A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee
1 other identifier
observational
255
8 countries
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2012
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedFirst Posted
Study publicly available on registry
March 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2031
November 25, 2025
November 1, 2025
19.8 years
February 27, 2012
November 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
AMERICAN KNEE SOCIETY KNEE SCORE
Improvement of American Knee Society Knee Score between pre-operative and 2 years post-operative follow up
24 months postoperative
Secondary Outcomes (1)
Survivorship
10 years postoperative
Study Arms (5)
Vanguard SSK 360 with PS Bearing
Patients enrolled using a Vanguard SSK 360 Posterior-Stabilized (non-constrained) tibial bearing.
Vanguard SSK 360 with PSC Bearing
Patients enrolled using a Vanguard SSK 360 Posterior-Stabilized Constrained tibial bearing.
Vanguard DA 360
Patients enrolled using a Vanguard DA 360 component.
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 PSC Bearing
The Vanguard 360 TiNbN is the same system and functions in the same manner as the non-coated device.
Interventions
non-constrained tibial bearing
non-constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur
constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur
Eligibility Criteria
Patients prescribed the Vanguard 360 Revision Knee System
You may qualify if:
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
- 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.
You may not qualify if:
- infection
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zimmer Biometlead
Study Sites (12)
Illinois Bone and Joint
Morton Grove, Illinois, 60053, United States
Orthopedic Institute of Henderson
Henderson, Nevada, 89052, United States
University of Utah Orthopedic Center
Salt Lake City, Utah, 84108, United States
OrthoVirginia West End Orthopedic Clinic
Richmond, Virginia, 23235, United States
University Hopital Pellenberg
Pellenberg, Belgium
Aarhus university hospital
Aarhus, Denmark
Ch Lyon Sud
Lyon, 69000, 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, B31 2AP, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Emilie Rohmer
Zimmer Biomet
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2012
First Posted
March 2, 2012
Study Start
March 1, 2012
Primary Completion (Estimated)
December 1, 2031
Study Completion (Estimated)
December 1, 2031
Last Updated
November 25, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share