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Study to collect outcomes data for patients who are undergoing an Exactech Optetrak® primary total knee replacement using the Exactech Guided Personalized Surgery (eGPS®) manufactured or distributed by (Exactech, Gainesville, Florida, USA).
The purpose of this study is to collect patient outcomes data for patients who are undergoing an Exactech Optetrak® primary total knee replacement using the Exactech Guided Personalized Surgery (eGPS®) manufactured or distributed by (Exactech, Gainesville, Florida, USA). Patient outcomes data are important for assessing the post-market safety and effectiveness of orthopedic medical devices.
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| Measure | Description | Time Frame |
|---|---|---|
| Hospital for Special Surgery knee score (HSS) | total score, pain, function | 24 Months |
| Oxford Knee Score (OKS) | function, pain | 24 Months |
| Knee Society Score (KSS) | total score, pain, function | 24 Months |
| Knee injury and Osteoarthritis Outcome Score (KOOS) | total score and subscales | 24 Months |
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Exclusion Criteria:
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One hundred (100) subjects enrolled up to 4 sites. All subjects will be screened, enrolled and evaluated prospectively and be followed for up to two years. In the event a subject is enrolled and does not have surgery, additional patients may be screened and enrolled to reach the 100 subjects.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Exatech, Inc. | Gainesville | Florida | 32653 | United States |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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