ORIGIN® vs. VANGUARD® PS Observational Study

Last updated: October 3, 2024
Sponsor: Symbios Orthopedie SA
Overall Status: Active - Recruiting

Phase

N/A

Condition

Orthopedics

Treatment

VANGUARD PS System

ORIGIN PS System

Clinical Study ID

NCT04728542
CLIN-G-010
2019-14580
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion/exclusion criteria

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: VANGUARD PS System
Phase:
Study Start date:
March 25, 2021
Estimated Completion Date:
February 28, 2027

Study Description

This is a prospective, comparative, randomized, double arm, monocentric, observational, post-market study with 140 subjects with 2 years follow-up.

Connect with a study center

  • Lukas Eckhard

    Mainz, 55131
    Germany

    Active - Recruiting

  • University Medical Center of Johannes Gutenberg-University Mainz

    Mainz, 55131
    Germany

    Active - Recruiting

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