Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Clinical Investigation of the Vanguard™ Complete Knee System

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Biomet, Inc. Identifier:
First received: June 13, 2008
Last updated: February 4, 2015
Last verified: February 2015

June 13, 2008
February 4, 2015
March 2004
January 2026   (final data collection date for primary outcome measure)
KSS [ Time Frame: 10 year ] [ Designated as safety issue: No ]
Knee Society Score Assessment
Knee Society Score [ Time Frame: 6 weeks, 6 months, 1 year, 3 years, 5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00698854 on Archive Site
X-Ray Data [ Time Frame: 10 years ] [ Designated as safety issue: No ]
X-rays [ Time Frame: 6 months, 1 year, 3 years, 5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
A Clinical Investigation of the Vanguard™ Complete Knee System
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 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.

Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients in need of relief from painful or disabling joint disease

  • Osteoarthritis
  • Traumatic Arthritis
  • Rheumatoid Arthritis
Not Provided
  • Vanguard™ Complete Knee System
    Vanguard™ Complete Knee System
  • Vanguard™ Patient-Specific Femur
    Vanguard™ Patient-Specific Femur
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Enrolling by invitation
January 2026
January 2026   (final data collection date for primary outcome measure)

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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
Biomet 13594-53
Biomet, Inc.
Biomet, Inc.
Not Provided
Study Director: Russell A Schenck, Ph.D. Clinical Research, Biomet, Inc.
Biomet, Inc.
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP