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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01336114
Acronym
MODEL MAKER
Enrollment
11
Registered
2011-04-15
Start date
2011-07-31
Completion date
Unknown
Last updated
2014-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis

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.

Interventions

None listed

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
12 Years to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Photographs of the back and spine radiographs for making a corset3 yearsThe 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

MeasureTime frameDescription
Recording of pressure from the brace3 yearsThe 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).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026