NCT02219230

Use of Passive, Adaptive, and Active Prosthetic Knees in Persons With Unilateral, Transfemoral Amputation

Outcomes Associated With Use of Passive, Adaptive, and Active Prosthetic Knees in Persons With Unilateral, Transfemoral Amputation: a Randomized Crossover Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goals of this study are to assess measured, observed, and self-reported outcomes achieved through the use of passive (mechanical), active(motorized) and adaptive (magnetorheological) prosthetic knee control systems in individuals with unilateral, transfemoral amputation.

Detailed description

An interrupted time-series trial with pre/post baseline assessments, randomized crossover of interventions, and within-phase repeated measures is used to evaluate and compare the effectiveness of the Össur Power Knee II and the Össur Rheo Knee in individuals with unilateral, transfemoral amputation. A rigorous and clinically-meaningful experimental protocol is applied to verify study participants receive appropriate training, experience, and assessment in each knee condition. A suite of standardized and ad-hoc physical performance tests, patient-reported questionnaires, and monitoring technologies were carefully selected to assess important, clinically-relevant participant outcomes. Comparative effectiveness of three prosthetic knee interventions are evaluated using direct measurement (i.e., timed tests), observed clinical ratings (i.e., subjective assessments of gait quality) and self-report instruments (i.e., health status surveys). Analyses will focus on identifying differences between control system technologies inherent to each type of prosthetic knee (i.e., passive \[mechanical\], adaptive \[magnetorheological\], and active \[power\]). Outcomes will be used to establish recommendations for which activities and patients knees are most appropriate or likely to produce a desired effect.

Conditions

• Transfemoral Amputation

Interventions

Type	Name	Description
DEVICE	Active knee (Ossur Power Knee II)	Prosthetic knee with active control system.
DEVICE	Adaptive knee (Ossur Rheo)	Prosthetic knee with adaptive control system.
DEVICE	Passive knee (Various manufacturers)	Prosthetic knee with mechanical control system.

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2014-08-18
• Last updated: 2015-12-28

Locations

1 site across 1 country: United States