Skip to main content
MedPathMedPath Home
Clinical Trials/NCT05142462
NCT05142462
Active, not recruiting
Not Applicable

Post Market Clinical Follow-up of EUROSCUP Fixe Acetabular Cup

EUROS4 sites in 1 country120 target enrollmentOctober 27, 2021
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsHip ArthropathyHip OsteoarthritisHip NecrosisHip FracturesHip DysplasiaHip Arthritis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Arthropathy
Sponsor
EUROS
Enrollment
120
Locations
4
Primary Endpoint
Safety of EUROSCUP Fixe
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
October 27, 2021
End Date
July 2032
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
EUROS
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Safety of EUROSCUP Fixe

Time Frame: 1 year

Collect the safety of the device trought complications occurence rate

Secondary Outcomes

  • Radiological performances of EUROSCUP Fixe(1 year)
  • Survival of EUROSCUP Fixe(10 years)
  • Clinical performances of EUROSCUP Fixe(1 year)

Study Sites (4)

Loading locations...

Similar Trials

Active, not recruiting
Not Applicable
Post Market Clinical Follow-up of Dual-mobility Acetabular Cup EUROSCUP MOBILEHip ArthropathyHip OsteoarthritisHip ArthritisHip FracturesHip NecrosisHip Dysplasia
NCT04993638EUROS147
Active, not recruiting
Not Applicable
Post Market Clinical Follow-up of EUROSTEM Femoral StemHip OsteoarthritisHip ArthropathyHip ArthritisHip NecrosisHip FracturesHip Dysplasia
NCT04995822EUROS131
Terminated
Phase 3
A Randomised Multi-centre Study to Compare the Long-term Performance of the Future Hip to 3 Other Implants in Primary Total Hip ReplacementOsteoarthritisPost-traumatic ArthritisCollagen DisordersAvascular NecrosisTraumatic Femoral FracturesNonunion of Femoral FracturesCongenital Hip DysplasiaSlipped Capital Femoral EpiphysisPerthes Disease
NCT00208468DePuy International317
Recruiting
Not Applicable
Post Market Clinical Follow-up of Hip Surgery Using FH ORTHO Company Medical Devices.Hip Surgery
NCT05966220FH ORTHO800
Completed
Not Applicable
PMCF Study on PEEK Suture Anchors for Hip IndicationsSoft Tissue to Bone Fixation
NCT03814044Smith & Nephew, Inc.149