Observational Study to Collect Safety Data and PROMs on Primary THA

Last updated: February 4, 2025
Sponsor: Corin
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Total hip arthroplasty with a Trinity cup and a Meije Duo cementless stem

Clinical Study ID

NCT06518993
CSP2022-04
  • Ages > 18
  • All Genders

Study Summary

This observational study is designed to collect safety data and PROMs on retrospective primary total hipa arthroplasty surgeries with Trinity cup and Meije Duo cementless hip system

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Both genders.

  • Adult subjects.

  • Subjects who received a primary THR with Trinity cup and Meije Duo cementlessfemoral stem.

  • The subject is willing to comply with the required follow-up visits as per protocol.

  • The subject has signed a Patient Informed Consent Form (PICF), specific to thisstudy, and approved by the local EC.

Exclusion

Exclusion Criteria:

  • Subjects under guardianship.

  • Subjects in the opinion of the Investigator/ investigative team who will be unableto comply with study procedures (Examples: recent psychotic or mania disorders,alcohol, drug or substance abusers) and/or those unable for any medical or otherreason to comply with study procedures/visits.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Total hip arthroplasty with a Trinity cup and a Meije Duo cementless stem
Phase:
Study Start date:
April 19, 2024
Estimated Completion Date:
September 01, 2026

Study Description

The major goal of this study is to collect safety and patient-reported outcomes measures (PROMs) data on Trinity cup in combination with Meije Duo cementless hip stem when used in primary total hip arthroplasty (THA).

Data collected from this study will be fed into the Post-Market Surveillance (PMS) and Clinical Evaluation processes of the devices under assessment annually and support presentations at orthopaedic congresses and/or peer-reviewed publication(s) on mid- and long-term safety and clinical performance.

Connect with a study center

  • CH Valenciennes

    Valenciennes, 59300
    France

    Active - Recruiting

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