FREEFORM FABRICATION OF TRANSTIBIAL PROSTHETIC SOCKET - PHASE II

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 对于大多数下肢截肢者来说，成功的康复包括假肢安装和训练。假肢装配成功的关键是一个舒适、适配良好的插座，但要做到这一点仍然是一个临床挑战，20%-55%的下肢截肢者会受到残肢疼痛和插座不适的影响。使用传统假体技术实现可接受的承窝适合性，需要在劳动密集型、成本高昂的过程中进行个人定制成型和制造，这取决于熟练假体的供应越来越有限。为了确保截肢者的持续最佳康复，需要其他制造假体插座的方法来提高假体提供的效率，增强舒适度和适合性，或降低成本。该项目将继续开发一种基于选择性激光烧结(SLS)技术的基于固体自由形状制造(SFF)的新的有前途的插座制造方法。SFF允许直接制造假体插座，而不需要传统技术所需的中间模具和层压工艺。 该项目的总体长期目标是开发一种临床实用的快速假肢提供系统，该系统将计算机辅助设计与固体自由形式制造技术相结合。这项建议建立在我们之前成功证明SFF插座制造的可行性的基础上，并将解决支撑其临床可行性的几个关键问题。拟议工作的具体目标是：(1)开发SFF经胫骨假体插座的改进设计，允许使用行业标准的吊架并加入可变顺应性元素；(2)确定可变壁顺应性元素在提高经胫骨假体插座舒适性和适合性方面的临床有效性；以及(3)确定SFF假体插座在扩大临床使用期间的耐用性和功能性。拟议工作的初始阶段将使用迭代工程设计-建模-评估过程来开发可变的合规要素和行业标准的塔架安装适配器。在拟议工作的第二阶段，将研究SFF假体插座的临床评估。通过SFF插座与传统叠层插座的受试者内案例比较研究，将确定可变顺应性元件在提高舒适性和适合性方面的有效性。采用行业标准塔架安装系统的SFF插座的耐用性将在为期12个月的临床现场试验中确定。 退伍军人医疗保健系统本质上是其老年患者群体，是美国截肢者医疗保健的主要提供者之一，在改进为新的和现有的下肢截肢者服务所需的康复和假肢技术方面一直处于领先地位。退伍军人管理局是开发和实施CAD/CAM以及假肢自动化制造的先驱。这项拟议的研究建立在先前研究的基础上，通过建立使用SFF用于假体插座的临床可行性。成功的SFF有可能在假体插座的提供方面创造一个重大的范式转变。使用SLS的SFF假肢插座将不再需要模具、手部分层和精加工程序，从而朝着快速提供假肢的集成CAD/CAM系统的目标迈进了一大步。SLS自由形状制造特别有吸引力，因为它可以商业使用，并且能够以最小的成本损失创建复杂的几何形状。这一独特的优势极大地扩展了开发替代插座设计的选择。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Successful rehabilitation for the majority of lower extremity amputees includes prosthetic limb fitting and training. Critical to the success of prosthetic fitting is a comfortable, well fitting socket, but accomplishing this remains a clinical challenge with residual limb pain and socket discomfort affecting 20-55% of lower limb amputees. Achieving an acceptable socket fit using conventional prosthetic techniques requires individual custom molding and fabrication in a labor intensive, costly process that is dependent on the availability of an increasingly limited supply of skilled prosthetics. Alternative methods of fabricating prosthetic sockets that can improve efficiency in prosthetic provision, enhance comfort and fit, or reduce cost are needed to ensure the continued optimal rehabilitation of the amputee. This project will continue the development of a new promising method of socket fabrication using solid freeform fabrication (SFF) based on selective laser sintering (SLS) technology. SFF allows the direct manufacture of a prosthetic socket without the intermediate molds and laminating process required with conventional techniques. The overall long-term goal of this project is the development of a clinically practical system for rapid prosthetic limb provision that integrates computer-aided design with solid freeform fabrication techniques. This proposal builds on our previous successful demonstration of the feasibility of SFF socket fabrication and will address several key issues that underlie its clinical viability. The specific objectives of the proposed work are: (1) to develop improved designs for SFF transtibial prosthetic sockets that allow the use of industry standard pylon mounts and incorporate variable compliance elements; (2) determine the clinical effectiveness of variable wall compliance elements in enhancing the comfort and fit of transtibial prosthetic sockets; and (3) determine the durability and functionality of SFF sockets during extended clinical use. The initial phase of the proposed work will use an iterative engineering design-modeling-evaluation process to develop variable compliance elements and an industry standard pylon mount adapter. During the second phase of the proposed work, clinical evaluations of SFF prosthetic sockets will be studied. The effectiveness of variable compliant elements in enhancing comfort and fit will be determined using a within-subject case comparison study of SFF sockets with conventional laminated sockets. Durability of SFF sockets that incorporate an industry standard pylon mounting system will be determined during a 12-month clinical field trial. The Veterans Health Care System by nature of its elderly patient population, is one of the nation's major providers of amputee health care and has been a leader in improving the rehabilitation and prosthetic technology needed to serve both new and existing lower extremity amputees. The VA has pioneered the development and implementation of CAD/CAM and automated fabrication of prosthetic limbs. The proposed study builds on this prior research by establishing the clinical viability of using SFF for prosthetic sockets. Successful SFF has the potential to create a major paradigm shift in the provision of prosthetic sockets. SFF prosthetic sockets using SLS would eliminate the need for molds, hand lamination, and finishing procedures enabling a major step forward toward the goal of an integrated CAD/CAM system of rapid prosthetic limb provision. SLS freeform fabrication is particularly attractive because it is commercially available and has ability to create complex geometries with minimal cost penalty. This unique advantage significantly expands the options for developing alternate socket designs.