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Prospective and Obsevational Study of Total Hip Prothesis: HYPE Stem
Sponsor: Societe dEtude, de Recherche et de Fabrication
Summary
The purpose of this study is to validate the performance and the safety of the HYPE (SERF) prothesis in compliance with the 93/42/EEC directive and in relation to the recommendations of the MEDDEV 2.7.1 guide ( guideline for post-market follow-up), which provides for the implementation of a systematic procedure for the follow-up of 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
2024-07-12
Healthy Volunteers
No
Conditions
Locations (1)
CHU de ROUEN
Rouen, France