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

December 11, 2018 updated by: Kenton R. Kaufman, Ph.D., Mayo Clinic
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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)
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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

American Orthotic and Prosthetic Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

September 8, 2014

First Submitted That Met QC Criteria

September 11, 2014

First Posted (Estimate)

September 15, 2014

Study Record Updates

Last Update Posted (Actual)

December 12, 2018

Last Update Submitted That Met QC Criteria

December 11, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 14-002930
  • Foundation (Other Identifier: Ivy Foundation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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