RecruitingNCT05956236

Hip Prospective Study

Hip Prospective Study: Long-term Post-market Clinical Follow-up on the Use of SERF Hip Prostheses

Sponsor

Societe dEtude, de Recherche et de Fabrication

Enrollment

5,000 participants

Start Date

Apr 24, 2023

Study Type

OBSERVATIONAL

Conditions

Hip Arthropathy

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

Min Age: 18 Years

Inclusion Criteria7

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 Criteria8

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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