Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02531945
Other study ID # RC31/14/7419
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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...)

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT04848376 - Post-Market Clinical Follow-up Study of A-SPINE's Products
Recruiting NCT05944393 - Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery N/A
Recruiting NCT05888038 - Virtual Reality's Effect on Decreasing Pain and Subsequent Opioid Use in Pediatric Patients in the Post-Operative Period Following Scoliosis Repair N/A
Completed NCT02890654 - Scoliosis and Quality of Life of Adolescents
Completed NCT02558985 - Pulmonary Compliance Changes During Manipulation of Early Onset Scoliosis and Cast Application
Completed NCT02413788 - Impact of Aerobic Training and Combined in Inflammatory Markers in Patients With Adolescent Idiopathic Scoliosis N/A
Terminated NCT02134704 - MOUVSCO: Kinematic Analysis of the Trunk in Patients With Moderate Scoliosis N/A
Completed NCT02609009 - Back Pain and Spinal Manipulation in Adolescent Scoliosis N/A
Completed NCT02285621 - Validation of a New Generation of Optimized Orthoses for Personalized Treatment of Adolescent Idiopathic Scoliosis N/A
Withdrawn NCT00768313 - Phase IV Comparing Rods of Yield Strengths to Correct Adolescent Idiopathic Scoliosis. Phase 4
Completed NCT00155545 - Influence of Leg Length Discrepancy on the Spinal Shape and Biomechanics in Functional and Idiopathic Scoliosis Patients Phase 1
Completed NCT00154505 - Effects of Lateral Trunk Support on Spinal Alignment in Spinal Cord Injured Persons Phase 1
Completed NCT00320619 - Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery N/A
Completed NCT00273598 - Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis Phase 2
Completed NCT03135665 - Using Radiation-free Ultrasound for Screening Scoliosis Among School Children in Hong Kong to Reduce Unnecessary X-ray Exposure N/A
Completed NCT06428864 - Effect of the Use of a 3D Scanner Application on a Smartphone to Mold Garchois Orthotic Device in Neuromuscular Diseases Patients With Scoliosis
Recruiting NCT04423146 - Anesthesiologic Management Effect on Perioperative Outcome in Scoliosis Surgery
Completed NCT03814239 - Blood and Fluid Management During Scoliosis Surgery
Withdrawn NCT02058238 - ADDRESS - Adult Deformity Robotic vs. Freehand Surgery to Correct Spinal Deformity
Completed NCT02904421 - 6 Years Study on Changes in Bone Quality, Bone Turnover and Curve Severity in AIS With and Without Calcium and Vit-D Supplementation