Varus DeformityVGRDE1NCT02088372
Prospective Multi-Center Study on Vanguard With E1 Bearing
An observational study of Varus Deformity and Valgus Deformity, run by Zimmer Biomet at 4 sites in South Korea.
Trial summary
Evaluate Clinical Performance of Vanguard Knee with E1 Bearing in Korean Patient Population Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Varus Deformity, Valgus Deformity, Posttraumatic Deformity
- What is being tested?
- Vanguard with E1 PS Bearing
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Nov 2012to Feb 2021
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Painful and disabled knee joint resulting from osteoarthritis or traumatic arthritis where one or more compartments are involved, varus, valgus, or posttraumatic deformity, and revision of unsuccessful osteotomy at Chungnam Nat'l Univ. Hospital, Kangwon Nat'l Univ. Hospital, Gacheon Uni. Gil Medical Center, and Chonbuk Nat'l Univ. Hospital.
Who may be able to join
- Patients will be included in this study if they received Vanguard knee with E1 Bearing per the approved indications for use for Vanguard Knee. Specifically
- Painful and disabled knee joint resulting from osteoarthritis or traumatic arthritis where one or more compartments are involved
- Correction of varus, valgus, or posttraumatic deformity
- Correction or revision of unsuccessful osteotomy
Who cannot join
- Exclusion Criteria for this study should comply with the stated contraindications on package inserts of Vanguard™ Knee and the E1™ Tibial Bearing. These indications 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
Show all 11Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Kangwon Nat'l Univ. Hospital
Chuncheon
Chungnam Nat'l Univ. Hospital
Daejeon
Gacheon Gil Univ. Gil Medical Center
Incheon
Chonbuk Nat'l Univ. Hospital
Jeonju
About this study
Official title: Evaluate Clinical Performance of Vanguard Knee With E1 Bearing in Korean Patient Population
Evaluate Clinical Performance of Vanguard Knee with E1 Bearing in Korean Patient Population
Read the detailed description
E1™ Vitamin E doping of highly cross-linked polyethylene is a proposed method for insuring long-term oxidative stability of highly cross-linked ultra-high molecular weight polyethylene for use in total joint arthroplasty. In vitro research and development studies have shown that this material has improved wear performance, retention of mechanical properties, and a high resistance to oxidation due to the anti-oxidative properties of Vitamin E. Biomet Inc, has received FDA clearance to market tibial polyethylene components made of E1™ for use in the Vanguard total knee replacement system.
Vanguard Total Knee System™ The Vanguard™ Knee System was designed to incorporate features from prior designs, including: ACG, Maxim, \& Ascent. The Vanguard Knee includes a streamlined design, rounded sagittal profile, and a deeper trochlear groove. The femoral component is available in Cruciate Retaining (CR), Posterior Stabilizing (PS), and Super Stabilized (SSK). Tibial Bearings are available in various levels of constraint required by the surgeon (CR, PS, AS, etc.).
For this study, ONLY Vanguard with PS Bearing will be used.
The purpose of the study is to evaluate clinical performance of Vanguard Knee with E1 Bearing in TKA in Korean patient population. The clinical performance will be evaluated based on patient outcomes, radiographic assessment and survivorship.
- Conditions
- Varus Deformity, Valgus Deformity, Posttraumatic Deformity, Osteoarthritis, Knee, Unspecified Disorder of Knee Joint
- Being tested
- Vanguard with E1 PS Bearing
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vanguard with E1 PS BearingDevice
Evaluate Clinical Performance of Vanguard Knee with E1 Bearing in Korean Patient Population
| Study group | Role | What they receive |
|---|---|---|
| Vanguard with E1 PS Bearing | E1™ Vitamin E doping of highly cross-linked polyethylene is a proposed method for insuring long-term oxidative stability of highly cross-linked ultra-high molecular weight polyethylene for use in total joint arthroplasty.
Vanguard Total Knee System™ The Vanguard™ Knee System was designed to incorporate features from prior designs, including: ACG, Maxim, \& Ascent. Receives: Device: Vanguard with E1 PS Bearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Score
scoring system to rate the knee and patient's functional abilities such as walking and stair climbing before and after TKA
Measured: 1 year
Secondary outcomes (20)
Knee Sociey Score
scoring system to rate the knee and patient's functional abilities such as walking and stair climbing before and after TKA
Measured: 6 Months
Knee Society Score
scoring system to rate the knee and patient's functional abilities such as walking and stair climbing before and after TKA
Measured: 3 Years
Knee Society Score
scoring system to rate the knee and patient's functional abilities such as walking and stair climbing before and after TKA
Measured: 5 Years
KOOS
Knee injuries \& Osteoarthritis Outcome Score
Measured: 6 Months
KOOS
Knee injuries \& Osteoarthritis Outcome Score
Measured: 1 Year
KOOS
Knee injuries \& Osteoarthritis Outcome Score
Measured: 3 Years
KOOS
Knee injuries \& Osteoarthritis Outcome Score
Measured: 5 Years
EQ5D
standardised instrument for use as a measure of health outcome.
Measured: 6 Months
EQ5D
standardised instrument for use as a measure of health outcome.
Measured: 1 Year
EQ5D
standardised instrument for use as a measure of health outcome.
Measured: 3 Years
EQ5D
standardised instrument for use as a measure of health outcome.
Measured: 5 Years
Modified University of California Los Angeles (UCLA) Activity Score
It asks patients to rate their activity level from 1 to 10, with 1 defined as "no physical activity" and 10 defined as "regular participation in impact sports".
The UCLA scale has demonstrated construct validity, excellent reliability, and the best completion rates.
Measured: 6 Months
Modified University of California Los Angeles (UCLA) Activity Score
It asks patients to rate their activity level from 1 to 10, with 1 defined as "no physical activity" and 10 defined as "regular participation in impact sports".
The UCLA scale has demonstrated construct validity, excellent reliability, and the best completion rates.
Measured: 1 Year
Modified University of California Los Angeles (UCLA) Activity Score
It asks patients to rate their activity level from 1 to 10, with 1 defined as "no physical activity" and 10 defined as "regular participation in impact sports".
The UCLA scale has demonstrated construct validity, excellent reliability, and the best completion rates.
Measured: 3 Years
Modified University of California Los Angeles (UCLA) Activity Score
It asks patients to rate their activity level from 1 to 10, with 1 defined as "no physical activity" and 10 defined as "regular participation in impact sports".
The UCLA scale has demonstrated construct validity, excellent reliability, and the best completion rates.
Measured: 5 Years
Radiographic Assessment
Radiographic Evaluation
Measured: Immediate Post-op(2 - 4 Weeks)
Radiographic Assessment
Radiographic Evaluation
Measured: 6 Months
Radiographic Assessment
Radiographic Evaluation
Measured: 1 Year
Radiographic Assessment
Radiographic Evaluation
Measured: 3 Years
Radiographic Assessment
Radiographic Evaluation
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startNov 2012
- Primary completionDec 2014
- Study completionFeb 2021
Why it stopped: All 4 sites were terminated due to low follow-up of patients and low interest in the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varus DeformityStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Young Mo Kim, Ph.D, Principal investigator, Chungnam Nat'l Univ. HospitalKye Young Han, Ph.D, Principal investigator, Kangwon Nat'l Univ. HospitalJae Ang Shim, Ph.D, Principal investigator, Gacheon Uni. Gil Medical CenterJoo Hong Lee, Ph. D, Principal investigator, Chonbuk Nat'l Univ. Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088372
- Sponsor's protocol ID
- INT.CR.GK4
- Acronym
- VGRDE1
- Status last verified
- Oct 2022
- First submitted
- 13 Mar 2014
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate Clinical Performance of Vanguard Knee With E1 Bearing in Korean Patient Population
- ClinicalTrials.gov ID
- NCT02088372
- Acronym / sponsor ID
- VGRDE1 / INT.CR.GK4
- Conditions
- Varus Deformity, Valgus Deformity, Posttraumatic Deformity, Osteoarthritis, Knee, Unspecified Disorder of Knee Joint
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: All 4 sites were terminated due to low follow-up of patients and low interest in the study
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 14 Mar 2014 (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.
Evaluate Clinical Performance of Vanguard Knee with E1 Bearing in Korean Patient Population
Detailed description
E1™ Vitamin E doping of highly cross-linked polyethylene is a proposed method for insuring long-term oxidative stability of highly cross-linked ultra-high molecular weight polyethylene for use in total joint arthroplasty. In vitro research and development studies have shown that this material has improved wear performance, retention of mechanical properties, and a high resistance to oxidation due to the anti-oxidative properties of Vitamin E. Biomet Inc, has received FDA clearance to market tibial polyethylene components made of E1™ for use in the Vanguard total knee replacement system.
Vanguard Total Knee System™ The Vanguard™ Knee System was designed to incorporate features from prior designs, including: ACG, Maxim, \& Ascent. The Vanguard Knee includes a streamlined design, rounded sagittal profile, and a deeper trochlear groove. The femoral component is available in Cruciate Retaining (CR), Posterior Stabilizing (PS), and Super Stabilized (SSK). Tibial Bearings are available in various levels of constraint required by the surgeon (CR, PS, AS, etc.).
For this study, ONLY Vanguard with PS Bearing will be used.
The purpose of the study is to evaluate clinical performance of Vanguard Knee with E1 Bearing in TKA in Korean patient population. The clinical performance will be evaluated based on patient outcomes, radiographic assessment and survivorship.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vanguard with E1 PS Bearing | – | Device: Vanguard with E1 PS BearingE1™ Vitamin E doping of highly cross-linked polyethylene is a proposed method for insuring long-term oxidative stability of highly cross-linked ultra-high molecular weight polyethylene for use in total joint arthroplasty. Vanguard Total Knee System™ The Vanguard™ Knee System was designed to incorporate features from prior designs, including: ACG, Maxim, \& Ascent. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Painful and disabled knee joint resulting from osteoarthritis or traumatic arthritis where one or more compartments are involved, varus, valgus, or posttraumatic deformity, and revision of unsuccessful osteotomy at Chungnam Nat'l Univ. Hospital, Kangwon Nat'l Univ. Hospital, Gacheon Uni. Gil Medical Center, and Chonbuk Nat'l Univ. Hospital.
Key inclusion criteria (4 listed)
- Patients will be included in this study if they received Vanguard knee with E1 Bearing per the approved indications for use for Vanguard Knee. Specifically
- Painful and disabled knee joint resulting from osteoarthritis or traumatic arthritis where one or more compartments are involved
- Correction of varus, valgus, or posttraumatic deformity
- Correction or revision of unsuccessful osteotomy
Key exclusion criteria (11 listed)
- Exclusion Criteria for this study should comply with the stated contraindications on package inserts of Vanguard™ Knee and the E1™ Tibial Bearing. These indications are stated below:
- Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions,
- Osteoporosis
- Metabolic disorders which may impair bone formation
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 with E1 PS BearingEvaluate Clinical Performance of Vanguard Knee with E1 Bearing in Korean Patient Population | Device | Vanguard with E1 PS Bearing |
Primary outcome
Knee Society Score
Time frame: 1 year
scoring system to rate the knee and patient's functional abilities such as walking and stair climbing before and after TKA
20 secondary outcomes
Knee Sociey Score
Time frame: 6 Months
Knee Society Score
Time frame: 3 Years
Knee Society Score
Time frame: 5 Years
KOOS
Time frame: 6 Months
KOOS
Time frame: 1 Year
KOOS
Time frame: 3 Years
KOOS
Time frame: 5 Years
EQ5D
Time frame: 6 Months
EQ5D
Time frame: 1 Year
EQ5D
Time frame: 3 Years
EQ5D
Time frame: 5 Years
Modified University of California Los Angeles (UCLA) Activity Score
Time frame: 6 Months
Modified University of California Los Angeles (UCLA) Activity Score
Time frame: 1 Year
Modified University of California Los Angeles (UCLA) Activity Score
Time frame: 3 Years
Modified University of California Los Angeles (UCLA) Activity Score
Time frame: 5 Years
Radiographic Assessment
Time frame: Immediate Post-op(2 - 4 Weeks)
Radiographic Assessment
Time frame: 6 Months
Radiographic Assessment
Time frame: 1 Year
Radiographic Assessment
Time frame: 3 Years
Radiographic Assessment
Time frame: 5 Years
Results and safety
The study was stopped early (reason given: All 4 sites were terminated due to low follow-up of patients and low interest in the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Varus Deformity
Active, not recruitingObservational study
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Persona SoluTion PPS Femur PMCF
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Active, not recruiting
Persona Ti-Nidium Post-Market Clinical Follow-up
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Active, not recruiting
Cemented vs Cementless Persona Keel RCT
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Active, not recruiting
Persona Total Knee Arthroplasty Outcomes Study
Knee Pain Chronic, Osteoarthritis
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.
Young Mo Kim, Ph.D principal investigator
Chungnam Nat'l Univ. Hospital
Kye Young Han, Ph.D principal investigator
Kangwon Nat'l Univ. Hospital
Jae Ang Shim, Ph.D principal investigator
Gacheon Uni. Gil Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varus Deformity and Valgus Deformity, 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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 21 Oct 2022. 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 was stopped early (reason given: All 4 sites were terminated due to low follow-up of patients and low interest in the study). Results are not available in the source record.
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?
Knee Society Score (time frame: 1 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 21 Oct 2022; AzTrials last refreshed its copy on 28 Oct 2026.