Overview
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
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.