Post Market Clinical Follow-up of EUROSTEM Femoral Stem

Active, not recruiting

• Conditions: Hip Osteoarthritis; Hip Arthropathy; Hip Necrosis; Hip Fractures; Hip Arthritis; Hip Dysplasia
• Interventions: Device: hip arthroplasty

• Registration Number: NCT04995822
• Lead Sponsor: EUROS

Brief Summary

EUROSSTEM is intended for use in primary and revision total hip replacement surgery.

Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

As part of post market vigilance, EUROS will collect data on EUROSTEM performances and safety

Detailed Description

Post market observational study. This study is multicenter, prospective, non comparative.

Study Timeline

• Study Start: 2021-05-21
• Study First Submitted: 2021-07-30
• Study First Submitted QC: 2021-07-30
• Study First Posted: 2021-08-09
• Primary Completion: 2022-11-06
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20
• Study Completion: 2032-11-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

• Patient who received EUROSTEM
• Patient informed of its participation to the study
• Patient aged over 18 to date of surgery

Exclusion Criteria

• Patient presenting a contraindication to EUROSTEM implantation.
• Patient who refused to participate to the study
• Vulnerable subjects

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EUROSTEM femoral stem	hip arthroplasty	All patients who received EUROSTEM femoral stem whatever the version (cemented or cementless)

Primary Outcome Measures

Name	Time	Method
Safety of EUROSTEM Femoral Stem	1 year	Collect the safety of the device trought complications occurence rate

Secondary Outcome Measures

Name	Time	Method
Survival of EUROSTEM Femoral Stem	10 year	Assess the survival rate of the device
Radiological performances of EUROSTEM Femoral Stem	1 year	Collect the performances of the device trought radiological evaluation
Clinical performances of EUROSTEM Femoral Stem	1 year	Collect the performances of the device trought clinical scores

Trial Locations

Locations (9)

Clinique Esquirol St Hilaire; 🇫🇷 Agen, France

Clinique du Mail; 🇫🇷 Puilboreau, La Rochelle, France

CH Aix en Provence; 🇫🇷 Aix-en-Provence, France

Polyclinique du Beaujolais; 🇫🇷 Arnas, France

Clinique Montagard; 🇫🇷 Avignon, France

Polyclinique du Parc Drevon; 🇫🇷 Dijon, France

Clinique du Palais; 🇫🇷 Grasse, France

Hôpital privé Drôme Ardèche - Clinique Pasteur; 🇫🇷 Guilherand Granges, France

Clinique Richelieu; 🇫🇷 Saintes, France