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The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguardâ„¢ Complete Knee System.
This is a 10-year prospective observational data collection on the Vanguard Total Knee system. Patients are asked to come in for a preop, operative, immediate post-operative, 6 Month, 1 Year, 3 Year,5 Year, 7 year, and 10 year visits to check on the function, range of motion, and radiographic assessment of their total knee device.
The Vanguard Knee is an FDA cleared device, and has been on the market since 2004.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vanguardâ„¢ Complete Knee System | Vanguard Total Knee System, Cruciate-Retaining (CR) or Posterior-Stabilized (PS) |
| |
| Vanguardâ„¢ Patient-Specific Femur | Vanguard Total Knee System used in combination with Signature technique to provide a patient-specific femur |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vanguardâ„¢ Complete Knee System | Device | Primary Total Knee System, Cruciate-Retaining (CR) or Posterior-Stabilized (PS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| KSS | Knee Society Score Assessment | 10 year |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Information | Radiographic Evaluation Report | 10 years |
| Survivorship | Knee Society Score Assessment | 10 years |
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Inclusion criteria:
Patient selection factors to be considered include:
Exclusion criteria:
Absolute contraindications include:
Relative contraindications include:
Additional exclusion criteria includes: failure of a previous joint replacement
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Patients in need of relief from painful or disabling joint disease
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| Name | Affiliation | Role |
|---|---|---|
| Kacy C Arnold, RN MBA | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physicians Clinic of Iowa Orthopedics | Cedar Rapids | Iowa | 52403 | United States | ||
| The Orthopaedic Center |
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| Vanguardâ„¢ Patient-Specific Femur | Device | Primary Total Knee System used with Signature technique to provide a patient-specific femur |
|
|
| Rockville |
| Maryland |
| 20850 |
| United States |
| Advanced Orthopedic Specialists | Cape Girardeau | Missouri | 63701 | United States |
| Orthopaedic Associates of Rochester | Rochester | New York | 14626 | United States |
| Texas Orthopedic Specialists | Grapevine | Texas | 76015 | United States |
| Orthopedic Associates | Fishersville | Virginia | 22939 | United States |
| Spokane Orthopedics | Spokane | Washington | 99207 | United States |
| Othopaedic & Sports Medicine Clinic of Monroe | Monroe | Wisconsin | 53566 | United States |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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