RecruitingNCT04728542

ORIGIN® vs. VANGUARD® PS Observational Study

A Post-market Observational ORIGIN® vs. VANGUARD® PS Clinical Study: a Comparative, Prospective, Randomized Controlled Clinical and Radiological Evaluation.

Sponsor

Symbios Orthopedie SA

Enrollment

140 participants

Start Date

Mar 25, 2021

Study Type

OBSERVATIONAL

Conditions

Knee arthroplasty Replacement

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called ORIGIN PS System and a medical device called VANGUARD PS System for people with knee, replacement, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEORIGIN PS System

70 surgeries with the ORIGIN PS System

DEVICEVANGUARD PS System

70 surgeries with the VANGUARD System

Locations(1)

University Medical Center of Johannes Gutenberg-University Mainz

Mainz, Germany

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