A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

Zimmer Biomet

Status: Enrolling

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

Treatments: Device: Vanguard SSK 360 with PSC bearing; Device: Vanguard 360 TiNbN Femur with PS bearing; Device: Vanguard 360 TiNbN Femur with PSC bearing; Device: Vanguard SSK 360 with PS Bearing; Device: Vanguard DA 360

Study type: Observational

Funder types: Industry

Identifiers

NCT01542580

GBMET.CR.G1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 255 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

255 participants in 5 patient groups

Vanguard SSK 360 with PS Bearing

Description:

Patients enrolled using a Vanguard SSK 360 Posterior-Stabilized (non-constrained) tibial bearing.

Treatment:

Device: Vanguard SSK 360 with PS Bearing

Vanguard SSK 360 with PSC Bearing

Description:

Patients enrolled using a Vanguard SSK 360 Posterior-Stabilized Constrained tibial bearing.

Treatment:

Device: Vanguard SSK 360 with PSC bearing

Vanguard DA 360

Description:

Patients enrolled using a Vanguard DA 360 component.

Treatment:

Device: Vanguard DA 360

Vanguard 360 TiNbN Femur with PS Bearing

Description:

The Vanguard 360 TiNbN is the same system and functions in the same manner as the non-coated device.

Treatment:

Device: Vanguard 360 TiNbN Femur with PS bearing

Vanguard 360 TiNbN Femur with PSC Bearing

Description:

The Vanguard 360 TiNbN is the same system and functions in the same manner as the non-coated device.

Treatment:

Device: Vanguard 360 TiNbN Femur with PSC bearing