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
- Are there results?
- Not yet: the study is under way
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
Show all 13Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee
- ClinicalTrials.gov ID
- NCT01542580
- Acronym / sponsor ID
- GBMET.CR.G1
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Post Traumatic Deformity, Complications; Arthroplasty, Deformity of Limb
- Keywords
- Revision surgery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Mar 2012 (actual)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 2 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Vanguard SSK 360 with PS Bearing | – | Device: Vanguard SSK 360 with PS BearingPatients enrolled using a Vanguard SSK 360 Posterior-Stabilized (non-constrained) tibial bearing. |
| Vanguard SSK 360 with PSC Bearing | – | Device: Vanguard SSK 360 with PSC bearingPatients enrolled using a Vanguard SSK 360 Posterior-Stabilized Constrained tibial bearing. |
| Vanguard DA 360 | – | Device: Vanguard DA 360Patients enrolled using a Vanguard DA 360 component. |
| Vanguard 360 TiNbN Femur with PS Bearing | – | Device: Vanguard 360 TiNbN Femur with PS bearingThe 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 | – | Device: Vanguard 360 TiNbN Femur with PSC bearingThe Vanguard 360 TiNbN is the same system and functions in the same manner as the non-coated device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients prescribed the Vanguard 360 Revision Knee System
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- infection
- sepsis
- osteomyelitis
- An uncooperative patient or a patient with neurologic disorders who is incapable of following directions
- Osteoporosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vanguard SSK 360 with PS Bearingnon-constrained tibial bearing | Device | Vanguard SSK 360 with PS Bearing |
| Vanguard SSK 360 with PSC bearingconstrained tibial bearing | Device | Vanguard SSK 360 with PSC Bearing |
| Vanguard DA 360Dual-articulation device, only cleared in EU | Device | Vanguard DA 360 |
| Vanguard 360 TiNbN Femur with PS bearingnon-constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur | Device | Vanguard 360 TiNbN Femur with PS Bearing |
| Vanguard 360 TiNbN Femur with PSC bearingconstrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur | Device | Vanguard 360 TiNbN Femur with PSC Bearing |
Primary outcome
AMERICAN KNEE SOCIETY KNEE SCORE
Time frame: 24 months postoperative
Improvement of American Knee Society Knee Score between pre-operative and 2 years post-operative follow up
1 secondary outcome
Survivorship
Time frame: 10 years postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie Rohmer study director
Zimmer Biomet
12 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Rheumatoid Arthritis, run by Zimmer Biomet at 12 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Italy, Belgium, Denmark, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AMERICAN KNEE SOCIETY KNEE SCORE (time frame: 24 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.