Prospective two group cross over investigation, comparing the investigational device (Power Knee, a powered microprocessor controlled prosthetic knee) and subjects prescribed microprocessor prosthetic knee (MPK). The primary objective was to evaluate the efficacy of the investigational device in reducing exertion during walking compared to passive MPKs. Additionally to evaluate the efficacy of the investigational device in the short and long term compared to passive MPKs and previous versions of the Power Knee, during daily living activities i.e. walking on level ground, in stairs and inclines, rising from and sitting down to a chair as well as performance of gait functions and ease of set up for average to highly active transfemoral/knee disarticulation amputees and Certified Prosthetists/Orthotists (CPOs).
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Mean Difference in Borg Category Rating Scale Before and After 6MWT at 2 Weeks
Timeframe: At baseline, after 2 weeks of either using the Power knee or their own prescription prosthesis, and at the fourth follow-up (at approximately weeks 22-16)
Average Distance Walked in 6 Minute Walk Test
Timeframe: At baseline, after 2 weeks of either using the Power knee or their own prescription prosthesis, and at the fourth follow-up (at approximately weeks 22-16)