Evaluating surgical treatment for children's vertebral malformations
Official title: Assessment and Follow-up of Surgical Treatment of Hemivertebra in Children
Run by University Hospital, Tours · NCT03772119 · Data updated 2026-11-12
This study tests different surgical methods to see how well they help children aged 3 to 10 with spine problems caused by hemivertebra and what risks might come with the surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 3 Years to 10 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | University Hospital, Tours Academic / other |
| Locations | 13 sites (Bordeaux and 12 other locations) |
| Status | Recruiting |
| Started | February 4, 2019 |
| Main results expected | February 2039 |
| Study ends | February 2039 |
| Registry record updated | April 30, 2026 |
| Trial ID | NCT03772119 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 3 to 10 years with a vertebral malformation that necessitates surgical intervention for hemivertebra.
✕Probably not a fit
Patients who have previously undergone spinal surgery or those with different surgical needs will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study assesses the outcomes of surgical resection for hemivertebra in children aged 3 to 10 years. It focuses on evaluating early complications, skeletal maturity, and the maintenance of surgical correction post-operation. The study aims to gather data on various surgical techniques and their effectiveness in treating vertebral malformations. By monitoring these children, the research seeks to improve understanding of the risks and benefits associated with these complex surgeries.
Why it matters
Potential benefit: If successful, this study could enhance surgical techniques and outcomes for children with vertebral malformations.
How similar studies have gone: While there have been studies on surgical techniques for vertebral malformations, this specific observational approach focusing on early complications and skeletal maturity is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Child from 3 to 10 years old * with a vertebral malformation requiring surgery for hemivertebras Exclusion Criteria: * Child previously operated on the spine * Different procedure of a surgical resection of vertebral malformation * Absence of medical follow-up * Parents refusal concerning data storage
Where it's running
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Pediatric Surgery Service, University Hospital, Bordeaux
Bordeaux, France Recruiting -
Pediatric Surgery Service, University Hospital, Marseille
Marseille, France Recruiting -
Pediatric Surgery Service, University Hospital, Nantes
Nantes, France Recruiting -
Pediatric Surgery Service, University Hospital, Nice
Nice, France Recruiting -
Pediatric Surgery Service, University Hospital, Armand Trousseau Hospital, AP-HP
Paris, France Recruiting -
Pediatric Surgery Service, Robert-Debré Hospital, AP-HP
Paris, France Recruiting
Show 7 more locations
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Pediatric Surgery Service, University Hospital, Necker Hospital, AP-HP
Paris, France Recruiting -
Pediatric Surgery Service, University Hospital, Rennes
Rennes, France Recruiting -
Pediatric Surgery Service, University Hospital, Saint-Etienne
Saint-Etienne, France Recruiting -
Pediatric Surgery Service, University Hospital, Toulouse
Toulouse, France Recruiting -
Pediatric Surgery Service, University Hospital, Tours
Tours, France Recruiting -
Pediatric Surgery Service, University Hospital, Grenoble
Grenoble, France Not yet recruiting -
Pediatric Surgery Service, University Hospital, Lyon
Lyon, France Not yet recruiting
Study contacts
- Study coordinator: Thierry ODENT, MD-PhD
- Email: T.ODENT@chu-tours.fr
- Phone: 02 47 47 38 22
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.