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

NCT ID: NCT01336114

Last Updated: 2014-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Scoliosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

15 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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philippe violas

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

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Rennes University Hospital

Rennes, Brittany Region, France

Site Status

Countries

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France

Other Identifiers

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LOC/10-14

Identifier Type: -

Identifier Source: secondary_id

2010-A01263-36

Identifier Type: -

Identifier Source: org_study_id