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Completed

NCT Number: NCT02531945

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

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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Key information

Conditions

Scoliosis Bone Diseases Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Age range

10 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UH toulouse

Toulouse, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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...)

Treatment and study plan

Use of Biomod device

Device

Primary outcomes

  1. Correlation between the measurement of Cobb angle by conventional .radiography and surface topography.

    Time frame: up to 1 year

    Number of participants with the same cobb angle measured by surface topography and measured by x-ray.

Secondary outcomes

  1. Reproducibility within the operator of measurement of the angle by surface topography

    Time frame: At each visit two successive measurements are made by the operator for the same patient. up to 1 year

    up to 1 year

  2. Reproducibility between the operator of measurement of the angle by surface topography

    Time frame: up to 1 year

    Two independent operators will measures.

  3. The sensitivity of the topography on the detection of the deterioration of the Cobb angle

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: SCOBIOMOD

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 25, 2015
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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