Evaluating surgical treatment for children's vertebral malformations
Assessment and Follow-up of Surgical Treatment of Hemivertebra in Children
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 |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 3 Years to 10 Years |
| Sex | All |
| Sponsor | University Hospital, Tours Academic / other |
| Locations | 13 sites (Bordeaux and 12 other locations) |
| Trial ID | NCT03772119 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 10 years with a vertebral malformation that necessitates surgical intervention for hemivertebra.
Not a fit: Patients who have previously undergone spinal surgery or those with different surgical needs will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance surgical techniques and outcomes for children with vertebral malformations.
How similar studies have performed: 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.
Eligibility criteria
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 this trial is running
Bordeaux and 12 other locations
- Pediatric Surgery Service, University Hospital, Bordeaux — Bordeaux, France (Recruiting)
- Pediatric Surgery Service, University Hospital, Grenoble — Grenoble, France (Not_yet_recruiting)
- Pediatric Surgery Service, University Hospital, Lyon — Lyon, France (Not_yet_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)
- 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)
Study contacts
- Study coordinator: Thierry ODENT, MD-PhD
- Email: T.ODENT@chu-tours.fr
- Phone: 02 47 47 38 22
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.