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

Hip Arthropathy Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05524350
Study type Observational
Source Societe dEtude, de Recherche et de Fabrication
Contact
Status Active, not recruiting
Phase
Start date December 5, 2017
Completion date January 20, 2031
View Details
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