Related Report
      2004 Annual Research Report
  • [Journal Article] Cervical spine injuries associated with lateral mass and facet joint fractures : new classification and surgical treatment with pedicle screw fixation.2005

    • Author(s)
      Kotani Y, et al.
    • Journal Title

      Eur Spine Journal 14

      Pages: 69-77

    • NAID

      120000963007

    • Related Report
      2004 Annual Research Report
  • [Journal Article] A biomimetic artificial disc with improved peroperties compared to biological intervertebral discs.2004

    • Author(s)
      Shikinami Y
    • Journal Title

      Advanced Functional Materials 14

      Pages: 1039-1046

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2004 Final Research Report Summary
  • [Journal Article] Two-year observation of artificial intervertebral disc replacement : results after supplemental ultra-high strength bioresorbable spinal stabilization.2004

    • Author(s)
      Kotani Y
    • Journal Title

      J Neurosurg (Spine) 100

      Pages: 337-342

    • NAID

      120000957893

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2004 Final Research Report Summary
  • [Journal Article] A biomimetic artificial disc with improved peroperties compared to biological intervertebral discs.2004

    • Author(s)
      Shikinami Y, Kotani Y, Cunningham BW, Abumi K, Kaneda K
    • Journal Title

      Advanced Functional Materials 14

      Pages: 1039-1046

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2004 Final Research Report Summary
  • [Journal Article] Two-year observation of artificial intervertebral disc replacement : results after supplemental ultra-high strength bioresorbable spinal stabilization.2004

    • Author(s)
      Kotani Y, Abumi K, Shikinami Y, Takahata M, Kadoya K, Kadosawa T, Minami A, Kaneda K.
    • Journal Title

      J Neurosurg. 100 (Spine 5)

      Pages: 337-342

    • NAID

      120000957893

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2004 Final Research Report Summary
  • [Journal Article] A biomimetic artificial disc with improved peroperties compared to biological intervertebral discs.2004

    • Author(s)
      Shikinami Y, Kotani Y, et al.
    • Journal Title

      Advanced Functional Materials 14

      Pages: 1039-1046

    • Related Report
      2004 Annual Research Report
  • [Journal Article] Two-year observation of artificial intervertebral disc replacement : results after supplemental ultra-high strength2004

    • Author(s)
      Kotani Y, et al.
    • Journal Title

      J Neurosurg (Spine) 100

      Pages: 337-342

    • Related Report
      2004 Annual Research Report
  • [Journal Article] Bone ingrowth fixation of artificial intervertebral disc consisting of bioceramic-coated three-dimensional fabric2003

    • Author(s)
      Takahata M
    • Journal Title

      Spine 28

      Pages: 637-644

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2004 Final Research Report Summary
  • [Journal Article] Bone ingrowth fixation of artificial intervertebral disc consisting of bioceramic-coated three-dimensional fabric.2003

    • Author(s)
      Takahata M, Kotani Y, Abumi K, Shikinami Y, Kadosawa T, Kaneda K, Minami A.
    • Journal Title

      Spine. 28

      Pages: 637-644

    • NAID

      10017363964

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2004 Final Research Report Summary
  • [Journal Article] Artificial intervertebral disc replacement using bioactive three-dimensional fabric : design, development, and preliminary animal study2002

    • Author(s)
      Kotani Y
    • Journal Title

      Spine 27

      Pages: 929-935

    • NAID

      10016393866

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2004 Final Research Report Summary
  • [Journal Article] Artificial intervertebral disc replacement using bioactive three-dimensional fabric : design, development, and preliminary animal study.2002

    • Author(s)
      Kotani Y, Abumi K, Shikinami Y, Takada T, Kadoya K, Shimamoto N, Ito M, Kadosawa T, Fujinaga T, Kaneda K.
    • Journal Title

      Spine. 27

      Pages: 929-935

    • NAID

      10016393866

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2004 Final Research Report Summary
  • [Publications] Takahata M, Kotani Y, et al.: "Bone ingrowth fixation of artificial intervertebral disc consisting of bioceramic-coated three-dimensional fabric"Spine. 28. 637-644 (2003)

    • Related Report
      2003 Annual Research Report
  • [Publications] Shimamoto N, Kotani Y, et al.: "Static and dynamic analysis of five anterior instrumentation systems for thoracolumbar scoliosis"Spine. 28. 1678-1685 (2003)

    • Related Report
      2003 Annual Research Report
  • [Publications] Kotani Y, Abumi K, et al.: "Improved accuracy of computer-assisted cervical pedicle screw insertion"J Neurosurg. 99. 257-263 (2003)

    • Related Report
      2003 Annual Research Report
  • [Publications] Kotani Y, Abumi K, Kaneda K, et al.: "Artificial intervertebral disc replacement using bioactive three-dimensional fabric. Design, development, and preliminary animal study"SPINE. 27. 929-935 (2002)

    • Related Report
      2002 Annual Research Report
  • [Publications] Takahata M, Kotani Y, Abumi K, et al.: "Bone ingrowth fixation of artificial intervertebral disc consisting of bioceramic coated three-dimensional fabric"SPINE. 28(in press). (2003)

    • Related Report
      2002 Annual Research Report
  • [Publications] 小谷善久, 鐙 邦芳, 三浪明男: "トピックス/椎間板再生「人工椎間板」"現代医療. 34. 631-633 (2002)

    • Related Report
      2002 Annual Research Report
  • [Publications] 小谷善久: "最新学術情報:人工椎間板"関節外科. 21. 116-117 (2002)

    • Related Report
      2002 Annual Research Report
  • [Publications] 小谷善久: "基礎研究最前線、焦点、人工椎間板開発と臨床応用の展望"脊椎脊髄ジャーナル. 14. 369-373 (2002)

    • Related Report
      2002 Annual Research Report

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Published: 2002-04-01   Modified: 2016-04-21  

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