NCT01906177

A Prospective Munti-center Study on VANGUARD™ PS Total Knee Replacement System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Osteoarthritis
• Rheumatoid Arthritis
• Traumatic Arthritis
• Posttraumatic Deformity

Timeline

• Start date: 2012-07-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2013-07-24
• Last updated: 2018-06-26

Locations

2 sites across 1 country: South Korea