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

Recruiting

• Conditions: Hip Disease; Hip Fractures
• Interventions: Device: Hip prosthesis - ESOP 2 cementless femoral stem

• Registration Number: NCT04193163
• Lead Sponsor: FH ORTHO

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2019-11-28
• Status Verified: 2019-12
• Study Start: 2019-12-01
• Study First Submitted QC: 2019-12-06
• Study First Posted: 2019-12-10
• Last Update Submitted: 2019-12-13
• Last Update Posted: 2019-12-16
• Primary Completion: 2030-12-01
• Study Completion: 2030-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 268

Inclusion Criteria

• Subject implanted with ESOP 2 stem in one of the following indication according to the instructions for use: hip disorders; femoral neck fracture
• Subject who received an information form and is willing to participate in the study

Exclusion Criteria

• Contraindications described in the instructions for use
• Usual surgical contraindications
• Subject who is not able to express his/her non-opposition

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients receiving ESOP 2 stem	Hip prosthesis - ESOP 2 cementless femoral stem	-

Primary Outcome Measures

Name	Time	Method
Survival rate	10 years post-op

Secondary Outcome Measures

Name	Time	Method
Radiographies evaluation	immediate post-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op	Radiological results such as stability, osteointegration will be evaluated.
Rate of complications	per-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op	All complications will be gathered during intervention and up to 10 years postoperatively.
Functional outcomes such as pain, mobility	pre-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op	Functional outcomes will be determined by the Harris Hip score. This score ranges from 0 to 100, where, the higher the score, the better the patient outcome.
Quality of life evaluation	pre-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op	Quality of life will be determined by the OXFORD-12 score. This score ranges from 12 points to 60 points, where, the higher the score, the better the patient outcome.

Trial Locations

Locations (7)

Clinique Tivoli Ducos; 🇫🇷 Bordeaux, France

Nouvelle Clinique Bel-Air; 🇫🇷 Bordeaux, France

CH Pasteur; 🇫🇷 Colmar, France

CH Raymond POINCARE; 🇫🇷 Garches, France

Clinique du Val d'Ouest; 🇫🇷 Écully, France

CH de Haguenau; 🇫🇷 Haguenau, France

Groupe Hospitalier Pitié-Salpêtrière; 🇫🇷 Paris, France