Post-Market Observational Study of the HARMONY® Evolution Implants and Instruments
Recruiting
Observational Study
Total Hip Replacement
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 – 99
- Sex
- Any
- Study type
- Observational
- Participants needed
- 264 (estimated)
- Sponsor
- Symbios Orthopedie SA · Industry
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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 o…
Trial Locations
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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 pe…
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