Observational Study to Collect Safety Data and PROMs on Primary THA

Recruiting

• Conditions: Osteoarthritis, Hip; Coxitis; Femoral Head Necrosis; Femoral Neck Fractures; Hip Arthritis

• Registration Number: NCT06518993
• Lead Sponsor: Corin

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2024-04-19
• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-07-19
• Study First Posted: 2024-07-25
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06
• Primary Completion: 2026-03-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of hip functional performance	2 years	Improvement of Oxford Hip Score (OHS)

Secondary Outcome Measures

Name	Time	Method
Evaluation of outcome after hip arthroplasty	2 years	Number, severity and causal relationship procedure of implant-related adverse events
Evaluation of clinical outcomes	2 years	Improvement of Harris Hip Score (HHS)
Assessment of health-related quality of life	2 years	Change of EQ-5D-5L
Assessment of patient's satisfaction	2 years	Improvement of patient's satisfaction following surgery using Self-Administered Patient Satisfaction Scale
Confirmation of safety of the study devices	2 years	Number, severity and causal relationship procedure of implant-related adverse events

Trial Locations

Locations (1)

CH Valenciennes; 🇫🇷 Valenciennes, France