The specimens are tested for ultimate tensile strength and fatigue life and are compared to similar values obtained from more traditional fabrication techniques and from factory-delivered extruded plate. Clinical trials involve the fitting of sockets to amputees and evaluating their mechanical performance over time. Participants in the study are provided with limbs incorporating sockets made using the device and are asked to use those limbs in unrestricted activity. Periodic follow-ups are made in which the sockets are evaluated for signs of mechanical degradation. Progress - The device is able to fabricate sockets during unattended operation.
Clinical tests are underway and on-going.
Additional materials are being investigated for future use. Results - Tensile and fatigue tests have indicated that polypropylene homopolymer is suitable for socket fabrication using the device and for unrestricted use of the fabricated sockets. To date, a single subject has been using a socket made with the device for a period of twenty months, and two additional subjects have been using sockets for a period of three months each. The subject is an active below-knee amputee and has used the socket exclusively for the entire time without restriction in activity. A blow-molding technique shows promise for this application as well as for fabrication of replacement liners for any socket.