Vanguard Complete Knee Versus Vanguard High Flex Rotating Platform (RP) Knee Study
NCT01010269 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2018-06-26
Summary
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.
Conditions
- Osteoarthritis
- Rheumatoid Arthritis
- Traumatic Arthritis
Interventions
- DEVICE
-
Vanguard Complete Knee
Vanguard Knee is a metal and polyethylene system indicated for cemented tibial and femoral use.
- DEVICE
-
Vanguard High Flex RP
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.
Sponsors & Collaborators
-
Zimmer Biomet
lead INDUSTRY
Principal Investigators
-
Myung-Chul Lee, M.D., Ph.D. · Seoul National University Hospital
-
Chul-Won Ha, M.D., Ph.D. · Samsung Medical Center
-
Seong-Il Bin, M.D., Ph.D. · Asan Medical Center
-
Yong In, M.D., Ph.D. · Catholic University Uijungbu St. Mary's Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-10-31
- Primary Completion
- 2012-10-31
- Completion
- 2017-10-31
Countries
- South Korea
Study Locations
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