RecruitingOBSERVATIONAL

FH ORTHO Shoulder Observatory

This study, called the FH ORTHO Shoulder Observatory, is collecting information long-term about people who have had shoulder operations for injuries or arthritis. Doctors use special medical devices made by FH ORTHO during these operations. The main aim is to see how these devices perform over a long time – typically 5 to 10 years. This helps make sure the devices are still safe and effective for patients even after they've been used in many operations. This is an "observational" study, meaning you'll receive your usual care, and the researchers will simply collect information about your progress. It's an important way to understand the real-life effectiveness and safety of medical implants over many years.

At a glance

Status

Recruiting

Sponsor

FH ORTHO

Enrolment target

500

Start

08 Sep 2022

Estimated completion

08 Sep 2035

Trauma Arthropathy Shoulder

What is this study about?

This study is called the FH ORTHO Shoulder Observatory. It's a special type of study that looks at how patients recover after having shoulder surgery for injuries or conditions like arthritis. When you have an operation on your shoulder, surgeons often use medical devices, and in this study, they're specifically looking at devices made by a company called FH ORTHO.

The main idea is to follow people over a long period, usually between 5 and 10 years, to see how these shoulder devices work in real life. This means they'll gather information from patients during their regular hospital appointments and check-ups. They're trying to make sure that the devices continue to be beneficial and safe for patients who have them implanted.

This study is important because it helps monitor medical devices after they've been approved for use. By collecting information over a long time, researchers can understand the long-term effects and make sure the devices keep helping patients and don't cause unexpected problems. This kind of research helps improve future treatments for people with shoulder problems.

Key takeaways

This study observes how well FH ORTHO shoulder devices work long-term.
It's for people having shoulder surgery for injury or arthritis.
You'll receive your usual medical care; no new treatments are involved.
Information will be collected over 5 to 10 years during your regular appointments.
The goal is to ensure the devices remain safe and effective for patients.

Who may be eligible?

To be able to join this study, you must be at least 18 years old. You'd be considered if you're having — or have already had — a shoulder operation using a medical device from FH ORTHO for a shoulder replacement or injury repair at one of the hospitals taking part in this study.

Before you join, you'll need to agree to take part after hearing and reading all about the study. In some places, you might also need to be part of the national health insurance system, like in France, to be included.

However, you won't be able to join if you can't participate in the study, for example, if you find it difficult to fill out questionnaires. You also can't participate if you simply decide you don't want to be involved.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 18 years old?
Are you having or have you had a shoulder operation using an FH ORTHO device for injury or arthritis?
Are you able to fill out questionnaires or provide information when asked?
Are you willing to agree to be part of the study after it's explained to you?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you won't be given any new treatments or asked to do anything differently than your usual post-surgery care. This is an "observational" study, which means the researchers will simply collect information about your health and recovery during your routine hospital visits after your shoulder operation. They'll be looking at how you're doing over the long term, typically for 5 to 10 years, depending on the specific device you receive. This involves reviewing your medical notes and potentially asking you to complete questionnaires during your standard follow-up appointments.

Potential risks and benefits

There are no direct medical benefits or risks from simply being part of this study, as it doesn't involve new treatments or medical procedures. The benefits are for future patients, as the information gathered helps ensure the continued safety and effectiveness of shoulder implants. You always have the right to withdraw from the study at any time without it affecting your medical care.

Locations (3)

Clinique VIA DOMITIA
Verified postcode
Lunel, France· Recruiting
Clinique Bizet
Verified postcode
Paris, France· Recruiting
Clinique de l'Union
Verified postcode
Saint-Jean, France· Recruiting

Common questions

What is an 'observatory' study?

It's a study where doctors simply watch and collect information about how patients are doing with their usual treatments, without making any changes to their care.

Will I get any special treatment in this study?

No, you will receive your standard medical care and follow-up. The study just collects information about your progress.

How long will I be followed in this study?

The study aims to follow patients for a long time, typically between 5 and 10 years after their shoulder surgery.

What kind of information will the study collect?

They will collect information about your shoulder recovery and the performance of the implanted device during your routine check-ups.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time without it affecting your medical care.

How to find out more

Cédric FERRY

c.ferry@fhortho.com +33 (0)6 49 63 78 29 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.