Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: February 4, 2015
Last verified: February 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 Phase
Osteoarthritis
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

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
Vanguard 360
Vanguard 360 - 255 total cases, including Vanguard 360 with PS bearing, Vanguard 360 with PSC bearing, and Vanguard DA360

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 from pre-operatively to 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:

  • Acute infection at the time of surgery, sepsis, and osteomyelitis
  • An uncooperative patient or a patient with neurologic disorders who is incapable of following directions
  • Metabolic disorders which may impair bone formation
  • Osteomalacia
  • Distant source(s) of infections which may spread to the implant site
  • Vascular insufficiency, muscular atrophy, neuromuscular disease
  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, Alabama
Lemak Sports Medicine and Orthopedics
Birmingham, Alabama, United States, 35213
United States, Illinois
Illinois Bone and Joint
Morton Grove, Illinois, United States, 60053
United States, Kentucky
Lexington Clinic
Lexington, Kentucky, United States, 40504
United States, Michigan
Michigan Orthopedic Center
Lansing, Michigan, United States, 48910
United States, Nevada
Orthopedic Institute of Henderson
Henderson, Nevada, United States, 89052
United States, New York
Insall Scott Kelly Institute
New York, New York, United States, 10065
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
Principal Investigator: Simon CARTER, Mr ROYAL ORTHOPAEDIC HOSPITAL
  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: February 4, 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:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on February 25, 2015