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Completed

NCT Number: NCT02240186

Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees

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).

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Key information

Conditions

Lower Limb Amputation Above Knee (Injury) Wounds and Injuries

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microprocessor Knee (MPK)

Device

MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.

Non-Microprocessor Knee (NMPK)

Device

A NMPK is a mechanical knee with either hydraulic or pneumatic controls.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • American Orthotic and Prosthetic Association

Registry information

Acronym: MPK-AOPA

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 15, 2014
Registry last updated
Dec 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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