OsteoarthritisVanguardNCT01064063
Randomized Controlled Clinical Evaluation to Compare Vanguard Cruciate Retaining and AGC Total Condylar Knee Implants
A study testing Vanguard CR and AGC knee in people with Osteoarthritis and Rheumatoid Arthritis, run by Zimmer Biomet at 1 site in United Kingdom.
Trial summary
This evaluation is being conducted on the relative new knee system, the Vanguard Cruciate Retaining (CR) to evaluate clinical efficacy of the Vanguard CR components. 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 CR and AGC knee
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Feb 2011to 10 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Pre-op knee score of <70
- Scheduled to undergo primary total knee replacement with any of the following indication:
- pain and disabled knee joint resulting from Osteoarthritis, Rheumatoid Arthritis, or Traumatic arthritis.
- One or more compartments involved.
- Need to obtain pain relief and improve function
- Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations
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- A good nutritional state of the patient
- Full skeletal maturity of the patient, patients who are at least 18 years of age.
- Patients of either sex
- Consent form read, understood, and signed by patient
Who cannot join
- Pre-op knee score greater than or equal to 70
- Infection
- Osteomyelitis
- Previous partial or total prosthetic knee replacement on the operative side
- Skeletal immaturity of the patient, patients who are less than 18 years of age.
- Sepsis
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- Uncooperative patient or patient with neurological disorders who are incapable of following directions
- Osteomalacia
- Distant foci of infections
- Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
- Vascular insufficiency, muscular atrophy, or neuromuscular disease in affected limb
- Incomplete or deficient soft tissue surrounding the knee
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
East Sussex Hospital NHS Trust
Saint Leonards-on-Sea, East Sussex, TN37 7RD
About this study
This evaluation is being conducted on the relative new knee system, the Vanguard Cruciate Retaining (CR) to evaluate clinical efficacy of the Vanguard CR components.
Read the detailed description
This clinical trial was initially designed as a multi-centre, randomized controlled study, comparing the Vanguard CR with the AGC in routine use. The study now is a single centre study.
The Vanguard CR system has been specifically designed to give greater knee stability through the use of more anatomic patello-femoral kinematics.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
- Being tested
- Vanguard CR, AGC knee
- 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 CRDevice
The Vanguard CR is a metal and polyethylene total condylar knee system. The system contains three primary components: femoral, tibial, and bearing components, and a peripheral component: the patella button.
AGC kneeDevice
The AGC knee is a metal and polyethylene total condylar knee system offering complete component interchangeability.
| Study group | Role | What they receive |
|---|---|---|
| AGC knee | Active comparator | Patients were randomised to receive an AGC Cruciate Retaining cement knee. This is the control group in the study; the AGC is the gold standard of Biomets' knee products. Receives: Device: AGC knee |
| Vanguard CR | Experimental | Patients were randomised to receive a Vanguard Cruciate Retaining Knee from the Vanguard system which encompasses concepts used in the AGC family of knees. The Vanguard is specifically designed to give greater knees stability through use of more anatomic patello-femoral kinematics. Receives: Device: Vanguard CR |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Knee Society Knee Score
Objective scoring system to rate the knee and patient's functional abilities before and after TKA
Measured: 2 year
Secondary outcomes (6)
Patient success
Defined as Knee Score greater than or equal to 80, No component revisions or removals, No pending component revisions or removals, Absence of osteolysis, No migration/subsidence of >3mm or >3 degrees
Measured: 2 year
American Knee Society Score, Oxford Knee-12, SF-12
Objective scoring instruments to rate the knee and patient's functional abilities before and after TKA including scoring systems based on patient questionnaires
Measured: 6w, 6m, 1y, 2y, 3y, 5y, 7y, 10y
Radiographic evaluation
Assessment of patient x-rays
Measured: 6m,1y, 2y, 3y, 5y, 10y
Adverse Events
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons, whether or not related to the investigational medical device.
Measured: any
Survivorship
Implant survivorship based on removal of a study device.
Measured: 10 years
Noble & Weiss Knee Score, Kujala Score
Scoring systems based on patient questionnaires
Measured: 6w, 6m, 1y, 2y
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study start15 Feb 2011
- Primary completion15 Dec 2013
- Study completion10 May 2022
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomised into two arms, one receiving the AGC CR cement knee system (control group), and the other receiving Vanguard CR cement knee system (trial group).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- East Sussex Healthcare NHS Trust, Biomet U.K. Ltd.
- Responsible party
- Sponsor
- Investigators
- A. Butler-Manual, FRCS, Principal investigator, East Sussex Hospital NHS Trust - Conquest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064063
- Sponsor's protocol ID
- BMETEU.CR.LEU29
- Other IDs
- NCT01064063
- Acronym
- Vanguard
- Status last verified
- Nov 2025
- First submitted
- 4 Feb 2010
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To be confirmed.
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Evaluation to Compare Vanguard Cruciate Retaining and AGC Total Condylar Knee Implants
- ClinicalTrials.gov ID
- NCT01064063
- Acronym / sponsor ID
- Vanguard / BMETEU.CR.LEU29
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- East Sussex Healthcare NHS Trust, Biomet U.K. Ltd.
- Study start
- 15 Feb 2011 (actual)
- Primary completion
- 15 Dec 2013 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 8 Feb 2010 (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.
This evaluation is being conducted on the relative new knee system, the Vanguard Cruciate Retaining (CR) to evaluate clinical efficacy of the Vanguard CR components.
Detailed description
This clinical trial was initially designed as a multi-centre, randomized controlled study, comparing the Vanguard CR with the AGC in routine use. The study now is a single centre study.
The Vanguard CR system has been specifically designed to give greater knee stability through the use of more anatomic patello-femoral kinematics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomised into two arms, one receiving the AGC CR cement knee system (control group), and the other receiving Vanguard CR cement knee system (trial group).
| Arm | Type | Receives |
|---|---|---|
| AGC knee | Active comparator | Device: AGC kneePatients were randomised to receive an AGC Cruciate Retaining cement knee. This is the control group in the study; the AGC is the gold standard of Biomets' knee products. |
| Vanguard CR | Experimental | Device: Vanguard CRPatients were randomised to receive a Vanguard Cruciate Retaining Knee from the Vanguard system which encompasses concepts used in the AGC family of knees. The Vanguard is specifically designed to give greater knees stability through use of more anatomic patello-femoral kinematics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pre-op knee score of <70
- Scheduled to undergo primary total knee replacement with any of the following indication:
- Need to obtain pain relief and improve function
- Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations
- A good nutritional state of the patient
Key exclusion criteria (12 listed)
- Pre-op knee score greater than or equal to 70
- Infection
- Osteomyelitis
- Previous partial or total prosthetic knee replacement on the operative side
- Skeletal immaturity of the patient, patients who are less than 18 years of age.
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 CRThe Vanguard CR is a metal and polyethylene total condylar knee system. The system contains three primary components: femoral, tibial, and bearing components, and a peripheral component: the patella button. | Device | Vanguard CR |
| AGC kneeThe AGC knee is a metal and polyethylene total condylar knee system offering complete component interchangeability. | Device | AGC knee |
Primary outcome
American Knee Society Knee Score
Time frame: 2 year
Objective scoring system to rate the knee and patient's functional abilities before and after TKA
6 secondary outcomes
Patient success
Time frame: 2 year
American Knee Society Score, Oxford Knee-12, SF-12
Time frame: 6w, 6m, 1y, 2y, 3y, 5y, 7y, 10y
Radiographic evaluation
Time frame: 6m,1y, 2y, 3y, 5y, 10y
Adverse Events
Time frame: any
Survivorship
Time frame: 10 years
Noble & Weiss Knee Score, Kujala Score
Time frame: 6w, 6m, 1y, 2y
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No. To be confirmed.
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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.
A. Butler-Manual, FRCS principal investigator
East Sussex Hospital NHS Trust - Conquest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vanguard CR and AGC knee in people with Osteoarthritis and Rheumatoid Arthritis, run by Zimmer Biomet at 1 site in United Kingdom.
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 10 inclusion and 12 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: finished, as of the sponsor's last update on 26 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 1 site in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 2 year). 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 26 Nov 2025.