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

Toulouse University Hospital

Status: Completed

Conditions: Scoliosis

Treatments: Device: Use of Biomod device

Study type: Interventional

Funder types: Other

Identifiers

NCT02531945

RC31/14/7419

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 patients

Sex: All

Ages: 10 to 13 years old

Volunteers: No Healthy Volunteers

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...)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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125 participants in 1 patient group

Intervention

Experimental group

Description:

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.

Treatment:

Device: Use of Biomod device