NCT05524350

Assessment of Safety and Performances of HYPE Stems Associated to a SERF Acetabular Cup in Hip Arthroplasty (2017-01-NH)

Study of the Total Hip Prosthesis With a HYPE Stem in Hip Arthroplasty

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 180 (actual)
• Sponsor: Societe dEtude, de Recherche et de Fabrication · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The use of cementless femoral stems is known to provide satisfactory long-term clinical results. Extensive and durable osseointegration of these implants has been reported in numerous series, despite the use of stems with different geometry and coating distribution. This study will validate the performance and safety of the HYPE (SERF) stems in the context of the 93/42/EEC directive and in relation to the recommendations of the MEDDEV 2.7.1 (Guideline for post-marketing follow-up), which provides for a systematic procedure for monitoring clinical data in order to verify the performance claimed for medical devices.

Conditions

• Hip Arthropathy

Timeline

• Start date: 2017-12-05
• Primary completion: 2031-01-20
• Completion: 2031-01-20
• First posted: 2022-09-01
• Last updated: 2025-03-17

Locations

1 site across 1 country: France