OsteoarthritisNCT01542580
A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee
An observational study of Osteoarthritis and Rheumatoid Arthritis, run by Zimmer Biomet at 12 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
- What is being tested?
- Vanguard SSK 360 with PS Bearing, Vanguard SSK 360 with PSC bearing and Vanguard DA 360
- Type of treatment
- Medical device
- How many people
- 255 participants
- Where
- 12 sitesin 8 countries
- Study dates
- Mar 2012to Dec 2031
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients prescribed the Vanguard 360 Revision Knee System
Who may be able to join
- 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.
Who cannot join
- infection
- sepsis
- osteomyelitis
- Relative Contraindications:
- An uncooperative patient or a patient with neurologic disorders who is incapable of following directions
- Osteoporosis
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- 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
- Additional research-related exclusion criteria: patients who have a history of or current infection in the affected knee.
Trial locations and contacts
12 sites in 8 countries.
12 sites in 8 countries
United States4 sites
Orthopedic Institute of Henderson
Henderson, Nevada, 89052
Illinois Bone and Joint
Morton Grove, Illinois, 60053
OrthoVirginia West End Orthopedic Clinic
Richmond, Virginia, 23235
University of Utah Orthopedic Center
Salt Lake City, Utah, 84108
Italy2 sites
IRCCS Istituto Ortopedico Galeazzi
Milan
Azienda Ospedaliero Universitaria Pisana
Pisa
About this study
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.
Read the detailed description
This investigation is being conducted on a new complete revision knee system, Vanguard 360, which incorporates:
- 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
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Post Traumatic Deformity, Complications; Arthroplasty, Deformity of Limb
- Being tested
- Vanguard SSK 360 with PS Bearing, Vanguard SSK 360 with PSC bearing, Vanguard DA 360, Vanguard 360 TiNbN Femur with PS bearing, Vanguard 360 TiNbN Femur with PSC bearing
- Keywords
- Revision surgery
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vanguard SSK 360 with PS BearingDevice
non-constrained tibial bearing
Vanguard SSK 360 with PSC bearingDevice
constrained tibial bearing
Vanguard DA 360Device
Dual-articulation device, only cleared in EU
Vanguard 360 TiNbN Femur with PS bearingDevice
non-constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur
Vanguard 360 TiNbN Femur with PSC bearingDevice
constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur
| Study group | Role | What they receive |
|---|---|---|
| Vanguard SSK 360 with PS Bearing | Patients enrolled using a Vanguard SSK 360 Posterior-Stabilized (non-constrained) tibial bearing. Receives: Device: Vanguard SSK 360 with PS Bearing | |
| Vanguard SSK 360 with PSC Bearing | Patients enrolled using a Vanguard SSK 360 Posterior-Stabilized Constrained tibial bearing. Receives: Device: Vanguard SSK 360 with PSC bearing | |
| Vanguard DA 360 | Patients enrolled using a Vanguard DA 360 component. Receives: Device: Vanguard DA 360 | |
| 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. Receives: Device: Vanguard 360 TiNbN Femur with PS bearing | |
| 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. Receives: Device: Vanguard 360 TiNbN Femur with PSC bearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
AMERICAN KNEE SOCIETY KNEE SCORE
Improvement of American Knee Society Knee Score between pre-operative and 2 years post-operative follow up
Measured: 24 months postoperative
Secondary outcomes (1)
Survivorship
Survivorship at 10 years post-operative follow up
Measured: 10 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emilie Rohmer, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542580
- Sponsor's protocol ID
- GBMET.CR.G1
- Status last verified
- Nov 2025
- First submitted
- 27 Feb 2012
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No