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Randomized Controlled Clinical Evaluation to Compare Vanguard Cruciate Retaining and AGC Total Condylar Knee Implants (Vanguard)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
East Sussex Hospitals NHS Trust
Biomet U.K. Ltd.
Information provided by (Responsible Party):
Zimmer Biomet
ClinicalTrials.gov Identifier:
NCT01064063
First received: February 4, 2010
Last updated: March 9, 2017
Last verified: March 2017
  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
Intervention Model: Parallel Assignment
Intervention Model Description:
Patients will be randomised into two arms, one receiving the AGC CR cement knee system (control group), and the other receiving Vanguard CR cement knee system (trial group).
Masking: 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 Zimmer Biomet:

Primary Outcome Measures:
  • American Knee Society Knee Score [ Time Frame: 2 year ]

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 ]
  • American Knee Society Score, Oxford Knee-12, SF-12 [ Time Frame: 6w, 6m, 1y, 2y, 3y, 5y, 7y, 10y ]
  • Radiographic evaluation [ Time Frame: 6m,1y, 2y, 3y, 5y, 10y ]
  • Adverse Events [ Time Frame: any ]
  • Survivorship [ Time Frame: 10 years ]
  • Noble & Weiss Knee Score, Kujala Score [ Time Frame: 6w, 6m, 1y, 2y ]

Enrollment: 150
Actual Study Start Date: February 15, 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
Patients were randomised to receive an AGC Cruciate Retaining cement knee. This is the control group in the study; the AGC is the gold standard of Biomets' knee products.
Device: AGC knee
The AGC knee is a metal and polyethylene total condylar knee system offering complete component interchangeability.
Experimental: Vanguard CR
Patients were randomised to receive a Vanguard Cruciate Retaining Knee from the Vanguard system which encompasses concepts used in the AGC family of knees. The Vanguard is specifically designed to give greater knees stability through use of more anatomic patello-femoral kinematics.
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 was initially designed as a multi-centre, randomized controlled study, comparing the Vanguard CR with the AGC in routine use. The study now is a single centre study.

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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: NCT01064063

Locations
United Kingdom
East Sussex Hospital NHS Trust
St. Leonards on Sea, East Sussex, United Kingdom, TN37 7RD
Sponsors and Collaborators
Zimmer Biomet
East Sussex Hospitals NHS Trust
Biomet U.K. Ltd.
Investigators
Principal Investigator: A. Butler-Manual, FRCS East Sussex Hospital NHS Trust - Conquest Hospital
  More Information

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01064063     History of Changes
Other Study ID Numbers: BMETEU.CR.EU29
Study First Received: February 4, 2010
Last Updated: March 9, 2017
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: To be confirmed.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

ClinicalTrials.gov processed this record on June 28, 2017