Active not recruitingOBSERVATIONAL

Observational Study to Evaluate Safety and Performance of the Total Ankle Prosthesis, EasyMove®

This study is checking on a new type of ankle replacement called EasyMove. It's an important study that helps doctors understand the long-term safety and how well the EasyMove ankle works for people who've had it fitted. Researchers will follow patients for up to five years to see if the replacement helps them move better and if there are any problems. This is known as a 'post-market' study, meaning the device is already in use, and this research helps gather more information on how it performs in real-life situations, just as the manufacturer intended. It’s like checking in to make sure everything is working as it should be over time.

At a glance

Status

Active not recruiting

Sponsor

FH ORTHO

Enrolment target

Start

14 Sep 2021

Estimated completion

13 Sep 2029

Ankle Injuries and Disorders

What is this study about?

This study is all about a specific type of ankle replacement, called the EasyMove prosthesis. If you've had, or are considering, an ankle replacement because of severe arthritis (like rheumatoid arthritis, or arthritis after an injury), this study might be interesting. The EasyMove is designed to replace your damaged ankle joint.

The main goal of this research is to keep an eye on people who have already had the EasyMove ankle replacement. Doctors want to understand how safe it is and how well it helps patients get around in their daily lives over a long period – up to five years. This helps to make sure that the EasyMove is performing as expected and is a good option for future patients.

This isn't a study where new treatments are tested. Instead, it's about watching how the EasyMove works for people under normal circumstances. It helps to collect important information about how the replacement helps people, and if any problems come up over time. This kind of information is really valuable for doctors and patients alike when making decisions about ankle surgery.

Key takeaways

This study looks at the safety and performance of the EasyMove ankle replacement.
It collects information from patients who have already had this ankle replacement.
The study follows people for up to five years, during their normal check-ups.
It helps doctors understand how the EasyMove works in real-life situations.
You won't receive extra treatment or visits just for the study.

Who may be eligible?

To be part of this study, you need to have already had the EasyMove ankle replacement fitted. This operation must have been done because you had severe ankle arthritis, whether it was from an injury, wear and tear, or a condition like rheumatoid arthritis. The surgery should have followed the standard guidelines for using the EasyMove.

You also need to be an adult, aged 18 years or older. You must be able to understand the information about the study and be happy to take part. It's important that you agree to be involved after carefully considering everything.

However, you can't join if your doctor has advised against using this type of ankle replacement for any health reasons, or if there are any other specific reasons mentioned in the device instructions that mean it's not suitable for you. You also need to be able to clearly say if you don't want to be in the study.

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.

Have you had an EasyMove ankle replacement fitted?
Was your ankle replacement for severe arthritis or an injury?
Are you 18 years old or older?
Are you willing to participate and understand the study information?
Do you have any medical reasons that might prevent you from taking part (as discussed with your doctor)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it means that the doctors will continue to follow up on your progress after your EasyMove ankle replacement surgery. This study lasts for up to five years. You won't be given any new treatments or medicines. Instead, the researchers will collect information about your health and how your ankle replacement is working during your regular check-up appointments. This usually involves asking you questions about your pain, how well you can move, and generally how you're feeling. They might also look at your medical notes. You won't need extra visits just for the study; it will be combined with your usual follow-up care for your ankle replacement.

Potential risks and benefits

Taking part in this study won't directly improve your health further than your ankle replacement already does, as it's observing care you'd already be getting. However, your involvement provides valuable information that helps doctors and future patients understand the long-term safety and effectiveness of the EasyMove ankle replacement. There are no additional direct medical risks beyond those associated with your standard follow-up care after ankle replacement surgery. You are absolutely free to decide not to be in the study, or to leave at any time, without it affecting the care you receive.

Locations (6)

Chu Brest
Verified postcode
Brest, France
CH Raymond-Poincaré
Verified postcode
Garches, France
Centre Hospitalier Départemental Vendée
Verified postcode
La Roche-sur-Yon, France
Clinique Victor HUGO
Verified postcode
Paris, France
Clinique Jouvenet
Verified postcode
Paris, France
Centre hospitalier universitaire vaudois
Verified postcode
Lausanne, Switzerland

Common questions

What is the EasyMove ankle replacement?

It's a type of artificial joint used to replace a damaged ankle, often due to severe arthritis or injury.

Will I get any special treatment in this study?

No, this study just observes how you get on with your EasyMove ankle replacement over time during your normal follow-up appointments.

How long will I be in the study?

The study will follow your progress for up to five years after your ankle replacement surgery.

Do I have to do extra visits for the study?

No, the study will collect information during your routine check-ups for your ankle replacement.

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.