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

含椎体固定机构的新型人工椎间盘设计的建立及其临床应用

基本信息

  • 批准号:
    14571352
  • 负责人:
  • 金额:
    $ 2.56万
  • 依托单位:
  • 依托单位国家:
    日本
  • 项目类别:
    Grant-in-Aid for Scientific Research (C)
  • 财政年份:
    2002
  • 资助国家:
    日本
  • 起止时间:
    2002 至 2004
  • 项目状态:
    已结题

项目摘要

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
本研究的目的是建立一种新型的人工椎间盘设计,包括颈椎和腰椎的椎体固定机制。设计了前路全椎间盘置换术和后路次全椎间盘置换术。使用高强度生物可吸收材料,结合使用生物可吸收钉创建多孔生物可吸收接骨板,提供对椎体的可靠固定。制作颈、腰椎前路全椎间盘置换模型和后路次全椎间盘置换模型。使用这些模型,在人尸体脊柱模型中进行体外生物力学评价,以及在非人灵长类动物模型中进行体内评价直到12个月。体外研究表明,在C5/6水平的置换脊柱节段显示出与正常脊柱节段相似的生物力学特性。腰椎间盘假体的植入, ...更多信息 试验期间未显示任何器械移位或脱位。置换的脊柱节段表现出与正常腰椎节段等同的力学性能。使用44只成年狒狒进行了体内研究,这些狒狒接受了前部全置换和次全置换手术,直至12个月。术后6个月,颈椎置换节段在屈伸、轴向旋转和侧弯载荷下的ROM分别为108%、72%和65%。所有手术动物均未报告神经系统障碍或器械失效。人工椎间盘与椎体的界面组织学上显示了良好的骨性接触和稳定的环境。基于上述实验结果,向日本厚生省提交了人类人工椎间盘置换的临床试验,计划采用颈椎前路全椎间盘置换和腰椎后路次全椎间盘置换设计进行多中心研究。少

项目成果

期刊论文数量(54)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
Artificial intervertebral disc replacement using bioactive three-dimensional fabric - Design, development, and preliminary animal study
  • DOI:
    10.1097/00007632-200205010-00008
  • 发表时间:
    2002-05-01
  • 期刊:
  • 影响因子:
    3
  • 作者:
    Kotani, Y;Abumi, K;Kaneda, K
  • 通讯作者:
    Kaneda, K
小谷善久: "最新学術情報:人工椎間板"関節外科. 21. 116-117 (2002)
小谷义久:《最新学术资料:人工椎间盘》《关节外科》21. 116-117 (2002)。
  • DOI:
  • 发表时间:
  • 期刊:
  • 影响因子:
    0
  • 作者:
  • 通讯作者:
Two-year observation of artificial intervertebral disc replacement : results after supplemental ultra-high strength
人工椎间盘置换术的两年观察:补充超高强度后的结果
  • DOI:
  • 发表时间:
    2004
  • 期刊:
  • 影响因子:
    0
  • 作者:
    Kotani Y;et al.
  • 通讯作者:
    et al.
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)
Kotani Y、Abumi K、Kaneda K 等人:“使用生物活性三维织物进行人工椎间盘置换。设计、开发和初步动物研究”SPINE。
  • DOI:
  • 发表时间:
  • 期刊:
  • 影响因子:
    0
  • 作者:
  • 通讯作者:
Cervical spine injuries associated with lateral mass and facet joint fractures: New classification and surgical treatment with pedicle screw fixation
  • DOI:
    10.1007/s00586-004-0793-2
  • 发表时间:
    2005-02-01
  • 期刊:
  • 影响因子:
    2.8
  • 作者:
    Kotani, Y;Abumi, K;Minami, A
  • 通讯作者:
    Minami, A
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KOTANI Yoshihisa其他文献

KOTANI Yoshihisa的其他文献

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{{ truncateString('KOTANI Yoshihisa', 18)}}的其他基金

Clinical application of artificial intervertebral disc and development of novel hybrid type regenerative disc
人工椎间盘的临床应用及新型混合型再生椎间盘的研制
  • 批准号:
    20591734
  • 财政年份:
    2008
  • 资助金额:
    $ 2.56万
  • 项目类别:
    Grant-in-Aid for Scientific Research (C)
Clinical application of cervical and lumbar artificial intervertebral disc consisting of composite material for the anterior and posterior replacement
复合材料颈腰椎人工椎间盘前后路置换的临床应用
  • 批准号:
    17390407
  • 财政年份:
    2005
  • 资助金额:
    $ 2.56万
  • 项目类别:
    Grant-in-Aid for Scientific Research (B)

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The Development of Advanced Bioresorbable Cervical Spacers for Human Spinal Reconstruction
用于人体脊柱重建的先进生物可吸收颈椎垫片的开发
  • 批准号:
    319199-2005
  • 财政年份:
    2007
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    $ 2.56万
  • 项目类别:
    Postgraduate Scholarships - Doctoral
The Development of Advanced Bioresorbable Cervical Spacers for Human Spinal Reconstruction
用于人体脊柱重建的先进生物可吸收颈椎垫片的开发
  • 批准号:
    319199-2005
  • 财政年份:
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The Development of Advanced Bioresorbable Cervical Spacers for Human Spinal Reconstruction
用于人体脊柱重建的先进生物可吸收颈椎垫片的开发
  • 批准号:
    319199-2005
  • 财政年份:
    2005
  • 资助金额:
    $ 2.56万
  • 项目类别:
    Postgraduate Scholarships - Doctoral
Development of advanced intervertebral spacers for human spinal reconstruction
开发用于人体脊柱重建的先进椎间垫片
  • 批准号:
    269676-2003
  • 财政年份:
    2004
  • 资助金额:
    $ 2.56万
  • 项目类别:
    Strategic Projects - Group
Development of advanced intervertebral spacers for human spinal reconstruction
开发用于人体脊柱重建的先进椎间垫片
  • 批准号:
    269676-2003
  • 财政年份:
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    $ 2.56万
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spinal reconstruction using recombinant human bone morphogenic protein after total spondylectomy
全脊椎切除术后使用重组人骨形态发生蛋白进行脊柱重建
  • 批准号:
    14571366
  • 财政年份:
    2002
  • 资助金额:
    $ 2.56万
  • 项目类别:
    Grant-in-Aid for Scientific Research (C)
Experimental Study of Spinal Reconstruction Using Bioabsorbable Material
生物可吸收材料脊柱重建的实验研究
  • 批准号:
    13671481
  • 财政年份:
    2001
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Development and Clinical Application of the Internal Fixation System and Cervical Spinal Prosthesis for Cervical Spinal Reconstruction
颈椎重建内固定系统及颈椎假体的研制及临床应用
  • 批准号:
    05807131
  • 财政年份:
    1993
  • 资助金额:
    $ 2.56万
  • 项目类别:
    Grant-in-Aid for General Scientific Research (C)
Reserch on Spinal Reconstruction for Malignant Spinal Tumors and Development of Biomaterials and Spinal Instrumentation
脊柱恶性肿瘤的脊柱重建研究及生物材料和脊柱器械的开发
  • 批准号:
    63480336
  • 财政年份:
    1988
  • 资助金额:
    $ 2.56万
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