Actively Recruiting
Post-Market Observational Study of the HARMONY Evolution Implants and Instruments for Total Hip Replacement
Led by Symbios Orthopedie SA · Updated on 2024-10-04
264
Participants Needed
5
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of the HARMONY Evolution implants in patients who have undergone Total Hip Replacement (THR). This observational, multi-center, non-randomized study aims to show that these implants meet current standards, with specific goals of achieving a PMA score above 15 points and maintaining acceptable revision rates over 10 years. The study seeks to validate implant performance and safety claims through long-term follow-up. Approximately 264 eligible patients will be treated with the HARMONY Evolution devices. Participants will be enrolled over a 12-month period and followed for 10 years. The study does not involve comparison groups or randomization, focusing instead on monitoring outcomes in patients receiving the implants as part of standard care. During the study, participants will have regular follow-up visits at 2 months, 1 year, 3 years, 5 years, and 10 years. Researchers will assess safety by tracking adverse events and evaluate performance using clinical assessments, quality of life scores, and surgeon satisfaction questionnaires. This ongoing monitoring helps ensure long-term safety and effectiveness of the implants over a decade.
CONDITIONS
Brief 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 who are not pregnant and do 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 and quality likely to affect implant stability (severe osteoporosis)
- Any concomitant condition likely to affect implant integration or function
- Allergy or hypersensitivity to any materials used
- Subjects weighing more than 70 kg cannot receive the HARMONY� Evolution Standard stem size 8
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months enrollment period
Participants undergo Total Hip Replacement surgery using the HARMONY Evolution implants.
1 visit for surgery
Duration - 10 years
Participants are followed for safety and performance assessments of the implant.
Visits at 2 months, 1 year, 3 years, 5 years, and 10 years post-surgery
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
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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