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Clinical 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


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT01906177
Study type Observational
Source Zimmer Biomet
Contact
Status Completed
Phase
Start date July 2012
Completion date July 2017

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