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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "In Office" | These subjects will come into the office to perform the consenting process, and complete all evaluations required at the only visit in the study. |
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| "Telephone Arm" | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cruciate-retaining Foundation Knee system | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The study will include only subjects who received the cruciate-retaining Foundation Knee System during or before the year 2000 and who voluntarily consent to take part in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Richard J Friedman, M.D. | Charleston Orthopedic Association | Principal Investigator |
| Joseph A Longo III, M.D. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale | Arizona | 85251 | United States | |||
| Charleston Orthopaedic Assoc. |
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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 |
| Charleston |
| South Carolina |
| 29414 |
| United States |