A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee
NCT ID: NCT01542580
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
255 participants
OBSERVATIONAL
2012-03-31
2031-12-31
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.
A Clinical Investigation of the Vanguard™ Complete Knee System
NCT00698854
Vanguard™ Deep Dish Rotating Platform Knee Clinical Evaluation
NCT00753090
Vanguard Complete Knee Versus Vanguard High Flex Rotating Platform (RP) Knee Study
NCT01010269
Vanguard Knee Anterior Stabilized Versus Posterior Stabilized Bearing Study
NCT01308515
Clinical Evaluation of Vanguard DD RP
NCT04076202
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Fixed Bearing Knee - Vanguard SSK360 with PS Bearing and PSC Bearing
* Fixed Bearing Knee - Vanguard SSK360 TiNbN Femur with PS Bearing and PSC Bearing
* Mobile Bearing Knee - Vanguard DA360 (only being collected in Europe)
The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment, clinical outcomes and survivorship.
The efficacy and performance of the devices will be assessed by improvement of pain, function, range of motion and patient satisfaction measured pre-operatively and post-operatively. Secondary performance and safety will be determined by radiographic investigation, incidence of complications and revision rates.
Surgical techniques and patient care are to be standard for the surgeon participating in the protocol. There will be no experimental or investigational devices used. There will be no experimental or investigational surgical techniques used. The devices and products will be used in accordance with their instructions for use and/or approved labeling.
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.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vanguard SSK 360 with PS Bearing
Patients enrolled using a Vanguard SSK 360 Posterior-Stabilized (non-constrained) tibial bearing.
Vanguard SSK 360 with PS Bearing
non-constrained tibial bearing
Vanguard SSK 360 with PSC Bearing
Patients enrolled using a Vanguard SSK 360 Posterior-Stabilized Constrained tibial bearing.
Vanguard SSK 360 with PSC bearing
constrained tibial bearing
Vanguard DA 360
Patients enrolled using a Vanguard DA 360 component.
Vanguard DA 360
Dual-articulation device, only cleared in EU
Vanguard 360 TiNbN Femur with PS Bearing
The Vanguard 360 TiNbN is the same system and functions in the same manner as the non-coated device.
Vanguard 360 TiNbN Femur with PS bearing
non-constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur
Vanguard 360 TiNbN Femur with PSC Bearing
The Vanguard 360 TiNbN is the same system and functions in the same manner as the non-coated device.
Vanguard 360 TiNbN Femur with PSC bearing
constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vanguard SSK 360 with PS Bearing
non-constrained tibial bearing
Vanguard SSK 360 with PSC bearing
constrained tibial bearing
Vanguard DA 360
Dual-articulation device, only cleared in EU
Vanguard 360 TiNbN Femur with PS bearing
non-constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur
Vanguard 360 TiNbN Femur with PSC bearing
constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Correction of varus, valgus or post-traumatic deformity
* Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure
* Ability and willingness of the patient to attend follow-up visit.
* Willing to give written informed consent
* Patients are at least 18 years of age, no upper age limit, must have reached full skeletal maturity.
Exclusion Criteria
* sepsis
* osteomyelitis
Relative Contraindications:
* An uncooperative patient or a patient with neurologic disorders who is incapable of following directions
* Osteoporosis
* Metabolic disorders which may impair brain function
* 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
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.
Emilie Rohmer
Role: STUDY_DIRECTOR
Zimmer Biomet
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Illinois Bone and Joint
Morton Grove, Illinois, United States
Orthopedic Institute of Henderson
Henderson, Nevada, United States
University of Utah Orthopedic Center
Salt Lake City, Utah, United States
OrthoVirginia West End Orthopedic Clinic
Richmond, Virginia, United States
University Hopital Pellenberg
Pellenberg, , Belgium
Aarhus university hospital
Aarhus, , Denmark
Ch Lyon Sud
Lyon, , France
Klinik fur Endoprothetik und gelenkchirurgie
Bad Wildbad, , Germany
IRCCS Istituto Ortopedico Galeazzi
Milan, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
University Hospital Mutua de Terrasa
Terrassa, , Spain
Royal Orthopaedic Hospital
Birmingham, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GBMET.CR.G1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.