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Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System (GK9B)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02175576
Recruitment Status : Active, not recruiting
First Posted : June 26, 2014
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Study Description
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Brief Summary:
Randomized Controlled Study to determine if preservation of ligaments provides increased functional ability post-operatively in comparison to traditional TKA which sacrifices soft tissue.

Condition or disease Intervention/treatment Phase
Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis Lower Limb Deformity Post-traumatic Deformity Complications, Arthroplasty Device: Vanguard XP Bicruciate Knee System Device: Vanguard CR Knee System Not Applicable

Detailed Description:
Randomized Controlled Study to compare clinical and patient reported outcomes of the Vanguard XP Bicruciate Total Knee System to the Vanguard CR Knee System through 10 years of follow-up.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System
Actual Study Start Date : October 2014
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : October 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: Vanguard XP Bicruciate Knee System
153 patients receive Vanguard XP Bicruciate Knee System
 Device: Vanguard XP Bicruciate Knee System
The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue.
Active Comparator: Vanguard CR Knee System
153 patients receive Vanguard CR Knee System
 Device: Vanguard CR Knee System
The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Modified Knee Society Score [ Time Frame: 12 months ]
    The objective component of the Knee Society score will be collected by clinical personnel. The pain and function component of the score will be patient complete questionnaire


Secondary Outcome Measures :
  1. Complications [ Time Frame: Pre-op, Post op at 3 & 6 month, 1, 2, 3, 5, 7 & 10 year intervals ]
    Serious and device related adverse events will be collected for the duration of the study

  2. Survivorship [ Time Frame: Post op at 1, 2, 3, 5, 7 & 10 year intervals ]
    KM survivorship will be calculated based on device revisions and removals through out duration of the study

  3. Change in Patient Reported Outcome Measures on KOOS [ Time Frame: 12 months ]
    Patients will complete questionnaires to determine overall satisfaction and outcomes of TKA including KOOS

  4. Change in Patient Reported Outcome Measures on Oxford Knee Score [ Time Frame: 12 months ]
    Patients will complete questionnaires to determine overall satisfaction and outcomes of TKA including Oxford Knee Score

  5. Change in Patient Reported Outcome Measures on EQ 5D [ Time Frame: 12 months ]
    Patients will complete questionnaires to determine overall satisfaction and outcomes of TKA including EQ-5D


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cemented application of components
  • bilateral subjects randomized by knee
  • patients with pre-existing contralateral knee surgery
  • painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved
  • correction of varus, valgus, or posttraumatic deformity
  • sufficient soft tissue surrounding the knee, including the Anterior Cruciate Ligament

Exclusion Criteria:

  • cementless application of components
  • BMI greater than or equal to 40
  • use of Anterior Stabilized Bearings
  • patients with severe pre-operative varus or valgus deformity greater than or equal to 15 degrees
  • correction or revision of previous joint replacement procedure on index knee
  • infection
  • sepsis
  • osteomyelitis

Relative exclusion criteria:

  • uncooperative patient or patient with neurological disorders who is incapable of following directions
  • osteoporosis
  • metabolic disorders which may impair bone formation
  • 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, including the anterior cruciate ligament
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175576


Locations
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United States, Illinois
Midwest Orthopaedics at Rush University Medical Center
Chicago, Illinois, United States, 60605
United States, Utah
University of Utah Orthopaedic Center
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Study Director: Kacy Arnold, RN, MBA Zimmer Biomet
More Information
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT02175576    
Other Study ID Numbers: ORTHO.CR.GK9B
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Arthritis
Congenital Abnormalities
Joint Diseases
Musculoskeletal Diseases