Hip Prospective Study

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05956236
Study type	Observational
Source	Societe dEtude, de Recherche et de Fabrication
Contact	Clinical department
Phone	0472056010
Email	clinical@serf.fr
Status	Recruiting
Phase
Start date	April 24, 2023
Completion date	April 2046

View Details

See also
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