NCT00698854

A Clinical Investigation of the Vanguard™ Complete Knee System

A Prospective, Non-controlled, Clinical Investigation of the Vanguard™ Complete Knee System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 552 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Osteoarthritis
• Traumatic Arthritis
• Rheumatoid Arthritis
• Lower Limb Deformity
• Complications, Arthroplasty

Interventions

Type	Name	Description
DEVICE	Vanguard™ Complete Knee System	Primary Total Knee System, Cruciate-Retaining (CR) or Posterior-Stabilized (PS)
DEVICE	Vanguard™ Patient-Specific Femur	Primary Total Knee System used with Signature technique to provide a patient-specific femur

Timeline

• Start date: 2004-03-01
• Primary completion: 2021-01-01
• Completion: 2024-03-01
• First posted: 2008-06-17
• Last updated: 2024-09-19

Locations

8 sites across 1 country: United States