Evaluating the HARMONY® Evolution implants for hip replacement
Post-Market Observational Study of the HARMONY® Evolution Implants and Instruments
This study is testing how safe and effective the HARMONY® Evolution implants are for people getting a total hip replacement over a 10-year period.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 264 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Symbios Orthopedie SA Industry-sponsored |
| Locations | 5 sites (Besançon and 4 other locations) |
| Trial ID | NCT06628336 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are clinically indicated for total hip replacement and can provide informed consent.
Not a fit: Patients with acute or chronic infections, severe osteoporosis, or other conditions that may affect implant integration or function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence supporting the long-term safety and effectiveness of the HARMONY® Evolution implants for hip replacement patients.
How similar studies have performed: While this study is observational and post-market, similar studies evaluating implant safety and performance have shown success in validating new orthopedic devices.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Besançon and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.