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OpenTrials
Completed

NCT Number: NCT00421356

Comparison of Prosthetic Knee Performance During Sitting and Standing

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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Key information

Conditions

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of South Florida

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: Yes

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

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:
  • Active Extension Group: Power Knee
  • Microprocessor Stance Control Group: C-Leg, Rheo, Adaptive
  • Non-Microprocessor Stance Control Group: Mauch, Catech or other stance control units
  • 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:
  • at least 21 years of age,
  • mentally independent, and
  • able to give informed consent.

Exclusion criteria

  • Subjects are not candidates if they:
  • are under 21 years of age
  • are mentally dependent and unable to provide their own informed consent
  • have worn the present prosthesis for less than 90 days in the current condition
  • 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.

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Official study title

Kinetic and Kinematic Comparison of Power Assisted Versus Stance Control Artificial Knees During Sit To Stand

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jan 12, 2007
Registry last updated
Dec 14, 2023

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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