Post-Market Observational Study of the HARMONY® Evolution Implants and Instruments
ConditionTotal Hip Replacement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorSymbios Orthopedie SA
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- HARMONY EVOLUTION
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov