A Prospective Munti-center Study on VANGUARD™ PS Total Knee Replacement System
1 other identifier
observational
100
1 country
2
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2012
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 7, 2013
CompletedFirst Posted
Study publicly available on registry
July 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedJune 26, 2018
June 1, 2018
5 years
January 7, 2013
June 21, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
American Knee Society Score
Primary Endpoint: Knee Society Score (KSS) at 1 Year Postop
1 year Post Op
Secondary Outcomes (4)
Survivorship
3 years post op
EQ-5D
3 year post op
Radiographic Assessment
3 year Post Op
Complications
3 year Post Op
Eligibility Criteria
Total 100 cases each site of 6 sites delegated to enroll 50 cases each
You may qualify if:
- 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).
You may not qualify if:
- infection
- sepsis
- osteomyelitis
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zimmer Biometlead
Study Sites (2)
Gangneung Asan Hospital
Gangneung-Si, Gangwon-do, 210-711, South Korea
Chonnam National University Hwasun Hospital
Jeongnam, Jeollanam-do, 519-809, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Young Joon Choi, PHD
Gangneung Asan Hospital
- PRINCIPAL INVESTIGATOR
Jong Keun Seon, PHD
Chonnam National University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2013
First Posted
July 24, 2013
Study Start
July 1, 2012
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
June 26, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share