Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05956236

Hip Prospective Study

Sponsor: Societe dEtude, de Recherche et de Fabrication

View on ClinicalTrials.gov

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