A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Biomet, Inc.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01542580
First received: February 27, 2012
Last updated: March 21, 2014
Last verified: March 2014
  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: April 2027
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Vanguard 360
Vanguard SSK360 with PS Bearing: 85 total cases Vanguard SSK360 with PSC Bearing: 85 total cases Vanguard DA360: 85 total cases

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.

The data gathered would be collated and used to provide feedback to designing engineers; support marketing efforts, and answer potential questions from reimbursement agencies.

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

Contacts
Contact: Maggie SHEN 01793607601 ext +44 maggie.shen@biomet.com

Locations
United States, Alabama
Lemak Sports Medicine and Orthopedics Not yet recruiting
Birmingham, Alabama, United States, 35213
United States, Illinois
Illinois Bone and Joint Not yet recruiting
Morton Grove, Illinois, United States, 60053
United States, Kentucky
Lexington Clinic Not yet recruiting
Lexington, Kentucky, United States, 40504
United States, Michigan
Michigan Orthopedic Center Not yet recruiting
Lansing, Michigan, United States, 48910
United States, Nevada
Orthopedic Institute of Henderson Enrolling by invitation
Henderson, Nevada, United States, 89052
United States, New York
Insall Scott Kelly Institute Not yet recruiting
New York, New York, United States, 10065
United States, Utah
University of Utah Orthopedic Center Enrolling by invitation
Salt Lake City, Utah, United States, 84108
United States, Virginia
OrthoVirginia West End Orthopedic Clinic Enrolling by invitation
Richmond, Virginia, United States, 23235
Belgium
University Hopital Pellenberg Recruiting
Pellenberg, Belgium
Contact: Bellemans, Pr         
Principal Investigator: Bellemans, Pr         
Denmark
Aarhus university hospital Not yet recruiting
Aarhus, Denmark
Contact: A Odgaard, Dr         
Principal Investigator: A Odgaard, Dr         
France
Ch Lyon Sud Recruiting
Lyon, France, 69000
Contact: Julien Chouteau, Dr         
Principal Investigator: Julien CHOUTEAU, Dr         
Germany
Klinik fur Endoprothetik und gelenkchirurgie Recruiting
Bad Wildbad, Germany
Contact: Stefan SELL, Pr         
Principal Investigator: Stefan SELL, Pr         
Italy
Casa di Cura Abano Terme Withdrawn
Abano Terme, Padova, Italy
Spain
University Hospital Mutua de Tarrasa Recruiting
Tarrasa, Spain
Contact: S Sabates, Dr         
Principal Investigator: S SABATES, Dr         
United Kingdom
University Hospital of Wales Not yet recruiting
Cardiff, Wales, United Kingdom
Contact: R Morgan-Jones         
Principal Investigator: R Morgan-Jones         
Sub-Investigator: M Forster         
Royal Orthopaedic Hospital Recruiting
Birmingham, United Kingdom, B31 2AP
Contact: Simon CARTER, Mr         
Principal Investigator: Simon CARTER, Mr         
Sub-Investigator: Lee JEYS, Mr         
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: BMET.CR.G1
Study First Received: February 27, 2012
Last Updated: March 21, 2014
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 October 23, 2014