Hip Prospective Study

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.

NCT Number	NCT05956236
Lead Sponsor	Societe dEtude, de Recherche et de Fabrication
Conditions	Hip Arthropathy
Enrollment	5,000 participants
Start Date	2023-04-24
Primary Completion	2046-04 (estimated)
Study Completion	2046-04 (estimated)
Updated on ClinicalTrials.gov	2026-04-14