Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Effect of botulinum toxin on hamstring contracture and the occurrence of cyclops syndrome following anterior cruciate ligament reconstruction

This clinical trial is exploring if a special injection, similar to Botox, given into the hamstring muscle can stop a rare but troublesome issue called 'Cyclops syndrome' from developing after knee surgery. Cyclops syndrome sometimes occurs after an Anterior Cruciate Ligament (ACL) reconstruction, which is an operation to fix a major knee ligament. It involves scar tissue forming inside the knee joint, making it difficult to fully straighten the knee. The study aims to see if relaxing the hamstring muscle, which helps bend the knee, might reduce the chance of this scar tissue forming. This is a Phase II study, meaning it's an early-stage investigation to see if the treatment works and is safe.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Ramsay Generale De Sante, Groupement de Coopération Sanitaire Ramsay Santé pour l’Enseignement et la Recherche

Enrolment target

132

Start

16 May 2024

Cyclops syndrome

What is this study about?

Imagine you've had an operation to fix a major ligament in your knee, called the Anterior Cruciate Ligament (ACL). This surgery helps stabilise your knee, especially if you're active. Sometimes, after this type of operation, a problem called 'Cyclops syndrome' can happen. It's when a small lump of scar tissue forms inside your knee joint, which can stop you from fully straightening your leg. This can be quite frustrating and may even require further treatment.

This study is looking into a new way to try and prevent Cyclops syndrome. Researchers are investigating whether injecting a muscle-relaxing medicine, similar to Botox, into your hamstring muscle (the large muscle at the back of your thigh) might help. The idea is that if the hamstring muscle is relaxed, it might reduce the tension around your knee joint, potentially making it less likely for that particular scar tissue to form. It’s an early-stage study to see if this idea works and if it's a safe approach.

By finding new ways to prevent complications like Cyclops syndrome, doctors hope to improve recovery for people who have ACL surgery, making it easier and quicker for them to get back to their normal activities. This research is important because it could lead to better outcomes for patients in the future.

Key takeaways

This study explores an injection to prevent scar tissue in the knee after ACL surgery.
The scar tissue, called Cyclops syndrome, can make it hard to straighten your knee.
The injection aims to relax hamstring muscles, which might reduce scar tissue formation.
This is an early-stage study (Phase II) to check effectiveness and safety.
Anyone aged 18 or over having ACL surgery might be eligible.
Participation involves clinic visits, injections, and regular health checks.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. Both men and women can potentially take part. The study is specifically for people who are having, or have recently had, an Anterior Cruciate Ligament (ACL) reconstruction surgery.

Crucially, you would be included if you are at risk of developing Cyclops syndrome or if the researchers believe this treatment might be helpful for your specific situation after ACL surgery. There will be other specific health requirements that the study doctors will check to make sure the study is safe for you.

The study team will carefully review your medical history and current health to determine if this trial is the right fit. It's important to discuss any health conditions you have with them.

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?
Are you having or have you recently had ACL reconstruction surgery?
Do you understand this is for preventing a problem called Cyclops syndrome?
Are you comfortable with receiving injections?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would have a series of visits to the clinic. During these visits, the study team would give you the special injection into your hamstring muscle. They would also carry out various checks and assessments, such as examining your knee, asking about your pain levels and how well you can move your leg, and possibly doing scans or other tests to see how your knee is healing and whether Cyclops syndrome is developing. You would also need to attend follow-up appointments over a period of time to monitor your progress and look for any side effects. The total duration of your participation in the study, including all treatments and follow-up checks, would be explained to you by the study team.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as contributing to scientific knowledge and potentially helping to prevent Cyclops syndrome in your knee. However, there are also potential risks involved, similar to any medical treatment. The most common might include temporary pain or bruising at the injection site, or other side effects related to the muscle-relaxing medicine. The study team will explain all known side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is ACL reconstruction?

It's an operation to fix a major knee ligament called the Anterior Cruciate Ligament, often done after a sports injury, to make the knee stable again.

What is Cyclops syndrome?

It's a complication after ACL surgery where scar tissue forms in the knee, making it hard to fully straighten your leg.

What kind of injection is being used?

It's a muscle-relaxing injection, similar to Botox, given into the hamstring muscle at the back of your thigh.

Is this a new medicine?

The medicine used (botulinum toxin) isn't new, but using it in this way to prevent Cyclops syndrome is what's being studied.

What does Phase II mean?

Phase II means it's an early-stage study to see if the treatment works for this condition and is safe, before it's tested on a larger group of people.