SBIR Phase II: Development of an Innovative Total Knee Replacement Device Leveraging Truss Implant Technology

这个小型企业创新研究(SBIR)第二阶段项目的更广泛的影响/商业潜力旨在减少膝关节炎的影响，并改善患有这种衰弱疾病的人的生活质量，同时通过开发一种新颖的全膝关节置换技术为学生提供独特的研究机会，从而加强学术界和产业界之间的联系。每年进行的膝关节置换手术总数超过60万例，占所有医疗保险支出的8%。2012年，这种手术的总住院费用接近400亿美元。这项手术的修复率很高：10年为10%，20年为20%。考虑到美国人口老龄化，膝关节置换和翻修手术的总数正在稳步增加，其中大部分将在联邦医疗保险覆盖范围内完成。翻修手术的主要原因是植入物松动。这一创新旨在开发一种植入型骨科装置的锚定方法，通过在骨骼和装置之间建立更稳定的界面来减少翻修操作的总次数，从而提高对骨科植入物的科学和技术理解。拟议的项目是一种装置，利用载荷传递和桁架设计等结构工程原理来改进全膝关节置换植入物的骨结合；这种装置可能比目前的设计更有效。目前可用的系统在植入后很短的一段时间内就会有很大的更新率。随着接受这些植入物的年轻患者的接受，需要开发出能够提供这些患者所需的灵活性和生活质量的设备。将全膝关节置换术的胫骨托盘固定到骨中的新型腹板结构应该提供改进的初始固定，减少微小运动，并消除无菌性松动，所有这些都有助于降低翻修率和改善患者舒适性。在使用从第一阶段SBIR调查中获得的信息为计算模型提供信息后，该设备的设计将最终完成。然后，该设备将接受严格的机械测试，以调查其在体内的性能，同时满足FDA批准的强制性测试要求。

The broader impact/ commercial potential of this Small Business Innovation Research (SBIR) Phase II project is aimed at reducing the impact of knee arthritis and improving the quality of life for those suffering from this debilitating condition, while simultaneously strengthening the bond between academia and industry by providing students with unique research opportunities through the development of a novel Total Knee Replacement technology. Over 600,000 total knee replacement procedures are performed annually, comprising 8% of all Medicare spending. Total hospital charges for this procedure approached $40 billion for 2012. The revision rates for this procedure are significant: 10% at 10 years and 20% at 20 years. Considering the aging population of the United States, the number of total knee replacements and revisions are steadily increasing and the majority of these will be completed under Medicare coverage. The primary cause for revision surgery is loosening of the implants. This innovation aims to develop an anchoring method for implantable orthopedic devices that will reduce the total number of revision procedures performed by creating a more stable interface between the bone and the device, and therefore enhance the scientific and technological understanding of orthopedic implants in general.The proposed project is a device that utilizes structural engineering principles such as load transfer and truss design to improve osteo-incorporation of a total knee replacement implant; such a device is likely to be more efficacious than current designs. Currently available systems suffer from significant revision rates after being implanted only a short while. With younger patients receiving these implants, devices need to be developed that will give the mobility and quality of life required by these patients. The novel web structure fixing the tibial tray of a total knee replacement into the bone should provide improved initial fixation, reduce micro-motion, and eliminate aseptic loosening, all of which contribute towards a reduced revision rate and improved patient comfort. After using the information gained from the Phase I SBIR investigation to inform computational models, the design of this device will be finalized. The device will then be subjected to rigorous mechanical testing to investigate its performance in vivo, while simultaneously serving to satisfy the testing requirements mandatory for FDA approval.