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| Name | Class |
|---|---|
| Stanford University | OTHER |
| Aalborg University Hospital | OTHER |
| Göteborg University | OTHER |
| Hospital Universitario La Paz |
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This study has been designed to document the long-term outcome of the E1® Tibial Bearings used with the Vanguard® Knee System in 500 patients receiving total knee arthroplasty. All patients will receive the E1® Tibial Bearing in a Vanguard® knee replacement. Radiographic analysis and patient reported outcomes will be used as follow-up measures to track wear, mechanical performance, and patient satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E1 Tibial bearing | Experimental | All patients undergoing primary total knee replacement surgery will receive a tibial bearing made of E1 polyethylene, which is the material being monitored in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total knee arthroplasty | Procedure | Primary total knee arthroplasty surgery for the treatment of osteoarthritis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survivorship, as determined by the implant remaining within the patient. | 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Bragdon, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| OTHER |
| Hvidovre University Hospital | OTHER |
| Seoul National University Hospital | OTHER |
| Ulsan University Hospital | OTHER |
| Sydney Private Hospital, Australia | UNKNOWN |
| Kennedy Center at Ascension Mercy Hospital | OTHER |
| Southern Joint Replacement Institute | UNKNOWN |
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| D012216 |
| Rheumatic Diseases |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |