Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees

Conditions
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Lower Limb Amputation Above Knee (Injury)

Intervention / Treatment
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* Device: Microprocessor Knee (MPK)
* Device: Non-Microprocessor Knee (NMPK)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prosthetic knee joints<br>Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design. | Device: Microprocessor Knee (MPK)<br>* MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.<br>Device: Non-Microprocessor Knee (NMPK)<br>* A NMPK is a mechanical knee with either hydraulic or pneumatic controls.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Activity Measured With Triaxial Accelerometers | 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. | 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) | 
| Falls as Assessed by the Prosthesis Evaluation Questionnaire Addendum (PEQ-A) | 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. | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | The condition-specific Prosthesis Evaluation Questionnaire (PEQ) was used to quantify patient satisfaction with each prosthesis. The outcome was a difference in PEQ scores between the NPMK and MPK measurements. The PEQ is a self-administered questionnaire composed of nine validated scales (ambulation, appearance, frustration, perceived response, residual limb health, social burden, sounds, utility, well being). Scores range from 0 to 100 for each sub-scale. Higher scores indicated a higher functioning prosthesis/quality of life. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microprocessor-controlled knee, prosthesis, amputation