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CompletedNCT00421356Updated Dec 14, 2023

Comparison of Prosthetic Knee Performance During Sitting and Standing

An observational study in Amputation, sponsored by University of South Florida. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-14.

Sponsored by University of South Florida · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
28
Ages
21 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Amputation

Keywords

  • amputation, transfemoral, lower extremity, prosthetic knee
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In context

Lead sponsor

University of South Florida is the lead sponsor of 333 studies on the registry; 63 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
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

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.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
28 participants (actual)

Groups and cohorts

  • Transfemoral Power Knee group

    Transfemoral amputees who used the power assisted Ossur Power Knee who used the knee daily without adjustments for at least 90 days prior to the study.

  • Transfemoral C-Leg knee group

    Transfemoral amputees who used the stance control Otto Bock C-Leg who used the knee daily without adjustments for at least 90 days prior to the study.

  • Transfemoral Mauch knee group

    Transfemoral amputees who used the mechanical fluid controlled Mauch Swing and Stance Knee who used the knee daily without adjustments for at least 90 days prior to the study.

  • Non amputee control group

    Healthy, non-amputee control group

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Study locations

1 site
  • University of South Florida
    Tampa, Florida 33612, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00421356
Lead sponsor
University of South Florida
Responsible party
Jason Highsmith (Assistant Professor, University of South Florida) — Principal investigator
First posted
Jan 12, 2007
Start date
Jan 2007
Primary completion
Sep 30, 2010
Completion
Nov 30, 2010
Last update
Dec 14, 2023

Study contacts

M. Jason Highsmith, DPT, CP
principal investigator · USF School of Physical Therapy & Rehab Sciences
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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