RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-01
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06218238

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.

Ages Eligible for Study:45 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Unilateral, transfemoral amputation (any etiology).
  2. * Age from 45-75 years.
  3. * Residual limb length classified as standard (i.e., medium) to long.
  4. * Prosthesis user for at least 1 year prior to enrolling in the study.
  5. * K3 or K4 level ambulator.
  6. * Good sensation on their residual limb(s) (upon routine clinical examination).
  7. * Good skin integrity upon visual inspection.
  8. * Does not require the use of assistive devices to walk for short distances.
  9. * Not currently taking medications that are known to affect balance or gait.
  10. * Presents with good socket fit based upon a standard assessment by the study prosthetist.
  1. * Bilateral amputations
  2. * Individuals with a knee disarticulation

Contacts and Locations

Study Contact

Rebecca Stine, MS
CONTACT
(312) 503-5726
rebecca.stine@va.gov
Steven A Gard, PhD
CONTACT
(312) 238-6525
steven.gard@va.gov

Principal Investigator

Steven A Gard, PhD
PRINCIPAL_INVESTIGATOR
Jesse Brown VA Medical Center, Chicago, IL

Study Locations (Sites)

Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, 60612
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Steven A Gard, PhD, PRINCIPAL_INVESTIGATOR, Jesse Brown VA Medical Center, Chicago, IL

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 Registration Dates

Study Start Date2024-04-01
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2024-04-01
Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

  • amputation
  • limb loss
  • limb deficiency
  • transfemoral
  • above-knee
  • prosthesis
  • knee joint

Additional Relevant MeSH Terms

  • Transfemoral Amputation
  • Limb Loss
  • Limb Absence