A Clinical Investigation of the Vanguard™ Complete Knee System

Zimmer Biomet

Status: Completed

Conditions: Traumatic Arthritis; Osteoarthritis; Lower Limb Deformity; Complications, Arthroplasty; Rheumatoid Arthritis

Treatments: Device: Vanguard™ Patient-Specific Femur; Device: Vanguard™ Complete Knee System

Study type: Observational

Funder types: Industry

Identifiers

NCT00698854

ORTHO.CR.K005

Details and patient eligibility

About

The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguard™ Complete Knee System.

Full description

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.

Enrollment: 552 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 posttraumatic deformity
• Correction or revision of unsuccessful osteotomy, or arthrodesis

Patient selection factors to be considered include:

• Need to obtain pain relief and improve function
• Ability and willingness of the patient to follow instructions
• Including control of weight and activity level
• Good nutritional state of the patient
• Patient must have reached full skeletal maturity

Exclusion criteria

Absolute contraindications include:

• Infection
• Sepsis
• Osteomyelitis
• Failure of a previous joint replacement

Relative contraindications include:

• Uncooperative patient or patient with neurologic disorders who are incapable of following directions
• Osteoporosis
• Metabolic disorders which may impair bone formation
• 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 exclusion criteria includes: failure of a previous joint replacement

Trial design

552 participants in 2 patient groups

Vanguard™ Complete Knee System

Description:

Vanguard Total Knee System, Cruciate-Retaining (CR) or Posterior-Stabilized (PS)

Treatment:

Device: Vanguard™ Complete Knee System

Vanguard™ Patient-Specific Femur

Description:

Vanguard Total Knee System used in combination with Signature technique to provide a patient-specific femur

Treatment:

Device: Vanguard™ Patient-Specific Femur