Comparison of Prosthetic Knee Performance During Sitting and Standing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00421356
Recruitment Status : Completed
First Posted : January 12, 2007
Last Update Posted : August 6, 2010
Information provided by:
University of South Florida

Brief Summary:
The Ossur Prosthetic Power Knee claims to assist in helping people with transfemoral amputation to walk up stairs and stand up from sitting. We expect to find that this product has the ability to help unload the sound knee during these tasks. We plan to collect force and motion data while people stand up from a chair. We will compare the data from people using several types of prosthetic knees, including the power knee as well as from people who are not amputees to see what the force and motion contributions are from the different knees evaluated.

Condition or disease

Study Type : Observational
Estimated Enrollment : 35 participants
Time Perspective: Prospective
Official Title: Kinetic and Kinematic Comparison of Power Assisted Versus Stance Control Artificial Knees During Sit To Stand
Study Start Date : January 2007
Actual Study Completion Date : February 2009

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Persons with Transfemoral Amputation

Inclusion Criteria:

  • 7 control subjects with normal lower extremity function: mentally independent adults with intact extremities. These individuals shall have no significant medical history that would impair their ability to perform 3, repeated, sit to stand trials. Exclusionary examples might include history positive for total joint arthroplasty of the hip or knee and significant cardiomyopathy. Control subjects will be non-amputee, generally healthy individuals, mentally capable of providing informed consent. They will have no significant medical history that could be perceived by investigators to hinder the ability to transfer. Anyone not meeting these criteria cannot be a control subject.
  • 28 subjects with unilateral amputation at the level of the thigh. 7 each in four groups:

    1. Active Extension Group: Power Knee
    2. Microprocessor Stance Control Group: C-Leg, Rheo, Adaptive
    3. Non-Microprocessor Stance Control Group: Mauch, Catech or other stance control units
    4. Non-Microprocessor and Non-Stance Control units: WASB, polycentrics, pneumatics Each subject must have a prosthesis for which they have had for a minimum of 90 days in its present condition.
  • All subjects must be:

    1. at least 21 years of age,
    2. mentally independent, and
    3. able to give informed consent.

Exclusion Criteria:

  • Subjects are not candidates if they:

    1. are under 21 years of age
    2. are mentally dependent and unable to provide their own informed consent
    3. have worn the present prosthesis for less than 90 days in the current condition
    4. have bilateral amputation
  • Subjects with an amputation are not candidates if they only use a prosthesis for transfers or therapy (K0 or K1 Medicare functional class). They must be independently ambulatory, at some level in the community (Medicare functional class "K2-K4"). They are furthermore not a candidate for this study if they have bilateral amputation (at any level) of the lower extremity as the purpose is to determine sound versus involved side loading, then against control. If all of the latter criteria are satisfied, the final piece is the 90 day prosthetic accommodation period. Candidacy then hinges upon the fact that they are accommodated to their current prosthesis as evident by having worn the current device, unaltered for the 90 days prior to testing.

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 identifier (NCT number): NCT00421356

United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
Sponsors and Collaborators
University of South Florida
Principal Investigator: M. Jason Highsmith, DPT, CP USF School of Physical Therapy & Rehab Sciences

Responsible Party: M. Jason Highsmith-PI, University of South Florida Identifier: NCT00421356     History of Changes
Other Study ID Numbers: 104850
US DOE RSA Award # H235J050020
First Posted: January 12, 2007    Key Record Dates
Last Update Posted: August 6, 2010
Last Verified: April 2007

Keywords provided by University of South Florida:
amputation, transfemoral, lower extremity, prosthetic knee