Observational Study to Collect Safety Data and PROMs on Primary THA

NCT06518993 | Terminated

• 1 other identifier: CSP2022-04
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

total hip arthroplasty

Outcome Measures

Primary Outcomes (1)

• Evaluation of hip functional performance

  Improvement of Oxford Hip Score (OHS)

  2 years

Secondary Outcomes (5)

• Confirmation of safety of the study devices

  2 years

• Evaluation of outcome after hip arthroplasty

  2 years

• Evaluation of clinical outcomes

  2 years

• Assessment of health-related quality of life

  2 years

• Assessment of patient's satisfaction

  2 years

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corin: lead

Study Sites (1)

CH Valenciennes

Valenciennes, 59300, France

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Femoral Neck Fractures

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Charles BERTON, MD

  CH VALENCIENNES

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 25, 2024
• Study Start: April 19, 2024
• Primary Completion: June 20, 2025
• Study Completion: June 20, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)