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Hip Prospective Study
Sponsor: Societe dEtude, de Recherche et de Fabrication
Summary
In an evaluation report dated 2014, the HAS (Haute Autorité de Santé -French National Authority for Health) highlights that long-term clinical data on hip prostheses are needed in the context of the French healthcare system. In addition, per the European Regulation 2017/745, medical devices manufacturers shall conduct Post-Market Clinical Follow-up (PMCF) on their devices or provide a justification why PMCF is not applicable. Therefore, as part of the PMCF process of their hip prostheses, SERF wants to conduct a PMCF investigation to ensure the long-term real-life performance, safety and benefits of these prostheses. HiPS is a non-comparative, prospective, multicentric, national, 15-year follow-up clinical investigation.
Official title: Hip Prospective Study: Long-term Post-market Clinical Follow-up on the Use of SERF Hip Prostheses
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
5000
Start Date
2023-04-24
Completion Date
2046-04
Last Updated
2024-07-12
Healthy Volunteers
No
Conditions
Locations (1)
CHU St Etienne
Saint-Priest-en-Jarez, France