Observational Study to Collect Safety Data and PROMs on Primary THA

NCT ID: NCT06518993

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-19

Study Completion Date

2025-06-20

Brief Summary

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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

Detailed Description

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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.

Conditions

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Hip Arthritis Osteoarthritis, Hip Coxitis Femoral Head Necrosis Femoral Neck Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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

Subjects clinically suitable for a primary THR surgery with Trinity cup and Meije Duo cementless femoral stem.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Both genders.
* Adult subjects.
* Subjects who received a primary THR with Trinity cup and Meije Duo cementless femoral 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 this study, and approved by the local EC.

Exclusion Criteria

* Subjects under guardianship.
* Subjects in the opinion of the Investigator/ investigative team who will be unable to comply with study procedures (Examples: recent psychotic or mania disorders, alcohol, drug or substance abusers) and/or those unable for any medical or other reason to comply with study procedures/visits.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Corin

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles BERTON, MD

Role: PRINCIPAL_INVESTIGATOR

CH VALENCIENNES

Locations

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CH Valenciennes

Valenciennes, , France

Site Status

Countries

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France

Other Identifiers

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CSP2022-04

Identifier Type: -

Identifier Source: org_study_id

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