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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Hip Fractures; Hip Dysplasia; Hip Osteoarthritis; Hip Arthritis; Hip Arthropathy; Hip Necrosis
• Intervention / Treatment: Device: hip arthroplasty

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 147

Contacts and Locations

Study Locations

• France
  • Avignon, France, 84000
    • Clinique Montagard
  • Clermont-Ferrand, France, 63000
    • Chu Gabriel Montpied
  • Lyon, France, 69007
    • Hôpital Saint Joseph-Saint Luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient who fulfill the criteria of eligilibilty according to the instructions for use of EUROSCUP MOBILE

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EUROSCUP MOBILE cementless; 107 who received cementless version of EUROSCUP MOBILE	Device: hip arthroplasty; Hip prosthesis surgery
EUROSCUP MOBILE cemented; 40 who received cemented version of EUROSCUP MOBILE	Device: hip arthroplasty; Hip prosthesis surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of EUROSCUP MOBILE	Collect the safety of the device trought complications occurence rate	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiological performances of EUROSCUP MOBILE	Collect the performances of the device trought radiological evaluation	1 year
Clinical performances of EUROSCUP MOBILE	Collect the performances of the device trought clinical scores	1 year
Survival of EUROSCUP MOBILE	Assess the survival rate of the device	10 year

Collaborators and Investigators

• Sponsor: EUROS

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): June 1, 2034
• Study Completion (Estimated): June 1, 2034

Study Registration Dates

• First Submitted: June 4, 2021
• First Submitted That Met QC Criteria: July 30, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fractures, Bone; Wounds and Injuries; Leg Injuries; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Femoral Fractures; Hip Injuries; Musculoskeletal Abnormalities; Joint Dislocations; Osteoarthritis; Necrosis; Hip Fractures; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Osteoarthritis, Hip
• Other Study ID Numbers: EC-310-02-01-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No