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

Recruiting now

Conditions studied: Total Hip Replacement

In brief

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.

Key facts

Study ID

NCT06628336

Run by

Symbios Orthopedie SA

People needed

264

Starts

2023-10-11

Expected to finish

2035-03-11

Last updated by the study team

2024-10-04

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Polyclinique de Franche-Comté — Besançon, France (enrolling)
• Clinique Belledonne — Grenoble, France (enrolling)
• Clinique Juge — Marseille, France (enrolling)
• Clinique Arago — Paris, France (enrolling)
• Médipôle Garonne — Toulouse, France (enrolling)

Full record on ClinicalTrials.gov

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