RecruitingOBSERVATIONAL

Assessment and Follow-up of Surgical Treatment of Hemivertebra in Children

This study aims to understand and improve surgery for children aged 3 to 10 who have a spinal condition called hemivertebra. This condition means one of their spinal bones hasn't formed completely, leading to a curved spine. Doctors want to see how effective these complex surgeries are in correcting the curve, and if the correction lasts as the child grows. They'll also be looking at any immediate problems that might happen during or after surgery. Because these operations are major, the study wants to check on the children's health, how their spines continue to develop, and how well the surgery holds up over many years. This research helps improve care for children needing this specific type of spinal surgery.

At a glance

Status

Recruiting

Sponsor

University Hospital, Tours

Enrolment target

150

Start

04 Feb 2019

Estimated completion

01 Feb 2039

Hemivertebra

What is this study about?

This research is all about helping children who have a spinal problem called hemivertebra. Imagine your spine as a stack of building blocks; in hemivertebra, one of these blocks (a vertebra) isn't fully formed. This can make the spine grow in a curve. While there have been many advances in treating these conditions, the surgery to fix a hemivertebra is often quite complex and can involve major operations.

Doctors want to take a closer look at these surgeries. They need to understand exactly how well they work the first time, what kind of early problems might come up, and how a child's spine continues to grow and change for many years after the operation. This isn't just about making the spine straight; it's about making sure that the correction lasts as the child gets older and that they have the best possible outcome.

The study will collect information on children who have had or will have this specific type of surgery. By carefully tracking their progress, including how the spine corrects and whether any curves come back or get worse, doctors can learn how to make these treatments even better in the future. This kind of research is vital for improving the care of children with spinal malformations, helping them lead healthier lives.

Key takeaways

This study looks at surgery for spinal problems in children aged 3-10.
It aims to understand how well current hemivertebra surgeries work and if corrections last.
No new treatments or procedures are given as part of this research.
Information will be collected from your child's usual doctor appointments.
Parental consent is essential for a child to be part of the study.
Understanding the surgery's long-term effects can improve care for other children.

Who may be eligible?

To be considered for this study, a child must be between 3 and 10 years old. They must also have a specific type of spinal problem called hemivertebra that their doctor believes needs surgery.

There are some reasons why a child might not be able to join. For example, if they have already had surgery on their spine before, this study might not be suitable. Also, if the planned surgery for their hemivertebra is a different type than what the study is focusing on, they wouldn't be able to take part.

Finally, if a child's family isn't able to attend regular follow-up appointments, or if parents prefer not to have their child's medical information used for research, then that child would not be included in the study.

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 between 3 and 10 years old?
Has your child been diagnosed with hemivertebra?
Is your child scheduled for (or has recently had) hemivertebra surgery?
Has your child NOT had spine surgery before for other reasons?
Are you able to attend regular follow-up appointments for your child's spine post-surgery?

Answer every question to see your result.

What does participation involve?

This study focuses on children who are having or have had surgery for hemivertebra. You wouldn't be given any new treatments or medications specifically for the study. Instead, the doctors will be closely observing the child's progress and collecting information from their regular medical appointments and scans that would happen anyway as part of their standard care. This often includes looking at things like how their spine is healing and growing, and checking for any changes over time.

The study would involve doctors using information from your child's routine follow-up visits, which happen periodically after spinal surgery to check on their recovery and how their spine is developing. The overall length of time your child's data might be followed in the study would depend on how long their doctors usually recommend follow-up after this type of surgery to monitor their growth and spine correction.

Potential risks and benefits

Taking part in this study means your child's medical information from their standard care will help doctors learn more about hemivertebra surgery, potentially leading to better treatments for other children in the future. There are no new medical procedures or risks specifically from being in the study itself, as it mainly observes routine care. However, it's important to remember that the surgery for hemivertebra does carry its own risks, which your medical team will discuss with you. You are completely free to withdraw your child's information from the study at any time without affecting their medical care.

Locations (13)

Pediatric Surgery Service, University Hospital, Bordeaux
Verified postcode
Bordeaux, France· Recruiting
Pediatric Surgery Service, University Hospital, Grenoble
Verified postcode
Grenoble, France· Not yet recruiting
Pediatric Surgery Service, University Hospital, Lyon
Verified postcode
Lyon, France· Not yet recruiting
Pediatric Surgery Service, University Hospital, Marseille
Verified postcode
Marseille, France· Recruiting
Pediatric Surgery Service, University Hospital, Nantes
Verified postcode
Nantes, France· Recruiting
Pediatric Surgery Service, University Hospital, Nice
Verified postcode
Nice, France· Recruiting
Pediatric Surgery Service, University Hospital, Armand Trousseau Hospital, AP-HP
Verified postcode
Paris, France· Recruiting
Pediatric Surgery Service, Robert-Debré Hospital, AP-HP
Verified postcode
Paris, France· Recruiting
Pediatric Surgery Service, University Hospital, Necker Hospital, AP-HP
Verified postcode
Paris, France· Recruiting
Pediatric Surgery Service, University Hospital, Rennes
Verified postcode
Rennes, France· Recruiting
Pediatric Surgery Service, University Hospital, Saint-Etienne
Verified postcode
Saint-Etienne, France· Recruiting
Pediatric Surgery Service, University Hospital, Toulouse
Verified postcode
Toulouse, France· Recruiting

Common questions

What is hemivertebra?

Hemivertebra is a condition where one of the bones in a child's spine (a vertebra) has not fully formed, which can cause the spine to curve.

Will my child receive any new treatments in this study?

No, this study is about observing and learning from the standard surgical care your child would already receive for hemivertebra, not trying new treatments.

How long will my child be involved in the study?

The study will collect information from your child's regular follow-up appointments, which will continue for as long as their doctor recommends for monitoring their spine after surgery.

Can I decide not to let my child's information be used?

Yes, your participation is completely voluntary, and you can choose not to have your child's data included in the study at any time.

What is the study hoping to achieve?

The study aims to better understand how well hemivertebra surgery works, what complications might occur, and how children's spines grow over time, to improve future care.

How to find out more

Thierry ODENT, MD-PhD

t.odent@chu-tours.fr 02 47 47 38 22 Official trial record

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