Scientific Publications by FDA Staff

PM R 2019 Dec;11(12):1261-71

Patient perspectives on osseointegration: a national survey of veterans with upper limb amputation.

Resnik L, Benz H, Borgia M, Clark MA

INTRODUCTION: Osseointegrated (OI) prostheses have a unique benefit-risk profile among prosthetic alternatives and have been marketed in the United States under a Humanitarian Device Exemption since 2015. Information about upper limb prosthesis user perspectives on benefits and risks, prosthesis-user subpopulations for whom OI is most acceptable, and outcomes that matter most to patients could help inform clinical and regulatory decision-making. Recent 21st Century Cures legislation expanded the role of patient experience data in the decision-making process of the U.S. Food and Drug Administration, recognizing that patient perspectives may be informative to regulators. OBJECTIVE: To better understand prosthesis user perspectives about the benefits and risks associated with upper limb OI prostheses. DESIGN: Patient perspective survey. SETTING: Telephone administration. PARTICIPANTS: National sample of veterans with upper limb loss. INTERVENTIONS: NA MAIN OUTCOME MEASURES: Benefit-risk survey developed for this study. RESULTS: Twenty-eight percent of unilateral and 13% of bilateral amputees were willing to consider osseointegration surgery. Multivariate logistic regression models [OR; 95% CI] showed that transhumeral amputation level [OR 1.40; 1.01-1.98] was associated with greater willingness to consider surgery, whereas older age [OR 0.17; 0.09-0.32] and higher VR-12 Mental Component Summary [OR 0.53; 0.35-0.81] were associated with less willingness. Having a durable/reliable device, the ability to do more activities, and having a comfortable device were rated as very important or somewhat important by 98% or more for every risk condition. CONCLUSIONS: Persons who were older, had transradial amputation (compared to transhumeral), and those who had better mental functioning were less willing to consider this surgery. Respondents who were willing to consider surgery indicated that the most important potential benefits were obtaining a durable/reliable device, the ability to do more activities, and having a comfortable device. Most were willing to accept one or more risks of surgery, with long-term risks including chronic pain, loss of nerve function, or device failure considered the most unacceptable. LEVEL OF EVIDENCE: III.