Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System (GK9B)
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ClinicalTrials.gov Identifier: NCT02175576 |
Recruitment Status :
Active, not recruiting
First Posted : June 26, 2014
Last Update Posted : August 7, 2020
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 |
Arm | Intervention/treatment |
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Experimental: Vanguard XP Bicruciate Knee System
153 patients receive Vanguard XP Bicruciate Knee System
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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
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Device: Vanguard CR Knee System
The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design. |
- 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
- 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

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

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
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 |
Study Director: | Kacy Arnold, RN, MBA | Zimmer Biomet |
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: | August 7, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Arthritis Congenital Abnormalities Joint Diseases Musculoskeletal Diseases |