Vanguard CR vs. AGC

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Biomet U.K. Ltd.
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01064063
First received: February 4, 2010
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

This evaluation is being conducted on the relative new knee system, the Vanguard Cruciate Retaining (CR)to evaluate clinical efficacy of the Vanguard CR components.


Condition Intervention
Osteoarthritis
Rheumatoid Arthritis
Traumatic Arthritis
Device: Vanguard CR
Device: AGC knee

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Clinical Evaluation to Compare Vanguard Cruciate Retaining and AGC Total Condylar Knee Implants

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • American Knee Society Knee Score [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient success (defined as Knee Score greater than or equal to 80, No component revisions or removals, No pending component revisions or removals, Absence of osteolysis, No migration/subsidence of >3mm or >3 degrees) [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
  • American Knee Society Score, Oxford Knee-12, SF-12 [ Time Frame: 6w, 6m, 1y, 2y, 3y, 5y, 7y, 10y ] [ Designated as safety issue: No ]
  • Radiographic evaluation [ Time Frame: 6m,1y, 2y, 3y, 5y, 10y ] [ Designated as safety issue: Yes ]
  • Adverse Events [ Time Frame: any ] [ Designated as safety issue: Yes ]
  • Survivorship [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Noble & Weiss Knee Score, Kujala Score [ Time Frame: 6w, 6m, 1y, 2y ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: May 2011
Estimated Study Completion Date: June 2023
Estimated Primary Completion Date: February 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AGC knee Device: AGC knee
The AGC knee is a metal and polyethylene total condylar knee system offering complete component interchangeability.
Experimental: Vanguard CR Device: Vanguard CR
The Vanguard CR is a metal and polyethylene total condylar knee system. The system contains three primary components: femoral, tibial, and bearing components, and a peripheral component: the patella button.

Detailed Description:

This clinical trial is designed as a multi-centre, randomized controlled study, comparing the Vanguard CR with the AGC in routine use.

The Vanguard CR system has been specifically designed to give greater knee stability through the use of more anatomic patello-femoral kinematics.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pre-op knee score of <70
  • Scheduled to undergo primary total knee replacement with any of the following indication:

    1. pain and disabled knee joint resulting from Osteoarthritis, Rheumatoid Arthritis, or Traumatic arthritis.
    2. One or more compartments involved.
  • Need to obtain pain relief and improve function
  • Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations
  • A good nutritional state of the patient
  • Full skeletal maturity of the patient, patients who are at least 18 years of age.
  • Patients of either sex
  • Consent form read, understood, and signed by patient

Exclusion Criteria:

  • Pre-op knee score greater than or equal to 70
  • Infection
  • Osteomyelitis
  • Previous partial or total prosthetic knee replacement on the operative side
  • Skeletal immaturity of the patient, patients who are less than 18 years of age.
  • Sepsis
  • Uncooperative patient or patient with neurological disorders who are incapable of following directions
  • Osteomalacia
  • Distant foci of infections
  • Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
  • Vascular insufficiency, muscular atrophy, or neuromuscular disease in affected limb
  • Incomplete or deficient soft tissue surrounding the knee
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064063

Locations
United Kingdom
East Sussex Hospital NHS Trust
St. Leonards on Sea, East Sussex, United Kingdom, TN37 7RD
Sponsors and Collaborators
Biomet, Inc.
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Biomet U.K. Ltd.
Investigators
Principal Investigator: Charles Mann, FRCS Norfolk and Norwich University Hospital NHS Trust
Principal Investigator: A. Butler-Manual, FRCS East Sussex Hospital NHS Trust
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01064063     History of Changes
Other Study ID Numbers: LEU29, LEU29
Study First Received: February 4, 2010
Last Updated: February 10, 2014
Health Authority: United Kingdom: National Health Service

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

ClinicalTrials.gov processed this record on April 14, 2014