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.
Study Type
OBSERVATIONAL
Enrollment
100
Gangneung Asan Hospital
Gangneung-Si, Gangwon-do, South Korea
Chonnam National University Hwasun Hospital
Jeongnam, Jeollanam-do, South Korea
American Knee Society Score
Primary Endpoint: Knee Society Score (KSS) at 1 Year Postop
Time frame: 1 year Post Op
Survivorship
To access the number of patients with implants
Time frame: 3 years post op
EQ-5D
Quality of life on patients
Time frame: 3 year post op
Radiographic Assessment
Access on subsidence, migration, and radiolucency
Time frame: 3 year Post Op
Complications
Any AEs to patients
Time frame: 3 year Post Op
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