NCT05227924 Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty
| NCT ID | NCT05227924 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dedienne Sante S.A.S. |
| Condition | Degenerative Hip Joint Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 747 participants |
| Start Date | 2021-09-21 |
| Primary Completion | 2034-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 747 participants in total. It began in 2021-09-21 with a primary completion date of 2034-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SYMBOL range of medical devices. The study will evaluate the outcome of Total Hip Arthroplasty using medical devices from SYMBOL range over a period of 10 years.
Eligibility 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.
Contact & Investigator
Thomas Rousseau
PRINCIPAL INVESTIGATOR
Clinique Mutualiste Catalane
Frequently Asked Questions
Who can join the NCT05227924 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Degenerative Hip Joint Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05227924 currently recruiting?
Yes, NCT05227924 is actively recruiting participants. Contact the research team at reg.aff@dedienne-sante.com for enrollment information.
Where is the NCT05227924 trial being conducted?
This trial is being conducted at Beaumont, France, Marmande, France, Montredon-des-Corbières, France, Nîmes, France and 5 additional locations.
Who is sponsoring the NCT05227924 clinical trial?
NCT05227924 is sponsored by Dedienne Sante S.A.S.. The principal investigator is Thomas Rousseau at Clinique Mutualiste Catalane. The trial plans to enroll 747 participants.