Long Term Foundation Knee Study

Encore Medical

Status: Completed

Conditions: Total Knee Replacement

Treatments: Device: cruciate-retaining Foundation Knee system

Study type: Observational

Funder types: Industry

Identifiers

NCT01274546

PS-705

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

43 participants in 2 patient groups

"In Office"

Description:

These subjects will come into the office to perform the consenting process, and complete all evaluations required at the only visit in the study.

Treatment:

Device: cruciate-retaining Foundation Knee system

"Telephone Arm"

Description:

These subjects will be consented over the phone and give a verbal consent to participate. They will complete all aspects of the study over the phone except for the knee society score evaluation and the x-ray.

Treatment:

Device: cruciate-retaining Foundation Knee system