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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 an extremely painful and/or disabled joint and insufficiently improved by alternative treatment options after an observation period lasting from a few weeks to a few months
* Implantation of investigational medical devices as integrated systems (all components from SERF, no component from another manufacturer)
* For an intended purpose and indication listed in the IFUs
* Affiliated to French social security
* Who provided a dated and signed informed consent form
Exclusion Criteria:
* Patient protected by a French legal measure
* Patient not able to express his/her consent as deemed by the investigator
* Patient deprived of liberty or hospitalized without consent
* Pregnant or breastfeeding women
* Patient contraindicated to investigational medical devices implantation per the IFUs
* Patient contraindicated to radiographic follow-up
* Patient a priori not able to meet the follow-up visits as deemed by the investigator
* Patient not able to fulfil a self-assessment questionnaire as deemed by the investigator.
Primary outcome measure(s)
Survival rate — Per operative period to 15 years To assess the survival rate of the investigational medical devices at the end of their claimed implantation duration
Trial sites (1)
Facility
City
Region
Status
CHU St Etienne
Saint-Priest-en-Jarez
France
Recruiting
More Societe dEtude, de Recherche et de Fabrication trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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