Status:
COMPLETED
Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
American Orthotic and Prosthetic Association
Conditions:
Lower Limb Amputation Above Knee (Injury)
Eligibility:
All Genders
55+ years
Phase:
NA
Brief Summary
This study will assess if the functional performance and musculoskeletal outcome of transfemoral amputees are improved after receiving a Microprocessor Knee (MPK) compared to a Non-Microprocessor Knee...
Detailed Description
The study design is a reversal design whereby only the prosthetic knee joint will be changed. Each subject will be tested using their current NMPK, fit and tested with a MPK, and then tested again wit...
Eligibility Criteria
Inclusion
- Unilateral transfemoral amputee
- Medicare Functional Classification Level K2 or K3
- Currently using NMPK prosthesis
- No current residual limb problems, such as skin breakdown
- Able to ambulate without a gait aid
Exclusion
- Previous stroke or other neuromuscular complications currently affecting gait
- Currently undergoing dialysis treatments
- Amputation of the contralateral limb
- Poor fit of current NMPK prosthesis
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02240186
Start Date
June 1 2014
End Date
December 1 2017
Last Update
December 12 2018
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905