A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

February 13, 2024 updated by: Zimmer Biomet
The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment, clinical outcomes and survivorship.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This investigation is being conducted on a new complete revision knee system, Vanguard 360, which incorporates:

  • Fixed Bearing Knee - Vanguard SSK360 with PS Bearing and PSC Bearing
  • Fixed Bearing Knee - Vanguard SSK360 TiNbN Femur with PS Bearing and PSC Bearing
  • Mobile Bearing Knee - Vanguard DA360 (only being collected in Europe)

The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment, clinical outcomes and survivorship.

The efficacy and performance of the devices will be assessed by improvement of pain, function, range of motion and patient satisfaction measured pre-operatively and post-operatively. Secondary performance and safety will be determined by radiographic investigation, incidence of complications and revision rates.

Surgical techniques and patient care are to be standard for the surgeon participating in the protocol. There will be no experimental or investigational devices used. There will be no experimental or investigational surgical techniques used. The devices and products will be used in accordance with their instructions for use and/or approved labeling.

Study Type

Observational

Enrollment (Estimated)

255

Contacts and Locations

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

Study Contact

Study Locations

  • Belgium
      • Pellenberg, Belgium
        • Enrolling by invitation
        • University Hopital Pellenberg
  • Denmark
      • Aarhus, Denmark
        • Suspended
        • Aarhus University Hospital
  • France
      • Lyon, France, 69000
        • Terminated
        • Ch Lyon Sud
  • Germany
      • Bad Wildbad, Germany
        • Terminated
        • Klinik fur Endoprothetik und gelenkchirurgie
  • Italy
      • Milano, Italy
        • Recruiting
        • IRCCS Istituto Ortopedico Galeazzi
      • Pisa, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
  • Spain
      • Terrassa, Spain
        • Enrolling by invitation
        • University Hospital Mutua de Terrasa
  • United Kingdom
      • Birmingham, United Kingdom, B31 2AP
        • Completed
        • Royal Orthopaedic Hospital
  • United States
    • Illinois
      • Morton Grove, Illinois, United States, 60053
        • Not yet recruiting
        • Illinois Bone and Joint
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Enrolling by invitation
        • Orthopedic Institute of Henderson
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Enrolling by invitation
        • University of Utah Orthopedic Center
    • Virginia
      • Richmond, Virginia, United States, 23235
        • Enrolling by invitation
        • OrthoVirginia West End Orthopedic Clinic

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients prescribed the Vanguard 360 Revision Knee System

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 post-traumatic deformity
  • Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure
  • Ability and willingness of the patient to attend follow-up visit.
  • Willing to give written informed consent
  • Patients are at least 18 years of age, no upper age limit, must have reached full skeletal maturity.

Exclusion Criteria:

  • infection
  • sepsis
  • osteomyelitis

Relative Contraindications:

  • An uncooperative patient or a patient with neurologic disorders who is incapable of following directions
  • Osteoporosis
  • Metabolic disorders which may impair brain function
  • 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 research-related exclusion criteria: patients who have a history of or current infection in the affected knee.

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 SSK 360 with PS Bearing
Patients enrolled using a Vanguard SSK 360 Posterior-Stabilized (non-constrained) tibial bearing.
Device: Vanguard SSK 360 with PS Bearing
non-constrained tibial bearing
Vanguard SSK 360 with PSC Bearing
Patients enrolled using a Vanguard SSK 360 Posterior-Stabilized Constrained tibial bearing.
Device: Vanguard SSK 360 with PSC bearing
constrained tibial bearing
Vanguard DA 360
Patients enrolled using a Vanguard DA 360 component.
Device: Vanguard DA 360
Dual-articulation device, only cleared in EU
Vanguard 360 TiNbN Femur with PS Bearing
The Vanguard 360 TiNbN is the same system and functions in the same manner as the non-coated device.
Device: Vanguard 360 TiNbN Femur with PS bearing
non-constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur
Vanguard 360 TiNbN Femur with PSC Bearing
The Vanguard 360 TiNbN is the same system and functions in the same manner as the non-coated device.
Device: Vanguard 360 TiNbN Femur with PSC bearing
constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AMERICAN KNEE SOCIETY KNEE SCORE
Time Frame: 24 months postoperative
Improvement of American Knee Society Knee Score between pre-operative and 2 years post-operative follow up
24 months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survivorship
Time Frame: 10 years postoperative
Survivorship at 10 years post-operative follow up
10 years postoperative

Collaborators and Investigators

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

Sponsor

Zimmer Biomet

Investigators

  • Study Director: Russell Schenk, PhD, 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 (Actual)

March 1, 2012

Primary Completion (Estimated)

December 1, 2031

Study Completion (Estimated)

December 1, 2031

Study Registration Dates

First Submitted

February 27, 2012

First Submitted That Met QC Criteria

February 27, 2012

First Posted (Estimated)

March 2, 2012

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GBMET.CR.G1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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