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ORIGIN® vs. VANGUARD® PS Observational Study

NCT04728542 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2024-10-04

No results posted yet for this 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.

Conditions

  • Arthroplasty
  • Replacement
  • Knee

Interventions

DEVICE

ORIGIN PS System

70 surgeries with the ORIGIN PS System

DEVICE

VANGUARD PS System

70 surgeries with the VANGUARD System

Sponsors & Collaborators

  • Symbios Orthopedie SA

    lead INDUSTRY

Principal Investigators

  • Philippe Drees, Prof · Johannes Gutenberg University Mainz

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-25
Primary Completion
2025-02-28
Completion
2027-02-28

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04728542 on ClinicalTrials.gov