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The primary objectives of this pilot clinical study include:
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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| Measure | Description | Time Frame |
|---|---|---|
| American Knee Society Score | Primary Endpoint: Knee Society Score (KSS) at 1 Year Postop | 1 year Post Op |
| Measure | Description | Time Frame |
|---|---|---|
| Survivorship | To access the number of patients with implants | 3 years post op |
| EQ-5D | Quality of life on patients | 3 year post op |
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Inclusion Criteria:
Exclusion Criteria:
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Total 100 cases
each site of 6 sites delegated to enroll 50 cases each
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| Name | Affiliation | Role |
|---|---|---|
| Young Joon Choi, PHD | Gangneung Asan Hospital | Principal Investigator |
| Jong Keun Seon, PHD | Chonnam National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangneung Asan Hospital | Gangneung-Si | Gangwon-do | 210-711 | South Korea | ||
| Chonnam National University Hwasun Hospital |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Radiographic Assessment | Access on subsidence, migration, and radiolucency | 3 year Post Op |
| Complications | Any AEs to patients | 3 year Post Op |
| Jeongnam |
| Jeollanam-do |
| 519-809 |
| South Korea |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |