RecruitingNCT05649007

Post-marketing Surveillance Study of the Saphir Stem in Primary Hip Surgery


Sponsor

Gruppo Bioimpianti S.r.l.

Enrollment

630 participants

Start Date

Sep 30, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

Post-market clinical follow up investigation on the use of saphir stem and FIN Cup or Dualis system in the treatment of pathologies requiring hip arthroplasty. The main object of the clinical investigation is the evaluation of long term survival rate of Saphir stem.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This post-market study follows patients who receive a hip replacement using a specific device called the Saphir Stem. The goal is to collect long-term, real-world data on how well this hip implant performs, including pain relief, movement, and how long the implant lasts. No experimental treatment is given — this is an observation study for people already receiving this device as standard care. You may be eligible if: - You are 18 years old or older - You are scheduled for a primary (first-time) total hip replacement - You have osteoarthritis (up to age 85) or a femoral neck fracture (up to age 90) - You have a social security scheme and have given consent to participate You may NOT be eligible if: - You are under 18 years old - You are pregnant - You have already had a hip replacement on the same side - You have a cancer that has spread to the bone or surrounding area - You are unable to understand the study requirements or give consent - You are under legal guardianship Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEhip arthroplasty with prosthesis

Use of femoral stem and acetabular cup for hip arthroplasty


Locations(1)

Hopital Ducuing

Toulouse, France

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NCT05649007


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