Long Term Foundation Knee Study

Study Overview
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Brief Summary
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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.

Official Title
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A Long-term, Multicenter Follow Up Study of the Cruciate-retaining Foundation Knee System

Conditions
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Total Knee Replacement

Intervention / Treatment
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* Device: cruciate-retaining Foundation Knee system


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| In Office<br>These subjects will come into the office to perform the consenting process, and complete all evaluations required at the only visit in the study. | Device: cruciate-retaining Foundation Knee system<br>* subjects who received the cruciate-retaining Foundation Knee system greater than or equal to 10 years ago and still maintain the original device in their knee.<br>|
| Telephone Arm<br>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. | Device: cruciate-retaining Foundation Knee system<br>* subjects who received the cruciate-retaining Foundation Knee system greater than or equal to 10 years ago and still maintain the original device in their knee.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship of the Device | The subject meets the inclusion/exclusion of the study and has a Foundation Knee that has survived without revision to date. | Single visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score Evaluation | The knee society score includes both a subjective and a function score. The subjective score includes pain, stability and range of motion. The function score includes values for walking distance and climbing stairs. | Single visit | 
| Short Form - 36 | SF-36 quality of life assessment questionnaire. | Single Visit | 
| Oxford Knee Score Assessment | Questionnaire | Single visit | 
| WOMAC Osteoarthritis Index | Questionnaire | Single visit | 
| Range of Motion | Physician measurements of the subjects range of motion on the operated knee. | Single visit | 
| Radiographic failure | Radiographic failure is defined as a shift in the position of the component >3mm or 3 degrees or a >2mm radiolucency completely around the prosthesis. | Single visit |