Analyses of InSitu and Explanted Surgical Implant Devices

描述（由申请人提供）：政府和专业协会关于“通过分析植入手术器械改善医疗保健”会议的建议，特别是NIH-BECON倡议，为多学科研究提供了一个新的机会，通过NIH-BRP机制研究这一关键问题。我们提出了一种独特的方法来研究尸体原位植入物，直接与从植入的骨科器械中观察到的变化进行比较，以证明这些类型研究的可行性和价值，其总体目的是回答旨在提高器械和治疗寿命的基本问题。这种新方法最大限度地减少了器械回收和分析程序存在的许多限制。生物工程师、物理学家、医生、统计学家、记录人员和学生将在一个大学校园内进行互动，以更全面地研究宿主、手术技术和器械性能之间的关系，因为它们与公认的生物相容性问题有关，这些问题可能会影响年轻患者的寿命。重点是组织和宿主对全髋关节和膝关节假体骨界面关节和固定产生的碎片的反应。与器官和组织回收设施的这种伙伴关系将发展和评估：新的基础设施;规程和标准作业程序;以及参与专业协会和标准组织。活动将包括：伙伴关系主任通过校内和校外委员会进行管理和审查;利用现有的尸体处理设施和核心实验室获取、处理和分析标本;根据研究假设和共识协议举行联合会议和研究。后续活动将侧重于一个中心的可行性和价值，在最初几年进行基础设施、信息和评估，以加强治疗，提高接受假肢装置治疗的活跃和老龄人口的生活质量和寿命。

DESCRIPTION (provided by applicant): Recommendations from governmental and professional society based conferences on "improvements in health care through analyses of explanted surgical implant devices", and specifically the NIH-BECON initiatives, has afforded a new opportunity for multidisciplinary research to study this critical problem through the NIH-BRP mechanism. We propose a unique approach to the study of cadaveric in situ implants for direct comparison with changes noted from explanted orthopaedic devices to demonstrate the feasibility and value of these type studies with an overall intent to answer basic questions intended to enhance device and treatment longevities. This new approach minimizes many of the limitations that have existed for device retrieval and analysis programs. Bioengineers, physicists, physicians, statisticians, records personnel and students would interact on a single university campus to more fully investigate relationships among host, surgical technology and device properties as they relate to recognized biocompatibility issues that could compromise longevities for younger patients. The focus would be on tissue and host responses to debris generated from articulation and fixation of bone interfaces for total hip and knee prostheses. This partnership with organ and tissue recovery facilities would develop and evaluate: a new infrastructure; protocols and standard operating procedures; and participation in professional society and standard organizations. Activities would include: management and review by directors of the partnership through intra-and extra-mural committees; use of existing cadaver processing facilities and core laboratories for obtaining, processing and analyzing specimens; and joint meetings and studies based on research hypotheses and consensus protocols. Sequential activities would focus on feasibility and value at one center for infrastructure, information and assessment in the first years intended to enhance treatment and enhanced quality and longevity of life in an active and aging population treated with prosthetic devices.