Analyses of InSitu and Explanted Surgical Implant Devices

原位和外植手术植入装置的分析

基本信息

批准号：
7273491
负责人：
Jack E Lemons
金额：
$ 62.15万
依托单位：
UNIVERSITY OF ALABAMA AT BIRMINGHAM
依托单位国家：
美国
项目类别：
财政年份：
2005
资助国家：
美国
起止时间：
2005-09-30 至 2009-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7273491
关键词：
Address Advisory Committees Affect Alabama Area Arthroplasty Biocompatible Materials Biological Biomechanics Biomedical Engineering Biometry Bone Tissue Books Businesses Cadaver Cardiovascular system Ceramics Cessation of life Characteristics Charge Chemicals Chemistry Clinical Clinical Research Clinical Sciences Clinical Services Clinical Treatment Collaborations Computers Condition Confidentiality Confidentiality of Patient Information Consensus Core Facility Data Data Collection Dental Dental Faculty Dental Records Depth Development Devices Discipline Education Elements End Point Engineering Environment Etiology Evaluation Excision Extramural Activities Faculty Failure Forensic Medicine Future Gender Generations Goals Government Publications Grant Guidelines Head Health Insurance Portability and Accountability Act Healthcare Hip region structure Histocompatibility Testing Human Human Resources Immune response Implant In Situ In Vitro Individual Industry Information Dissemination Informed Consent Interdisciplinary Communication Interdisciplinary Study International Investigation Ions Joints Journals Knee Prosthesis Laboratories Language Lead Leadership Life Localized Longevity Mechanics Medical Medical Records Medicine Metals Methods Nature Numbers Operative Surgical Procedures Organ Organ Donations Orthopedics Outcome Study Participant Pathologic Pathology Pathway interactions Patient Rights Patients Peer Review Phase Physicians Physics Polymers Principal Investigator Procedures Process Property Prosthesis Protocols documentation Publications Race Recommendation Reconstructive Surgical Procedures Records Recovery Regenerative Medicine Research Research Design Research Ethics Committees Research Infrastructure Research Personnel Research Project Grants Retrieval Role Science Scientist Site Societies Specimen Standards of Weights and Measures Statistical Study Structure Students Surface System Technology Testing Time Tissue Donations Tissue Donors Tissue Engineering Tissue Procurements Tissue and Organ Procurement Tissues Training Training and Education United States National Institutes of Health Universities Writing abstracting aging population base biomaterial compatibility bone concept design dissemination research experience functional outcomes implantable device improved in vivo insight interest interfacial knee replacement arthroplasty multidisciplinary novel strategies physical science programs reconstruction repository response sample fixation size symposium

项目摘要

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.

描述（由申请人提供）：来自政府和专业协会的会议关于“通过分析外植手术植入装置改善医疗保健”的建议，特别是 NIH-BECON 倡议，为多学科研究提供了新的机会来研究这一关键问题通过 NIH-BRP 机制解决问题。我们提出了一种独特的方法来研究尸体原位植入物，以便与外植骨科设备的变化进行直接比较，以证明这些类型研究的可行性和价值，总体目的是回答旨在提高设备和治疗寿命的基本问题。这种新方法最大限度地减少了设备检索和分析程序中存在的许多限制。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、手术技术和设备特性之间的关系，因为它们与公认的生物相容性问题有关，这些问题可能会损害年轻患者的寿命。重点是组织和宿主对全髋关节和膝关节假体的关节和骨界面固定产生的碎片的反应。与器官和组织恢复设施的这种伙伴关系将开发和评估：新的基础设施；协议和标准操作程序；以及参与专业协会和标准组织。活动包括：合伙企业董事通过内部和外部委员会进行管理和审查；利用现有尸体处理设施和核心实验室获取、处理和分析标本；基于研究假设和共识协议的联合会议和研究。后续活动将侧重于第一年基础设施、信息和评估中心的可行性和价值，旨在加强使用假肢装置治疗的活跃和老龄化人群的治疗并提高其生活质量和寿命。