RecruitingNAINTERVENTIONAL

LIVing Donor Allograft for Anterior Cruciate Ligament Reconstruction Study

This study explores a new approach for fixing a common knee injury, an Anterior Cruciate Ligament (ACL) tear, in young people aged 8 to 17. When a child tears their ACL, it's often tricky to find the best material for repair because their own tendons are smaller. This trial uses a technique where a parent (usually) donates a small piece of their hamstring tendon to be used in the child's knee surgery. The goal is to provide a strong graft for the child's knee without using their own smaller tendons, which could make recovery smoother and prevent re-injury. The study will follow patients closely to see how well this method works.

At a glance

Status

Recruiting

Phase

Sponsor

Maidstone & Tunbridge Wells NHS Trust

Enrolment target

Start

15 Sep 2021

Estimated completion

01 Sep 2028

ACL

What is this study about?

An ACL tear is a common knee injury, especially in active young people. The ACL is a strong band of tissue that helps keep your knee stable. When it tears, your knee can feel wobbly and unstable. For children and teenagers, doctors often recommend surgery to fix the ACL, as it helps them get back to their activities and prevents further damage to the knee.

The challenge with repairing an ACL in a young person is that their bodies are still growing. Their own tendons, which are often used for this surgery in adults, might be too small or could affect their growth. While tendons from deceased donors can be used, they sometimes don't hold up as well. This is why doctors are always looking for better ways to do these repairs in young patients.

This study is looking into a different option: using a piece of tendon from a living donor, usually a parent. In this procedure, a small part of a parent's hamstring tendon is carefully removed and used to repair their child's ACL. The idea is that the parent's tendon will be a good size for the child and will be very healthy as it comes directly from a living person. This method also means the child's own tendons are left untouched. Researchers want to find out how effective and safe this technique is for children and teenagers with ACL tears.

Key takeaways

A new way to fix ACL tears in children (8-17 years old).
Uses a small piece of a parent's hamstring tendon to repair the child's knee.
Aims to provide a strong graft while avoiding the use of the child's own smaller tendons.
Both the child and parent will undergo surgery on the same day.
Regular follow-up appointments are required to monitor recovery.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, the patient must be between 8 and 17 years old and have a confirmed ACL tear that needs surgery. It's also important that both the child and their parent agree to this specific type of surgery where the parent donates a tendon. If the child has had previous knee problems, like meniscus surgery, they might still be able to join.

For the parent who might donate, they must not have had hamstring surgery on the leg they would donate from. They also need to be in good health for a minor operation under general anaesthetic, and pass some screening tests to make sure there are no risks of passing on infections.

However, some people won't be able to join. This includes children who have already had ACL surgery on the same knee, or anyone with a weakened immune system. Also, if either the child or parent can't commit to all the follow-up appointments, or if screening tests show any potential health concerns for the donor, they wouldn't be able to take part.

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.

Is your child aged between 8 and 17 years old?
Does your child have a confirmed ACL tear that needs surgery?
Are both you and your child happy for a parent to donate a tendon?
Has the donating parent NOT had hamstring surgery on the leg they would donate from?
Is the donating parent generally healthy for a small operation?
Can you commit to all planned follow-up appointments?

Answer every question to see your result.

What does participation involve?

If you and your child decide to take part, you'll first have a meeting with the study team to go through all the details and make sure you understand everything. If you both agree, some screening tests will be done. For the surgery itself, both the child and the parent will have an operation on the same day. The parent will have a small procedure to remove a piece of their hamstring tendon, and then the child will have their ACL reconstructed using that tendon.

After the surgery, there will be a series of follow-up appointments. These are important for the doctors to check how well the knee is healing and how the child is recovering. During these visits, there will be physical examinations, the child might need to fill in questionnaires about their knee, and special tests might be done to check the strength and stability of the knee. The total duration of follow-up is not specified but will be explained in detail by the study team.

Potential risks and benefits

Taking part in this study could offer the benefit of a healthy, appropriately sized tendon for the child's ACL repair, potentially leading to a good recovery without using the child's own smaller tendons. However, like any surgery, there are risks involved for both the child and the parent, such as infection, pain, or problems with healing. The parent donating the tendon will experience some temporary pain and weakness in their hamstring. 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.

Trauma & Orthopaedic Dept, Tunbridge Wells Hospital
Verified postcode
Pembury, United Kingdom· Recruiting

Common questions

What is an ACL tear?

An ACL tear is an injury to a key ligament in your knee that helps keep it stable. When it tears, your knee can feel unstable and wobbly.

Why is this surgery different for children?

Children are still growing, so using their own tendons can be tricky. This study uses a parent's tendon, which is usually larger and leaves the child's own tendons untouched.

Will the parent be okay after donating a tendon?

Yes, parents typically recover well. The surgery to remove the tendon is small, and the body usually adjusts to the removed portion with time and physiotherapy.

What happens if we decide not to join the study?

Your child will still receive the best standard care for their ACL injury. Deciding not to join will not affect their medical treatment in any way.

How long will the recovery take for the child?

Recovery from ACL surgery generally involves physiotherapy and takes several months to a year. The study team will provide a detailed recovery plan.

How to find out more

Helen Sankey, MSc

h.sankey@nhs.net 01892 635488 Official trial record

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