Evaluation of the Surface Topography for Monitoring Scoliosis Patients Aged 10-13 Years
SCOBIOMOD
Scoliosis Patients Aged 10-13 Years: Monitoring of Scoliosis by the Surface Topography
1 other identifier
interventional
125
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2015
CompletedFirst Posted
Study publicly available on registry
August 25, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2017
CompletedDecember 10, 2025
May 1, 2018
1.7 years
August 18, 2015
December 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correlation between the measurement of Cobb angle by conventional .radiography and surface topography.
Number of participants with the same cobb angle measured by surface topography and measured by x-ray.
up to 1 year
Secondary Outcomes (3)
Reproducibility within the operator of measurement of the angle by surface topography
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
up to 1 year
The sensitivity of the topography on the detection of the deterioration of the Cobb angle
up to 1 year
Study Arms (1)
Intervention
EXPERIMENTALThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patient with secondary scoliosis (neurological, Prader Willi syndrome...)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UH toulouse
Toulouse, 31059, France
Related Publications (1)
Bolzinger M, Bernardini I, Thevenin Lemoine C, Gallini A, Accadbled F, Sales de Gauzy J. Monitoring adolescent idiopathic scoliosis by measuring ribs prominence using surface topography device. Spine Deform. 2021 Sep;9(5):1349-1354. doi: 10.1007/s43390-021-00327-1. Epub 2021 Mar 29.
PMID: 33782905RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jérôme SALES DE GAUZY
UH Toulouse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2015
First Posted
August 25, 2015
Study Start
September 1, 2015
Primary Completion
May 31, 2017
Study Completion
May 31, 2017
Last Updated
December 10, 2025
Record last verified: 2018-05