EFFECTS OF THE GENIUM KNEE SYSTEM ON FUNCTIONAL LEVEL, STAIR AMBULATION, PERCEPTIVE AND ECONOMIC OUTCOMES IN TRANSFEMORAL AMPUTEES.

Compared to non-microprocessor knees, the C-Leg microprocessor knee (MPK) is bioenergentically and economically more efficient and safer for transfemoral amputation (TFA) patients. The Genium MPK has demonstrated improvements in perceived function, knee kinematics, and physical functional performance compared to C-Leg. Clinical and health economic analyses have not been conducted with the Genium knee system. The purpose of this study was to determine if laboratory determined benefits of Genium are detectable using common clinical assessments and if there are economic benefits associated with its use. This study utilized a randomized AB crossover study with 60 d follow-up including cost-effectiveness analysis. Twenty TFA patients tested with both knees in mobility and preference measures. Incremental cost-effectiveness ratios (ICER) were calculated based on performance measures. Stair Assessment Index scores improved with Genium. Mean stair completion times and descent stepping rate were not different between knees. Stair ascent stepping rate for C-Leg was greater compared with Genium (p = 0.04). Genium use decreased Four square step test completion time and increased functional level and step activity (p ≤ 0.05). Further, Genium use improved (p ≤ 0.05) function and safety in three out of five Activities of Daily Living (ADL) survey domains. Finally, more subjects preferred Genium following testing. Functional measures were used to calculate ICERs. ICER values for Genium fall within established likely-to-accept value ranges. Compared with C-Leg, Genium use improved stair walking performance, multi-directional stepping, functional level, and perceived function. In this group of community ambulators with TFA, Genium was preferred, and, while more costly, it may be worth funding due to significant improvements in functional performance with ADLs.

RCT Entities:   Population Interventions Outcomes