Clinical trial NCT02531945: Evaluation of the Surface Topography for Monitoring Scoliosis Patients Aged 10-13 Years
Official title: Scoliosis Patients Aged 10-13 Years: Monitoring of Scoliosis by the Surface Topography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scoliosis
Keywords: topography
cobb angle
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2015-08-25
Enrollment: 125
Sex: ALL
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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...)

Primary outcomes:
measure: Correlation between the measurement of Cobb angle by conventional .radiography and surface topography.
timeFrame: up to 1 year
Secondary outcomes:
measure: Reproducibility within the operator of measurement of the angle by surface topography
timeFrame: At each visit two successive measurements are made by the operator for the same patient. up to 1 year
measure: Reproducibility between the operator of measurement of the angle by surface topography
timeFrame: up to 1 year
measure: The sensitivity of the topography on the detection of the deterioration of the Cobb angle
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Toulouse
country: France
facility: UH toulouse
Study officials:
affiliation: UH Toulouse
name: Jérôme SALES DE GAUZY
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Bunnell WP. An objective criterion for scoliosis screening. J Bone Joint Surg Am. 1984 Dec;66(9):1381-7.
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.
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.