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

Not Applicable

Completed

• Conditions: Scoliosis
• Interventions: Device: Use of Biomod device

• Registration Number: NCT02531945
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study First Submitted: 2015-08-18
• Study First Submitted QC: 2015-08-24
• Study First Posted: 2015-08-25
• Study Start: 2015-09
• Primary Completion: 2017-05-31
• Study Completion: 2017-05-31
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-30
• Last Update Posted: 2018-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Use of Biomod device	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Reproducibility within the operator of measurement of the angle by surface topography	At each visit two successive measurements are made by the operator for the same patient. up to 1 year	up to 1 year
Reproducibility between the operator of measurement of the angle by surface topography	up to 1 year	Two independent operators will measures.
The sensitivity of the topography on the detection of the deterioration of the Cobb angle	up to 1 year	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.

Trial Locations

Locations (1)

UH toulouse; 🇫🇷 Toulouse, France