Assessment and Follow-up of Surgical Treatment of Hemivertebra in Children
Condition(s) studied
Investigational drug(s) / intervention(s)
Surgical resection: Surgical resection of hemivertebra
Study summary
The treatment of child's vertebral malformations has evolved a lot including the realization of surgical vertebral resections. The surgical techniques used are multiple, require heavy surgery, one or more approaches and surgical time, transfusions, a neurological risk (up to 20% in some series, risk of non-consolidation, insufficient correction). These surgical techniques deserve an evaluation of the early complications and the skeletal maturity of these children (maintenance of the surgical correction, evolution of the associated curvatures).
Eligibility
Primary outcome measure(s)
- Immediate effectiveness of surgery: Evolution of Cobb angle — From baseline to 6 months after surgery
Effectiveness of immediate correction : spinal deformities measured by the Cobb angle on radios face and profile - Appearances of complications — From baseline to 6 months after surgery
Appearances of complications (neurological, vascular, non consolidation) at 6 months. These complications will be gathered from hospitalization reports. - Late persistence of complications — From 6 months after surgery to 15 years
Persistent complications will be collected through clinical examination at follow-up visits.
Trial sites (13)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More University Hospital, Tours trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03772119 on ClinicalTrials.gov ↗ ← All trials in France