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Observational Study Conducted on Patients Receiving the ESOP 2 Stem to Confirm Security and Performance of the Device — ESOP2  

Hip Fractures Clinical Trial

Official title:
Prospective Observational Clinical Study Conducted Over a 10-year Period on Patients Who Received the ESOP 2 Stem to Restore Joint Function, in Order to Confirm Security and Performance of the Device

Clinical Trial Summary

This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the ESOP 2 stem, which is intended to be implanted in case of total hip replacement, when used in real life conditions according to the instructions for use.

Clinical Trial Description

The primary objective of this study is to evaluate the security of the ESOP 2 stem by calculating the survival rate up to 10 years of follow-up.

The secondary objectives are to evaluate the security and performance of the device by assessing radiological data, gathering complications and evaluating functional score and quality of life score up to 10 years of follow-up. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04193163
Study type Observational
Source FH Orthopedics
Contact Clinical Project Leader
Phone 0033389818827
Email n.mathias@groupe-fh.fr
Status Recruiting
Phase
Start date December 1, 2019
Completion date December 1, 2030
View Details
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