Evaluating the HARMONY® Evolution implants for hip replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the safety and performance of the HARMONY® Evolution implants in patients undergoing total hip replacement (THR). It will involve approximately 264 subjects who will be monitored over a 10-year period to validate the implants' performance and safety claims. The study is non-comparative and non-randomized, focusing on real-world outcomes following the use of these implants. Participants will be followed up for 10 years to ensure compliance with established performance metrics and acceptable revision rates.

Why it matters

Who can join: the full rules

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.

Where it's running

• Polyclinique de Franche-Comté
  Besançon, France Recruiting
• Clinique Belledonne
  Grenoble, France Recruiting
• Clinique Juge
  Marseille, France Recruiting
• Clinique Arago
  Paris, France Recruiting
• Médipôle Garonne
  Toulouse, France Recruiting

Study contacts

• Principal investigator: Christophe Castelain, Dr. — Clinique Arago
• Study coordinator: Bojana Gannevat
• Email: bojana.gannevat@symbios.ch
• Phone: +41 24 424 26 26

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.