OsteoarthritisNCT01906177
A Prospective Munti-center Study on VANGUARD™ PS Total Knee Replacement System
An observational study of Osteoarthritis and Rheumatoid Arthritis, run by Zimmer Biomet at 2 sites in South Korea.
Trial summary
The primary objectives of this pilot clinical study include: Evaluate clinical outcomes and quality of life on patients who received Vanguard PS Total Knee in Korean population Evaluate safety of Vanguard PS Total Knee in Korean population Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
- How many people
- 100 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jul 2012to Jul 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Total 100 cases each site of 6 sites delegated to enroll 50 cases each
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 posttraumatic deformity.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure
- 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, and
- The patient must have reached full skeletal maturity (at least 18 years old).
Who cannot join
- infection
- sepsis
- osteomyelitis
- 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
2 sites in 1 country.
South Korea2 sites
Gangneung Asan Hospital
Gangneung-Si, Gangwon-do, 210-711
Chonnam National University Hwasun Hospital
Jeongnam, Jeollanam-do, 519-809
About this study
The primary objectives of this pilot clinical study include:
- Evaluate clinical outcomes and quality of life on patients who received Vanguard PS Total Knee in Korean population
- Evaluate safety of Vanguard PS Total Knee in Korean population
Read the detailed description
This study is a prospective, single cohort, multi-center study of Vanguard PS system and will be conducted in Korea with 2 institutions. The study will be conducted over a period of 10 years. Patients will be followed at immediate post-op, 6 weeks, 6 months and 1 year, 3 years.
Total of 2 sites will be involved in this study. 50 cases on each sites and total of 100 subjects will be enrolled in the study.
Primary end-point will be KSS at 1 year post op and secondary end-points are Survivorship of the product, KSS, EQ5D, High-Flexion Knee Score, Radiographic Assessment, and any kind of complication including lost to follow up.
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
American Knee Society Score
Primary Endpoint: Knee Society Score (KSS) at 1 Year Postop
Measured: 1 year Post Op
Secondary outcomes (4)
Survivorship
To access the number of patients with implants
Measured: 3 years post op
EQ-5D
Quality of life on patients
Measured: 3 year post op
Radiographic Assessment
Access on subsidence, migration, and radiolucency
Measured: 3 year Post Op
Complications
Any AEs to patients
Measured: 3 year Post Op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startJul 2012
- Primary completionJul 2017
- Study completionJul 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Young Joon Choi, PHD, Principal investigator, Gangneung Asan HospitalJong Keun Seon, PHD, Principal investigator, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906177
- Sponsor's protocol ID
- INT.CR.GK5
- Status last verified
- Jun 2018
- First submitted
- 7 Jan 2013
- 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 Munti-center Study on VANGUARD™ PS Total Knee Replacement System
- ClinicalTrials.gov ID
- NCT01906177
- Acronym / sponsor ID
- INT.CR.GK5
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Jul 2012 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 24 Jul 2013 (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 primary objectives of this pilot clinical study include:
- Evaluate clinical outcomes and quality of life on patients who received Vanguard PS Total Knee in Korean population
- Evaluate safety of Vanguard PS Total Knee in Korean population
Detailed description
This study is a prospective, single cohort, multi-center study of Vanguard PS system and will be conducted in Korea with 2 institutions. The study will be conducted over a period of 10 years. Patients will be followed at immediate post-op, 6 weeks, 6 months and 1 year, 3 years.
Total of 2 sites will be involved in this study. 50 cases on each sites and total of 100 subjects will be enrolled in the study.
Primary end-point will be KSS at 1 year post op and secondary end-points are Survivorship of the product, KSS, EQ5D, High-Flexion Knee Score, Radiographic Assessment, and any kind of complication including lost to follow up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Total 100 cases each site of 6 sites delegated to enroll 50 cases each
Key inclusion criteria (7 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 posttraumatic deformity.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure
- 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 (11 listed)
- infection
- sepsis
- osteomyelitis
- Uncooperative patient or patient with neurologic disorders who are 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.
Primary outcome
American Knee Society Score
Time frame: 1 year Post Op
Primary Endpoint: Knee Society Score (KSS) at 1 Year Postop
4 secondary outcomes
Survivorship
Time frame: 3 years post op
EQ-5D
Time frame: 3 year post op
Radiographic Assessment
Time frame: 3 year Post Op
Complications
Time frame: 3 year Post Op
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.
Young Joon Choi, PHD principal investigator
Gangneung Asan Hospital
Jong Keun Seon, PHD principal investigator
Chonnam National University Hospital
2 sites in 1 country: 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 2 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 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: 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 2 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 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 26 Jun 2018.