Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty
Recruiting · NCT05227924 · Observational (researchers observe without assigning treatment) · Lead sponsor: Dedienne Sante S.A.S.
View the official record on ClinicalTrials.gov →Interventions studied
Total hip arthroplasty (primary or revision)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
9 locations listed.
- Hôpital Privé de la Châtaigneraie - Beaumont, France
- CH de Marmande - CHIC - Marmande, France
- Hôpital Privé du Grand Narbonne - Montredon-des-Corbières, France
- Polyclinique Grand Sud - Nîmes, France
- Clinique Mutualiste Catalane - Perpignan, France
- CH de Péronne - Péronne, France
- Clinique Mutualiste - Saint-Etienne, France
- Hôpital d'Instruction des Armées Saint-Anne - Toulon, France
- Hôpital Robert Schuman - UNEOS - Vantoux, France