Not yet recruitingOBSERVATIONAL

FH ORTHO SAS Knee Observatory

This study is like a long-term look at how well knee surgery devices from FH Ortho work for people in their everyday lives. It's not a typical trial with new treatments, but rather a way to check on devices that are already approved and widely used in surgeries, including knee replacements and ligament repairs. The main goal is to gather information on how safe and effective these devices are over many years. This helps make sure they continue to meet high safety and performance standards. The study will collect information from patients and surgeons, sometimes for as long as 20 years, to understand both the short-term and long-term results.

At a glance

Status

Not yet recruiting

Sponsor

FH ORTHO

Enrolment target

487

Start

01 May 2024

Estimated completion

01 Jun 2044

Knee Surgery

What is this study about?

Imagine you're having knee surgery, either to replace part of your knee or repair a ligament. This study, called the FH ORTHO SAS Knee Observatory, is designed to keep an eye on how well the specific FH Ortho devices used in your surgery perform after you've gone home and are living your life. It's not about trying out new devices or asking you to do anything extra or unusual for your treatment. Instead, it's about watching how these already-approved devices work for many people in different situations.

The main reason for this study is to make sure that these knee devices continue to be safe and effective over a long time. In Europe, medical devices need to meet certain quality and safety standards. This study helps answer any ongoing questions about the devices once they are being used by many patients. The researchers want to understand how different versions and combinations of these devices work, including how long they last and if there are any issues. This helps them improve future devices and ensures patients receive the best care.

To do this, the study will collect information from your surgeons and, with your permission, directly from you using easy-to-use digital tools like smartphone apps or websites. This information will be gathered at different points, sometimes for up to 20 years for knee replacements and up to 5 years for ligament repairs. This long-term tracking helps researchers understand the full picture of how these devices perform over time, ensuring they remain a good option for people needing knee surgery.

Key takeaways

This study tracks how approved knee surgery devices work over time.
It helps ensure the devices aresafe and effective for many years.
Participation involves sharing information from your surgery and sometimes completing online surveys.
There are no extra medical procedures or medications involved.
You can stop participating at any time without affecting your care.
The study aims to improve future knee surgery for everyone.

Who may be eligible?

To be able to join this study, you would typically need to be 18 years old or older and having or have already had knee surgery using FH Ortho devices at one of the hospitals taking part in the study. You'd also need to fully understand what's involved and agree to take part, usually by giving your written consent.

There are some reasons why you might not be able to join. For knee replacement surgery, this includes having an infection, certain mental or nerve conditions that could affect the surgery's success, or not having enough bone to support the implant. Also, if you have allergies to the materials in the device or certain metabolic bone diseases, you might not be suitable.

For ligament reconstruction, similar conditions like active infection, certain mental or nerve conditions, or insufficient bone stock would mean you couldn't participate. If you have known allergies to the device materials or specific metabolic diseases, or if you're unable to follow medical advice, you would not be able to join. While pregnant or breastfeeding women aren't automatically excluded, it's generally advised they don't join for safety reasons, though the devices themselves are used under normal circumstances.

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 18 years old or older?
Are you having or have you had knee surgery using FH Ortho devices at a participating hospital?
Do you understand what the study involves and are you willing to take part?
Do you not have an active infection or certain other severe health-related issues that might affect your surgery or recovery?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your involvement will mostly revolve around allowing your clinical information related to your knee surgery to be collected. This information will come from your surgeons concerning your surgery details and progress during your regular follow-up visits. You might also be asked to complete questionnaires about your recovery and how your knee feels, known as 'patient-reported outcomes'. These will likely be done through a smartphone app, tablet, or computer, making it very convenient for you.

The study aims to follow patients for a long time – up to 20 years for knee replacements and up to 5 years for ligament repairs. This means you might be asked to complete these questionnaires at various points over many years, for example, at one, two, five, and ten years after your surgery. The platform might send you reminders when it's time to provide an update. Your participation will not involve extra hospital visits or additional procedures beyond your standard care.

Potential risks and benefits

The main benefit of taking part in this study is contributing to our understanding of how well current knee surgery devices work in the long term, helping improve future treatments for everyone. Since the devices are already approved and used as part of standard care, there are no additional medical risks from the study itself. Your privacy is very important, and your data will be handled carefully. You always have the right to withdraw from the study at any time without this affecting your medical care.

Locations (10)

Clinique De La Chataigneraie
Verified postcode
Beaumont, France
Clinique De La Miotte
Verified postcode
Belfort, France
Polyclinique St Privat
Verified postcode
Boujan-sur-Libron, France
Clinique Du Val D'Ouest
Verified postcode
Écully, France
C.H. Raymond Poincare
Verified postcode
Garches, France
Hôpital Saint Vincent de Paul
Verified postcode
Lille, France
Hôpital Prive St Grégoire
Verified postcode
Saint-Grégoire, France
Polyclinique De L'Europe
Verified postcode
Saint-Nazaire, France
Medipole Garonne
Verified postcode
Toulouse, France
Hôpital Privé Océane
Verified postcode
Vannes, France

Common questions

What is the main goal of this study?

The main goal is to follow how well FH Ortho knee surgery devices work and how safe they are over many years in real patients like you.

Will I have to take new medicine or have extra medical tests?

No, you will not have to take any new medicine or have extra medical tests beyond what your doctor would normally recommend for your knee surgery recovery.

How long will I be involved in the study?

Your involvement could last a long time, up to 20 years for knee replacements and up to 5 years for ligament repairs, as researchers want to see long-term results.

How will my information be collected?

Information will be collected from your surgeon and, with your permission, you might be asked to complete questionnaires on your smartphone or computer at home.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, and this will not affect the medical care you receive.

How to find out more

Cindy Lai

c.lai@fhortho.com 631315494 Official trial record

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