OsteoarthritisVGASPSNCT01308515
Vanguard Knee Anterior Stabilized Versus Posterior Stabilized Bearing Study
A study testing Vanguard Knee System with AS Bearing and Vanguard Knee System with PS Bearing in people with Osteoarthritis and Degenerative Arthritis, run by Zimmer Biomet.
Trial summary
The purpose of this study is to compare the performance of two FDA-cleared tibial bearings (replacement for cartilage in the knee) by collecting data on patients through 3 years of follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Degenerative Arthritis
- What is being tested?
- Vanguard Knee System with AS Bearing and Vanguard Knee System with PS Bearing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Sep 2010
- 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
Inclusion Criteria are identical to the indications stated in the FDA approved labeling for the device 510(k) K023546, K033489, and K050222. These indications are stated below:
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
- Correction of varus, valgus, or posttraumatic deformity.
- Correction or revision of unsuccessful osteotomy, or arthrodesis.
Patient selection factors to be considered include:
- Need to obtain pain relief and improve function
- Ability and willingness of the patient to follow instructions, including control of weight and activity level
- A good nutritional state of the patient
- The patient must have reached full skeletal maturity
Exclusion criteria will be identical to the contraindications stated in the FDA approved labeling for the device 510(k) K023546, K033489, and K050222.
These contraindications are stated below:
-Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement.
Relative contraindications include:
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions
- Osteoporosis,
- Metabolic disorders which may impair bone formation
- 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
About this study
Official title: A Comparative Clinical Evaluation of the Vanguard Knee System's Anterior Stabilized & Posterior Stabilized Tibial Bearings
The purpose of this study is to compare the performance of two FDA-cleared tibial bearings (replacement for cartilage in the knee) by collecting data on patients through 3 years of follow-up.
- Conditions
- Osteoarthritis, Degenerative Arthritis
- Being tested
- Vanguard Knee System with AS Bearing, Vanguard Knee System with PS Bearing
- Keywords
- knee, osteoarthritis, joint, replacement, knee surgery
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vanguard Knee System with AS BearingDevice
FDA cleared Tibial bearing that stabilizes the knee with an anterior lip, and is used with FDA cleared Vanguard CR (Cruciate Retaining) Femoral Component.
Vanguard Knee System with PS BearingDevice
FDA cleared Tibial bearing that stabilizes the knee with a post that articulates with the FDA cleared Vanguard PS(Posterior Stabilizing) Femoral Component.
| Study group | Role | What they receive |
|---|---|---|
| Posterior Stabilized | Other | Patients who received a PS (Posterior Stabilized) Tibial Bearing. Receives: Device: Vanguard Knee System with PS Bearing |
| Anterior Stablized | Other | Patients who received an AS (Anterior Stabilized) Tibial Bearing Receives: Device: Vanguard Knee System with AS Bearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Knee Score
Average objective knee score; includes a combination of range of motion and pain scores.
Measured: 1 Year Post-op
Secondary outcomes (4)
Knee Society Score
Average total knee score. Includes the objective and functional aspects of the knee score.
Measured: 3 Years
Dislocation
Rate of Dislocation as reported by patients in a complication.
Measured: 3 Years
Survivorship
Reports surivival of implant.
Measured: 3 Years
Reports of Radiographic Loosening via Complication Form
A more specific survivorship element; will indicate rate of loosening if it occurs.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startSep 2010
- Primary completionSep 2010 (estimated)
- Study completionSep 2010 (estimated)
Why it stopped: Could not find interested researchers/clinicians to complete study protocol.
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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ken Beres, MD, Study director, Biomet (no investigators were selected for this study)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308515
- Sponsor's protocol ID
- 090809
- Acronym
- VGASPS
- Status last verified
- Jun 2017
- First submitted
- 2 Jun 2010
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Clinical Evaluation of the Vanguard Knee System's Anterior Stabilized & Posterior Stabilized Tibial Bearings
- ClinicalTrials.gov ID
- NCT01308515
- Acronym / sponsor ID
- VGASPS / 090809
- Conditions
- Osteoarthritis, Degenerative Arthritis
- Keywords
- knee, osteoarthritis, joint, replacement, knee surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Could not find interested researchers/clinicians to complete study protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 4 Mar 2011 (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 compare the performance of two FDA-cleared tibial bearings (replacement for cartilage in the knee) by collecting data on patients through 3 years of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior Stabilized | Other | Device: Vanguard Knee System with PS BearingPatients who received a PS (Posterior Stabilized) Tibial Bearing. |
| Anterior Stablized | Other | Device: Vanguard Knee System with AS BearingPatients who received an AS (Anterior Stabilized) Tibial Bearing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 Knee System with AS BearingFDA cleared Tibial bearing that stabilizes the knee with an anterior lip, and is used with FDA cleared Vanguard CR (Cruciate Retaining) Femoral Component. | Device | Anterior Stablized |
| Vanguard Knee System with PS BearingFDA cleared Tibial bearing that stabilizes the knee with a post that articulates with the FDA cleared Vanguard PS(Posterior Stabilizing) Femoral Component. | Device | Posterior Stabilized |
Primary outcome
Objective Knee Score
Time frame: 1 Year Post-op
Average objective knee score; includes a combination of range of motion and pain scores.
4 secondary outcomes
Knee Society Score
Time frame: 3 Years
Dislocation
Time frame: 3 Years
Survivorship
Time frame: 3 Years
Reports of Radiographic Loosening via Complication Form
Time frame: 3 Years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
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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.
Ken Beres, MD study director
Biomet (no investigators were selected for this study)
Questions about this trial
What is this clinical trial studying?
A study testing Vanguard Knee System with AS Bearing and Vanguard Knee System with PS Bearing in people with Osteoarthritis and Degenerative Arthritis, run by Zimmer Biomet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Objective Knee Score (time frame: 1 Year Post-op). 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 21 Jun 2017.