OBJECTIVES : Understand patient’s preferences for an osseointegration device for attachment of their lower limb prosthetic to assist in decision making for FDA device approval.

METHODS : Sixty five adults with lower limb loss completed a choice-based conjoint survey. Patient and clinical expert interviews were conducted for selection and definition of attributes of risk: treatable infection, complete device failure, chance of daily pain, time without prosthetic, activity limitations and of benefit: improved motion and fatigue, limb perception, and avoiding socket problems. The survey consisted of 20 pairs of prosthetic choices created using a random, full profile, balanced overlap design via Sawtooth Software. Beta coefficients were calculated using a mixed effects regression model to determine most and least important attributes to inform our survey attribute choice for a larger follow-up study.

RESULTS : Respondents showed the strongest negative preferences were for risks of treatable infection (β = -1.69, p<0.001) and complete device failure (β = -1.49, p<0.001) (the biggest risks associated with osseointegration) and also chance of daily pain (β = -1.54, p<0.001) (which osseointegration can decrease). There was no significant preference for improved motion and fatigue allowed with osseointegration. Also important was avoiding time spent without use of their device (β = -0.989, p<0.001). In preliminary sub-group analysis, men favored avoiding socket problems much more than women who valued a greater sense of limb perception.

CONCLUSIONS : Patients showed strong negative preferences for the major risks of the osseointegration procedure. The importance shown avoiding time without their prosthetic will be important as approval decisions are made for the riskier one stage instead of two stage surgical procedure, allowing faster time to weight bearing. A larger study will explore more differences across gender and other patient characteristics.