NCT05956236

Hip Prospective Study

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Societe dEtude, de Recherche et de Fabrication · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2023-04-24
• Primary completion: 2046-04-01
• Completion: 2046-04-01
• First posted: 2023-07-21
• Last updated: 2026-04-14

Locations

1 site across 1 country: France