Hip Prospective Study

NCT05956236 | Recruiting

• 1 other identifier: HiPS
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Arthropathy

Keywords

Hip arthropalsty; Hip Prosthesis

Outcome Measures

Primary Outcomes (1)

• Survival rate

  To assess the survival rate of the investigational medical devices at the end of their claimed implantation duration

  Per operative period to 15 years

Secondary Outcomes (11)

• Intermediate survival rates

  Per operative period to 10 years

• Functional improvement

  Per operative period to 15 years

• Functional improvement

  Per operative period to 15 years

• Functional improvement

  Per operative period to 15 years

• Functional improvement

  Per operative period to 15 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients corresponding to the target treated population of the investigational medical devices, planned to be implanted with investigational medical devices per the Instructions for Use (IFU), who can participate to a clinical investigation, are not vulnerable and can meet the follow-up visits (a priori) and fulfil a self-assessment questionnaire will be included.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Societe dEtude, de Recherche et de Fabrication: lead

Study Sites (1)

CHU St Etienne

Saint-Priest-en-Jarez, 42270, France

RECRUITING

Central Study Contacts

Clinical department

CONTACT

0472056010; clinical@serf.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: July 21, 2023
• Study Start: April 24, 2023
• Primary Completion (Estimated): April 1, 2046
• Study Completion (Estimated): April 1, 2046
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

FR (1)