Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00698854
Recruitment Status : Recruiting
First Posted : June 17, 2008
Last Update Posted : June 11, 2020
Sponsor:
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.

Layout table for study information
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 ]
    Radiographic Evaluation Report

  2. Survivorship [ Time Frame: 10 years ]
    Knee Society Score Assessment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT00698854


Contacts
Layout table for location contacts
Contact: Sonia Berkey, BS 574-373-2124 sonia.berkey@zimmerbiomet.com
Contact: Kacy Arnold kacy.arnold@zimmerbiomet.com

Locations
Layout table for location information
United States, Iowa
Physicians Clinic of Iowa Orthopedics Active, not recruiting
Cedar Rapids, Iowa, United States, 52403
United States, Maryland
The Orthopaedic Center Terminated
Rockville, Maryland, United States, 20850
United States, Missouri
Advanced Orthopedic Specialists Recruiting
Cape Girardeau, Missouri, United States, 63701
United States, New York
Orthopaedic Associates of Rochester Completed
Rochester, New York, United States, 14626
United States, Texas
Texas Orthopedic Specialists Completed
Grapevine, Texas, United States, 76015
United States, Virginia
Orthopedic Associates Completed
Fishersville, Virginia, United States, 22939
United States, Washington
Spokane Orthopedics Completed
Spokane, Washington, United States, 99207
United States, Wisconsin
Othopaedic & Sports Medicine Clinic of Monroe Completed
Monroe, Wisconsin, United States, 53566
Sponsors and Collaborators
Zimmer Biomet
Investigators
Layout table for investigator information
Study Director: Russell A Schenck, Ph.D. Clinical Research, Biomet, Inc.
Layout table for additonal information
Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00698854    
Other Study ID Numbers: ORTHO.CR.K005
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
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:
Layout table for MeSH terms
Arthritis
Joint Diseases
Musculoskeletal Diseases