A Clinical Investigation of the Vanguard™ Complete Knee System

Active, not recruiting

• Conditions: Osteoarthritis; Traumatic Arthritis; Rheumatoid Arthritis; Lower Limb Deformity; Complications, Arthroplasty
• Interventions: Device: Vanguard™ Patient-Specific Femur; Device: Vanguard™ Complete Knee System

• Registration Number: NCT00698854
• Lead Sponsor: Zimmer Biomet

Brief 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.

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2008-06-13
• Study First Submitted QC: 2008-06-13
• Study First Posted: 2008-06-17
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-27
• Last Update Posted: 2023-08-29
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vanguard™ Patient-Specific Femur	Vanguard™ Patient-Specific Femur	Vanguard Total Knee System used in combination with Signature technique to provide a patient-specific femur
Vanguard™ Complete Knee System	Vanguard™ Complete Knee System	Vanguard Total Knee System, Cruciate-Retaining (CR) or Posterior-Stabilized (PS)

Primary Outcome Measures

Name	Time	Method
KSS	10 year	Knee Society Score Assessment

Secondary Outcome Measures

Name	Time	Method
Radiographic Information	10 years	Radiographic Evaluation Report
Survivorship	10 years	Knee Society Score Assessment

Trial Locations

Locations (8)

The Orthopaedic Center; 🇺🇸 Rockville, Maryland, United States

Texas Orthopedic Specialists; 🇺🇸 Grapevine, Texas, United States

Physicians Clinic of Iowa Orthopedics; 🇺🇸 Cedar Rapids, Iowa, United States

Advanced Orthopedic Specialists; 🇺🇸 Cape Girardeau, Missouri, United States

Orthopaedic Associates of Rochester; 🇺🇸 Rochester, New York, United States

Orthopedic Associates; 🇺🇸 Fishersville, Virginia, United States

Spokane Orthopedics; 🇺🇸 Spokane, Washington, United States

Othopaedic & Sports Medicine Clinic of Monroe; 🇺🇸 Monroe, Wisconsin, United States