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Active, Not Recruiting

NCT Number: NCT04995822

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hip Osteoarthritis Arthritis Femoral Fractures Fractures, Bone Hip Arthritis Hip Arthropathy Hip Dislocation Hip Dysplasia Hip Fractures Hip Injuries Hip Necrosis Joint Diseases Joint Dislocations Leg Injuries Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique du Mail, Puilboreau, La Rochelle, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hip arthroplasty

Device

Hip prosthesis surgery

Primary outcomes

  1. Safety of EUROSTEM Femoral Stem

    Time frame: 1 year

    Collect the safety of the device trought complications occurence rate

Secondary outcomes

  1. Radiological performances of EUROSTEM Femoral Stem

    Time frame: 1 year

    Collect the performances of the device trought radiological evaluation

  2. Clinical performances of EUROSTEM Femoral Stem

    Time frame: 1 year

    Collect the performances of the device trought clinical scores

  3. Survival of EUROSTEM Femoral Stem

    Time frame: 10 year

    Assess the survival rate of the device

Sponsors and collaborators

Lead sponsor

EUROS

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2032
First posted
Aug 9, 2021
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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