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

Scoliosis Clinical Trial

— MODEL MAKER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01336114
• Other study ID #: 2010-A01263-36
• Secondary ID: LOC/10-14
• Status: Completed
• Phase: N/A
• First received: April 6, 2011
• Last updated: November 25, 2014
• Start date: July 2011

Study information

• Verified date: November 2014
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 15 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Scoliosis

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes	Brittany

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No