Report on the evaluation of the DAV/Seattle Knee

The Department of Veterans Affairs (VA) Rehabilitation Research and Development Service, Technology Transfer Section (TTS) managed a clinical evaluation of the DAV/Seattle Knee with collaboration from the Prosthetic and Sensory Aids Service (PSAS), VA Central Office (VACO) at 16 VA Medical Facilities, recruiting 46 subjects. The DAV/Seattle Knee was designed to provide a functional, lightweight artificial knee that would give veterans, with above-knee amputations, greater mobility than they experienced with other comparative man-made knees. This national evaluation was conducted to determine the acceptance of the DAV/Seattle Knee by veterans prescriptive criteria and to determine what modifications, if any, were needed to improve the product for optimal use by the targeted population and to enhance its marketability. TTS, with collaboration from PSAS/VACO, managed a clinical evaluation on 28 units with fluid swing control. The evaluation trials were conducted between May 1992 and May 1993. During the initial phase of the clinical trials, a common problem of the piston shaft end breaking was identified. This was a fail-safe situation; the knee support structure maintained its integrity and did not cause the subject to fall. All units were immediately returned to the manufacturer for installation of new damper mounts. Forty-six subjects were accepted; 28 fitted; 23 completed evaluation for 30 days, 8 subjects are currently wearing the DAV/Seattle Knee. The subjects' responses from the clinical trials successfully demonstrated that the DAV/Seattle Knee is safe and reliable when properly matched to the user's weight, stump length, and activity requirements.