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

• 批准号: 8072560
• 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
• 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/8072560
• 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

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，总关节置换中的第三个身体效应可以消除许多磨损率的改进，否则与高级轴承材料（例如高度交联的聚乙烯）相关。虽然长期以来一直被认为是潜在的临床问题，但不幸的是，量化第三次身体挑战的困难使它在很大程度上局限于模糊猜想的领域。因此，试图减少第三个身体的起源和/或研究其对植入物绩效的影响的尝试是零星，异质性的，并且在临床现实主义中通常是可疑的基础。现在，基于一系列最近的研究，这些研究帮助阐明了将第三个身体挑战，植入物损伤和磨损速率加速的机制，现在提出了两个新的转化研究方向。这些方向中的第一个是量化主要术中主要手术步骤的第三个体内生成倾向。此类数据应该有助于强调特定程序阶段的相对有害性，这是朝着和记录有效技术改进的必要第一步。第二个研究方向是为实验室第三身体磨损测试的可行共识方案建立一个临床上的框架。为了获得广泛的接受，这种协议将需要涉及可靠的可靠量化的第三个身体挑战，从而造成临床现实的反面损害。而且，它将需要具有可重复性地在临床现实范围内可重复提供磨损速率加速度的能力，理想情况下，具有单调的机械剂量/响应关系。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。在患者手术和尸体制剂中，将在术中的各个阶段获得螺旋壁组织和流体样本，从中，将分离并进行定量分析第三体碎片。第三个身体诱导的磨损速率加速度的计算模型将扩展，以说明形态上可识别的股骨头刮伤损伤，并在物理上直接验证。将使用新颖的三维激光微米来编制有关股骨的检索股头的刮擦损伤注册表，这为临床代表性的划痕损伤方案和严重程度范围提供了客观的基础。实验室方案将被完善，以产生（注册中）的股骨头，该股骨头会从聚乙二烯包裹的第三体碎片中刮擦，然后将损坏的头部用于标准化的实验室磨损测试。在拟议的工作结束时，我们希望已经确定了三个手术植入的步骤在第三体碎片的产生方面最有问题。而且，我们预计将开发出一种机械基础的协议，用于实验室模拟第三个身体磨损速率加速度，该协议适合作为共识测试标准的概念平台。 公共卫生相关性：在全髋关节置换的患者中，由于植入物周围的组织或液体，有时在植入物周围的组织或液体中，有时会出现由金属，骨水泥或骨骼等硬材料组成的小颗粒，原因尚不清楚。这些颗粒被称为第三身体，可以找到植入物本身的球插座机理的方式，在那里它们使原本非常光滑的轴承表面粗糙，从而导致植入物迅速磨损，从而导致临床衰竭。重要的是要找到最小化这些第三个身体颗粒并发展对第三体损伤具有更耐药的植入物的方法。