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The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment, clinical outcomes and survivorship.
This investigation is being conducted on a new complete revision knee system, Vanguard 360, which incorporates:
The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment, clinical outcomes and survivorship.
The efficacy and performance of the devices will be assessed by improvement of pain, function, range of motion and patient satisfaction measured pre-operatively and post-operatively. Secondary performance and safety will be determined by radiographic investigation, incidence of complications and revision rates.
Surgical techniques and patient care are to be standard for the surgeon participating in the protocol. There will be no experimental or investigational devices used. There will be no experimental or investigational surgical techniques used. The devices and products will be used in accordance with their instructions for use and/or approved labeling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vanguard SSK 360 with PS Bearing | Patients enrolled using a Vanguard SSK 360 Posterior-Stabilized (non-constrained) tibial bearing. |
| |
| Vanguard SSK 360 with PSC Bearing | Patients enrolled using a Vanguard SSK 360 Posterior-Stabilized Constrained tibial bearing. |
| |
| Vanguard DA 360 | Patients enrolled using a Vanguard DA 360 component. |
| |
| Vanguard 360 TiNbN Femur with PS Bearing | The Vanguard 360 TiNbN is the same system and functions in the same manner as the non-coated device. |
| |
| Vanguard 360 TiNbN Femur with PSC Bearing | The Vanguard 360 TiNbN is the same system and functions in the same manner as the non-coated device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vanguard SSK 360 with PS Bearing | Device | non-constrained tibial bearing |
|
| Measure | Description | Time Frame |
|---|---|---|
| AMERICAN KNEE SOCIETY KNEE SCORE | Improvement of American Knee Society Knee Score between pre-operative and 2 years post-operative follow up | 24 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Survivorship | Survivorship at 10 years post-operative follow up | 10 years postoperative |
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Inclusion Criteria:
Exclusion Criteria:
Relative Contraindications:
Additional research-related exclusion criteria: patients who have a history of or current infection in the affected knee.
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Patients prescribed the Vanguard 360 Revision Knee System
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| Name | Affiliation | Role |
|---|---|---|
| Emilie Rohmer | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Illinois Bone and Joint | Morton Grove | Illinois | 60053 | United States | ||
| Orthopedic Institute of Henderson |
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| Vanguard SSK 360 with PSC bearing | Device | constrained tibial bearing |
|
| Vanguard DA 360 | Device | Dual-articulation device, only cleared in EU |
|
| Vanguard 360 TiNbN Femur with PS bearing | Device | non-constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur |
|
| Vanguard 360 TiNbN Femur with PSC bearing | Device | constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur |
|
| Henderson |
| Nevada |
| 89052 |
| United States |
| University of Utah Orthopedic Center | Salt Lake City | Utah | 84108 | United States |
| OrthoVirginia West End Orthopedic Clinic | Richmond | Virginia | 23235 | United States |
| University Hopital Pellenberg | Pellenberg | Belgium |
| Aarhus university hospital | Aarhus | Denmark |
| Ch Lyon Sud | Lyon | 69000 | France |
| Klinik fur Endoprothetik und gelenkchirurgie | Bad Wildbad | Germany |
| IRCCS Istituto Ortopedico Galeazzi | Milan | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Italy |
| University Hospital Mutua de Terrasa | Terrassa | Spain |
| Royal Orthopaedic Hospital | Birmingham | B31 2AP | United Kingdom |
| 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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