Analyses of InSitu and Explanted Surgical Implant Devices

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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.