Rolling Joint Prosthetic Leg

第二阶段项目将完成一种新型滚动关节假肢的开发，包括滚动关节（自由流动）足和踝关节以及滚动关节假肢膝关节。两种假体的原始设计均基于申请人最近开发的滚动关节技术。1999年10月，滚动关节足和踝关节被商业化。本研究I期的主要工作是设计、制造和测试新型滚动关节膝关节。第一阶段的研究结果表明，滚动关节假肢的开发值得继续。滚动关节膝关节的开发和测试将在拟定的第二阶段完成。将进行额外的研究以验证经股截肢患者将受益于在旋转关节腿中组装两个旋转关节单元的假设。将开发用于假体关键参数的个体调整的新方法。它将为下肢截肢者提供更正常、更少疼痛的运动，并增加接受假肢治疗的患者数量。第二阶段项目的具体目标。完成一个新的膝关节单元原型的开发，该原型具有顺应性胫骨部件;对20名经股截肢者进行比较力学测试和生物力学步态研究，以验证一个假设，即具有拟定力学结果的新假体器械通过在步态站立阶段使“残肢-接受腔”界面正常化，改善了经股截肢者的步态。拟议研究的长期目标是开发一个功能，可靠和经济的假肢模块化系统。拟定的商业应用：潜在的商业应用是创建滚动关节足和膝关节产品线。RJ Leg将在不增加成本的情况下提高经股截肢者的性能，从而在假肢康复领域提供极具竞争力的产品。

The Phase II project is to complete development of a new Rolling Joint Prosthetic Leg comprising a Rolling Joint (Free-Flow) Foot and Ankle and the Rolling Joint Prosthetic Knee. Original design of both prostheses is based on a Rolling Joint Technology, recently developed by the applicants. The Rolling Joint Foot and Ankle was commercialized in October of 1999. Major efforts during the Phase I of the current study were developed to design, manufacture and testing of the new Rolling Joint Knee. As results of the Phase I study showed, development of Rolling Joint Prosthetic Leg has merit to be continued. Development and testing of the Rolling Joint Knee will be completed during the Phase II proposed. Additional research will be conducted to verify the hypothesis that patients with trans-femoral amputations will benefit from aan assembly of both Rolling Joint Units in a Rolling Joint Leg. New methodology for individual tuning of critical parameters of prostheses will be developed. It will provide more normal, less painful locomotion in a lower limb amputee and increase number of patients to be managed prosthetically. The specific aims of the Phase II project. Complete a development of a new Knee unit prototype with compliant tibial component; conduct a comparative mechanical tests and biomechanical gait study with 20 trans-femoral amputees to verify the hypothesis that a new prosthetic device with the proposed mechanical outcome improves a trans-femoral amputee gait by normalizing "stump-socket" interface during stance phase of gait. Long term objectives of the proposed research are to develop a functional, reliable and economical prosthetic modular system. PROPOSED COMMERCIAL APPLICATIONS: Potential commercial application is the creation of a product line of Rolling Joint Feet and Knees. The RJ Leg will enhance performance of transfemoral amputees without increasing the cost, thus providing a highly competitive product in the field of prosthetic rehabilitation.