Hip Prospective Study
ConditionHip Arthropathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSociete dEtude, de Recherche et de Fabrication
About this trial
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 criteria
Qualifiers
Male or female adults
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Source ClinicalTrials.gov