Assessing the safety and performance of SYMBOL medical devices in hip surgeries
Official title: Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty
Run by Dedienne Sante S.A.S. · NCT05227924 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 747 (estimated) |
| Sponsor | Dedienne Sante S.A.S. Industry-sponsored |
| Locations | 9 sites (Beaumont and 8 other locations) |
| Status | Recruiting |
| Started | September 21, 2021 |
| Main results expected | September 2034 |
| Study ends | September 2034 |
| Registry record updated | August 27, 2024 |
| Trial ID | NCT05227924 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old who are scheduled for total hip arthroplasty using SYMBOL medical devices.
✕Probably not a fit
Patients who are unable to follow study procedures or have previously participated in the study will not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Hôpital Privé de la Châtaigneraie
Beaumont, France Recruiting -
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
Show 3 more locations
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Hôpital d'Instruction des Armées Saint-Anne
Toulon, France Recruiting -
Hôpital Robert Schuman - UNEOS
Vantoux, France Recruiting -
CH de Marmande - CHIC
Marmande, France Terminated
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.