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

December 2, 2025 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • UH Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 13 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Use of Biomod device

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.
Time Frame: up to 1 year
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
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
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
Time Frame: up to 1 year
Two independent operators will measures.
up to 1 year
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.
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Jérôme SALES DE GAUZY, UH Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

May 31, 2017

Study Completion (Actual)

May 31, 2017

Study Registration Dates

First Submitted

August 18, 2015

First Submitted That Met QC Criteria

August 24, 2015

First Posted (Estimated)

August 25, 2015

Study Record Updates

Last Update Posted (Estimated)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/14/7419

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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