A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

Last updated: February 20, 2025
Sponsor: Zimmer Biomet
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rheumatoid Arthritis

Bone Diseases

Birth Defects

Treatment

Vanguard SSK 360 with PSC bearing

Vanguard 360 TiNbN Femur with PSC bearing

Vanguard SSK 360 with PS Bearing

Clinical Study ID

NCT01542580
GBMET.CR.G1
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 ofprevious 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 fullskeletal maturity.

Exclusion

Exclusion Criteria:

  • infection

  • sepsis

  • osteomyelitis

Relative Contraindications:

  • An uncooperative patient or a patient with neurologic disorders who is incapable offollowing 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 onroentgenogram

  • 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 Design

Total Participants: 255
Treatment Group(s): 5
Primary Treatment: Vanguard SSK 360 with PSC bearing
Phase:
Study Start date:
March 01, 2012
Estimated Completion Date:
December 31, 2031

Study 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.

Connect with a study center

  • University Hopital Pellenberg

    Pellenberg,
    Belgium

    Site Not Available

  • Aarhus university hospital

    Aarhus,
    Denmark

    Suspended

  • Ch Lyon Sud

    Lyon, 69000
    France

    Terminated

  • Klinik fur Endoprothetik und gelenkchirurgie

    Bad Wildbad,
    Germany

    Terminated

  • Casa di Cura Abano Terme

    Abano Terme, Padova
    Italy

    Site Not Available

  • IRCCS Istituto Ortopedico Galeazzi

    Milano,
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa,
    Italy

    Active - Recruiting

  • University Hospital Mutua de Tarrasa

    Tarrasa,
    Spain

    Site Not Available

  • University Hospital Mutua de Terrasa

    Terrassa,
    Spain

    Site Not Available

  • University Hospital of Wales

    Cardiff, Wales
    United Kingdom

    Site Not Available

  • Royal Orthopaedic Hospital

    Birmingham, B31 2AP
    United Kingdom

    Completed

  • Illinois Bone and Joint

    Morton Grove, Illinois 60053
    United States

    Site Not Available

  • Lexington Clinic

    Lexington, Kentucky 40504
    United States

    Site Not Available

  • Michigan Orthopedic Center

    Lansing, Michigan 48910
    United States

    Site Not Available

  • Orthopedic Institute of Henderson

    Henderson, Nevada 89052
    United States

    Terminated

  • Insall Scott Kelly Institute

    New York, New York 10065
    United States

    Site Not Available

  • Texas Hip and Knee Center

    Fort Worth, Texas 76132
    United States

    Site Not Available

  • University of Utah Orthopedic Center

    Salt Lake City, Utah 84108
    United States

    Completed

  • OrthoVirginia West End Orthopedic Clinic

    Richmond, Virginia 23235
    United States

    Site Not Available

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