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

Primary Purpose

Scoliosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Use of Biomod device
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Scoliosis focused on measuring topography, cobb angle

Eligibility Criteria

10 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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...)

Sites / Locations

  • UH toulouse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Reproducibility within the operator of measurement of the angle by surface topography
up to 1 year
Reproducibility between the operator of measurement of the angle by surface topography
Two independent operators will measures.
The sensitivity of the topography on the detection of the deterioration of the Cobb angle
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.

Full Information

First Posted
August 18, 2015
Last Updated
May 30, 2018
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT02531945
Brief Title
Evaluation of the Surface Topography for Monitoring Scoliosis Patients Aged 10-13 Years
Acronym
SCOBIOMOD
Official Title
Scoliosis Patients Aged 10-13 Years: Monitoring of Scoliosis by the Surface Topography
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
May 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis
Keywords
topography, cobb angle

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Use of Biomod device
Primary Outcome Measure Information:
Title
Correlation between the measurement of Cobb angle by conventional .radiography and surface topography.
Description
Number of participants with the same cobb angle measured by surface topography and measured by x-ray.
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Reproducibility within the operator of measurement of the angle by surface topography
Description
up to 1 year
Time Frame
At each visit two successive measurements are made by the operator for the same patient. up to 1 year
Title
Reproducibility between the operator of measurement of the angle by surface topography
Description
Two independent operators will measures.
Time Frame
up to 1 year
Title
The sensitivity of the topography on the detection of the deterioration of the Cobb angle
Description
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.
Time Frame
up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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...)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jérôme SALES DE GAUZY
Organizational Affiliation
UH Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
22321868
Citation
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.
Results Reference
background
PubMed Identifier
6501335
Citation
Bunnell WP. An objective criterion for scoliosis screening. J Bone Joint Surg Am. 1984 Dec;66(9):1381-7.
Results Reference
background
PubMed Identifier
11224901
Citation
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.
Results Reference
background
PubMed Identifier
16609858
Citation
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.
Results Reference
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Evaluation of the Surface Topography for Monitoring Scoliosis Patients Aged 10-13 Years

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