Comparison of Prosthetic Knee Performance During Sitting and Standing

Amputation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00421356
• Other study ID #: 104850
• Secondary ID: US DOE RSA Award
• Status: Completed
• Start date: January 2007
• Est. completion date: November 30, 2010

Study information

• Verified date: December 2023
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 30, 2010
• Est. primary completion date: September 30, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amputation

Locations

Country	Name	City	State
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States,