Patient Perspectives on Osseointegration: A National Survey of Veterans with Upper Limb Amputation

Abstract

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 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.

Emerging Value of Osseointegration for Intuitive Prosthetic Control after Transhumeral Amputations: A Systematic Review

“…Ultimately, a better fitting of the osseointegrated prosthesis resulted in better patient satisfaction and integration of the prosthetic device into the daily life activities, as reported by all eight studies included in this review. Moreover, a recent patient perspective study by Resnik et al 27 reported that more than 20% of patients with unilateral amputations are willing to consider OI surgery to gain better prosthetic control. The results of the included studies do not only emphasize a more durable and reliable fixation of the prosthetic device compared with the conventional socket fitting but also report on the improvement in terms of comfort from the patients’ perspective.…”

Prosthesis preferences for those with upper limb loss: Discrete choice study of PULLTY® for use in regulatory decisions

“…40 Finally, in a large study in Veterans with a diagnosis of major upper limb amputation who were surveyed by telephone indicated that about 41% of amputees would consider surgery to restore a sense of touch, while 49% indicated they would consider surgery to gain more movement control. 41 Our study is informed by these studies, but unique in using choice based conjoint analysis to ask those with ULL to directly weigh the risks and benefits of osseointegration and myoelectric control choices. We found that patients preferred complete independence in cooking dinner above all other positive attributes which likely reflects their desire for independence in their daily life tasks.…”

“… 40 Finally, in a large study in Veterans with a diagnosis of major upper limb amputation who were surveyed by telephone indicated that about 41% of amputees would consider surgery to restore a sense of touch, while 49% indicated they would consider surgery to gain more movement control. 41 …”

Toward higher-performance bionic limbs for wider clinical use

“…Although preliminary long-term assessments have indicated improved quality of life for individuals who have undergone osseointegration 45 , large-scale cohort studies with long follow-up periods are needed to assess the safety and performance outcomes of the procedure. A survey of the veteran population in the on United States reported that only 28% of unilateral limb amputees and 13% of bilateral upper-limb amputees would consider osseointegration rather than traditional fixation of the device via a conventional socket or refraining from using any prosthesis 46 .…”