Overview

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

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.