LUMBAR SPINE ARTIFICIAL DISC IMPLANT STUDY

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH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 中心，不一定是研究者的机构。 在SFBR之前的狒狒研究中测试了新的人工椎间盘概念的生物安全性和器械稳定性。这两个目标都达到了：植入物稳定，椎间盘高度保持不变，没有下沉，软组织组织学与尸检时观察到的大体病理学一致。由于生产了先前研究中使用的器械，因此对临床器械的设计进行了修改。材料或生产工艺均未进行修改。设计修改包括（i）足印形状变更，旨在改善器械的生物力学性能，（ii）主要固定特征设计变更，旨在改善器械在原位长期固定之前的短期稳定性。

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.