Assessing the safety and performance of SAGITTA EVL R hip implants
Ambispective Study to Assess the Safety and the Performance of SAGITTA EVL R Stem
This study is testing how safe and effective the SAGITTA EVL R hip implants are for people who have had hip surgery, looking at their long-term success and how satisfied patients are over the next 7 to 10 years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 61 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Societe dEtude, de Recherche et de Fabrication Industry-sponsored |
| Locations | 1 site (Challans, Vendée) |
| Trial ID | NCT06096155 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect data on the safety and performance of the SAGITTA EVL R revision femoral stems used in hip arthroplasty. It will evaluate the long-term survival rate of these implants over a period of 7 to 10 years post-operation, alongside assessing patient satisfaction and potential complications. The study adheres to regulatory guidelines to ensure systematic monitoring of clinical data related to the performance of the medical device.
Who should consider this trial
Good fit: Ideal candidates include patients over 18 years old who received a SAGITTA EVL R revision femoral stem between 2010 and 2015 and are affiliated with the French health insurance system.
Not a fit: Patients who have opted out of using their personal data or those unable to follow post-operative instructions 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 SAGITTA EVL R hip implants, potentially improving patient outcomes.
How similar studies have performed: While this study focuses on a specific implant, similar observational studies have shown success in evaluating long-term outcomes of hip prostheses.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient over 18 years old at the time of surgery, * Patient implanted with a SAGITTA EVL R revision femoral stem within its indications between 01/01/2010 and 31/12/2015, * Affiliated to French health insurance system Exclusion Criteria: * Patient who has rejected to the use of his/her personal data, * Patient unable to understand the surgeon's instructions or to carry out the post-operative follow-up.
Where this trial is running
Challans, Vendée
- Centre Hospitalier Loire Vendée Océan — Challans, Vendée, France (Recruiting)
Study contacts
- Study coordinator: Lydie BONNEVAY
- Email: l.bonnevay@serf.fr
- Phone: 04 72 05 60 10
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.