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NCT05142462 Clinical Trial

Post Market Clinical Follow-up of EUROSCUP Fixe Acetabular Cup

Hip Fractures Clinical Trial

Official title:
Post Market Clinical Follow-up of EUROSCUP Fixe Acetabular Cup

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05142462
Other study ID # EC-310-01-01
Secondary ID 2021-A01650-41
Status Active, not recruiting
Phase
First received
Last updated
Start date October 27, 2021
Est. completion date July 2032

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

Clinical Trial 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

Description:

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 120
Est. completion date July 2032
Est. primary completion date July 29, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Hip arthroplasty
Hip prosthesis surgical implantation

Locations
Country Name City State
France Clinique Esquirol Saint Hilaire Agen
France Clinique de L'Atlantique Puilboreau
France Centre Hospitalier SECLIN Seclin
France Clinique St Roch Toulon

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 Fixe Collect the safety of the device trought complications occurence rate 1 year
Secondary Clinical performances of EUROSCUP Fixe Collect the performances of the device trought clinical scores 1 year
Secondary Radiological performances of EUROSCUP Fixe Collect the performances of the device trought radiological evaluation 1 year
Secondary Survival of EUROSCUP Fixe Assess the survival rate of the device 10 years
See also
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