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.
Investigators
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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