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Assessment of Safety and Performances of HYPE Stems Associated to a SERF Acetabular Cup in Hip Arthroplasty (2017-01-NH)
Sponsor: Societe dEtude, de Recherche et de Fabrication
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.
Official title: Study of the Total Hip Prosthesis With a HYPE Stem in Hip Arthroplasty
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
180
Start Date
2017-12-05
Completion Date
2031-01-20
Last Updated
2025-03-17
Healthy Volunteers
Not specified
Conditions
Locations (1)
Rouen University Hospital Center
Rouen, France