A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01542580
First received: February 27, 2012
Last updated: April 15, 2015
Last verified: April 2015
  Purpose

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 Intervention Phase
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
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • AMERICAN KNEE SOCIETY KNEE SCORE [ Time Frame: 24 months postoperative ] [ Designated as safety issue: No ]
    Improvement of American Knee Society Knee Score between pre-operative and 2 years post-operative follow up


Secondary Outcome Measures:
  • Survivorship [ Time Frame: 10 years postoperative ] [ Designated as safety issue: Yes ]
    Survivorship at 10 years post-operative follow up


Estimated Enrollment: 255
Study Start Date: March 2012
Estimated Study Completion Date: December 2027
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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
  • 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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, Texas
Texas Hip and Knee Center
Fort Worth, Texas, United States, 76132
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
Spain
University Hospital Mutua de Tarrasa
Tarrasa, Spain
United Kingdom
University Hospital of Wales
Cardiff, Wales, United Kingdom
Royal Orthopaedic Hospital
Birmingham, United Kingdom, B31 2AP
Sponsors and Collaborators
Biomet, Inc.
Investigators
Study Director: Russell Schenk Biomet, Inc.
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01542580     History of Changes
Other Study ID Numbers: GBMET.CR.G1
Study First Received: February 27, 2012
Last Updated: April 15, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Keywords provided by Biomet, Inc.:
Revision surgery

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

ClinicalTrials.gov processed this record on July 01, 2015