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NCT04995822 Clinical Trial

Post Market Clinical Follow-up of EUROSTEM Femoral Stem

Hip Fractures Clinical Trial

Official title:
Post Market Clinical Follow-up of EUROSTEM Femoral Stem

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04995822
Other study ID # EC-309-01
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 21, 2021
Est. completion date November 6, 2032

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

Clinical Trial Summary

EUROSSTEM 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 EUROSTEM performances and safety

Description:

Post market observational study. This study is multicenter, prospective, non comparative.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 131
Est. completion date November 6, 2032
Est. primary completion date November 6, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient who received EUROSTEM - Patient informed of its participation to the study - Patient aged over 18 to date of surgery Exclusion Criteria: - Patient presenting a contraindication to EUROSTEM 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 Esquirol St Hilaire Agen
France CH Aix en Provence Aix-en-Provence
France Polyclinique du Beaujolais Arnas
France Clinique Montagard Avignon
France Polyclinique du Parc Drevon Dijon
France Clinique du Palais Grasse
France Hôpital privé Drôme Ardèche - Clinique Pasteur Guilherand Granges
France Clinique du Mail Puilboreau La Rochelle
France Clinique Richelieu Saintes

Sponsors (1)
Lead Sponsor Collaborator
EUROS

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety of EUROSTEM Femoral Stem Collect the safety of the device trought complications occurence rate 1 year
Secondary Radiological performances of EUROSTEM Femoral Stem Collect the performances of the device trought radiological evaluation 1 year
Secondary Clinical performances of EUROSTEM Femoral Stem Collect the performances of the device trought clinical scores 1 year
Secondary Survival of EUROSTEM Femoral Stem 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
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