RecruitingPHASE2INTERVENTIONAL

Surgical Release of Hand Tendons with Wrapping of the Released Tendon Using an Amniotic Membrane

This study is investigating a new way to help people who have stiff hand tendons due to scarring, a condition called tendon adhesion. When these tendons are freed up in surgery, they sometimes get scarred again, limiting hand movement. Researchers are trying to find out if wrapping a special 'amniotic membrane' around the tendon after surgery can act as a barrier to stop this scarring from returning. The main goal is to see if this method can help people regain better use of their hand and prevent the need for further surgery. Participants will have surgery and then follow-up appointments over several months to check their progress.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

TBF Genie Tissulaire

Enrolment target

Start

15 Feb 2024

Estimated completion

01 Aug 2026

Tendon Adhesion Tenolysis

What is this study about?

Imagine your hand tendons as smooth ropes that help your fingers bend and straighten. Sometimes, after an injury or surgery, sticky scar tissue can form around these 'ropes,' making them unable to slide freely. This is called tendon adhesion, and it can make your hand feel stiff and difficult to move, even after a lot of physiotherapy.

Doctors can operate to free up these sticky tendons, a procedure known as tenolysis. However, sometimes the scar tissue can grow back, causing the problem to return. This study is exploring a new approach to try and prevent this from happening. Researchers are testing whether a special material, called an 'amniotic membrane,' can help. This membrane, which comes from the protective sac around a baby in the womb (donated after birth), is thought to have properties that can help prevent scar tissue from forming.

The idea is that during surgery, after the sticky scar tissue is removed, the doctor will wrap this thin membrane around the freed tendon. The main question this study hopes to answer is: can this membrane act like a protective shield, stopping new scar tissue from sticking to the tendon and helping you get back better hand movement without the stiffness returning? It's about finding a way to make the benefits of surgery last longer.

Key takeaways

This study is testing a new way to prevent scar tissue from reforming after hand tendon surgery.
It uses a special 'amniotic membrane' wrapped around the tendon to act as a barrier.
The goal is to improve hand movement and keep the stiffness from returning.
Participants will have surgery and follow-up checks over 6 months.
This is a Phase 2 study, meaning it's still in the earlier stages of research.
Your medical care will not be affected if you decide not to join, or to leave the study.

Who may be eligible?

To join this study, you generally need to be an adult between 18 and 65 years old who is experiencing stiffness in one of your hand fingers. This stiffness should be caused by scar tissue around a tendon, and it needs to have been present for at least three months, even after you've had good physical therapy after an earlier injury or surgery to that finger.

You should also be able to fully understand what the study involves and agree to take part. There are some situations where you wouldn't be able to join, such as if you are pregnant or breastfeeding, have certain complex hand injuries, or if there are other health conditions that would make it unsafe for you to have the surgery or follow the study plan. The study also needs you to be able to fully participate in rehabilitation.

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 65 years old?
Do you have a stiff finger due to scar tissue around a tendon?
Has this stiffness been present for at least 3 months, despite physio after an injury or surgery?
Are you able to understand the study and agree to take part?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have surgery on 'Day 0'. During this operation, the surgeon will free up the sticky tendon in your hand and then wrap the special amniotic membrane around it. After the surgery, you'll have specific follow-up appointments at the clinic. These visits will happen approximately 15 days, 6 weeks, 3 months, and 6 months after your surgery. During these visits, doctors and nurses will perform various tests to check how well your hand is recovering and how your movement is improving. The total duration of your active involvement in the study, including all follow-up visits, would be about six months after your surgery.

Potential risks and benefits

Participating in this study could potentially offer the benefit of reducing the chance of your tendon stiffness returning after surgery, leading to better long-term hand function. However, as with any surgery, there are always potential risks, such as infection, bleeding, or complications from the anaesthetic. There might also be unknown risks associated with using the amniotic membrane, although it's a material that has been used safely in other medical procedures. You will receive very thorough information about all known risks before you decide to join. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Institut Chirurgical de la Main et du Membre Supérieur
Verified postcode
Lyon, France· Recruiting

Common questions

What is an amniotic membrane?

It's a thin, protective layer from the sac around a baby in the womb, often donated after birth. It's used in medicine because it can help reduce scarring and inflammation.

What does 'tendon adhesion' mean?

It means scar tissue has formed around a tendon, making it stick to nearby tissues. This stops the tendon from moving smoothly and can make your hand stiff.

What is tenolysis?

Tenolysis is a surgical procedure where doctors remove the scar tissue that has built up around a tendon to help it move freely again.

Will I still need physiotherapy after the surgery?

Yes, rehabilitation and physiotherapy are a very important part of recovery after tendon surgery, even if you are in this study. It helps improve hand movement.

What if I decide I don't want to be in the study anymore?

You are free to leave the study at any time, for any reason, without having to explain. Your decision will not affect your medical care.

How to find out more

Justine BOSC, MSc

justine.bosc@tbf-lab.com 4 72 68 69 11 Official trial record

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