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

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.

Study Overview

• Status: Completed
• Conditions: Scoliosis

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• France
  • Brittany
    • Rennes, Brittany, France, 35033
      • Rennes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with idiopathic scoliosis

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Photographs of the back and spine radiographs for making a corset	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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recording of pressure from the brace	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).	3 years

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: philippe violas, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2011

Study Registration Dates

• First Submitted: April 6, 2011
• First Submitted That Met QC Criteria: April 13, 2011
• First Posted (Estimate): April 15, 2011

Study Record Updates

• Last Update Posted (Estimate): November 26, 2014
• Last Update Submitted That Met QC Criteria: November 25, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: 2010-A01263-36; LOC/10-14