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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Scoliosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

Use of Biomod device

Intervention Type DEVICE

Interventions

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Use of Biomod device

Intervention Type DEVICE

Eligibility Criteria

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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.