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RECRUITINGNCT06628336

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

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 evalua...

Lead sponsor: Symbios Orthopedie SA•5 locations•View source on ClinicalTrials.gov

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Contacts

Bojana Gannevat

CONTACT

+41 24 424 26 26 bojana.gannevat@symbios.ch

Sponsors

Lead Sponsor

Symbios Orthopedie SA

The study is prospective, multi-centric, observational, non-comparative, non-randomized and post market. About 264 subjects will be enrolled in this study to evaluate the safety and performance of the HARMONY® Evolution implants. Patients will be included in the study during 12 months and followed-up during 10 years.

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

No

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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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 4, 2024Terms

Trial snapshot

StatusRECRUITING

Phase—

Enrollment264

Start dateOct 2023

Last updatedOct 4, 2024

Condition

Total Hip Replacement

Locations shown

Polyclinique de Franche-Comté

Besançon

Clinique Belledonne

Grenoble

Clinique Juge

Marseille

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 4, 2024Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions