Actively Recruiting
Observational Study of Shoulder Surgery Using FH ORTHO Medical Devices
Led by FH ORTHO · Updated on 2024-07-22
500
Participants Needed
3
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are observing patients who have undergone shoulder joint replacement or repair after shoulder trauma. The study focuses on collecting long-term clinical data under usual surgical conditions and follow-up to evaluate the continued benefit and risk of specific medical devices used in these procedures. The study meets the post-market clinical follow-up requirements of European regulations and aims to include a large number of patients over 5 to 10 years depending on the device. The devices studied include CE-marked shoulder medical devices distributed by FH ORTHO SAS, such as the ARROW prosthesis, Telegraph Evolution humeral nail, and STRAPFLEX strapping system. Patients included have been treated with these devices either prospectively or retrospectively at participating centers. This is a non-interventional, real-life observational study designed for permanent long-term follow-up. Participants will be monitored through routine clinical follow-up visits and data collection over a period of up to 10 years. Researchers will evaluate the performance and revision rates of the medical devices during this time. Minimal clinical data and patient questionnaires will be collected as part of typical care to document device performance and safety. The study involves no experimental treatments and aims to understand device outcomes in usual practice.
CONDITIONS
Brief Title
FH ORTHO Shoulder Observatory
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any patient undergoing implantation of FH ORTHO medical devices for shoulder arthroplasty and trauma, used as approved, at participating centers (retrospectively or prospectively)
- Patient is at least 18 years old
- Patient agrees to participate after being informed, with written consent if required locally
- In some countries, patient must have social insurance to participate
You will not qualify if you...
- Patient unable to participate in the study or complete questionnaires
- Patient refuses to participate
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 - Day of surgery and immediate post-operative period
Participants undergo implantation of FH ORTHO shoulder medical devices for arthroplasty or trauma and receive immediate post-operative care.
1 surgical visit and immediate post-operative visits
Duration - Up to 10 years
Participants are monitored for performance and revision rates of the medical devices over a long-term follow-up.
Periodic visits depending on clinical need and follow-up schedule
Trial Site Locations
Total: 3 locations
1
Clinique VIA DOMITIA
Lunel, France, 34400
Actively Recruiting
2
Clinique Bizet
Paris, France, 75116
Actively Recruiting
3
Clinique de l'Union
Saint-Jean, France, 31243
Actively Recruiting
Research Team
C
Cédric FERRY
S
Stéphanie LHUILLIER
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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