Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System
NCT ID: NCT02175576
Last Updated: 2023-02-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
50 participants
INTERVENTIONAL
2014-10-31
2020-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
All Ligaments Left In Knee Arthroplasty Trial
NCT03302013
A Clinical Investigation of the Vanguard™ Complete Knee System
NCT00698854
Primary TKA Cruciate Retaining vs Cruciate Substituting With Rotating Platform Knee Prostheses
NCT00289081
Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties
NCT02921594
Vanguard Complete Knee Versus Vanguard High Flex Rotating Platform (RP) Knee Study
NCT01010269
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vanguard XP Bicruciate Knee System
153 patients receive Vanguard XP Bicruciate Knee System
Vanguard XP Bicruciate Knee System
The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue.
Vanguard CR Knee System
153 patients receive Vanguard CR Knee System
Vanguard CR Knee System
The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vanguard XP Bicruciate Knee System
The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue.
Vanguard CR Knee System
The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zimmer Biomet
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hillary Overholser
Role: STUDY_DIRECTOR
Zimmer Biomet
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Midwest Orthopaedics at Rush University Medical Center
Chicago, Illinois, United States
University of Utah Orthopaedic Center
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ORTHO.CR.GK9B
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.