LUMBAR SPINE ARTIFICIAL DISC IMPLANT STUDY

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 一种新的人造圆盘概念在SFBR之前的一项狒狒研究中进行了生物安全性和设备稳定性的测试。这两个目标都达到了：植入物稳定，椎间盘高度保持不下沉，软组织组织学与尸检观察的大体病理一致。由于先前研究中使用的设备是制造出来的，所以临床设备的设计进行了修改。没有一种材料或制造工艺被修改过。设计修改是(I)旨在改善装置的生物力学性能的足迹形状的改变，(Ii)旨在改善装置在原位长期固定之前的短期稳定性的主要固定特征的设计的改变。

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.