Clinical Trial Finder

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.

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.

Arms

: 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.

Interventions

Device: - Vanguard SSK 360 with PS Bearing

non-constrained tibial bearing

Device: - Vanguard SSK 360 with PSC bearing

constrained tibial bearing

Device: - Vanguard DA 360

Dual-articulation device, only cleared in EU

Device: - Vanguard 360 TiNbN Femur with PS bearing

non-constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur

Device: - Vanguard 360 TiNbN Femur with PSC bearing

constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur