A Clinical Investigation of the Vanguard™ Complete Knee System

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00698854
• Other study ID #: ORTHO.CR.K005
• Status: Active, not recruiting
• Start date: March 2004
• Est. completion date: January 2026

Study information

• Verified date: August 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Advanced Orthopedic Specialists	Cape Girardeau	Missouri
United States	Physicians Clinic of Iowa Orthopedics	Cedar Rapids	Iowa
United States	Orthopedic Associates	Fishersville	Virginia
United States	Texas Orthopedic Specialists	Grapevine	Texas
United States	Othopaedic & Sports Medicine Clinic of Monroe	Monroe	Wisconsin
United States	Orthopaedic Associates of Rochester	Rochester	New York
United States	The Orthopaedic Center	Rockville	Maryland
United States	Spokane Orthopedics	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KSS	Knee Society Score Assessment	10 year
Secondary	Radiographic Information	Radiographic Evaluation Report	10 years
Secondary	Survivorship	Knee Society Score Assessment	10 years