Post Market Clinical Follow-up of EUROSTEM Femoral Stem

NCT ID: NCT04995822

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

131 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-21

Study Completion Date

2032-11-06

Brief Summary

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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

Detailed Description

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

Conditions

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Hip Osteoarthritis Hip Arthropathy Hip Arthritis Hip Necrosis Hip Fractures Hip Dysplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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EUROSTEM femoral stem

All patients who received EUROSTEM femoral stem whatever the version (cemented or cementless)

hip arthroplasty

Intervention Type DEVICE

Hip prosthesis surgery

Interventions

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hip arthroplasty

Hip prosthesis surgery

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EUROS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique du Mail

Puilboreau, La Rochelle, France

Site Status

Clinique Esquirol St Hilaire

Agen, , France

Site Status

CH Aix en Provence

Aix-en-Provence, , France

Site Status

Polyclinique du Beaujolais

Arnas, , France

Site Status

Clinique Montagard

Avignon, , France

Site Status

Polyclinique du Parc Drevon

Dijon, , France

Site Status

Clinique du Palais

Grasse, , France

Site Status

Hôpital privé Drôme Ardèche - Clinique Pasteur

Guilherand-Granges, , France

Site Status

Clinique Richelieu

Saintes, , France

Site Status

Countries

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France

Other Identifiers

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EC-309-01

Identifier Type: -

Identifier Source: org_study_id

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