Hip Prospective Study
NCT05956236 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000
Last updated 2026-04-14
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.
Conditions
- Hip Arthropathy
Sponsors & Collaborators
-
Societe dEtude, de Recherche et de Fabrication
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-24
- Primary Completion
- 2046-04-30
- Completion
- 2046-04-30
Countries
- France
Study Locations
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