Collecting safety data and patient outcomes for hip replacement surgeries
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 study is trying to see how safe and effective a specific type of hip replacement surgery is for patients over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Corin Industry-sponsored |
| Locations | 1 site (Valenciennes) |
| Trial ID | NCT06518993 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather safety data and patient-reported outcomes measures (PROMs) related to primary total hip arthroplasty surgeries using the Trinity cup and Meije Duo cementless hip system. The study will analyze data from patients who have undergone this specific hip replacement procedure to assess mid- and long-term safety and clinical performance. The findings will contribute to post-market surveillance and clinical evaluations of the devices, with results potentially presented at orthopedic congresses and published in peer-reviewed journals.
Who should consider this trial
Good fit: Ideal candidates for this study are adults of any gender who have received a primary total hip replacement with the Trinity cup and Meije Duo cementless femoral stem.
Not a fit: Patients who are unable to comply with study procedures or have recent psychiatric disorders or substance abuse issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the safety and effectiveness of specific hip replacement devices, leading to improved patient outcomes.
How similar studies have performed: Other studies have successfully collected safety and PROMs data for similar orthopedic procedures, indicating a precedent for this type of research.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Valenciennes
- CH Valenciennes — Valenciennes, France (Recruiting)
Study contacts
- Principal investigator: Charles BERTON, MD — Ch Valenciennes
- Study coordinator: Vanessa GRIMAUD
- Email: vanessa.grimaud@coringroup.com
- Phone: 0667267075
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.