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 of 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.
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