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Post-Market Observational Study of the HARMONY® Evolution Implants and Instruments

Recruitingn/aAges 18 Years - 99 YearsAllSymbios Orthopedie SA
NCT06628336 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to evaluate the safety and performance of the HARMONY® Evolution implants in a series of operated subjects treated in THR. The objective is to demonstrate that the evaluated implants are compliant with the state of the art and the performance (PMA score \> 15 points) \& safety claims (The expected acceptable revision rate (state of the art with a confidence interval of 95%) is 3% at 3 years, 5% at 5 years, 7% at 7 years and 10% at 10 years). The endpoint of this study is to validate the expected performance of the HARMONY® Evolution implants with the PMA score at 10 years and to validate the safety claim with the expected acceptable revision rate at 10 years.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Subjects of 18 years of age and older * Each subject who is willing to give informed consent * Clinically indicated for a Total Hip Replacement * Women of childbearing age who are not pregnant and do not expect to become pregnant within 12 months. A pregnancy test should be performed for women of childbearing age * Geographically stable and willing to return to the implanting site for all follow-up visits Exclusion Criteria: * Acute or chronic, local or systemic infection * Muscular, neurological, psychological or vascular deficits * Poor bone density and quality likely to affect implant stability (severe osteoporosis) * Any concomitant condition likely to affect implant integration or function * Allergy or hypersensitivity to any of the materials used Specific: • The HARMONY® Evolution Standard stem size 8 shall not be implanted in subjects weighing more than 70 kg.
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What it tests

  • HARMONY EVOLUTION
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Where

5 sites
Polyclinique de Franche-Comté
Besançon, France
Clinique Belledonne
Grenoble, France
Clinique Juge
Marseille, France
Clinique Arago
Paris, France
Médipôle Garonne
Toulouse, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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