Assessing the safety and performance of SYMBOL medical devices in hip surgeries
Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty
This study is testing how safe and effective SYMBOL medical devices are for people having hip surgeries over a 10-year period.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 747 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dedienne Sante S.A.S. Industry-sponsored |
| Locations | 9 sites (Beaumont and 8 other locations) |
| Trial ID | NCT05227924 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and effectiveness of the SYMBOL range of medical devices used in total hip arthroplasty over a period of 10 years. It will involve patients who are undergoing either primary or revision hip surgeries with at least one SYMBOL device. The study will track patient outcomes and device performance to ensure long-term safety and efficacy. Participants must be informed and willing to take part, and they need to be able to understand French.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are scheduled for total hip arthroplasty using SYMBOL medical devices.
Not a fit: Patients who are unable to follow study procedures or have previously participated in the study will not benefit.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of SYMBOL medical devices for hip surgeries.
How similar studies have performed: Other studies assessing the safety and performance of medical devices in orthopedic surgeries have shown promising results, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient age \> 18 years at implantation. * Patient who will undergo, during the study's period of inclusion, a total hip arthroplasty (primary or revision) with at least one SYMBOL medical device (DEDIENNE Santé). * Patient informed of his/her participation and willing to participate in the study. * Patient able to read, write and understand French. Exclusion Criteria: * Patient deprived of freedom, under guardianship/curatorship or placed under judicial protection * Patient unable to follow study procedures. * Patient who has already been included in the study for a total hip arthroplasty (primary or revision) with at least one SYMBOL medical device.
Where this trial is running
Beaumont and 8 other locations
- Hôpital Privé de la Châtaigneraie — Beaumont, France (Recruiting)
- CH de Marmande - CHIC — Marmande, France (Terminated)
- Hôpital Privé du Grand Narbonne — Montredon-des-Corbières, France (Recruiting)
- Polyclinique Grand Sud — Nîmes, France (Recruiting)
- Clinique Mutualiste Catalane — Perpignan, France (Recruiting)
- CH de Péronne — Péronne, France (Recruiting)
- Clinique Mutualiste — Saint-Etienne, France (Recruiting)
- Hôpital d'Instruction des Armées Saint-Anne — Toulon, France (Recruiting)
- Hôpital Robert Schuman - UNEOS — Vantoux, France (Recruiting)
Study contacts
- Principal investigator: Thomas Rousseau — Clinique Mutualiste Catalane
- Study coordinator: Marion Burland
- Email: reg.aff@dedienne-sante.com
- Phone: +33 (0)4 66 28 06 85
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.