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RECRUITING
NCT04728542

ORIGIN® vs. VANGUARD® PS Observational Study

Sponsor: Symbios Orthopedie SA

View on ClinicalTrials.gov

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

Interventions

DEVICE

ORIGIN PS System

70 surgeries with the ORIGIN PS System

DEVICE

VANGUARD PS System

70 surgeries with the VANGUARD System

Locations (1)

University Medical Center of Johannes Gutenberg-University Mainz

Mainz, Germany