A Post-market Observational ORIGIN® vs. VANGUARD® PS Clinical Study: a Comparative, Prospective, Randomized Controlled Clinical and Radiological Evaluation.
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
Locations
Other Locations
Germany
University Medical Center of Johannes Gutenberg-University Mainz
RECRUITING
Mainz
Contact Information
Primary
Lukas Eckhard
lukas.eckhard@unimedizin-mainz.de
+496131177302
Time Frame
Start Date: 2021-03-25
Estimated Completion Date: 2027-02
Participants
Target number of participants: 140
Treatments
Origine
70 subjects with the ORIGIN PS System
Vanguard
70 subjects with the VANGUARD System
Authors
Related Therapeutic Areas
Sponsors
Leads: Symbios Orthopedie SA