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

这项研究的目的是建立一种新的人工椎间盘设计，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。使用超高强度的生物可吸收材料，结合使用生物可吸收钉对椎体提供可靠的固定，创建了多孔生物可吸收钢板。制作了颈椎和腰椎前路全椎间盘置换术模型和后路次全椎体置换术模型。使用这些模型，在人身体脊柱模型上进行了体外生物力学评估，并在非人类灵长类动物模型上进行了体内评估。体外研究表明，C5/6节段的替换脊柱节段具有与正常脊柱节段相似的生物力学特性。腰椎人工椎间盘做了n…更多的是在测试过程中显示任何装置移位或移位。置换后的腰椎节段表现出与正常腰椎节段相当的力学性能。这项活体研究使用了44只进行前全和次全置换手术的成年狒狒，直到12个月。术后6个月，颈椎替代节段在屈伸、轴向旋转和侧弯负荷下的ROM率分别为108%、72%和65%。所有手术动物均未见神经功能障碍或装置失效的报道。组织学上，人工椎间盘与椎体之间的界面显示出直接的骨性接触和稳定的环境。在上述实验结果的基础上，将人工腰椎间盘置换的临床试验提交给日本厚生劳动省，这项多中心研究计划采用前路颈椎全椎间盘置换和后路腰椎次全椎间盘置换设计。较少

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