Evaluating the results of a specific hip revision prosthesis
Ambispective Study Evaluating the Clinical Results of SAGITTA EVL R Revision Stems
This study is testing how well the SAGITTA EVL R hip replacement stems work and if they are safe for patients who had them implanted between 2016 and 2018.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Societe dEtude, de Recherche et de Fabrication Industry-sponsored |
| Locations | 1 site (Rouen, Seine Maritime) |
| Trial ID | NCT06096168 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect data on the clinical outcomes of patients who have received the SAGITTA EVL R revision femoral stems for hip arthroplasty. It will include a comprehensive series of patients implanted with this device between 2016 and 2018, reflecting current clinical practices. The study is designed to confirm the performance and safety of the stems in accordance with regulatory guidelines and to systematically monitor clinical data to verify the device's claimed performance.
Who should consider this trial
Good fit: Ideal candidates are patients over 18 years old who have received a SAGITTA EVL R revision femoral stem within its indications during the specified timeframe.
Not a fit: Patients who have not consented to data collection or who have contraindications to the use of the SAGITTA EVL R revision femoral stem may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of the SAGITTA EVL R revision femoral stems, potentially improving patient outcomes in hip arthroplasty.
How similar studies have performed: While this study focuses on a specific device, similar observational studies have successfully evaluated the performance of hip prostheses, suggesting a potential for valuable findings.
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 01/01/2016 and 31/12/2018, * Affiliated to French health insurance system Exclusion Criteria: * Patient who has not expressed consent for data collection and participation in the study, * Patient unable to understand the surgeon's instructions or to perform postoperative follow-up. * Patient with a contraindication to the use of the SAGITTA EVL R revision femoral stem * Patient implanted with a SAGITTA EVL R revision femoral stem outside its indication
Where this trial is running
Rouen, Seine Maritime
- Centre Hospitalier de Rouen - Hôpital Charles Nicolle — Rouen, Seine Maritime, 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.