Hip Prospective Study

Study Research and Manufacturing Company (SERF)

Status: Enrolling

Conditions: Hip Arthropathy

Study type: Observational

Funder types: Industry

Identifiers

NCT05956236

HiPS

Details and patient eligibility

About

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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.