Rheumatoid Arthritis Clinical Trial
Official title:
A Prospective Munti-center Study on VANGUARD™ PS Total Knee Replacement System
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
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.
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