Post Market Clinical Follow-up of EUROSCUP Fixe Acetabular Cup

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

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 retropective and prospective, non comparative.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

Study Locations

• France
  • Agen, France, 47000
    • Clinique Esquirol Saint Hilaire
  • Puilboreau, France, 17138
    • Clinique de l'Atlantique
  • Seclin, France, 59113
    • Centre Hospitalier SECLIN
  • Toulon, France, 83000
    • Clinique St Roch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EUROSCUP Fixe; 120 patients who received EUROSCUP Fixe	Device: Hip arthroplasty; Hip prosthesis surgical implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of EUROSCUP Fixe	Collect the safety of the device trought complications occurence rate	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: EUROS

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2021
• Primary Completion (Actual): July 29, 2022
• Study Completion (Estimated): July 1, 2032

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): December 2, 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-310-01-01; 2021-A01650-41 (Other Identifier: ANSM)

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