Active not recruitingNAINTERVENTIONAL

Hospital-Based Cluster Trial: Magnetically Controlled Growing Rods Using Distraction Intervals

This research is about children aged 5 to 9 who have a condition called Early-Onset Scoliosis, where their spine curves significantly. They are being treated with special MAGEC® growing rods, which are adjusted without surgery using a magnet. The study wants to see if adjusting these rods more often (every 6 weeks) compared to less often (every 16 weeks) makes a difference to how their spine grows over three years. The goal is to find the best way to help these children's spines grow as well as possible, aiming to improve their long-term health and well-being. It's a hospital-based study carefully comparing these two approaches.

At a glance

Status

Active not recruiting

Phase

Sponsor

Pediatric Spine Foundation

Enrolment target

210

Start

01 Nov 2019

Estimated completion

31 Dec 2027

Early-Onset Scoliosis Deformity of Spine

What is this study about?

This study is looking into a condition called Early-Onset Scoliosis. This is when a child's spine develops a significant curve before they turn 10 years old. If the curve is severe, exceeding 50 degrees, children might need a special surgical treatment using something called MAGEC® growing rods.

These MAGEC® rods are different from older types of growing rods. Once they are put in place during surgery, they can be made longer over time without needing another operation. This is done using a special magnetic controller held outside the body. It's a quick and painless procedure usually done by the surgeon during a regular clinic visit, meaning children don't need to go into hospital and have an anaesthetic every time their rods are adjusted.

Researchers want to find out the best schedule for adjusting these rods. They are comparing two groups of children: one group will have their rods adjusted every 6 weeks, and the other group will have them adjusted every 16 weeks. The main aim is to see which schedule helps the spine grow better and more effectively over a three-year period. This research could help doctors decide on the best treatment plans for young children with severe scoliosis.

Key takeaways

A study for children with severe Early-Onset Scoliosis (aged 5-9).
Compares two schedules for adjusting MAGEC® growing rods: every 6 weeks vs. every 16 weeks.
Aims to find the best way to help children's spines grow over three years.
Adjustments are non-surgical and done in a clinic.
Your child's participation means careful monitoring of their spinal growth.

Who may be eligible?

To be considered for this study, children need to have a diagnosis of Early-Onset Scoliosis, which means their spinal curve started before they were 10 years old. They must be between 5 and 9 years old (this includes children who are 5, 6, 7, 8, or 9 years old). Also, their main spinal curve needs to be quite severe, more than 50 degrees, at the time they had their initial surgery to put in the MAGEC® rods. They must have had two MAGEC® growing rods implanted, not just one, and these rods can be attached to either the spine or the ribs. It's also okay if they had special traction treatment before or during their surgery.

Children will not be able to join the study if they have had any previous spinal surgery, including other types of treatments aimed at guiding spinal growth. Also, if a child or their family would find it too difficult to attend all the necessary appointments, perhaps because they live very far away, they wouldn't be able to participate. This is to make sure everyone in the study can complete all the required follow-ups.

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 5 and 9 years old?
Does my child have Early-Onset Scoliosis with a curve over 50 degrees?
Has my child had two MAGEC® growing rods implanted?
Has my child NOT had any previous spine surgery?
Can we comfortably attend all clinic appointments for three years?

Answer every question to see your result.

What does participation involve?

If your child takes part, they will already have had MAGEC® growing rods implanted. The main difference will be how often their rods are adjusted. Depending on which group they are in, they will either have their rods lengthened by the surgeon every 6 weeks or every 16 weeks during clinic visits. These adjustments are usually quick and don't require further surgery or anaesthetic. The study will last for three years, during which time doctors will regularly check your child's spinal growth and general health. There are no additional medications involved in this study.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that it might help doctors understand the best way to adjust MAGEC® rods, which could improve long-term outcomes for children with scoliosis. For your child, it means they will receive very close monitoring of their spinal growth. As with any medical procedure, there are always some risks involved, even with non-invasive adjustments. Your child's doctor or the study team will explain any specific risks in detail to you. Remember, you can withdraw your child from the study at any time, for any reason, without it affecting their ongoing care.

Locations (20)

Children's Hospital Los Angeles
Verified postcode
Los Angeles, United States
Rady Children's Hospital - San Diego
Verified postcode
San Diego, United States
Children's Hospital Colorado
Verified postcode
Aurora, United States
Alfred I. DuPont Hospital for Children
Verified postcode
Wilmington, United States
Children's National Health System
Verified postcode
Washington D.C., United States
University of Florida
Verified postcode
Gainesville, United States
Children's Physican Group Orthopaedics/Children's Healthcare of Atlanta
Verified postcode
Atlanta, United States
Johns Hopkins University
Verified postcode
Baltimore, United States
C.S. Mott Children's Hospital, University of Michigan
Verified postcode
Ann Arbor, United States
Washington University School of Medicine, St. Louis Children's Hospital
Verified postcode
St Louis, United States
Columbia University Medical Center
Verified postcode
New York, United States
Rainbow Babies and Children's Hospital
Verified postcode
Cleveland, United States

Common questions

What is Early-Onset Scoliosis?

It's a condition where a child develops a significant curve in their spine before their 10th birthday.

What are MAGEC® growing rods?

These are special rods put in during surgery that can be gradually lengthened over time using a magnetic device outside the body, without needing more surgery.

Will my child need more surgery if they join?

No, the rod adjustments themselves don't require surgery or anaesthetic; they're done in a clinic by the surgeon.

How long will the study last?

The study will actively follow children for three years to observe the effects of the different adjustment schedules.

What's the main thing the study is trying to find out?

It's trying to discover if adjusting the MAGEC® rods every 6 weeks versus every 16 weeks makes a difference to how a child's spine grows.