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Clinical Trials/NCT02531945
NCT02531945
Completed
N/A

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

University Hospital, Toulouse1 site in 1 country125 target enrollmentSeptember 1, 2015
ConditionsScoliosis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Scoliosis
Sponsor
University Hospital, Toulouse
Enrollment
125
Locations
1
Primary Endpoint
Correlation between the measurement of Cobb angle by conventional .radiography and surface topography.
Status
Completed
Last Updated
4 months ago

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2015
End Date
May 31, 2017
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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...)

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)

Study Sites (1)

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