A Clinical Investigation of the Vanguard™ Complete Knee System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00698854
Recruitment Status : Enrolling by invitation
First Posted : June 17, 2008
Last Update Posted : June 23, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Osteoarthritis Traumatic Arthritis Rheumatoid Arthritis Lower Limb Deformity Complications, Arthroplasty Device: Vanguard™ Complete Knee System Device: Vanguard™ Patient-Specific Femur

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 Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-controlled, Clinical Investigation of the Vanguard™ Complete Knee System
Study Start Date : March 2004
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Vanguard™ Complete Knee System
Vanguard Total Knee System, Cruciate-Retaining (CR) or Posterior-Stabilized (PS)
Device: Vanguard™ Complete Knee System
Primary Total Knee System, Cruciate-Retaining (CR) or Posterior-Stabilized (PS)

Vanguard™ Patient-Specific Femur
Vanguard Total Knee System used in combination with Signature technique to provide a patient-specific femur
Device: Vanguard™ Patient-Specific Femur
Primary Total Knee System used with Signature technique to provide a patient-specific femur
Other Name: Vanguard Select

Primary Outcome Measures :
  1. KSS [ Time Frame: 10 year ]
    Knee Society Score Assessment

Secondary Outcome Measures :
  1. Radiographic Information [ Time Frame: 10 years ]
  2. Survivorship [ Time Frame: 10 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in need of relief from painful or disabling joint disease

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00698854

United States, Iowa
Physicians Clinic of Iowa Orthopedics
Cedar Rapids, Iowa, United States, 52403
United States, Maryland
The Orthopaedic Center
Rockville, Maryland, United States, 20850
United States, Missouri
Advanced Orthopedic Specialists
Cape Girardeau, Missouri, United States, 63701
United States, New York
Orthopaedic Associates of Rochester
Rochester, New York, United States, 14626
United States, Texas
Texas Orthopedic Specialists
Grapevine, Texas, United States, 76015
United States, Virginia
Orthopedic Associates
Fishersville, Virginia, United States, 22939
United States, Washington
Spokane Orthopedics
Spokane, Washington, United States, 99207
United States, Wisconsin
Othopaedic & Sports Medicine Clinic of Monroe
Monroe, Wisconsin, United States, 53566
Sponsors and Collaborators
Zimmer Biomet
Study Director: Russell A Schenck, Ph.D. Clinical Research, Biomet, Inc.

Responsible Party: Zimmer Biomet Identifier: NCT00698854     History of Changes
Other Study ID Numbers: ORTHO.CR.K005
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Zimmer Biomet:
Total Knee Arthroplasty
Total Knee Replacement
Knee Arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases