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

Launched by SYMBIOS ORTHOPEDIE SA · Oct 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a specific type of hip implant called the HARMONY® Evolution, which is used in total hip replacement surgeries. The goal is to see if these implants perform well and meet safety standards over a long period, specifically looking at how many patients may need another surgery (revision) after 10 years. Researchers want to ensure that the implants work as expected and that the rate of needing a revision surgery stays low.

To participate in this trial, individuals must be 18 years or older and need a total hip replacement. Women who can become pregnant must have a negative pregnancy test before joining. It's important that participants can return for follow-up visits after the surgery. However, people with certain health issues, like severe infections or poor bone quality, may not be eligible. If you join the study, you’ll be monitored closely to assess how well the implant is working and to keep track of any potential issues over time.

Gender

ALL

Eligibility 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.