Actively Recruiting
Hip Prospective Study
Led by Societe dEtude, de Recherche et de Fabrication · Updated on 2026-04-14
5000
Participants Needed
1
Research Sites
1196 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Hip Prospective Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adults
- Planned to be implanted with investigational medical devices per the IFUs
- Implantation in skeletally mature adults (usually aged 60-65 and over) with extremely painful or disabled joints not improved by other treatments
- Implantation of investigational devices as integrated systems with all components from SERF
- Intended purpose and indication listed in the IFUs
- Affiliated to French social security
- Provided a dated and signed informed consent form
You will not qualify if you...
- Patient protected by a French legal measure
- Patient unable to express consent as deemed by the investigator
- Patient deprived of liberty or hospitalized without consent
- Pregnant or breastfeeding women
- Patient contraindicated to investigational device implantation per IFUs
- Patient contraindicated to radiographic follow-up
- Patient deemed unable to meet follow-up visits by investigator
- Patient unable to complete self-assessment questionnaires as deemed by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHU St Etienne
Saint-Priest-en-Jarez, France, 42270
Actively Recruiting
Research Team
C
Clinical department
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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