A Clinical Investigation of the Vanguard™ Complete Knee System

August 27, 2023 updated by: Zimmer Biomet

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403
        • Physicians Clinic of Iowa Orthopedics
    • Maryland
      • Rockville, Maryland, United States, 20850
        • The Orthopaedic Center
    • Missouri
      • Cape Girardeau, Missouri, United States, 63701
        • Advanced Orthopedic Specialists
    • New York
      • Rochester, New York, United States, 14626
        • Orthopaedic Associates of Rochester
    • Texas
      • Grapevine, Texas, United States, 76015
        • Texas Orthopedic Specialists
    • Virginia
      • Fishersville, Virginia, United States, 22939
        • Orthopedic Associates
    • Washington
      • Spokane, Washington, United States, 99207
        • Spokane Orthopedics
    • Wisconsin
      • Monroe, Wisconsin, United States, 53566
        • Othopaedic & Sports Medicine Clinic of Monroe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients in need of relief from painful or disabling joint disease

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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 Names:
  • Vanguard Select

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KSS
Time Frame: 10 year
Knee Society Score Assessment
10 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Information
Time Frame: 10 years
Radiographic Evaluation Report
10 years
Survivorship
Time Frame: 10 years
Knee Society Score Assessment
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Investigators

  • Study Director: Kacy C Arnold, RN MBA, Zimmer Biomet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

June 13, 2008

First Submitted That Met QC Criteria

June 13, 2008

First Posted (Estimated)

June 17, 2008

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 27, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORTHO.CR.K005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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