Hill-Watson S, Sheredos S J
Rehabilitation Research and Development Service, Department of Veterans Affairs, Baltimore, MD 21202-4051.
J Rehabil Res Dev. 1994;31(1):62-9.
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.
退伍军人事务部（VA）康复研究与发展服务局技术转让科（TTS）在假肢与感官辅助服务局（PSAS）、VA中央办公室（VACO）的协作下，于16家VA医疗设施对DAV/西雅图膝关节进行了临床评估，招募了46名受试者。DAV/西雅图膝关节旨在提供一种功能性的、轻便的人工膝关节，使膝上截肢的退伍军人比使用其他同类人造膝关节时具有更大的活动能力。此次全国性评估旨在根据规定标准确定退伍军人对DAV/西雅图膝关节的接受程度，并确定是否需要进行任何改进，以优化该产品供目标人群使用并提高其市场竞争力。TTS在PSAS/VACO的协作下，对28个具有流体摆动控制功能的装置进行了临床评估。评估试验于1992年5月至1993年5月期间进行。在临床试验的初始阶段，发现了活塞轴端部断裂这一常见问题。这是一种故障安全情况；膝关节支撑结构保持完整，不会导致受试者摔倒。所有装置立即返回制造商处安装新的减震器支架。46名受试者被接纳；28人安装了该膝关节；23人完成了30天的评估，8名受试者目前仍在使用DAV/西雅图膝关节。临床试验中受试者的反馈成功表明，DAV/西雅图膝关节在与使用者的体重、残肢长度和活动需求适当匹配时是安全可靠的。
