An enhancement of the Genium™ microprocessor-controlled knee improves safety and different aspects of the perceived prosthetic experience for unilateral and bilateral users.

The study was not randomized or blinded, and the primary goal was product feasibility rather than efficacy testing. The sample size was small (25 participants) and not based on a power calculation, making it underpowered for detecting differences in secondary outcomes. Participants were already high-functioning (Medicare Functional Classification Level K2-K4) and experienced with the device, leaving little room for improvement in standard functional measures. The comparative ADL questionnaire relied on participants recalling their experience with their old knee while concurrently rating the new knee, which introduces recall bias. Key findings for pain and comfort improvements were driven by the unilateral group, while the bilateral group's improvements were primarily in perceived ease and safety of ADLs.

The study was funded by Ottobock Healthcare Products GmbH, the manufacturer of the knees being tested. Authors declared financial support for research, authorship, and/or publication.

Do not interpret the significant reduction in stumbles and pain as evidence of improved objective mobility or balance. The standard validated measures (L-Test, PLUS-M, ABC) showed no significant change. The improvements in daily living for bilateral users were subjective and may be influenced by the lack of blinding and the comparative nature of the questionnaire.