Post Market Clinical Follow-up of EUROSCUP Fixe Acetabular Cup

Active, not recruiting

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

• Registration Number: NCT05142462
• Lead Sponsor: EUROS

Brief Summary

EUROSCUP Fixe 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 Fixe performances and safety

Detailed Description

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

Study Timeline

• Study Start: 2021-10-27
• Study First Submitted: 2021-11-24
• Study First Submitted QC: 2021-11-24
• Study First Posted: 2021-12-02
• Primary Completion: 2022-07-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20
• Study Completion: 2032-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patient who received EUROSCUP Fixe.
• 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 Fixe 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 Fixe	Hip arthroplasty	120 patients who received EUROSCUP Fixe

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Clinique de L'Atlantique; 🇫🇷 Puilboreau, France

Clinique St Roch; 🇫🇷 Toulon, France

Clinique Esquirol Saint Hilaire; 🇫🇷 Agen, France

Centre Hospitalier SECLIN; 🇫🇷 Seclin, France