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.

Study Type: Observational

Study Design: Cohort, Prospective

Study Primary Completion Date: December 2013

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• Knee Society Score
  • Time Frame: 6 weeks, 6 months, 1 year, 3 years, 5 years
    Safety Issue?: No

Secondary Measures

• X-rays
  • Time Frame: 6 months, 1 year, 3 years, 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 Sponsor: Biomet Orthopedics, LLC

Overall Clinical Trial Officials and Contacts

Kenneth J Beres, MD Study Director Clinical Research, Biomet Orthopedics, LLC  

Information obtained from ClinicalTrials.gov on August 21, 2008

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