RecruitingNCT06628336

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

Sponsor

Symbios Orthopedie SA

Enrollment

264 participants

Start Date

Oct 11, 2023

Study Type

OBSERVATIONAL

Conditions

total hip replacement

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria5

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 Criteria7

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.