LUMBAR SPINE ARTIFICIAL DISC IMPLANT STUDY

腰椎人工椎间盘植入研究

• 批准号: 8172704
• 负责人: KAREN S RICE
• 金额: $ 8.21万
• 依托单位: TEXAS BIOMEDICAL RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-05-01 至 2011-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8172704
• 关键词: Autopsy; Biological; Biomechanics; Clinical; Computer Retrieval of Information on Scientific Projects Database; Devices; Funding; Grant; Height; Histology; Implant; In Situ; Institution; Modification; Papio; Pathology; Property; Research; Research Personnel; Resources; Safety; Shapes; Source; Testing; United States National Institutes of Health; Vertebral column; design; improved; manufacturing process; meetings; sample fixation; soft tissue

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. A new artificial disc concept was tested in a previous baboon study at SFBR for biological safety and device stability. Both objectives were met: the implants were stable, disc height was maintained with no subsidence, and soft tissue histology was consistent with the gross pathology observed at necropsy. Since the devices used in the previous study were manufactured, the design of the clinical device was modified. None of the materials, or the manufacture process, has been modified. The design modifications are (i) a change to the shape of the footprint intended to improve the biomechanical properties of the device, (ii) changes to the design of the primary fixation features intended to improve short term stability of the device prior to long term fixation in situ.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 SFBR 之前的一项狒狒研究测试了一种新的人造椎间盘概念，以确保其生物安全性和装置稳定性。这两个目标均得到满足：植入物稳定，椎间盘高度保持不变，且软组织组织学与尸检时观察到的大体病理学一致。由于先前研究中使用的设备已制造出来，因此临床设备的设计进行了修改。任何材料或制造工艺都没有被修改。设计修改包括 (i) 改变占地面积形状，旨在提高设备的生物力学性能，(ii) 改变主要固定特征的设计，旨在提高设备在长期使用之前的短期稳定性。原位固定。