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

Overview

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.

Full Title of Study: “Scoliosis Patients Aged 10-13 Years: Monitoring of Scoliosis by the Surface Topography”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 31, 2017

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

  • Device: Use of Biomod device

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • Reproducibility between the operator of measurement of the angle by surface topography
    • Time Frame: up to 1 year
    • Two independent operators will measures.
  • 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.

Participating in This Clinical Trial

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…)

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: 13 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Toulouse
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jérôme SALES DE GAUZY, Principal Investigator, UH Toulouse

References

de Seze M, Cugy E. Pathogenesis of idiopathic scoliosis: a review. Ann Phys Rehabil Med. 2012 Mar;55(2):128-38. doi: 10.1016/j.rehab.2012.01.003. Epub 2012 Jan 27. English, French.

Bunnell WP. An objective criterion for scoliosis screening. J Bone Joint Surg Am. 1984 Dec;66(9):1381-7.

Goldberg CJ, Kaliszer M, Moore DP, Fogarty EE, Dowling FE. Surface topography, Cobb angles, and cosmetic change in scoliosis. Spine (Phila Pa 1976). 2001 Feb 15;26(4):E55-63. doi: 10.1097/00007632-200102150-00005.

Minguez MF, Buendia M, Cibrian RM, Salvador R, Laguia M, Martin A, Gomar F. Quantifier variables of the back surface deformity obtained with a noninvasive structured light method: evaluation of their usefulness in idiopathic scoliosis diagnosis. Eur Spine J. 2007 Jan;16(1):73-82. doi: 10.1007/s00586-006-0079-y. Epub 2006 Apr 12.

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