A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

Study Overview
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Brief Summary
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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.

Detailed Description
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This investigation is being conducted on a new complete revision knee system, Vanguard 360, which incorporates: Fixed Bearing Knee - Vanguard SSK360 with PS Bearing and PSC Bearing Fixed Bearing Knee - Vanguard SSK360 TiNbN Femur with PS Bearing and PSC Bearing Mobile Bearing Knee - Vanguard DA360 (only being collected in Europe) 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.

Official Title
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A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

Conditions
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Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Post Traumatic Deformity, Complications; Arthroplasty, Deformity of Limb

Intervention / Treatment
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* Device: Vanguard SSK 360 with PS Bearing
* Device: Vanguard SSK 360 with PSC bearing
* Device: Vanguard DA 360
* Device: Vanguard 360 TiNbN Femur with PS bearing
* Device: Vanguard 360 TiNbN Femur with PSC bearing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. Correction of varus, valgus or post-traumatic deformity Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure Ability and willingness of the patient to attend follow-up visit. Willing to give written informed consent Patients are at least 18 years of age, no upper age limit, must have reached full skeletal maturity. Exclusion Criteria: infection sepsis osteomyelitis Relative Contraindications: An uncooperative patient or a patient with neurologic disorders who is incapable of following directions Osteoporosis Metabolic disorders which may impair brain function Osteomalacia Distant foci of infections which may spread to the implant site Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram Vascular insufficiency, muscular atrophy, neuromuscular disease Incomplete or deficient soft tissue surrounding the knee Additional research-related exclusion criteria: patients who have a history of or current infection in the affected knee.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vanguard SSK 360 with PS Bearing<br>Patients enrolled using a Vanguard SSK 360 Posterior-Stabilized (non-constrained) tibial bearing. | Device: Vanguard SSK 360 with PS Bearing<br>* non-constrained tibial bearing<br>|
| Vanguard SSK 360 with PSC Bearing<br>Patients enrolled using a Vanguard SSK 360 Posterior-Stabilized Constrained tibial bearing. | Device: Vanguard SSK 360 with PSC bearing<br>* constrained tibial bearing<br>|
| Vanguard DA 360<br>Patients enrolled using a Vanguard DA 360 component. | Device: Vanguard DA 360<br>* Dual-articulation device, only cleared in EU<br>|
| Vanguard 360 TiNbN Femur with PS Bearing<br>The Vanguard 360 TiNbN is the same system and functions in the same manner as the non-coated device. | Device: Vanguard 360 TiNbN Femur with PS bearing<br>* non-constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur<br>|
| Vanguard 360 TiNbN Femur with PSC Bearing<br>The Vanguard 360 TiNbN is the same system and functions in the same manner as the non-coated device. | Device: Vanguard 360 TiNbN Femur with PSC bearing<br>* constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship | Survivorship at 10 years post-operative follow up | 10 years postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Revision surgery