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A Clinical Investigation of the Vanguard™ Complete Knee System

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00698854
First Posted: June 17, 2008
Last Update Posted: June 23, 2017
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.
Information provided by (Responsible Party):
Zimmer Biomet
June 13, 2008
June 17, 2008
June 23, 2017
March 2004
January 2026   (Final data collection date for primary outcome measure)
KSS [ Time Frame: 10 year ]
Knee Society Score Assessment
Knee Society Score [ Time Frame: 6 weeks, 6 months, 1 year, 3 years, 5 years ]
Complete list of historical versions of study NCT00698854 on ClinicalTrials.gov Archive Site
  • Radiographic Information [ Time Frame: 10 years ]
  • Survivorship [ Time Frame: 10 years ]
X-rays [ Time Frame: 6 months, 1 year, 3 years, 5 years ]
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
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
  • Lower Limb Deformity
  • Complications, Arthroplasty
  • Device: Vanguard™ Complete Knee System
    Primary Total Knee System, Cruciate-Retaining (CR) or Posterior-Stabilized (PS)
  • Device: Vanguard™ Patient-Specific Femur
    Primary Total Knee System used with Signature technique to provide a patient-specific femur
    Other Name: Vanguard Select
  • Vanguard™ Complete Knee System
    Vanguard Total Knee System, Cruciate-Retaining (CR) or Posterior-Stabilized (PS)
    Intervention: Device: Vanguard™ Complete Knee System
  • Vanguard™ Patient-Specific Femur
    Vanguard Total Knee System used in combination with Signature technique to provide a patient-specific femur
    Intervention: Device: Vanguard™ Patient-Specific Femur
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
600
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

Additional exclusion criteria includes: failure of a previous joint replacement

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00698854
ORTHO.CR.K005
No
Not Provided
Plan to Share IPD: Undecided
Zimmer Biomet
Zimmer Biomet
Not Provided
Study Director: Russell A Schenck, Ph.D. Clinical Research, Biomet, Inc.
Zimmer Biomet
June 2017