Quantifying 3rd Body Challenge in Total Hip Arthroplasty

量化全髋关节置换术中的第三身体挑战

基本信息

批准号：
8254317
负责人：
THOMAS DUDLEY BROWN
金额：
$ 49.34万
依托单位：
UNIVERSITY OF IOWA
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-05-13 至 2015-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8254317
关键词：
3-Dimensional Acceleration Accounting Agreement Arthroplasty Bone Cements Cadaver Cataloging Catalogs Categories Clinical Communities Computer Simulation Consensus Data Data Set Dose Evaluation Failure Family Generations Harvest Head Hip region structure Human Implant Individual Iowa Joints Laboratories Lasers Link Liquid substance Maps Metals Modality Modification Motion Ohio Operative Surgical Procedures Osteolysis Particulate Patients Pattern Performance Polyethylenes Preparation Procedures Prosthesis Protocols documentation Regimen Registries Relative (related person)Replacement Arthroplasty Research Resistance Retrieval Series Severities Specimen Staging Surface Surgeon Testing Tissues Total Hip Replacement Translating Translational Research Universities Validation Variant Work base bone cohort crosslink design falls implantation improved interdisciplinary collaboration novel particle public health relevance response simulation

项目摘要

DESCRIPTION (provided by applicant): When present, 3rd body effects in total joint replacement can obviate many of the wear rate improvements otherwise associated with advanced bearing materials such as highly cross-linked polyethylenes. While long recognized as a potential clinical concern, the difficulties of quantifying 3rd body challenge unfortunately have kept it largely confined to the domain of nebulous conjecture. Consequently, attempts to reduce the genesis of 3rd bodies and/or to study their effects on implant performance have been sporadic, heterogeneous, and often of questionable grounding in clinical realism. Building on a series of recent studies which have helped clarify the mechanisms linking 3rd body challenge, implant surface damage, and wear rate acceleration, two new directions of translational research are now proposed. The first of these directions is to quantify the 3rd body generation propensity of major intra-operative procedural steps of THA implantation surgery. Such data should be helpful to highlight the relative deleteriousness of specific procedural stages, a necessary initial step toward conceiving and documenting effective technical improvements. The second research direction is to establish a clinically-grounded framework for a practicable consensus protocol for laboratory 3rd body wear testing. To gain widespread acceptance, such a protocol will need to involve a reliably quantifiable 3rd body challenge that causes clinically realistic counterface damage. And, it will need to have the ability to reproducibly deliver wear rate accelerations in a clinically realistic range, ideally with a monotonic, mechanistically-grounded dose/response relationship. The proposed work will involve interdisciplinary collaboration among research groups at the University of Iowa, the University of Leeds, and Ohio State University. Peri-prosthetic tissue and fluid specimens will be obtained at various stages intra-operatively during patient surgeries and in cadaver preparations, from which specimens the 3rd body debris will be isolated and quantitatively analyzed. Computational models of 3rd body-induced wear rate acceleration will be extended to account for morphologically identifiable femoral head scratch damage, with direct validation physically. A registry of scratch damage on retrieval femoral heads in constructs with documented 3rd body challenge will be compiled using novel 3-dimensional laser micrometry, providing an objective basis to document clinically representative scratch damage regimens, and ranges of severity. A laboratory protocol will be refined to generate (registry-consistent) femoral head scratching from polyethylene-embedded 3rd body debris, with the damaged heads then being applied in standardized laboratory wear testing. At the conclusion of the proposed work, we expect to have identified which steps of THA surgical implantation are most problematic in terms of 3rd body debris generation. And, we expect to have developed a mechanistically-grounded protocol for laboratory simulation of 3rd body wear rate acceleration, suitable as a conceptual platform for a consensus testing standard. PUBLIC HEALTH RELEVANCE: In patients with total hip replacements, small particles comprised of hard materials such as metal, bone cement, or bone sometimes are unintentionally present in the tissues or fluid surrounding the implant, for reasons not well understood. These particles, known as 3rd bodies, can find their way into the ball-in-socket mechanism of the implant itself, where they roughen the otherwise very smooth bearing surfaces, causing the implant to rapidly wear, leading to clinical failure. It is important to find ways to minimize these 3rd body particles, and to develop implants that are more resistant to 3rd body damage.

描述（由申请人提供）：当存在时，全关节置换中的第三体效应可以避免许多磨损率的改善，否则与高级轴承材料（例如高度交联的聚乙烯）相关。虽然长期以来被认为是一个潜在的临床问题，但不幸的是，量化第三体挑战的困难使其在很大程度上局限于模糊的猜想领域。因此，减少第三体的起源和/或研究其对植入物性能的影响的尝试一直是零星的、异质的，并且临床现实主义的基础常常值得怀疑。最近一系列研究有助于阐明第三体挑战、种植体表面损伤和磨损率加速之间的联系机制，在此基础上，现在提出了两个新的转化研究方向。第一个方向是量化 THA 植入手术主要术中程序步骤的第三体生成倾向。这些数据应该有助于强调特定程序阶段的相对有害性，这是构思和记录有效技术改进的必要的第一步。第二个研究方向是为实验室第三次身体磨损测试建立一个切实可行的共识协议的临床框架。为了获得广泛接受，这样的协议需要涉及可靠量化的第三体挑战，该挑战会导致临床上真实的对抗损伤。而且，它需要能够在临床实际范围内可重复地提供磨损率加速度，最好具有单调的、基于机械的剂量/反应关系。拟议的工作将涉及爱荷华大学、利兹大学和俄亥俄州立大学的研究小组之间的跨学科合作。将在患者手术期间和尸体准备过程中的各个术中阶段获取假体周围组织和液体样本，将从这些样本中分离出第三身体碎片并进行定量分析。第三体引起的磨损率加速的计算模型将扩展到考虑形态上可识别的股骨头划伤损伤，并直接进行物理验证。将使用新颖的 3 维激光测微法对具有记录的第三体挑战的结构中的检索股骨头划痕损伤进行登记，为记录具有临床代表性的划痕损伤方案和严重程度范围提供客观基础。实验室协议将被完善，以从聚乙烯嵌入的第三身体碎片中生成（与注册一致的）股骨头划痕，然后将受损的股骨头应用于标准化实验室磨损测试。在拟议工作结束时，我们希望能够确定 THA 手术植入的哪些步骤在第三次身体碎片生成方面最有问题。而且，我们希望开发出一种基于机械原理的协议，用于实验室模拟第三次身体磨损率加速，适合作为共识测试标准的概念平台。公众健康相关性：在全髋关节置换术患者中，由金属、骨水泥或骨头等硬质材料组成的小颗粒有时会无意中出现在植入物周围的组织或液体中，其原因尚不清楚。这些被称为第三体的颗粒可以进入植入物本身的球窝机制，使本来非常光滑的轴承表面变得粗糙，导致植入物快速磨损，导致临床失败。找到最小化这些第三体颗粒的方法并开发更能抵抗第三体损伤的植入物非常重要。