Identifying the benefits and risks of emerging integration methods for upper limb prosthetic devices in the United States: an environmental scan

ABSTRACT

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.

KEYWORDS:

• Upper-limb prostheses
• osseointegration
• targeted muscle reinnervation
• cortical integration
• peripheral nerve integration
• stated-preference methods

Acknowledgments

The authors sincerely thank the Community Advisory Board for their continued engagement and valuable contributions throughout this study.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This work was supported [in part] by a Center of Excellence in Regulatory Science and Innovation (CERSI) grant to Johns Hopkins University from the US Food & Drug Administration U01FD005942. The purpose of this funding is to enhance regulatory science through a unique FDA-Academic partnership. The statements in this work are solely the responsibility of the authors and do not necessarily represent the official views of the HHS or FDA.