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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 : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Tracking Information
First Submitted Date  ICMJE June 24, 2014
First Posted Date  ICMJE June 26, 2014
Last Update Posted Date August 7, 2020
Actual Study Start Date  ICMJE October 2014
Estimated Primary Completion Date October 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 24, 2014)
Percentage of patients reporting their knee feels "normal" [ Time Frame: 10 years post-op ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2014)
  • Patient Reported Outcome Measures (PROMS) [ Time Frame: 10 years post-op ]
  • Knee Society Score [ Time Frame: 10 years post-op ]
  • Complication Rate [ Time Frame: 10 years post-op ]
  • Survivorship [ Time Frame: 10 years post-op ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System
Official Title  ICMJE Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Traumatic Arthritis
  • Lower Limb Deformity
  • Post-traumatic Deformity
  • Complications, Arthroplasty
Intervention  ICMJE
  • Device: Vanguard XP Bicruciate Knee System
    The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue.
  • Device: Vanguard CR Knee System
    The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design.
Study Arms  ICMJE
  • Experimental: Vanguard XP Bicruciate Knee System
    153 patients receive Vanguard XP Bicruciate Knee System
    Intervention: Device: Vanguard XP Bicruciate Knee System
  • Active Comparator: Vanguard CR Knee System
    153 patients receive Vanguard CR Knee System
    Intervention: Device: Vanguard CR Knee System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 24, 2014)
306
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2026
Estimated Primary Completion Date October 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02175576
Other Study ID Numbers  ICMJE ORTHO.CR.GK9B
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zimmer Biomet
Study Sponsor  ICMJE Zimmer Biomet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kacy Arnold, RN, MBA Zimmer Biomet
PRS Account Zimmer Biomet
Verification Date August 2020

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