Post Market Clinical Follow-up of EUROSTEM Femoral Stem

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

Study Overview

• Status: Active, not recruiting
• Conditions: Hip Fractures; Hip Dysplasia; Hip Osteoarthritis; Hip Arthritis; Hip Arthropathy; Hip Necrosis
• Intervention / Treatment: Device: hip arthroplasty

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 131

Contacts and Locations

Study Locations

• France
  • Agen, France, 47000
    • Clinique Esquirol St Hilaire
  • Aix-en-Provence, France, 13100
    • CH Aix en Provence
  • Arnas, France, 69400
    • Polyclinique du Beaujolais
  • Avignon, France, 84000
    • Clinique Montagard
  • Dijon, France, 21000
    • Polyclinique du Parc Drevon
  • Grasse, France, 06130
    • Clinique du Palais
  • Guilherand Granges, France, àè(àà
    • Hôpital Privé Drôme Ardèche - Clinique Pasteur
  • Saintes, France, 17100
    • Clinique Richelieu
  • La Rochelle
    • Puilboreau, La Rochelle, France, 17138
      • Clinique du Mail

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient who fulfill the criteria of eligilibilty according to the instructions for use of EUROSTEM

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EUROSTEM femoral stem; All patients who received EUROSTEM femoral stem whatever the version (cemented or cementless)	Device: hip arthroplasty; Hip prosthesis surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of EUROSTEM Femoral Stem	Collect the safety of the device trought complications occurence rate	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiological performances of EUROSTEM Femoral Stem	Collect the performances of the device trought radiological evaluation	1 year
Clinical performances of EUROSTEM Femoral Stem	Collect the performances of the device trought clinical scores	1 year
Survival of EUROSTEM Femoral Stem	Assess the survival rate of the device	10 year

Collaborators and Investigators

• Sponsor: EUROS

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Actual): November 6, 2022
• Study Completion (Estimated): November 6, 2032

Study Registration Dates

• First Submitted: July 30, 2021
• First Submitted That Met QC Criteria: July 30, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fractures, Bone; Wounds and Injuries; Leg Injuries; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Femoral Fractures; Hip Injuries; Musculoskeletal Abnormalities; Joint Dislocations; Osteoarthritis; Necrosis; Hip Fractures; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Osteoarthritis, Hip
• Other Study ID Numbers: EC-309-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No