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Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees (MPK-AOPA)

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ClinicalTrials.gov Identifier: NCT02240186
Recruitment Status : Completed
First Posted : September 15, 2014
Results First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Collaborator:
American Orthotic and Prosthetic Association
Information provided by (Responsible Party):
Kenton R. Kaufman, Ph.D., Mayo Clinic

Study Description
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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).

Condition or disease Intervention/treatment Phase
Lower Limb Amputation Above Knee (Injury) Device: Microprocessor Knee (MPK) Device: Non-Microprocessor Knee (NMPK) Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees
Actual Study Start Date : June 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Arms and Interventions
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Arm Intervention/treatment
Experimental: Prosthetic knee joints
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)
MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.

Device: Non-Microprocessor Knee (NMPK)
A NMPK is a mechanical knee with either hydraulic or pneumatic controls.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) [ 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 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.



Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02240186


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
American Orthotic and Prosthetic Association
Investigators
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Principal Investigator: Kenton R Kaufman, PhD Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Kenton R. Kaufman, Ph.D., Mayo Clinic:
Study Protocol and Statistical Analysis Plan  [PDF] September 1, 2014

More Information
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Publications of Results:

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Responsible Party: Kenton R. Kaufman, Ph.D., Professor of Biomedical Engineering, College of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02240186    
Other Study ID Numbers: 14-002930
Foundation ( Other Grant/Funding Number: American Orthotic and Prosthetic Association )
First Posted: September 15, 2014    Key Record Dates
Results First Posted: December 12, 2018
Last Update Posted: December 12, 2018
Last Verified: December 2018
Keywords provided by Kenton R. Kaufman, Ph.D., Mayo Clinic:
Microprocessor-controlled knee
prosthesis
amputation