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Post Market Clinical Follow-up of EUROSTEM Femoral Stem

Post Market Clinical Follow-up of EUROSTEM Femoral Stem

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04995822
Enrollment
131
Registered
2021-08-09
Start date
2021-05-21
Completion date
2032-11-06
Last updated
2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICEhip arthroplasty

Hip prosthesis surgery

Sponsors

EUROS
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Safety of EUROSTEM Femoral Stem1 yearCollect the safety of the device trought complications occurence rate

Secondary

MeasureTime frameDescription
Radiological performances of EUROSTEM Femoral Stem1 yearCollect the performances of the device trought radiological evaluation
Clinical performances of EUROSTEM Femoral Stem1 yearCollect the performances of the device trought clinical scores
Survival of EUROSTEM Femoral Stem10 yearAssess the survival rate of the device

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026