Evaluation of the Surface Topography for Monitoring Scoliosis Patients Aged 10-13 Years

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to investigate the correlation between the measurement of the Cobb angle (angle of scoliosis) by conventional radiography and angle measured by surface topography. The device used in this research to the topography examination is three-dimensional morphometry device of AXS Medical society : the BIOMOD L.

Detailed Description
-----------------
For usual follow-up visit, patients will have a x-ray examination of the spine and the surface topography. The measurement of the angle of scoliosis is achieved by two independent operators for both methods. Patients then have a follow-up visit at 6 and 12 months.

Official Title
-----------------
Scoliosis Patients Aged 10-13 Years: Monitoring of Scoliosis by the Surface Topography

Conditions
-----------------
Scoliosis

Intervention / Treatment
-----------------
* Device: Use of Biomod device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with idiopathic scoliosis, Body mass index BMI below or equal to 25, Cobb angle measured on radiographs between 10 and 25 degrees, Parental authorization. Exclusion Criteria: Patient with secondary scoliosis (neurological, Prader Willi syndrome...)

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 13 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The device used in this research to the topography examination is three-dimensional morphometry device of AXS Medical society : the BIOMOD L. 'Use of Biomod device' for all the patient in addition to the conventional X-ray examination. | Device: Use of Biomod device<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between the measurement of Cobb angle by conventional .radiography and surface topography. | Number of participants with the same cobb angle measured by surface topography and measured by x-ray. | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reproducibility within the operator of measurement of the angle by surface topography | up to 1 year | At each visit two successive measurements are made by the operator for the same patient. up to 1 year | 
| Reproducibility between the operator of measurement of the angle by surface topography | Two independent operators will measures. | up to 1 year | 
| The sensitivity of the topography on the detection of the deterioration of the Cobb angle | The sensitivity of the surface topography to detect a worsening of one year more than 5 ° C over the Cobb angle will be assessed compared to the radiograph. It will be obtained by the ratio between the number of aggravations detected by the surface topography and the total number of exacerbations diagnosed by radiography. | up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
topography, cobb angle