OsteoarthritisNCT01010269
Vanguard Complete Knee Versus Vanguard High Flex Rotating Platform (RP) Knee Study
A study testing Vanguard Complete Knee and Vanguard High Flex RP in people with Osteoarthritis and Rheumatoid Arthritis, run by Zimmer Biomet at 4 sites in South Korea.
Trial summary
The purpose of this study is to compare Vanguard High Flex Rotating Platform to Vanguard Complete Knee System in Asian population in terms of early range of motion (ROM), clinical outcomes, and kinetic and kinematic characteristics in relation to healthy knees. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
- What is being tested?
- Vanguard Complete Knee and Vanguard High Flex RP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Oct 2009to Oct 2017
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Painful and disabled knee joint resulting form 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.
- Need to obtain pain relief and improve function.
- Ability and willingness of the patient to follow instructions, including control of weight and activity level.
- Good nutritional state of the patient.
- Patient must have reached full skeletal maturity.
Who cannot join
- Infection, sepsis, osteomyelitis, and failure of previous joint replacement.
- Uncooperative patient or patients 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
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- 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
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul Nat'l Uni. Hospital
Seoul
The Catholic Uni. of Korea, Seoul St. Mary's Hospital
Seoul
About this study
Official title: A Prospective Controlled Multi-center Study on Vanguard Complete Knee and Vanguard High Flex RP Knee
The purpose of this study is to compare Vanguard High Flex Rotating Platform to Vanguard Complete Knee System in Asian population in terms of early range of motion (ROM), clinical outcomes, and kinetic and kinematic characteristics in relation to healthy knees.
Read the detailed description
The primary objectives of this clinical study include:
- Evaluate size fit and long term performance of Vanguard Complete Knee ("Fixed") System in Asian and Latino population in comparison to competitor's similar product.
- Evaluate efficacy of Vanguard Complete Knee with Microplasty Tibial Tray.
- Compare Vanguard High Flex Rotating Platform ("High Flex") Knee System to Vanguard Complete Knee System in Asian population in terms of:
- Early ROM
- Clinical outcomes
- Kinetic and Kinematic characteristics in relation to Healthy Knees. o
- Compare current design to new design of Vanguard High Flex Rotating Platform Knee System in terms of :
- Early ROM
- Clinical outcomes
- Kinetic and Kinematic characteristics
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
- Being tested
- Vanguard Complete Knee, Vanguard High Flex RP
- 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 Complete KneeDevice
Vanguard Knee is a metal and polyethylene system indicated for cemented tibial and femoral use.
Vanguard High Flex RPDevice
Vanguard High Flex RP is an extension to the existing Vanguard Knee and has been specifically designed to facilitate greater than 135 degrees of knee flexion.
| Study group | Role | What they receive |
|---|---|---|
| Vanguard Complete Knee | Active comparator | Vanguard Completed Knee with Microplasty Tibial Tray is designed to hold the tibial knee bearings in a microplsty knee procedure. The Co-Cro-Mo trays are designed with a shorter stem. Receives: Device: Vanguard Complete Knee |
| Vanguard High Flex RP | Active comparator | VGRD High Flex RP knee is an extension to the exsting Vanguard Knee and has been specifically desinged to facilitate greather than 135 degrees of knee flextion as required by certain patients. Receives: Device: Vanguard High Flex RP |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Knee Society Knee Score
Including ROM
Measured: 1 Year postop
Secondary outcomes (4)
Kinematic Fluoroscopic Analysis
Kinematic Fluoroscopic Analysis
Measured: 3 yr
Gait Lab Analysis
Gait Lab Analysis
Measured: 3 yr
EQ5D
Quality of Life
Measured: 3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr
Radiographic Assessment
Radiographic Assessment
Measured: immediate postop, 3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2012
- Study completionOct 2017
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myung-Chul Lee, M.D., Ph.D., Principal investigator, Seoul National University HospitalChul-Won Ha, M.D., Ph.D., Principal investigator, Samsung Medical CenterSeong-Il Bin, M.D., Ph.D., Principal investigator, Asan Medical CenterYong In, M.D., Ph.D., Principal investigator, Catholic University Uijungbu St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010269
- Sponsor's protocol ID
- INT.CR.RROW1
- Status last verified
- Jun 2018
- First submitted
- 26 Oct 2009
- Last updated
- 26 Jun 2018
- 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 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Controlled Multi-center Study on Vanguard Complete Knee and Vanguard High Flex RP Knee
- ClinicalTrials.gov ID
- NCT01010269
- Acronym / sponsor ID
- INT.CR.RROW1
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 10 Nov 2009 (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 Vanguard High Flex Rotating Platform to Vanguard Complete Knee System in Asian population in terms of early range of motion (ROM), clinical outcomes, and kinetic and kinematic characteristics in relation to healthy knees.
Detailed description
The primary objectives of this clinical study include:
- Evaluate size fit and long term performance of Vanguard Complete Knee ("Fixed") System in Asian and Latino population in comparison to competitor's similar product.
- Evaluate efficacy of Vanguard Complete Knee with Microplasty Tibial Tray.
- Compare Vanguard High Flex Rotating Platform ("High Flex") Knee System to Vanguard Complete Knee System in Asian population in terms of:
- Early ROM
- Clinical outcomes
- Kinetic and Kinematic characteristics in relation to Healthy Knees. o
- Compare current design to new design of Vanguard High Flex Rotating Platform Knee System in terms of :
- Early ROM
- Clinical outcomes
- Kinetic and Kinematic characteristics
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vanguard Complete Knee | Active comparator | Device: Vanguard Complete KneeVanguard Completed Knee with Microplasty Tibial Tray is designed to hold the tibial knee bearings in a microplsty knee procedure. The Co-Cro-Mo trays are designed with a shorter stem. |
| Vanguard High Flex RP | Active comparator | Device: Vanguard High Flex RPVGRD High Flex RP knee is an extension to the exsting Vanguard Knee and has been specifically desinged to facilitate greather than 135 degrees of knee flextion as required by certain patients. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Painful and disabled knee joint resulting form 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.
- Need to obtain pain relief and improve function.
- Ability and willingness of the patient to follow instructions, including control of weight and activity level.
Key exclusion criteria (9 listed)
- Infection, sepsis, osteomyelitis, and failure of previous joint replacement.
- Uncooperative patient or patients with neurologic disorders who are incapable of following directions.
- Osteoporosis
- Metabolic disorders which may impair bone formation
- Osteomalacia
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 Complete KneeVanguard Knee is a metal and polyethylene system indicated for cemented tibial and femoral use. | Device | Vanguard Complete Knee |
| Vanguard High Flex RPVanguard High Flex RP is an extension to the existing Vanguard Knee and has been specifically designed to facilitate greater than 135 degrees of knee flexion. | Device | Vanguard High Flex RP |
Primary outcome
American Knee Society Knee Score
Time frame: 1 Year postop
Including ROM
4 secondary outcomes
Kinematic Fluoroscopic Analysis
Time frame: 3 yr
Gait Lab Analysis
Time frame: 3 yr
EQ5D
Time frame: 3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr
Radiographic Assessment
Time frame: immediate postop, 3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr
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 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Myung-Chul Lee, M.D., Ph.D. principal investigator
Seoul National University Hospital
Chul-Won Ha, M.D., Ph.D. principal investigator
Samsung Medical Center
Seong-Il Bin, M.D., Ph.D. principal investigator
Asan Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vanguard Complete Knee and Vanguard High Flex RP in people with Osteoarthritis and Rheumatoid Arthritis, run by Zimmer Biomet at 4 sites in South Korea.
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 7 inclusion and 9 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 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. 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: 1 Year postop). 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 Jun 2018.