Actively Recruiting
Post-Market Observational Study of the HARMONY® Evolution Implants and Instruments
Led by Symbios Orthopedie SA · Updated on 2024-10-04
264
Participants Needed
5
Research Sites
595 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post-Market Observational Study of the HARMONY® Evolution Implants and Instruments
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects of 18 years of age and older
- Willing to give informed consent
- Clinically indicated for total hip replacement
- Women of childbearing age must not be pregnant and not expect to become pregnant within 12 months; pregnancy test required
- Geographically stable and willing to return to the implanting site for all follow-up visits
You will not qualify if you...
- Acute or chronic, local or systemic infection
- Muscular, neurological, psychological, or vascular deficits
- Poor bone density or quality likely to affect implant stability (severe osteoporosis)
- Any condition likely to affect implant integration or function
- Allergy or hypersensitivity to any materials used in the implant
- Subjects weighing more than 70 kg should not receive the HARMONY4 Evolution Standard stem size 8
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Polyclinique de Franche-Comté
Besançon, France
Actively Recruiting
2
Clinique Belledonne
Grenoble, France, 38400
Actively Recruiting
3
Clinique Juge
Marseille, France, 13008
Actively Recruiting
4
Clinique Arago
Paris, France, 75014
Actively Recruiting
5
Médipôle Garonne
Toulouse, France, 31100
Actively Recruiting
Research Team
B
Bojana Gannevat
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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