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Completed

NCT Number: NCT01336114

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

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.

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Key information

Conditions

Scoliosis Bone Diseases Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Age range

12 year–15 year

Sex eligibility

Female

Study type

Observational

Primary location

Rennes University Hospital

Rennes, Brittany Region, 35033, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: MODEL MAKER

Important dates

Study start
2011
First posted
Apr 15, 2011
Registry last updated
Nov 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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