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Hip Prospective Study: Long-term Post-market Clinical Follow-up on the Use of SERF Hip Prostheses
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
CHU St Etienne
Saint-Priest-en-Jarez, France
Start Date
April 24, 2023
Primary Completion Date
April 1, 2046
Completion Date
April 1, 2046
Last Updated
July 12, 2024
5,000
ESTIMATED participants
Lead Sponsor
Societe dEtude, de Recherche et de Fabrication
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06942078