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

February 27, 2012
April 15, 2015
March 2012
December 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
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
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 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.

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

Patients prescribed the Vanguard 360 Revision Knee System

  • Osteoarthritis
  • Rheumatoid Arthritis
  • Traumatic Arthritis
  • Post Traumatic Deformity
  • Complications; Arthroplasty
  • Deformity of Limb
  • Device: Vanguard SSK 360 with PS Bearing
    non-constrained tibial bearing
  • Device: Vanguard SSK 360 with PSC bearing
    constrained tibial bearing
  • Device: Vanguard DA 360
    Dual-articulation device, only cleared in EU
  • Vanguard SSK 360 with PS Bearing
    Patients enrolled using a Vanguard SSK 360 Posterior-Stabilized (non-constrained) tibial bearing.
    Intervention: Device: Vanguard SSK 360 with PS Bearing
  • Vanguard SSK 360 with PSC Bearing
    Patients enrolled using a Vanguard SSK 360 Posterior-Stabilized Constrained tibial bearing.
    Intervention: Device: Vanguard SSK 360 with PSC bearing
  • Vanguard DA 360
    Patients enrolled using a Vanguard DA 360 component.
    Intervention: Device: Vanguard DA 360
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
255
December 2027
December 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:

  • 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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Denmark,   France,   Germany,   Spain,   United Kingdom
 
NCT01542580
GBMET.CR.G1
No
Biomet, Inc.
Biomet, Inc.
Not Provided
Study Director: Russell Schenk Biomet, Inc.
Biomet, Inc.
April 2015

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