Observational Study to Collect Safety Data and PROMs on Primary THA

Launched by CORIN · Jul 19, 2024

Keywords

ClinConnect Summary

This clinical trial is an observational study that aims to gather information about the safety and effectiveness of a specific type of hip replacement surgery, called primary total hip arthroplasty (THA), using the Trinity cup and Meije Duo cementless hip system. The study is focused on patients who have conditions like hip arthritis or osteoarthritis, and it will help researchers understand how well this procedure works and any potential risks involved.

To participate in this study, you need to be an adult aged 65 to 74 who has already undergone this specific hip replacement surgery with the Trinity cup and Meije Duo system. Both men and women can join, as long as they are willing to attend follow-up visits and have signed the necessary consent form. If you have certain conditions that might prevent you from following the study rules or if you are under guardianship, you may not be eligible. Participants can expect to provide information about their health and experiences after the surgery, which will help improve future treatments for hip problems.

Gender

ALL

Eligibility criteria

• 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.