Total Knee Replacement
Conditions
Brief summary
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.
Interventions
DEVICEcruciate-retaining Foundation Knee system
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.
Sponsors
Encore Medical, L.P.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survivorship of the Device | Single visit | The subject meets the inclusion/exclusion of the study and has a Foundation Knee that has survived without revision to date. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Form - 36 | Single Visit | SF-36 quality of life assessment questionnaire. |
| Oxford Knee Score Assessment | Single visit | Questionnaire |
| Knee Society Score Evaluation | Single visit | 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. |
| Range of Motion | Single visit | Physician measurements of the subjects range of motion on the operated knee. |
| Radiographic failure | Single visit | 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. |
| WOMAC Osteoarthritis Index | Single visit | Questionnaire |
Countries
United States
Outcome results
None listed