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Hip Prospective Study

Recruitingn/aAges 18 Years - anyAllSociete dEtude, de Recherche et de Fabrication
NCT05956236 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

1 site
CHU St Etienne
Saint-Priest-en-Jarez, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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