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NCT04993638 Clinical Trial

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

Hip Fractures Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04993638
Other study ID # EC-310-02-01-A
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date June 1, 2034

Study information
Verified date February 2024
Source EUROS
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 147
Est. completion date June 1, 2034
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• hip arthroplasty
Hip prosthesis surgery

Locations
Country Name City State
France Clinique Montagard Avignon
France Clinique montagard Avignon
France CHU Gabriel Montpied Clermont-Ferrand
France Hôpital Saint Joseph-Saint Luc Lyon

Sponsors (1)
Lead Sponsor Collaborator
EUROS

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety of EUROSCUP MOBILE Collect the safety of the device trought complications occurence rate 1 year
Secondary Radiological performances of EUROSCUP MOBILE Collect the performances of the device trought radiological evaluation 1 year
Secondary Clinical performances of EUROSCUP MOBILE Collect the performances of the device trought clinical scores 1 year
Secondary Survival of EUROSCUP MOBILE Assess the survival rate of the device 10 year
See also
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Active, not recruiting NCT02247791 - Uncemented Compared to Cemented Femoral Stems in Total Hip Arthroplasty N/A
Completed NCT00746876 - Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures. N/A
Completed NCT00058864 - The HIP Impact Protection Program (HIP PRO) N/A