Identifying the benefits and risks of emerging integration methods for upper limb prosthetic devices in the United States: an environmental scan.
Marcella A KelleyHeather BenzSusannah M EngdahlJohn F P BridgesPublished in: Expert review of medical devices (2019)
Objectives: Novel connective and control methods between an upper limb prosthetic device and end-user have large potential rewards and risks, making economic evaluation difficult. Methods: We conducted an environmental scan to assess user perspectives on advancements in upper limb prosthetic device integration. The environmental scan consisted of a PubMed literature search, grey literature review, formation of a community advisory board (CAB) and key informant interviews. The CAB guided the study and was comprised of adults with personal or professional experiences with upper limb prostheses. Results: The environmental scan highlights 4 main types of integration in upper-limb prostheses: osseointegration, targeted muscle reinnervation, cortical integration and peripheral nerve/muscle integration. The PubMed literature search resulted in the greatest number of matches for 'targeted muscle reinnervation upper limb' (N = 65) and 'upper limb osseointegration' (N = 54). The grey literature review found targeted muscle reinnervation and peripheral nerve/muscle integration to be most discussed amongst end-users and regulators. Of these four methods, greater device control versus invasiveness of implant is a clear benefit-risk tradeoff. Conclusion: This scan highlights a gap in user-centered research in upper limb prosthetic devices. Future directions include the development of a stated-preference instrument incorporating these methods of integration. Expert opinion: Upper limb loss greatly impacts one's productivity and quality of life. Despite a variety of prosthetic device options, high user dissatisfaction and rejection rates persist. Using community-based participatory research practices, we engaged end-users and identified the importance of option value. Many individuals said they would forego a present-day option to maintain the opportunity to adopt a device in the future, a point not addressed in the literature. Of the four emerging integration methods identified, targeted muscle reinnervation and peripheral nerve/muscle integration are highly promising, yet a better understanding of end-user preferences for these methods is still needed.