Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lower Limb Amputation Above Knee (Injury)
- Sponsor
- Mayo Clinic
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Daily Activity Measured With Triaxial Accelerometers
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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 Knees (NMPK).
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 with their NMPK. MPK prostheses from all manufacturers will be considered appropriate for testing. Each MPK to be used in this study is FDA approved. The foot will be in the L5981 class, e.g. flex foot or equivalent. The same socket, suspension, and foot will be used throughout the study in order to eliminate these confounding variables. All prosthesis fittings will be performed by the subject's own certified prosthetist according to manufacturers' fitting guidelines.
Investigators
Kenton R. Kaufman, Ph.D.
Professor of Biomedical Engineering, College of Medicine
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •Previous stroke or other neuromuscular complications currently affecting gait
- •Currently undergoing dialysis treatments
- •Amputation of the contralateral limb
- •Poor fit of current NMPK prosthesis
Outcomes
Primary Outcomes
Daily Activity Measured With Triaxial Accelerometers
Time Frame: Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)
Measurements will be obtained three times using activity monitors attached to waist, and bilaterally to the ankle and thigh for a period of 4 consecutive days, including 2 weekdays and 2 weekend days. Primary outcome will be the difference in activity level between the NMPK and MPK measurements.
Falls as Assessed by the Prosthesis Evaluation Questionnaire Addendum (PEQ-A)
Time Frame: Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)
The Prosthesis Evaluation Questionnaire (PEQ) addendum (PEQ-A) is a self-administered questionnaire to quantify balance confidence, concentration, stumbles, and falls. The outcome will be difference in falls per month between the Non-Microprocessor Knee (NPMK) and MPK measurements. The number of falls was recorded as the sum of items #5 and #7 in the PEQ-A.
Secondary Outcomes
- Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ)(Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time))