| NCT ID | NCT05956236 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Societe dEtude, de Recherche et de Fabrication |
| Condition | Hip Arthropathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2023-04-24 |
| Primary Completion | 2046-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2023-04-24 with a primary completion date of 2046-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05956236 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hip Arthropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05956236 currently recruiting?
Yes, NCT05956236 is actively recruiting participants. Contact the research team at clinical@serf.fr for enrollment information.
Where is the NCT05956236 trial being conducted?
This trial is being conducted at Saint-Priest-en-Jarez, France.
Who is sponsoring the NCT05956236 clinical trial?
NCT05956236 is sponsored by Societe dEtude, de Recherche et de Fabrication. The trial plans to enroll 5,000 participants.