Polyurethane Load Bearing Surfaces for Total Hip Joint Replacement

用于全髋关节置换的聚氨酯承重表面

• 批准号: 7394642
• 负责人: Ibrahim Sendijarevic
• 金额: $ 14.59万
• 依托单位: TROY POLYMERS, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-05-09 至 2008-11-09
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7394642
• 关键词: Adhesions; Animal Model; Antioxidants; Appearance; Arthroplasty; Biodegradation; Biomechanics; Biometry; Cervical; Characteristics; Chemicals; Collaborations; Cultured Cells; Development; Devices; Drug Formulations; Elastomers; Equipment; Evaluation; Facility Construction Funding Category; Failure; Film; Foreign-Body Reaction; Frequencies; Friction; Future; Generations; Goals; Grant; Guanosine Monophosphate; Hardness; Head; Heart Valves; Hip Joint; Hip region structure; Implant; In Vitro; Joints; Knee; Lead; Legal patent; Life; Link; Liquid substance; Longevity; Lubrication; Manufacturer Name; Marketing; Measures; Mechanics; Mediating; Medical; Medical Device; Mining; Numbers; Operative Surgical Procedures; Orthopedics; Osteolysis; Pacemakers; Pain; Patients; Performance; Phase; Physiological; Polyethylene; Polyethylenes; Polymers; Polyurethanes; Production; Property; Prosthesis; Public Health; Rate; Repeat Surgery; Replacement Arthroplasty; Resistance; Risk; Scientist; Second Look Surgery; Shock; Shoulder; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Solutions; Specialist; Structure; Surface; Surgeon; Survival Rate; System; Technology; Testing; Total Hip Replacement; Translating; Vascular Graft; Walking; Weight-Bearing state; Work; base; biomaterial compatibility; bone; commercial application; commercialization; design; experience; hydrophilicity; improved; in vivo; oxidation; particle; simulation; size; submicron; success; ultra-high molecular weight polyethylene

DESCRIPTION (provided by applicant): As total hip arthroplasty (THA) is being performed on increasingly younger patients, there is a need for THA implants that can sustain higher patient activity and number of loading cycle. UHMW-PE used in most common THA implants have been shown susceptible to high rates of wear, generating billions of sub-micron wear particles associated with the osteolysis-mediated implant failures. The objective of this study is to replace the UHMW-PE components of THA implants with polyurethane (PUR) elastomers specifically developed for this load-bearing application. The PUR elastomers were specifically developed with higher toughness, hardness, and modulus than the UHMW-PE, which should lead to lower deformation, adhesion, and abrasion. PUR elastomers are also significantly more hydrophilic than the UHMW-PEs, which should translate into more effective "fluid-film" lubrication between the articulating surfaces of THA implants, lower friction and ultimately lower wear. In Phase I we propose to compare the wear rates of selected PUR elastomers and UHMW-PE in a physiological hip joint simulator to demonstrate the potential of PUR elastomers to reduce the surface wear rates in THA implants and formation of sub-micron wear particles. Additionally, a study will be completed to compare the oxidation-mediate degradation of selected PUR elastomers and UHMW-PE, which is the primary cause for in vivo polymer degradation that can lead to considerable wear rate increases. PUR elastomer with the best combination of wear characteristics and resistance to oxidation will be selected for further optimization and evaluation in Phase II. Wear-property correlations and oxidation resistance-composition correlations determined in Phase I will be used as bases for further material optimization in Phase II. PROPOSED COMMERCIAL APPLICATIONS: With the expected lower wear rates and reduced potential for osteolysis, THA implants with PUR elastomer liners are expected to capture a significant portion of the THA implant market, which numbers over 270,000 THAs in the US and over 1.5 million world-wide. Successful application in THA is expected to lead to use of PUR elastomers as load bearing surfaces in total knee and shoulder implants and other joint replacements. PUBLIC HEALTH RELEVANCE: The overall goal of this project is to develop new load-bearing polyurethane surfaces for total hip replacement implants. The new load-bearing polyurethane surfaces will improve the durability and life- span of the replacement implants, significantly reducing the risk of failure. The technology developed in this study has the potential to improve lives of over 1.5 million new patients who each year undergo hip replacement surgeries.

描述（由申请人提供）：随着全髋关节置换术（THA）在越来越年轻的患者中实施，需要能够承受更高患者活动和负载循环次数的THA植入物。 在大多数常见的THA植入物中使用的聚乙烯已被证明易受高磨损率的影响，产生数十亿与骨质溶解介导的植入物失效相关的亚微米磨损颗粒。 本研究的目的是用专门为该承重应用开发的聚氨酯（PUR）弹性体替代THA植入物的聚乙烯（PE）组件。 PUR弹性体是专门开发的，其韧性、硬度和模量比EST-PE更高，这将导致更低的变形、粘附和磨损。 PUR弹性体的亲水性也明显高于PEG-PE，这应转化为THA植入物关节面之间更有效的“液膜”润滑，降低摩擦并最终降低磨损。 在第I阶段，我们建议在生理髋关节模拟器中比较选定的PUR弹性体和EST-PE的磨损率，以证明PUR弹性体降低THA植入物表面磨损率和亚微米磨损颗粒形成的潜力。 此外，还将完成一项研究，以比较选定的PUR弹性体和PET-PE的氧化介导降解，这是体内聚合物降解的主要原因，可导致磨损率显著增加。 将选择具有最佳耐磨性和抗氧化性组合的PUR弹性体，用于第二阶段的进一步优化和评估。 第一阶段确定的磨损性能相关性和抗氧化性组成相关性将作为第二阶段进一步材料优化的基础。 拟议的商业应用：由于预期的较低磨损率和骨质溶解的可能性降低，带有PUR弹性体内衬的THA植入物预计将占据THA植入物市场的很大一部分，美国的THA数量超过270，000例，全球超过150万例。 在THA中的成功应用预计将导致PUR弹性体用作全膝关节和肩关节植入物以及其他关节置换术中的承重表面。 公共卫生相关性：本项目的总体目标是为全髋关节置换植入物开发新的承重聚氨酯表面。 新的承重聚氨酯表面将提高置换植入物的耐久性和寿命，显著降低失效风险。 这项研究开发的技术有可能改善每年接受髋关节置换手术的150多万新患者的生活。