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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02531945
Acronym
SCOBIOMOD
Enrollment
125
Registered
2015-08-25
Start date
2015-09-30
Completion date
2017-05-31
Last updated
2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis

Keywords

topography, cobb angle

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.

Interventions

DEVICEUse of Biomod device

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 13 Years
Healthy volunteers
No

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...)

Design outcomes

Primary

MeasureTime frameDescription
Correlation between the measurement of Cobb angle by conventional .radiography and surface topography.up to 1 yearNumber of participants with the same cobb angle measured by surface topography and measured by x-ray.

Secondary

MeasureTime frameDescription
Reproducibility within the operator of measurement of the angle by surface topographyAt each visit two successive measurements are made by the operator for the same patient. up to 1 yearup to 1 year
Reproducibility between the operator of measurement of the angle by surface topographyup to 1 yearTwo independent operators will measures.
The sensitivity of the topography on the detection of the deterioration of the Cobb angleup to 1 yearThe 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026