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A New 3D Geometrical Modelisation of Adolescent Idiopathic Scoliosis and Conception of a Personal Brace (MODEL MAKER)

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ClinicalTrials.gov Identifier: NCT01336114
Recruitment Status : Completed
First Posted : April 15, 2011
Last Update Posted : November 26, 2014
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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.

Condition or disease
Scoliosis

Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A New 3D Geometrical Modelisation of Adolescent Idiopathic Scoliosis and Conception of a Personal Brace
Study Start Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Recording of pressure from the brace [ Time Frame: 3 years ]
    The recording of pressure from the brace is done through a web of pressure positioned in the brace. It is a structure "teck scan (Expert-Seat, Ergoresearch Inc)" containing polymeric pressure sensors. The pressure exerted by the brace on the trunk is registered in different positions (standing, lying).



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Ages Eligible for Study:   12 Years to 15 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with idiopathic scoliosis
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01336114


Locations
France
Rennes University Hospital
Rennes, Brittany, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: philippe violas Rennes University Hospital

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01336114     History of Changes
Other Study ID Numbers: 2010-A01263-36
LOC/10-14
First Posted: April 15, 2011    Key Record Dates
Last Update Posted: November 26, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases