A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

This study is currently recruiting participants.
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

February 27, 2012
March 21, 2014
March 2012
March 2017   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01542580 on ClinicalTrials.gov Archive Site
Survivorship [ Time Frame: 10 years postoperative ] [ Designated as safety issue: Yes ]
Survivorship at 10 years post-operative follow up
  • AMERICAN KNEE SOCIETY FUNCTION SCORE [ Time Frame: 24 months postoperative ] [ Designated as safety issue: No ]
    Improvement of American Knee Society Function Score between pre operative and 2 years post-operative follow up
  • Device related complications [ Time Frame: 10 years postoperative ] [ Designated as safety issue: Yes ]
    Survivorship at 10 years post-operative follow up
  • Radiographic evaluation [ Time Frame: 5 years postoperative ] [ Designated as safety issue: Yes ]
    Radiographic evaluation at 6 months, 1year, 2 years, 3 years and 5 years post-operative visit
Not Provided
Not Provided
 
A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee
A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients prescribed the Vanguard 360 Revision Knee System

Osteoarthritis
Not Provided
Vanguard 360
Vanguard SSK360 with PS Bearing: 85 total cases Vanguard SSK360 with PSC Bearing: 85 total cases Vanguard DA360: 85 total cases
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
255
April 2027
March 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Maggie SHEN 01793607601 ext +44 maggie.shen@biomet.com
United States,   Belgium,   Denmark,   France,   Germany,   Italy,   Spain,   United Kingdom
 
NCT01542580
BMET.CR.G1
No
Biomet, Inc.
Biomet, Inc.
Not Provided
Principal Investigator: Simon CARTER, Mr ROYAL ORTHOPAEDIC HOSPITAL
Biomet, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP