Active not recruitingNAINTERVENTIONAL

Efficacy of Additional Osteotomies to Correct Hallux Valgus

This study is about improving surgery for bunions, also known as hallux valgus. A bunion is when your big toe leans inwards towards your other toes, often causing pain and making it hard to wear shoes. There's a common surgery that corrects this, but sometimes the bunion can return. This study is exploring whether making additional, very small cuts in the bone during this standard operation could help prevent the bunion from coming back. These extra cuts aim to correct the big toe's position more completely. Researchers want to see if these modified surgeries reduce the chance of the bunion returning six months after the operation, hoping to improve long-term success for patients.

At a glance

Status

Active not recruiting

Phase

Sponsor

Elsan

Enrolment target

515

Start

11 Sep 2019

Estimated completion

11 Sep 2026

Hallux Valgus

What is this study about?

This study aims to refine how we treat bunions, medically known as hallux valgus. A bunion happens when your big toe drifts towards your other toes, often causing discomfort, pain, and difficulty finding comfortable shoes. When the pain is significant, surgery is often considered. One common surgical method already helps to straighten the toe, but sometimes, after surgery, the bunion can start to come back again.

Surgeons are now looking at different ways to improve this standard surgery. They're investigating if adding very small, precise bone cuts, called osteotomies, during the existing operation can make the correction more stable. These extra cuts are designed to address the way the toe might be twisting or leaning, which isn't fully corrected by the current common procedure. The goal is to see if these additional steps can reduce the chances of the bunion returning.

The researchers believe that by making these extra adjustments, the big toe will be better aligned and more likely to stay in its corrected position over time. They will follow patients for six months after surgery to see if these new approaches are more effective at preventing the bunion from recurring.

Key takeaways

The study aims to improve bunion surgery.
It tests if extra bone cuts can prevent bunions from returning.
The goal is a more stable and lasting correction.
Participants will have surgery and follow-up for six months.
It's for adults over 18 with bunions, without certain other foot conditions.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and agree to take part after understanding all the information provided. It's important that you don't have certain other health conditions.

You wouldn't be able to join if you need surgery on your smaller toes, or if you require any other operations on your midfoot, hindfoot, or ankle at the same time. Also, if you have specific nerve-related conditions like Charcot Marie Tooth disease, or severe arthritis in your big toe joint, this study might not be suitable for you.

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?
Do you have a bunion (Hallux Valgus) that might need surgery?
Do you *not* need surgery on your other smaller toes or elsewhere in your foot/ankle at the same time?
Do you *not* have specific nerve conditions or severe arthritis in your big toe?

Answer every question to see your result.

What does participation involve?

If you decide to participate in this study, the main part will be undergoing the bunion surgery. Instead of the standard procedure, your surgeon may use one of the modified techniques being tested, which involves making small, additional cuts in the bone during your operation. You would have follow-up appointments where doctors would check your recovery and the position of your toe, likely involving X-rays. The study aims to follow your progress for six months after the surgery to see how well the bunion has been corrected and if it has stayed corrected. The exact number of visits and tests would be explained in detail before you agree to take part.

Potential risks and benefits

Taking part in this study could potentially offer a benefit if the new surgical techniques prove to be more effective at preventing bunions from returning, leading to a better long-term outcome for you. However, as with any surgery, there are potential risks, including infection, pain, or problems with healing. Adding extra steps to the surgery might introduce very slightly different risks compared to the standard procedure, which will be fully explained. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

Clinique Lille sud
Verified postcode
Lesquin, France
Clinique du Parc Lyon
Verified postcode
Lyon, France
Clinique Mégival
Verified postcode
Saint-Aubin-sur-Scie, France
Clinique de l'Union
Verified postcode
Saint-Jean, France

Common questions

What is Hallux Valgus?

Hallux Valgus is the medical term for a bunion, which is when your big toe leans towards your other toes, often causing a bony bump on the side of your foot.

What are 'osteotomies'?

Osteotomies are small, precise surgical cuts made in a bone. In this study, they are trying different types of these cuts to help fix the bunion more effectively.

Why is this study needed?

Even after common bunion surgery, the bunion can sometimes come back. This study is looking for ways to improve the surgery so the correction lasts longer.

Will I know which type of surgery I'm getting?

Your medical team will explain the different surgical options and how they are studying them before you agree to participate.

How long will I be involved in the study?

The study will follow your recovery and the status of your bunion for six months after your surgery.