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

Scoliosis Clinical Trial

— SCOBIOMOD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02531945
• Other study ID #: RC31/14/7419
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: May 31, 2017

Study information

• Verified date: May 2018
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 13 Years

Eligibility

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...)

Related Conditions & MeSH terms

• Scoliosis

Intervention

Device:
• Use of Biomod device

Locations

Country	Name	City	State
France	UH toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (4)

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

de Sèze 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. Review. English, French. — View 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. — View Citation

Mínguez MF, Buendía M, Cibrián RM, Salvador R, Laguía M, Martín 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. Epub 2006 Apr 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reproducibility within the operator of measurement of the angle by surface topography	up to 1 year	At each visit two successive measurements are made by the operator for the same patient. up to 1 year
Secondary	Reproducibility between the operator of measurement of the angle by surface topography	Two independent operators will measures.	up to 1 year
Secondary	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.	up to 1 year