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
• 负责人: KOTANI Yoshihisa
• 金额: $ 4.76万
• 依托单位: Hokkaido University
• 依托单位国家: 日本
• 项目类别: Grant-in-Aid for Scientific Research (B)
• 财政年份: 2005
• 资助国家: 日本
• 起止时间: 2005 至 2007
• 项目状态: 已结题
• 来源: https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-17390407/
• 关键词: Artificial intervertebral disc; Spinal Reconstruction; Biomaterial; Hydroxyapatite; Poly-L-lactic acid; Bioresorbable material; 脊住再建

Our 3^<rd> model of artificial intervertebral disc prosthesis was accomplished based on the detailed in vitro experiment and the long-term animal study. This is the triaxial three-dimensional fabric consisting of ultra-high molecular weight polyethylene fiber and hydroxyapaite/ poly-L-lactic acid. According to the pretrial review with ministry of health in Japan, the randomized clinical trial was recommended for study design, however, the detailed condition of single-arm trial was also advised. This puts the emphasis on the segmental mobility as the originality of the new device based on meta-analysis of published data According to clinical 226 pts data which was retrieved by meta-analysis data, we determined the study population when considering the expected range of motion and the safety range. According to the collaborated study with Kurume biostatistical research center, the final statistical data was calculated and the final protocol for clinical trial was completed. Following the agreement with university medical ethical committee, the multicenter clinical trial is now prepared. We are designing the surgical instrument with US Medtronics Co.. Using the cadaveric spines, the actual modification procedures of surgical instruments were performed in both Memphis, USA and Soeul, Korea.

我们的3^<rd>人工椎间盘假体模型是在详细的体外实验和长期动物实验的基础上完成的。这是由超高分子量聚乙烯纤维和羟基磷灰石/聚l -乳酸组成的三轴三维织物。根据日本厚生劳动省的试验前审查，推荐随机临床试验作为研究设计，但也建议单臂试验的详细情况。根据荟萃分析数据检索到的临床226例数据，我们在考虑预期活动范围和安全范围的情况下确定了研究人群。根据与库鲁姆生物统计研究中心的合作研究，计算最终的统计数据，完成最终的临床试验方案。根据与大学医学伦理委员会的协议，目前正在准备多中心临床试验。我们正在与美国Medtronics公司合作设计手术器械。使用尸体脊柱，在美国孟菲斯和韩国首尔进行了手术器械的实际修改程序。

项目成果

Iliac crest reconstruction with a bioactive ceramic spacer

• DOI: 10.1007/s00586-004-0765-6
• 发表时间: 2005-02
• 期刊: European Spine Journal
• 影响因子: 2.8
• 作者: Manabu Ito;K. Abumi;Hiroshi Moridaira;Y. Shono;Y. Kotani;A. Minami;K. Kaneda

腰椎可動性温存の意義とMotion Preservation technologyの現状

保持腰椎活动度的意义及运动保持技术的现状

• 发表时间: 2007
• 期刊: 第17回腰痛シンポジウム講演記録集
• 作者: Takahata M;Kotani Y;et. Al.;小谷善久
• 通讯作者: 小谷善久

脊椎外科におけるMotion Preservation Technologyの現状と展望

脊柱手术中运动保护技术的现状与展望

• 发表时间: 2006
• 作者: Takahata M;Kotani Y;et al.;小谷 善久;Kotani Y.;小谷 善久
• 通讯作者: 小谷 善久

本邦における人工椎間板研究の現状と臨床展望

日本人工椎间盘研究现状及临床展望

• 发表时间: 2006
• 作者: Masuda H;Chikuda H;Suga T;Kawaguchi H;Kuro-o M;小谷 善久
• 通讯作者: 小谷 善久

Accuracy analysis of pedicle screw placement in posteior scoliosis surgery : Comparison between conventional fluoroscopic and computer-assisted technique.

后侧脊柱侧凸手术中椎弓根螺钉置入的准确性分析：传统荧光镜与计算机辅助技术的比较。

• 发表时间: 2007
• 期刊: Spine 31(In press)
• 作者: Kotani Y;et al.
• 通讯作者: et al.