RecruitingPHASE3INTERVENTIONAL

Meniscal INfiltration of Corticosteroid Guided With Ultra Sonography

This study, called "Meniscal INfiltration of Corticosteroid Guided With Ultra Sonography," is a Phase 3 trial aimed at understanding if a steroid injection can help with knee pain caused by a meniscus lesion. Many people experience this type of knee pain, and finding effective treatments is important. Researchers are injecting either betamethasone, a common steroid, or a saltwater solution (placebo) into the affected area of the knee, using an ultrasound machine to make sure the injection goes to the right spot. The main goal is to see if the steroid injection reduces pain more effectively than the placebo after one month. This research hopes to provide clearer evidence on whether this specific treatment is a good option for degenerative meniscal pain.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University Hospital, Toulouse

Enrolment target

152

Start

06 Mar 2025

Estimated completion

01 Jun 2028

Meniscus Lesion

What is this study about?

Knee pain is a very common problem, and often it's due to an issue with something called the meniscus. The meniscus is a C-shaped piece of cartilage that acts like a shock absorber in your knee. When it gets damaged, especially as we get older, it can cause pain and discomfort. Doctors often try different treatments before suggesting surgery, such as exercises, pain relief tablets, or injections directly into the knee joint.

One type of injection involves corticosteroids, which are strong anti-inflammatory medicines. This study specifically looks at injecting a steroid called betamethasone into the 'meniscal wall' – a particular part of the meniscus – using ultrasound guidance. Ultrasound helps the doctor see inside your knee to make sure the injection goes to exactly the right place. However, current evidence on how well these specific types of injections work for meniscus pain isn't very strong, and that's why this study is so important.

The main goal of this research is to compare the betamethasone injection to a 'placebo' injection. A placebo is often an inactive substance like saltwater, given in the same way as the real treatment. By comparing the two, researchers can clearly see if the betamethasone injection itself is effective at reducing pain from degenerative meniscus problems after one month. This study aims to provide clear, reliable answers to help doctors make the best treatment choices for patients in the future.

Key takeaways

This study investigates a steroid injection for knee pain caused by a meniscus problem.
It's a 'Phase 3' trial, meaning it's a key stage of testing for new treatments.
The injection is guided by ultrasound to ensure accuracy.
You might receive a steroid or an inactive saltwater (placebo) injection.
The main goal is to see if the steroid reduces pain after one month.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would typically need to have knee pain that doctors think is caused by a degenerative meniscus problem. This pain should also be causing you discomfort even after trying some basic pain relief like mild painkillers. You would also need to have had an MRI scan of your knee recently (within the last 6 months) that shows a specific type of meniscus lesion, and your doctor would need to confirm that this lesion matches your pain.

There are also some reasons why you might not be able to join. For example, if your MRI scan shows a very unstable or severe meniscus tear, or if you've had a recent severe knee injury, or knee surgery on that knee in the past. You also wouldn't be able to join if you've had a steroid injection in that knee in the last three months, or if you're pregnant or breastfeeding. Some other medical conditions or if you're taking certain medications might also mean you can't take part. The research team will carefully check all these details with 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.

Do you have knee pain that comes from a meniscus problem?
Has your knee pain persisted despite trying mild painkillers?
Have you had an MRI scan of your knee in the last 6 months?
Have you NOT had a steroid injection in that knee in the last 3 months?
Are you NOT pregnant or breastfeeding?
Are you able to provide your free and informed consent?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your first step will be a phone call at least a week before your initial visit to the clinic. On the day of your first clinic visit, after discussing everything and if you still want to participate, you'll be randomly assigned to receive either the betamethasone injection or the placebo injection. Neither you nor the doctors assessing your pain will know which one you receive, though the doctor giving the injection will know. The injection will be given using ultrasound to guide it precisely into your knee.

After the injection, the study team will follow up with you to check on your knee pain, particularly after one month, to see how well the treatment worked for you. They will use specific pain scores to measure this. The study involves a few visits for assessments and the injection itself, and then follow-up appointments or calls over a specific period, but the total duration of your participation isn't specified in detail here. You will need to avoid certain painkillers for 48 hours before the injection.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as receiving a new treatment that could help your condition or getting additional medical monitoring. However, there's always a chance you might receive the placebo and not the active drug, or that the treatment won't work for you. There are also potential risks with any injection, such as pain, swelling, or infection at the injection site, though these are usually minor. The steroids themselves can have side effects, though injections target a specific area to minimise these. Your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

UHToulouse
Verified postcode
Toulouse, France· Recruiting

Common questions

What is a meniscus lesion?

A meniscus lesion is damage to one of the C-shaped cartilage pads in your knee, often causing pain and sometimes swelling or clicking.

What is betamethasone?

Betamethasone is a type of steroid medicine that helps to reduce inflammation and pain.

What is a 'placebo' injection?

A placebo injection for this study would be an inactive solution, like sterile saltwater, given in the same way as the real treatment to compare its effects.

Why is ultrasound used for the injection?

Ultrasound helps the doctor see exactly where to put the needle, making sure the medicine goes to the right spot in your knee.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor the doctors assessing your pain will know. This is called 'double-blind' and helps ensure the results are accurate.

How to find out more

Marie FARUCH, MD

faruch.m@chu-toulouse.fr 05 61 77 22 97 Official trial record

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