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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01336114
First received: April 6, 2011
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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
Scoliosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A New 3D Geometrical Modelisation of Adolescent Idiopathic Scoliosis and Conception of a Personal Brace

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Photographs of the back and spine radiographs for making a corset [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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:
  • Recording of pressure from the brace [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 15
Study Start Date: July 2011
  Eligibility

Ages Eligible for Study:   12 Years to 15 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01336114

Contacts
Contact: philippe violas 33-2-9928-9371 philippe.violas@chu-rennes.fr

Locations
France
Rennes University Hospital Recruiting
Rennes, Brittany, France, 35033
Contact: philippe violas    33-2-9928-9371    philippe.violas@chu-rennes.fr   
Principal Investigator: philippe violas         
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: philippe violas Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01336114     History of Changes
Other Study ID Numbers: 2010-A01263-36, LOC/10-14
Study First Received: April 6, 2011
Last Updated: November 7, 2013
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

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

ClinicalTrials.gov processed this record on September 14, 2014