Status:
COMPLETED
Use of Passive, Adaptive, and Active Prosthetic Knees in Persons With Unilateral, Transfemoral Amputation
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Össur Iceland ehf
Conditions:
Transfemoral Amputation
Eligibility:
All Genders
45-75 years
Phase:
NA
Brief 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 kn...
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 ...
Eligibility Criteria
Inclusion
- age 45 - 75
- body weight less than 275lbs
- unilateral amputation between the hip and knee
- amputation due to non-vascular causes
- no other major limb amputations
- amputation occurred at least 2 years prior
- stable limb volume (i.e., at least 6 months on an unmodified prosthetic socket)
- intact skin tissue without open wounds or sores for at least 2 months
- physiologically stable medical condition (i.e., non-degenerative)
- possession and regular (i.e., daily) use of a prosthesis with a prosthetic knee with non-microprocessor (i.e., mechanical or fluid) stance control
- Medicare functional classification level (MFCL or "K-level") 3
Exclusion
- expect to receive or are expected to require a replacement prosthetic socket within 15 months
- complete reliance on an assistive device (i.e., cane or walker) for ambulation
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02219230
Start Date
June 1 2011
End Date
September 1 2013
Last Update
December 28 2015
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98195