A Clinical Investigation of the Vanguard™ Complete Knee System

Official Title: “A Prospective, Non-controlled, Clinical Investigation of the Vanguard™ Complete Knee System”

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

This is a 5-year prospective observational data collection on the Vanguard Total Knee system. Patients are asked to come in for a preop, operative, impo, 6 Month, 1 Year, 3 Year, & 5 Year visit 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.

Arms, Groups and Cohorts in this Clinical Trial

• : Vanguard™ Complete Knee System
  • Vanguard™ Complete Knee System

Primary Measures

• Knee Society Score
  • Time Frame: 5 years
    Safety Issue?: No

Secondary Measures

• X-Ray Data
  • Time Frame: 5 years
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Biomet, Inc. Industry

Overall Clinical Trial Officials and Contacts

Russell A Schenck, Ph.D. Study Director Clinical Research, Biomet, Inc.  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00698854

Study ID Number: Biomet 13594-53

ClinicalTrials.gov Identifier: NCT00698854

Health Authority: United States: Institutional Review Board