RecruitingNAINTERVENTIONAL

Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes With Lync

This research is investigating a new medical device, called Lync, designed to treat arthritis in the toes and fix crooked toe bones, like hammer, mallet, or claw toes. The main goal is to see if the Lync device can improve how your foot works after the operation, specifically 3 to 4 months later. Researchers will also check if it reduces pain, helps bones heal properly, and is safe to use by looking for any problems or side effects. This study aims to gather important information to confirm the benefits and safety of this new treatment option for toe conditions.

At a glance

Status

Recruiting

Phase

Sponsor

Novastep

Enrolment target

Start

04 Nov 2024

Estimated completion

01 May 2027

Arthritis Foot Bone Alignment Defaults

What is this study about?

This study is looking into a new treatment called the Lync device for common toe problems. Many people experience arthritis in their toes, which can cause pain and stiffness. Some also have toes that are bent or crooked, often called mallet, claw, or hammer toes. These conditions can make it hard to walk or wear shoes comfortably.

The Lync device is designed to be placed inside the toe to help correct its alignment and support healing. The researchers want to find out if this device really helps improve how your foot works, reduces pain, and fixes the bone alignment. They will carefully follow people who have the device implanted and check on their progress over several months. This is important to make sure new treatments are effective and safe for patients.

By doing this study, the doctors want to gather strong evidence about the Lync device. They're hoping to confirm that it offers a good and safe solution for individuals suffering from toe arthritis and misaligned toes. The results will help doctors understand if this is a good new option for people needing surgery for these conditions.

Key takeaways

This study is testing a new device called Lync for toe arthritis and crooked toes.
It aims to see if the Lync device improves foot function and reduces pain.
Participation involves surgery to implant the device and follow-up visits for several months.
Strict safety checks are in place, and doctors will monitor your healing and any side effects.
The study helps gather important information for future patient treatments.

Who may be eligible?

To join this study, you need to be an adult who has arthritis in your toes or crooked toe bones (like mallet, claw, or hammer toes) that require treatment. You must be having the Lync device implanted for your toe surgery. It's important that you are able to follow your surgeon's instructions and understand the study information.

There are certain situations where you wouldn't be able to join. For example, if you have a medical reason that makes the Lync device unsuitable for you, or if you're already taking part in another medical study. Also, if you are pregnant, breastfeeding, under legal protection (like guardianship), or in prison, you unfortunately cannot participate.

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 an adult aged 18 or over?
Do you have arthritis or bent bones in your toes that need treatment?
Will you be having the Lync device implanted as part of your toe surgery?
Are you able to understand study information and follow doctor's instructions?
Are you not pregnant or breastfeeding, and not already in another medical study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will have the Lync device implanted during your toe surgery. After your operation, the study team will ask you to come back for follow-up visits, usually around 3 to 4 months later, and potentially at 6 months if needed. During these visits, they will check how your foot is healing, ask about any pain, and take X-rays to see if your bones have mended well. You'll also be asked about how well you can use your foot and if you've experienced any problems. The total time you'd be involved in the study would be at least 3-4 months, possibly 6 months.

Potential risks and benefits

Taking part in any study has potential benefits and risks. The main benefit here is the possibility of receiving a new treatment that might improve your toe symptoms and how your foot works. However, as with any surgery, there are risks, such as infection or issues with healing. You will be closely monitored for any problems. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

Clinique Saint-Charles
Verified postcode
Lyon, France· Recruiting
Polyclinique du Val de Saône
Verified postcode
Mâcon, France· Recruiting
Centre Chirurgical ADR
Verified postcode
Nancy, France· Not yet recruiting
Clinique Mutualiste Catalane
Verified postcode
Perpignan, France· Recruiting
Polyclinique Lyon Nord
Verified postcode
Rillieux-la-Pape, France· Recruiting

Common questions

What is the Lync device?

It's a medical device designed to be placed inside your toe during surgery to help treat arthritis and correct bent toe bones.

What kind of toe problems is this study for?

It's for people with arthritis in their toes or those with crooked toe bones, such as mallet, claw, or hammer toes.

How long will I be in the study?

You'll be followed for at least 3 to 4 months after your surgery, and possibly up to 6 months.

Will I need extra appointments?

Yes, you will have follow-up visits after your surgery to check on your progress and take X-rays.

Can I leave the study if I change my mind?

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

How to find out more

Manon GUIGUEN

manon.guiguen@novastep-ortho.com +33 (0) 2 59 58 31 68 Official trial record

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