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A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

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ClinicalTrials.gov Identifier: NCT01542580
Recruitment Status : Enrolling by invitation
First Posted : March 2, 2012
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Brief 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.

Condition or disease Intervention/treatment
Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis Post Traumatic Deformity Complications; Arthroplasty Deformity of Limb Device: Vanguard SSK 360 with PS Bearing Device: Vanguard SSK 360 with PSC bearing Device: Vanguard DA 360 Device: Vanguard 360 TiNbN Femur with PS bearing Device: Vanguard 360 TiNbN Femur with PSC bearing

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
Estimated Enrollment : 255 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee
Study Start Date : March 2012
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2029

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Survivorship [ Time Frame: 10 years postoperative ]
    Survivorship at 10 years post-operative follow up



Information from the National Library of Medicine

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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 prescribed the Vanguard 360 Revision Knee System
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 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.


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): NCT01542580


Locations
United States, Illinois
Illinois Bone and Joint
Morton Grove, Illinois, United States, 60053
United States, Nevada
Orthopedic Institute of Henderson
Henderson, Nevada, United States, 89052
United States, Utah
University of Utah Orthopedic Center
Salt Lake City, Utah, United States, 84108
United States, Virginia
OrthoVirginia West End Orthopedic Clinic
Richmond, Virginia, United States, 23235
Belgium
University Hopital Pellenberg
Pellenberg, Belgium
Denmark
Aarhus university hospital
Aarhus, Denmark
France
Ch Lyon Sud
Lyon, France, 69000
Germany
Klinik fur Endoprothetik und gelenkchirurgie
Bad Wildbad, Germany
Italy
IRCCS Istituto Ortopedico Galeazzi
Milano, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Spain
University Hospital Mutua de Terrasa
Terrassa, Spain
United Kingdom
Royal Orthopaedic Hospital
Birmingham, United Kingdom, B31 2AP
Sponsors and Collaborators
Zimmer Biomet
Investigators
Study Director: Russell Schenk, PhD Zimmer Biomet

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01542580     History of Changes
Other Study ID Numbers: GBMET.CR.G1
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Zimmer Biomet:
Revision surgery

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Congenital Abnormalities
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases