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Clinical Trials/NCT01336114
NCT01336114
Completed
Not Applicable

A New 3D Geometrical Modelisation of Adolescent Idiopathic Scoliosis and Conception of a Personal Brace

Rennes University Hospital1 site in 1 country11 target enrollmentJuly 2011
ConditionsScoliosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Scoliosis
Sponsor
Rennes University Hospital
Enrollment
11
Locations
1
Primary Endpoint
Photographs of the back and spine radiographs for making a corset
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Adolescent idiopathic scoliosis (AIS) involves complex tridimensional deformities of the spine. In case of progressive curve deformity, the use of spinal bracing remains the standard non operative treatment of moderate AIS. Most of the time, the different types of braces don't take into account the individual biomechanical properties of each patient's spine. Actually, it is essential to better understand the effect of the loads applied on the trunk and on the spine, and a 3D geometrical modelisation of these components is essential. Many studies have been publishing concerning the use of radiographs for the geometrical reconstruction of the spine, and more recently the EOS system. But even then, it is still necessary to obtain an important number of geometrical data and discretisation is still a long procedure.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
TBD
Last Updated
11 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Rennes University Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 12 years
  • Pre menarchial for the girls
  • Risser 0 et Risser 3 on X rays. Radiologic classification of spine maturity (ossification of the iliac crests). Five stages.
  • Cobb angle ≥25° and \< 40°
  • Information to the parents and child, and signed approval

Exclusion Criteria

  • No idiopathic scoliosis
  • Previous brace treatment
  • Immediate indication for surgery
  • Previous thoracic surgery

Outcomes

Primary Outcomes

Photographs of the back and spine radiographs for making a corset

Time Frame: 3 years

The torso shape reconstruction is realized thanks to the system Model Maker(Proteor®) on adolescent idiopathic patients. Model Maker allows to reconstruct the external shape of the human body from about 20 images steaming from a standard digital camera.The spine reconstruction is has for her obtained by means of a software interface, from tow standard clinical X-rays in the digital format (frontal and sagittal) and images were used by Model Maker for the external shape reconstruction.

Secondary Outcomes

  • Recording of pressure from the brace(3 years)

Study Sites (1)

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