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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Hemivertebra

Intervention / Treatment
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* Procedure: Surgical resection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical treatment of hemivertebra<br>cohort of children with a vertebral malformation treated by surgical resection | Procedure: Surgical resection<br>* Surgical resection of hemivertebra<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate effectiveness of surgery: Evolution of Cobb angle | Effectiveness of immediate correction : spinal deformities measured by the Cobb angle on radios face and profile | From baseline to 6 months after surgery | 
| Appearances of complications | Appearances of complications (neurological, vascular, non consolidation) at 6 months. These complications will be gathered from hospitalization reports. | From baseline to 6 months after surgery | 
| Late persistence of complications | Persistent complications will be collected through clinical examination at follow-up visits. | From 6 months after surgery to 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term effectiveness of surgery: Evolution of Cobb angle | Maintaining local correction with growth: spinal deformities measured by the Cobb angle on radios face and profile | From 6 months after surgery to 15 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vertebral Malformation, Hemivertebra, Surgical resection, SOFOP