Active not recruitingNAINTERVENTIONAL

Clinical Assessment of a Motorized Spinal Distraction Rod in the Severe to Early Scoliosis Child

This study is looking at a new treatment for children aged 4 to 10 years who have severe scoliosis, a condition where the spine curves. The treatment uses a special motorized rod, called ASTS, which is placed inside the body. The aim is to see if this new device can help correct the spinal curve and allow the child's spine to grow gradually. Researchers hope this new rod will be comfortable for children and lead to fewer problems compared to current treatments, which often require many operations. They want to find out if it's a good and safe way to treat young children with this condition.

At a glance

Status

Active not recruiting

Phase

Sponsor

University Hospital, Toulouse

Enrolment target

Start

05 Feb 2019

Estimated completion

01 Dec 2025

Scoliosis

What is this study about?

Scoliosis is a condition where a child's spine develops a curve. When this happens at a very young age (before 3 years old) or is very severe, it's called early-onset scoliosis. This type of scoliosis can become more severe over time and can sometimes affect a child's breathing and heart.

Currently, if braces or casts don't work, surgery is an option. This usually involves placing rods along the spine to straighten it during an operation. However, as the child grows, they need more operations every six months to make the rods longer. These repeated surgeries can lead to problems like infections or the rods breaking, which means children have to go through surgery many times.

This study is testing a new type of rod called ASTS (Active Scoliosis Treatment System). It's a completely internal, motorized rod that doctors hope can be lengthened from outside the body without needing repeat surgeries. The main idea is that this new rod could help correct the spinal curve and allow the child's spine to lengthen as they grow, making them more comfortable and reducing the serious problems that come with many operations.

Key takeaways

Tests a new motorized growing rod for severe scoliosis in children.
Aims to reduce the number of surgeries children need.
May offer a more comfortable and less complicated treatment option.
For children aged 4 to 10 who haven't responded to other treatments.
Regular checks will be part of the study.
Your child's comfort and safety are priorities.

Who may be eligible?

To be considered for this study, children need to be between 4 and 10 years old and weigh between 15kg (about 33 pounds) and 50kg (about 110 pounds). They must have severe scoliosis that started early in life, and other treatments like casts or braces must not have worked for them, or they can't use them.

It's also essential that the child's parents or legal guardians give their written permission for the child to take part. The child also needs to agree, at least by saying yes, to participate.

Children cannot join the study if they have any other health conditions that would make surgery unsafe, or if they are younger than 4 or older than 10, or if their weight is outside the 15kg to 50kg range.

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 my child between 4 and 10 years old?
Does my child weigh between 15kg and 50kg?
Does my child have severe scoliosis that started early?
Have other treatments (like braces) not worked for my child?
Are we, as parents/guardians, willing to give written permission?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will have an operation to place the new motorized rod inside their back. After the surgery, the doctors will regularly check the rod and your child's spine. Instead of needing another operation every six months to lengthen the rod, this new device aims to be lengthened without further surgery. The study involves regular check-ups to monitor your child's progress, comfort, and any potential problems. The total duration of participation will depend on your child's growth and when they reach skeletal maturity.

Potential risks and benefits

Potential benefits of taking part could include a new way to treat severe scoliosis that might lead to fewer operations and reduce complications compared to current methods. However, as with any surgery, there are potential risks, including infection, pain, and issues with the implant. It's important to remember that you and your child have the right to withdraw from the study at any time, for any reason, without it affecting your child's future medical care.

Locations (1)

CHU de Toulouse
Verified postcode
Toulouse, France

Common questions

What is scoliosis?

Scoliosis is when a child's spine curves to the side, rather than being straight.

What is a 'growing rod'?

A 'growing rod' is a device surgically placed in the back to help straighten the spine and allow it to lengthen as a child grows.

How is this new rod different?

This new rod is motorized and can be lengthened without needing repeated surgeries, unlike traditional growing rods.

What does 'early-onset' mean?

Early-onset scoliosis means the spinal curving started when the child was very young, typically before age 10.

Will my child still need surgery?

Yes, an initial surgery is needed to implant the motorized rod.

How to find out more

Official trial record

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