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Clinical Trials/NCT04995822
NCT04995822
Active, not recruiting
Not Applicable

Post Market Clinical Follow-up of EUROSTEM Femoral Stem

EUROS9 sites in 1 country131 target enrollmentMay 21, 2021
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ConditionsHip OsteoarthritisHip ArthropathyHip ArthritisHip NecrosisHip FracturesHip Dysplasia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Osteoarthritis
Sponsor
EUROS
Enrollment
131
Locations
9
Primary Endpoint
Safety of EUROSTEM Femoral Stem
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
May 21, 2021
End Date
November 6, 2032
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
EUROS
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Safety of EUROSTEM Femoral Stem

Time Frame: 1 year

Collect the safety of the device trought complications occurence rate

Secondary Outcomes

  • Survival of EUROSTEM Femoral Stem(10 year)
  • Radiological performances of EUROSTEM Femoral Stem(1 year)
  • Clinical performances of EUROSTEM Femoral Stem(1 year)

Study Sites (9)

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