clinical trial · NCT05524350
Assessment of Safety and Performances of HYPE Stems Associated to a SERF Acetabular Cup in Hip Arthroplasty (2017-01-NH)
Societe dEtude, de Recherche et de Fabrication·—·active not recruiting·n = 180
Hip Arthropathy
brief 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.
started
Dec 5, 2017
primary completion
Jan 20, 2031
completion
Jan 20, 2031
last updated
Apr 24, 2026
official title
Study of the Total Hip Prosthesis With a HYPE Stem in Hip Arthroplasty
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol