Scoliosis Patients Aged 10-13 Years: Monitoring of Scoliosis by the Surface Topography
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 125
- Locations
- 2
- Primary Endpoint
- Correlation between the measurement of Cobb angle by conventional .radiography and surface topography.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 13 Years (Child)
- Sex
- All
- Accepts 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...)
Arms & Interventions
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.
Intervention: Use of Biomod device (Device)
Outcomes
Primary Outcomes
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
- 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)