Assessment and Follow-up of Surgical Treatment of Hemivertebra in Children
- Conditions
- Hemivertebra
- Interventions
- Procedure: Surgical resection
- Registration Number
- NCT03772119
- Lead Sponsor
- University Hospital, Tours
- Brief 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).
- Detailed Description
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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- Child from 3 to 10 years old
- with a vertebral malformation requiring surgery for hemivertebras
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Surgical treatment of hemivertebra Surgical resection cohort of children with a vertebral malformation treated by surgical resection
- Primary Outcome Measures
Name Time Method 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
Late persistence of complications From 6 months after surgery to 15 years Persistent complications will be collected through clinical examination at follow-up visits.
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.
- Secondary Outcome Measures
Name Time Method Long-term effectiveness of surgery: Evolution of Cobb angle From 6 months after surgery to 15 years Maintaining local correction with growth: spinal deformities measured by the Cobb angle on radios face and profile
Trial Locations
- Locations (13)
Pediatric Surgery Service, University Hospital, Bordeaux
🇫🇷Bordeaux, France
Pediatric Surgery Service, University Hospital, Marseille
🇫🇷Marseille, France
Pediatric Surgery Service, University Hospital, Nantes
🇫🇷Nantes, France
Pediatric Surgery Service, University Hospital, Nice
🇫🇷Nice, France
Pediatric Surgery Service, University Hospital, Lyon
🇫🇷Lyon, France
Pediatric Surgery Service, University Hospital, Tours
🇫🇷Tours, France
Pediatric Surgery Service, Robert-Debré Hospital, AP-HP
🇫🇷Paris, France
Pediatric Surgery Service, University Hospital, Necker Hospital, AP-HP
🇫🇷Paris, France
Pediatric Surgery Service, University Hospital, Saint-Etienne
🇫🇷Saint-Étienne, France
Pediatric Surgery Service, University Hospital, Grenoble
🇫🇷Grenoble, France
Pediatric Surgery Service, University Hospital, Rennes
🇫🇷Rennes, France
Pediatric Surgery Service, University Hospital, Armand Trousseau Hospital, AP-HP
🇫🇷Paris, France
Pediatric Surgery Service, University Hospital, Toulouse
🇫🇷Toulouse, France