Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
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 * Patien