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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
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Clinique Tivoli Ducos
Bordeaux, France
Nouvelle Clinique Bel-Air
Bordeaux, France
CH Pasteur
Colmar, France
Clinique du Val d'Ouest
Écully, France
CH Raymond POINCARE
Garches, France
CH de Haguenau
Haguenau, France
Groupe Hospitalier Pitié-Salpêtrière
Paris, France
Start Date
December 1, 2019
Primary Completion Date
September 1, 2022
Completion Date
September 1, 2022
Last Updated
February 2, 2026
10
ACTUAL participants
Hip prosthesis - ESOP 2 cementless femoral stem
DEVICE
Lead Sponsor
FH ORTHO
NCT06565910
NCT07432737
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06521671