Evaluating long-term outcomes of hip replacement surgeries
Multicentric Observational PMCF Study to Evaluate Long-term Outcome, Performance and Safety of Implantable Devices in Hip Arthroplasty
This study is trying to see how well Corin hip replacement devices work and how safe they are for people getting hip surgery over the long term.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Corin Industry-sponsored |
| Locations | 13 sites (Bordeaux and 12 other locations) |
| Trial ID | NCT02230826 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect long-term safety and efficacy data on commercially available hip arthroplasty products, specifically focusing on Corin hip devices. It will gather outcome data for post-market surveillance and clinical evaluations, which will contribute to peer-reviewed publications regarding the performance and safety of these devices over time. Participants will include individuals who are undergoing hip arthroplasty surgery with the specified devices and have consented to participate in the study.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who require hip arthroplasty surgery with Corin hip devices.
Not a fit: Patients with high surgical risks, existing tumors, or contraindications for arthroplasty with Corin devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of hip replacement surgeries using Corin devices.
How similar studies have performed: Other studies evaluating long-term outcomes of hip arthroplasty have shown success, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Man or woman \>18 years * Subjects with indication of arthroplasty surgery with Corin hip devices which are under assessment as part of this PMCF study * Subjects who agreed for study participation. Exclusion Criteria: * Subjects with existing tumour and/or particularly high surgical risk- * Subjects with anaesthetic risk class IV or higher * Subjects under guardianship and/or unable to follow procedures or matters related to the study (examples: Illiterate, recent psychotic or mania disorders and / or inability to comply with usual follow-up visits.) * Contraindications for arthroplasty with a Corin hip devices as per product IFU
Where this trial is running
Bordeaux and 12 other locations
- CHU de Bordeaux - Groupe Hospitalier Pellegrin — Bordeaux, France (Active_not_recruiting)
- clinique Oxford Cannes — Cannes, France (Terminated)
- CH Dunkerque — Dunkirk, France (Terminated)
- Polyclinique Henin Beaumont — Hénin-Beaumont, France (Recruiting)
- CHU de Nice — Nice, France (Recruiting)
- Centre Hospitalier Régionnal d'Orléans - Site La Source — Orléans, France (Terminated)
- Clinique Arago — Paris, France (Terminated)
- Hôpital de la Croix Saint-Simon — Paris, France (Recruiting)
- Hopital privé Saint-Martin — Pessac, France (Active_not_recruiting)
- Hôpital Provo — Roubaix, France (Recruiting)
- Polyclinique St Georges de Didonne — Saint-Georges-de-Didonne, France (Recruiting)
- Médipôle Garonne — Toulouse, France (Terminated)
- Hôpital Jean Bernard — Valenciennes, France (Recruiting)
Study contacts
- Study coordinator: Vanessa Grimaud
- Email: vanessa.grimaud@coringroup.com
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.