Observational Study to Collect Safety Data and PROMs on Primary THA

Observational Study to Collect Safety Data and Patient-reported Outcomes Measures (PROMs) on Retrospective Primary Total Hip Arthroplasty Surgeries With Trinity Cup and Meije Duo Cementless Hip Stem

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

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis, Hip; Femoral Neck Fractures; Hip Arthritis; Femoral Head Necrosis; Coxitis
• Intervention / Treatment: Device: Total hip arthroplasty with a Trinity cup and a Meije Duo cementless stem

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 Type: Observational
• Enrollment (Actual): 116

Contacts and Locations

Study Locations

• France
  • Valenciennes, France, 59300
    • Ch Valenciennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have undergone to a THA with Trinity cup and Meije Duo cementless hip will be invited to participate in this study. An initial review of the medical database of all Corin Trinity cup procedures performed in the selected study site will be conducted to assess the number of retrospective patients potentially available to join the study. A first contact with the patient will occur telephonically or via mail to explain the study and invite them to join.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of hip functional performance	Improvement of Oxford Hip Score (OHS)	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Corin
• Investigators: Principal Investigator: Charles BERTON, MD, Ch Valenciennes

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2024
• Primary Completion (Actual): June 20, 2025
• Study Completion (Actual): June 20, 2025

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 19, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: July 4, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: total hip arthroplasty
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Wounds and Injuries; Pathologic Processes; Arthritis; Joint Diseases; Rheumatic Diseases; Leg Injuries; Fractures, Bone; Osteoarthritis; Femoral Fractures; Hip Injuries; Hip Fractures; Necrosis; Osteoarthritis, Hip; Femoral Neck Fractures
• Other Study ID Numbers: CSP2022-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No