RecruitingNot ApplicableNCT06218238

A Biomechanical Evaluation of the Ossur Power Knee in Persons With Transfemoral Amputation

Do Transfemoral Prostheses With Powered Prosthetic Knee Flexion and Extension Improve Mobility? A Biomechanical Evaluation of the Ossur Power Knee


Sponsor

VA Office of Research and Development

Enrollment

20 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Microprocessor-controlled knees (MPKs) do not typically utilize motors to power joint rotation, but they automatically adjust resistance or damping in the joint to improve swing- and/or stance-phase control as appropriate for the prosthesis user during gait. The Ossur Power Knee is the only commercially-available MPK that uses a motor to provide active power generation during walking and other activities. The purpose of this proposed investigation is to perform and compare biomechanical evaluations of the Power Knee and Ossur Rheo XC, a passive MPK, during walking and other activities by prosthesis users. Furthermore, mobility between male and female subjects will be compared to determine if there are differences in prosthetic knee usage on the basis of sex.


Eligibility

Min Age: 45 YearsMax Age: 75 Years

Inclusion Criteria10

  • Unilateral, transfemoral amputation (any etiology).
  • Age from 45-75 years.
  • Residual limb length classified as standard (i.e., medium) to long.
  • Prosthesis user for at least 1 year prior to enrolling in the study.
  • K3 or K4 level ambulator.
  • Good sensation on their residual limb(s) (upon routine clinical examination).
  • Good skin integrity upon visual inspection.
  • Does not require the use of assistive devices to walk for short distances.
  • Not currently taking medications that are known to affect balance or gait.
  • Presents with good socket fit based upon a standard assessment by the study prosthetist.

Exclusion Criteria2

  • Bilateral amputations
  • Individuals with a knee disarticulation

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Interventions

OTHERPowered prosthetic knee joint

Subjects will be fitted and trained on the Ossur Power Knee. An accommodation of 1 month will be provided prior to evaluation with the knee joint.

OTHERConventional prosthetic knee joint

Subjects will be fitted and trained on the Ossur Rheo XC Knee. An accommodation of 1 month will be provided prior to evaluation with the knee joint.


Locations(1)

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, United States

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NCT06218238


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