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ORIGIN® vs. VANGUARD® PS Observational Study
Sponsor: Symbios Orthopedie SA
Summary
The study objective is to assess patient satisfaction after the surgery with a patient match CE marked implant (ORIGIN®) versus off-the-shelf (VANGUARD PS) device, and to document the clinical and device performance outcomes of the ORIGIN System used in routine hospital practice in a large patient cohort treatment of total knee arthroplasty.
Official title: A Post-market Observational ORIGIN® vs. VANGUARD® PS Clinical Study: a Comparative, Prospective, Randomized Controlled Clinical and Radiological Evaluation.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
140
Start Date
2021-03-25
Completion Date
2027-02
Last Updated
2024-10-04
Healthy Volunteers
No
Conditions
Interventions
ORIGIN PS System
70 surgeries with the ORIGIN PS System
VANGUARD PS System
70 surgeries with the VANGUARD System
Locations (1)
University Medical Center of Johannes Gutenberg-University Mainz
Mainz, Germany