Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare Vanguard High Flex Rotating Platform to Vanguard Complete Knee System in Asian population in terms of early range of motion (ROM), clinical outcomes, and kinetic and kinematic characteristics in relation to healthy knees.
The primary objectives of this clinical study include:
Evaluate size fit and long term performance of Vanguard Complete Knee ("Fixed") System in Asian and Latino population in comparison to competitor's similar product.
Evaluate efficacy of Vanguard Complete Knee with Microplasty Tibial Tray.
Compare Vanguard High Flex Rotating Platform ("High Flex") Knee System to Vanguard Complete Knee System in Asian population in terms of:
Compare current design to new design of Vanguard High Flex Rotating Platform Knee System in terms of :
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vanguard Complete Knee | Active Comparator | Vanguard Completed Knee with Microplasty Tibial Tray is designed to hold the tibial knee bearings in a microplsty knee procedure. The Co-Cro-Mo trays are designed with a shorter stem. |
|
| Vanguard High Flex RP | Active Comparator | VGRD High Flex RP knee is an extension to the exsting Vanguard Knee and has been specifically desinged to facilitate greather than 135 degrees of knee flextion as required by certain patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vanguard Complete Knee | Device | Vanguard Knee is a metal and polyethylene system indicated for cemented tibial and femoral use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| American Knee Society Knee Score | Including ROM | 1 Year postop |
| Measure | Description | Time Frame |
|---|---|---|
| Kinematic Fluoroscopic Analysis | Kinematic Fluoroscopic Analysis | 3 yr |
| Gait Lab Analysis | Gait Lab Analysis | 3 yr |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Myung-Chul Lee, M.D., Ph.D. | Seoul National University Hospital | Principal Investigator |
| Chul-Won Ha, M.D., Ph.D. | Samsung Medical Center | Principal Investigator |
| Seong-Il Bin, M.D., Ph.D. | Asan Medical Center | Principal Investigator |
| Yong In, M.D., Ph.D. | Catholic University Uijungbu St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea | ||||
| Samsung Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 5, 2014 | Jun 21, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vanguard High Flex RP | Device | Vanguard High Flex RP is an extension to the existing Vanguard Knee and has been specifically designed to facilitate greater than 135 degrees of knee flexion. |
|
| EQ5D | Quality of Life | 3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr |
| Radiographic Assessment | Radiographic Assessment | immediate postop, 3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr |
| Seoul |
| South Korea |
| Seoul Nat'l Uni. Hospital | Seoul | South Korea |
| The Catholic Uni. of Korea, Seoul St. Mary's Hospital | Seoul | South Korea |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |