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Could not find interested researchers/clinicians to complete study protocol.
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The purpose of this study is to compare the performance of two FDA-cleared tibial bearings (replacement for cartilage in the knee) by collecting data on patients through 3 years of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Posterior Stabilized | Other | Patients who received a PS (Posterior Stabilized) Tibial Bearing. |
|
| Anterior Stablized | Other | Patients who received an AS (Anterior Stabilized) Tibial Bearing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vanguard Knee System with AS Bearing | Device | FDA cleared Tibial bearing that stabilizes the knee with an anterior lip, and is used with FDA cleared Vanguard CR (Cruciate Retaining) Femoral Component. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Knee Score | Average objective knee score; includes a combination of range of motion and pain scores. | 1 Year Post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Score | Average total knee score. Includes the objective and functional aspects of the knee score. | 3 Years |
| Dislocation | Rate of Dislocation as reported by patients in a complication. |
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Inclusion Criteria are identical to the indications stated in the FDA approved labeling for the device 510(k) K023546, K033489, and K050222. These indications are stated below:
Patient selection factors to be considered include:
Exclusion criteria will be identical to the contraindications stated in the FDA approved labeling for the device 510(k) K023546, K033489, and K050222.
These contraindications are stated below:
-Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement.
Relative contraindications include:
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| Name | Affiliation | Role |
|---|---|---|
| Ken Beres, MD | Biomet (no investigators were selected for this study) | Study Director |
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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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| Vanguard Knee System with PS Bearing | Device | FDA cleared Tibial bearing that stabilizes the knee with a post that articulates with the FDA cleared Vanguard PS(Posterior Stabilizing) Femoral Component. |
|
| 3 Years |
| Survivorship | Reports surivival of implant. | 3 Years |
| Reports of Radiographic Loosening via Complication Form | A more specific survivorship element; will indicate rate of loosening if it occurs. | 3 Years |