Wear Analysis of Intervertebral Total Disc Replacements

描述(由申请人提供)：项目摘要/摘要椎间全盘置换(TDR)植入物可能预示着退行性间盘疾病管理的范式转变。保留活动可以避免邻近节段退变，这是公认的融合并发症。基于欧洲令人鼓舞的经验以及随后在2004年和2005年FDA的批准，Charity III和ProDisc TDR设备已被美国的许多脊柱外科医生投入临床使用。作为Fusion的替代方案(在美国约为每年300,000)，人们对这类设备日益广泛的使用非常感兴趣。然而，与磨损相关的晚期并发症的可能性令人不安。Chariti和ProDisc都使用金属对传统聚乙烯轴承，TDR患者比THR/TKR患者年轻10岁。此外，由于非常接近脊髓，植入失败的潜在后果比THR/TKR严重得多。科学界迅速面对TDR磨损问题至关重要。由父母资助的生物工程研究伙伴关系正在努力为识别和处理TDR中与磨损有关的问题提供坚实的科学基础。这项父母拨款研究(通知编号NOT-OD-09-058，标题为NIH宣布恢复法案资金可用于竞争性修订应用)涉及开发临床前阶段的TDR磨损评估技术(目标1)，实施体内TDR射线磨损测量的新技术(目标2)，以及评估TDR磨损碎片的功能生物活性(目标3)。建议对母基金进行修订，以扩展和改进父特定目标1中正在研究的计算磨损模拟方面。拟议修订研究的目标是确定一种方法，通过这种方法，可以从独立进行的销-板磨损试验中真实地确定TDR计算磨损模拟中使用的实验来源的摩擦学磨损系数，从而避免需要校准/连接到已经进行的TDR物理磨损模拟。这将为加速对本质上不同的TDR设计进行计算模拟以及测试与TDR磨损相关的新假设开辟道路，否则这些假设是不可能的。 公共卫生相关性：项目叙事相关性：全盘置换植入物磨损的计算机模拟对于工程设计目的和外科评估都有很大的用处。提出了修订研究的方法，通过提高作为这些模拟所需的输入信息的关键实验信息之一(称为磨损系数)的准确性，使这些计算机模拟更加准确和更加通用。

DESCRIPTION (provided by applicant): Project Summary/Abstract Intervertebral total disc replacement (TDR) implants potentially herald a paradigm shift in the management of degenerative disc disease. Preservation of motion may avoid adjacent-segment degeneration, a well- recognized complication of fusion. Based on encouraging experience in Europe and subsequent FDA approvals in 2004 and 2005, the Charity III and ProDisc TDR devices have come into clinical use by many spine surgeons in the US. As an alternative to fusion (~300,000/year in the U.S.), there is substantial interest in increasingly wide usage of this class of devices. However, the potential for late wear-related complications is disconcerting. Both Chariti and ProDisc involve metal-on-conventional-polyethylene bearings, and the TDR patient population is a decade younger than for THR/TKR. Moreover, owing to close proximity of the spinal cord, the potential consequences of implant failure are substantially more dire than for THR/TKR. It is crucial that the scientific community expeditiously confront the issue of TDR wear. A Bioengineering Research Partnership supported by the parent grant is working to provide a firm scientific basis for identifying and dealing with wear-related problems in TDR. This parent grant research (Notice Number NOT-OD-09-058 titled NIH Announces the Availability of Recovery Act Funds for Competitive Revision Applications) involves developing techniques for TDR wear assessment in the pre-clinical phase (Aim 1), implementing a novel technique for in vivo TDR radiographic wear measurement (Aim 2), and assessing the functional biologic activity of TDR wear debris (Aim 3). A revision to the parent grant is proposed to expand and improve upon the computational wear simulation aspects under study in parent Specific Aim 1. The goal of the proposed revision research is to identify methodology by means of which the experimentally-sourced tribologic wear factors used in TDR computational wear simulations can be realistically determined from independently conducted pin-on- plate wear tests, to avoid the need for calibration/linkage to already-performed TDR physical wear simulations. This will open the way to expedited computational simulations of substantively different TDR designs, and to testing of novel hypotheses related to TDR wear, that otherwise would not be possible. PUBLIC HEALTH RELEVANCE: Project Narrative Relevance: Computer simulation of the wear of total disc replacement implants has great usefulness both for engineering design purposes and for surgical assessments. Revision research is proposed for ways to make these computer simulations more accurate and more versatile, by means of better accuracy of one of the key pieces of experimental information (known as the wear factor) needed as input information for these simulations.