Comparison of Prosthetic Knee Performance During Sitting and Standing

NCT00421356 | Completed

• 2 other identifiers: 104850US DOE RSA Award # H235J050020
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation

Keywords

amputation, transfemoral, lower extremity, prosthetic knee

Study Arms (4)

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

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Persons with Transfemoral Amputation

You may qualify if:

• 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.

You may not qualify if:

• 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 & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

Location

Study Officials

• M. Jason Highsmith, DPT, CP

  USF School of Physical Therapy & Rehab Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 10, 2007
• First Posted: January 12, 2007
• Study Start: January 1, 2007
• Primary Completion: September 30, 2010
• Study Completion: November 30, 2010
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

US (1)