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

这项小企业创新研究（SBIR）二期项目的更广泛影响/商业潜力旨在减少膝关节关节炎的影响，改善患有这种衰弱疾病的人的生活质量，同时通过开发新型全膝关节置换术为学生提供独特的研究机会，加强学术界和工业界之间的联系。每年进行的全膝关节置换术超过60万例，占所有医疗保险支出的8%。2012年，该手术的医院总收费接近400亿美元。该手术的翻修率显著：10年为10%，20年为20%。考虑到美国人口的老龄化，全膝关节置换术和翻修术的数量正在稳步增加，其中大部分将在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。这项创新旨在为植入式骨科设备开发一种锚定方法，通过在骨骼和设备之间创造更稳定的界面来减少翻修手术的总数，从而增强对骨科植入物的科学和技术理解。该项目是一种利用结构工程原理，如负荷转移和桁架设计来改善全膝关节置换术植入物的骨融合的装置；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时间内就有很大的修正率。随着年轻患者接受这些植入物，需要开发能够提供这些患者所需的活动能力和生活质量的设备。将全膝关节置换术胫骨托盘固定在骨内的新型网状结构应提供更好的初始固定，减少微运动，消除无菌性松动，所有这些都有助于降低翻修率，提高患者舒适度。在利用第一阶段SBIR调查获得的信息为计算模型提供信息后，该装置的设计将最终确定。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.