Back to resultsRandomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System (GK9B)
Primary Purpose
Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vanguard XP Bicruciate Knee System
Vanguard CR Knee System
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility 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
Sites / Locations
- Midwest Orthopaedics at Rush University Medical Center
- University of Utah Orthopaedic Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vanguard XP Bicruciate Knee System
Vanguard CR Knee System
Arm Description
153 patients receive Vanguard XP Bicruciate Knee System
153 patients receive Vanguard CR Knee System
Outcomes
Primary Outcome Measures
Number of Knees Reported as "Feels Normal" on a Single Assessment Numeric Evaluation (SANE)
Participants answered a Single Assessment Numeric Evaluation (SANE) which asked how they rated their knee function. A score of 100 indicates normal and anything below 100 indicates a percentage of normal function.
Secondary Outcome Measures
Modified Knee Society Score
The American Knee Society Score is part clinical exam and part patient administered assessment of the knee. The objective part of the score was collected in the clinic by qualified personnel. The functional and pain components of the score were collected by patient completed questionnaire. Total scores can range from 0 to 200, with higher scores indicating better outcomes.
Revisions/Removals
Number of study device revisions or removals reported during the study.
Number of Knees Reported as "Feels at Least 80% of Normal" on a Single Assessment Numeric Evaluation (SANE)
Participants answered a Single Assessment Numeric Evaluation (SANE) which asked how they rated their knee function. A score of 100 indicates normal and anything below 100 indicates a percentage of normal function.
Number of Knees With Which Participants Reported Being "Happy" or "Very Happy"
Participants answered a survey which asked how they they would describe their satisfaction with their new joint. Options for answers included "I have never been happy," "Ok - but not perfect," "Happy," and "Very Happy."
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02175576
Brief Title
Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System
Acronym
GK9B
Official Title
Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Data no longer required to meet regulatory requirements.
Study Start Date
October 2014 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Lower Limb Deformity, Post-traumatic Deformity, Complications, Arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vanguard XP Bicruciate Knee System
Arm Type
Experimental
Arm Description
153 patients receive Vanguard XP Bicruciate Knee System
Arm Title
Vanguard CR Knee System
Arm Type
Active Comparator
Arm Description
153 patients receive Vanguard CR Knee System
Intervention Type
Device
Intervention Name(s)
Vanguard XP Bicruciate Knee System
Intervention Description
The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue.
Intervention Type
Device
Intervention Name(s)
Vanguard CR Knee System
Intervention Description
The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design.
Primary Outcome Measure Information:
Title
Number of Knees Reported as "Feels Normal" on a Single Assessment Numeric Evaluation (SANE)
Description
Participants answered a Single Assessment Numeric Evaluation (SANE) which asked how they rated their knee function. A score of 100 indicates normal and anything below 100 indicates a percentage of normal function.
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Modified Knee Society Score
Description
The American Knee Society Score is part clinical exam and part patient administered assessment of the knee. The objective part of the score was collected in the clinic by qualified personnel. The functional and pain components of the score were collected by patient completed questionnaire. Total scores can range from 0 to 200, with higher scores indicating better outcomes.
Time Frame
12 months
Title
Revisions/Removals
Description
Number of study device revisions or removals reported during the study.
Time Frame
3 years
Title
Number of Knees Reported as "Feels at Least 80% of Normal" on a Single Assessment Numeric Evaluation (SANE)
Description
Participants answered a Single Assessment Numeric Evaluation (SANE) which asked how they rated their knee function. A score of 100 indicates normal and anything below 100 indicates a percentage of normal function.
Time Frame
12 Months
Title
Number of Knees With Which Participants Reported Being "Happy" or "Very Happy"
Description
Participants answered a survey which asked how they they would describe their satisfaction with their new joint. Options for answers included "I have never been happy," "Ok - but not perfect," "Happy," and "Very Happy."
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hillary Overholser
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
Midwest Orthopaedics at Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60605
Country
United States
Facility Name
University of Utah Orthopaedic Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System
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