Clinical evaluation of a new, above-elbow, body-powered prosthetic arm: a final report.

The AdVAntage Arm is an above-elbow (AE) body-powered arm designed to improve upon, and overcome, some of the major limitations of conventional prostheses. It is the result of research and development (R&D) accomplished at the Center for Engineering Design (CED), University of Utah and Sarcos Research Corporation (SRC), Salt Lake City, UT. The AdVAntage Arm was developed to provide the following main features: lightweight, independent elbow and terminal device (TD) control, and a cable recovery system for full TD actuation at any elbow position. The Department of Veterans Affairs (VA) Rehab R&D Service's Technology Transfer Section (TTS), with collaboration from the VA National Prosthetic and Sensory Aids Service (PSAS), managed a multi-center clinical evaluation of the precommercial AdVAntage Arm (the Arm). The purpose was to objectively assess and affirm the Arm's functional advantages, reliability, clinical application, and commercial readiness. Eleven VA prosthetic services served as evaluation sites with a total of 16 subjects with amputation (14 unilateral and 2 bilateral). Fifteen prosthetists provided their comments. Overall, the results demonstrated that the Arm could be fit for use by persons with transhumeral, and even with forequarter, amputation. Once the learning curve was overcome, the majority of subjects reported that the Arm offered several functional advantages over their conventional prosthesis. Its overall light weight, separation of elbow and TD function, and cable recovery system allowed opening and closure of the TD at any elbow position; resulting in a more fluid manner of use and allowing subjects to perform more activities from waist level and above (especially in the outstretched and overhead positions). At the conclusion of clinical trials, 10 subjects elected to keep the Arm for continued use. The manufacturer is committed to the commercial marketing and technical support of the arm. Based upon the clinical findings, the AdVAntage Arm was recommended for commercial production and availability, upon prescription, to appropriate veteran beneficiaries.