Long Term Foundation Knee Study

Completed

Conditions studied: Total Knee Replacement

In brief

The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes data on patients who received the cruciate-retaining Foundation Knee system during or prior to the year 2000.

Key facts

Study ID

NCT01274546

Run by

Encore Medical, L.P.

People needed

43

Starts

2010-08-01

Expected to finish

2012-07-01

Last updated by the study team

2012-08-07

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject must have received a cruciate-retaining Foundation Knee system during or prior to the year 2000.
• Surgery must have been a primary knee replacement.
• Subject must have received only one primary knee replacement per hospitalization
• Subject must have had a primary diagnosis of osteoarthritis of the operative knee.
• Subject is able and willing to sign the informed consent document

You may not qualify if…

• Subject must not have had any previous knee implants (unicondylar or total joint replacements)
• Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
• Subject is a prisoner

Where it is running

• Study site — Scottsdale, Arizona, United States
• Charleston Orthopaedic Assoc. — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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