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Clinical Trials/NCT04993638
NCT04993638
Active, not recruiting
Not Applicable

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

EUROS3 sites in 1 country147 target enrollmentJune 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Arthropathy
Sponsor
EUROS
Enrollment
147
Locations
3
Primary Endpoint
Safety of EUROSCUP MOBILE
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
June 2034
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
EUROS
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Safety of EUROSCUP MOBILE

Time Frame: 1 year

Collect the safety of the device trought complications occurence rate

Secondary Outcomes

  • Radiological performances of EUROSCUP MOBILE(1 year)
  • Survival of EUROSCUP MOBILE(10 year)
  • Clinical performances of EUROSCUP MOBILE(1 year)

Study Sites (3)

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