Actively Recruiting
FH ORTHO Shoulder Observatory
Led by FH ORTHO · Updated on 2024-07-22
500
Participants Needed
3
Research Sites
678 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a real-life observatory designed to collect long-term clinical data on patients who have undergone shoulder joint replacement or repair following shoulder trauma. In this type of intervention, one or more medical devices distributed by FH ORTHO SAS may be used by surgeons. This study meets the requirement for post-market clinical follow-up (PMCF) as defined in the European Medical Device Regulation (MDR 2017/745). It therefore involves collecting in real life, i.e. under the usual conditions of surgery and short and long-term patient follow-up, minimal clinical data that will make it possible to document the continued benefit/risk of the medical devices concerned. This study is designed as a permanent long-term observatory, of a non-interventional nature, with the objective of having long-term follow-up data (5 to 10 years depending on the devices concerned) for a maximum number of patients included.
CONDITIONS
Official Title
FH ORTHO Shoulder Observatory
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing implantation of FH ORTHO SAS medical devices for shoulder arthroplasty or trauma in participating centers (retrospective or prospective)
- Patients aged 18 years or older
- Patients who agree to participate after receiving oral and written information, with written consent if required locally
- In some countries, such as France, patients must be socially insured to participate
You will not qualify if you...
- Patients unable to participate or complete questionnaires
- Patients who refuse to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
S
Stéphanie LHUILLIER
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
1
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