Post Market Clinical Follow-up of Dual-mobility Acetabular Cup EUROSCUP MOBILE

Active, not recruiting

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

• Registration Number: NCT04993638
• Lead Sponsor: EUROS

Brief Summary

EUROSCUP MOBILE 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 EUROSCUP MOBILE performances and safety

Detailed Description

Post market observational study. This study is retropective and prospective, non comparative.

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2021-06-04
• Study First Submitted QC: 2021-07-30
• Study First Posted: 2021-08-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28
• Primary Completion: 2034-06-01
• Study Completion: 2034-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

• Patient who received EUROSCUP MOBILE.
• Patient informed of its participation to the study
• Patient aged between 18 and 80 years old (<80).

Exclusion Criteria

• Patient presenting a contraindication to EUROSCUP MOBILE 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
EUROSCUP MOBILE cementless	hip arthroplasty	107 who received cementless version of EUROSCUP MOBILE
EUROSCUP MOBILE cemented	hip arthroplasty	40 who received cemented version of EUROSCUP MOBILE

Primary Outcome Measures

Name	Time	Method
Safety of EUROSCUP MOBILE	1 year	Collect the safety of the device trought complications occurence rate

Secondary Outcome Measures

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

Trial Locations

Locations (3)

CHU Gabriel Montpied; 🇫🇷 Clermont-Ferrand, France

Hôpital Saint Joseph-Saint Luc; 🇫🇷 Lyon, France

Clinique Montagard; 🇫🇷 Avignon, France