RecruitingNAINTERVENTIONAL

ALL Reconstruction Versus Modified Lemaire's LET in Combination With ACL Reconstruction With a Minimum Follow up of 2 Years

People who tear their ACL often have problems with another part of the knee called the anterolateral ligament (ALL). This can make the knee unstable and increase the risk of needing more surgery or damaging the knee further. Doctors use different surgical techniques to fix the ALL alongside ACL reconstruction. This study compares two common surgical procedures: the Lemaire technique and the ALL plasty. Both aim to stabilise the knee. Researchers are looking to see which of these two operations helps the knee recover better and for longer, over at least two years. They want to find out if one technique is superior in preventing future problems and improving a patient's knee function.

At a glance

Status

Recruiting

Phase

Sponsor

Hospices Civils de Lyon

Enrolment target

248

Start

16 Jan 2024

Estimated completion

16 Jan 2029

Anterior Cruciate Ligament Injuries

What is this study about?

When you injure your anterior cruciate ligament (ACL) in your knee, it can sometimes also affect another important structure called the anterolateral ligament (ALL). If the ALL is also damaged and not properly treated, your knee might feel unstable, like it's giving way. This instability could even lead to re-injuring your ACL or causing further damage to other parts of your knee in the future.

Surgeons perform an ACL reconstruction to help stabilise the knee. However, to address the ALL problem, they might also perform an additional procedure. Currently, there are two main techniques for this extra step: the Lemaire procedure and the ALL plasty. The Lemaire procedure has been around for some time and has a good track record. The ALL plasty is a newer technique that aims to reconstruct the ALL in a way that's closer to your natural anatomy, but we don't yet know if it's clinically better than the Lemaire technique.

Because both techniques are currently used, and doctors don't know for sure which one is best in the long term, this study aims to compare them. The main goal is to see which approach results in a more stable knee and prevents future problems for at least two years after the surgery. They will also look at how well patients can use their knee and how it affects their daily life after each procedure.

Key takeaways

Compares two surgical methods for knee stability after ACL reconstruction.
Aims to find out which procedure works best long-term.
Specifically for people aged 18-50 with unstable knees.
Involves surgery and at least two years of follow-up.
Could help improve future knee treatment for ACL injuries.

Who may be eligible?

This study is looking for men and women between the ages of 18 and 50 who have an ACL injury that makes their knee feel unstable. To be considered, your knee must feel chronically loose or 'give way' and show signs of rotational instability when a doctor examines it. This often applies to people who play sports that involve pivoting, like football or basketball.

You would also need to be willing to sign a consent form, which explains the study in detail and confirms you understand what's involved.

You would not be able to join the study if you need any other major knee surgery at the same time, apart from simple meniscus trimming or repair. This includes operations like bone realignment (osteotomy) or a meniscus transplant. You also can't take part if you are pregnant, or if you are in prison or under legal guardianship.

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 between 18 and 50 years old?
Does your knee feel unstable or 'give way' because of an ACL injury?
Do you play sports that involve twisting or pivoting?
Are you able to sign a consent form to participate?
Are you not pregnant and not undergoing other major knee surgeries?
Are you not in prison or under legal guardianship?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will undergo an ACL reconstruction surgery along with an additional procedure to stabilise your knee (either the Lemaire technique or the ALL plasty). The choice of which additional procedure you receive will be decided by your surgeon. After your surgery, you will have regular check-ups and assessments over at least a two-year period to monitor your knee's recovery and stability. These follow-up appointments will involve physical examinations and potentially other tests to see how well your knee is functioning and to check for any issues. The total duration of your participation in the study from your surgery to your final follow-up will be a minimum of two years.

Potential risks and benefits

Taking part in this study could potentially benefit you by helping to ensure your knee is as stable as possible after your ACL reconstruction. You would receive one of two established surgical procedures aimed at improving your knee's long-term function and reducing the risk of further injury. As with any surgery, there are risks, including those associated with anaesthesia, infection, bleeding, and potential complications from the surgery itself. There's also the chance that the surgery might not fully resolve your knee instability. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Service de chirurgie orthopédique et de médecine du sport
Verified postcode
Lyon, France· Recruiting

Common questions

What is an ACL injury?

An ACL injury is a tear or sprain of the anterior cruciate ligament, one of the main ligaments in your knee that helps keep it stable.

What does 'rotatory instability' mean?

It means your knee feels like it twists or gives way unexpectedly, especially with activities that involve turning or pivoting.

What's the difference between the two surgical techniques?

Both the Lemaire technique and ALL plasty are designed to add stability to the outside of your knee. The Lemaire uses a strip of tissue from your thigh, while the ALL plasty uses a small piece of one of your hamstring tendons. Doctors are trying to find out if one works better.

Will I know which technique I'm getting?

The choice between the two techniques will be decided by your surgeon based on what they think is best for you, as both are standard approaches.

How long will I be followed up after the surgery?

You will be followed up for at least two years after your surgery to check on your knee's recovery and stability.

How to find out more

Elvire SERVIEN, MD

elvire.servien@chu-lyon.fr 4 26 10 92 98 Official trial record

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