Bracing During Infantile Scoliosis: Airways Study (MASI)

June 11, 2012 updated by: Dr Nicolas LEBOULANGER, Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau

Bracing During Infantile Scoliosis: Airways Study by Acoustic Method, EOS™ Acquisition and Noninvasive Respiratory Muscles Assessment

Idiopathic juvenile thoracic scoliosis is a tridimensional deformation of the spine which may impact on the intrathoracic organs. Bracing is one of the oldest treatments of spinal deformities. It relies on the indirect manipulation of spinal curvatures in order to prevent curve progression, which may affect respiratory function.

The acoustic reflection method is based on the analysis of the reflection of a single transient planar wave giving the longitudinal cross-sectional area profile of the examined cavity. It is noninvasive and harmless.

The EOS™ device allows a double incidence, full body, and low-dose X-ray acquisition with thoracic 3D reconstruction.

The aim of the study is to evaluate the impact of bracing on the upper airways patency (by means of the acoustic method), on the breathing pattern (noninvasive respiratory muscles assessment), and on the thoracic penetration index (by means of the EOS™)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75012
        • Armand Trousseau University Hospital
      • Paris, France, 75013
        • Ecole Nationale Supérieure des Arts et Metiers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children with evolutive juvenile thoracic scoliosis requiring either a Milwaukee or a Cheneaux brace

Description

Inclusion Criteria:

  • children with evolutive juvenile thoracic scoliosis
  • with a Cobb angle ≥ 30°
  • requiring either a Milwaukee or a Cheneaux brace
  • in a stable respiratory state

Exclusion Criteria:

  • history of spine surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Milwaukee brace
Children with an infantile scoliosis requiring Milwaukee bracing
Device: Acoustic reflection method evaluation
Evaluation of airways by acoustic relection method, with and without the bracing device
Radiation: EOS™
Scoliosis and thoracic penetration index evaluation by EOS™ acquisition, with and without the bracing device
Other: Non invasive respiratory muscle assessment
Non invasive respiratory muscles assessment, with and without the bracing device.
Cheneaux brace
Children with an infantile scoliosis requiring Cheaneaux bracing
Device: Acoustic reflection method evaluation
Evaluation of airways by acoustic relection method, with and without the bracing device
Radiation: EOS™
Scoliosis and thoracic penetration index evaluation by EOS™ acquisition, with and without the bracing device
Other: Non invasive respiratory muscle assessment
Non invasive respiratory muscles assessment, with and without the bracing device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of bracing on airways
Time Frame: 6 months
The aim of the study is to evaluate the impact of bracing on the upper airways patency (by means of the acoustic method), on the breathing pattern (noninvasive respiratory muscles assessment), and on the thoracic penetration index (by means of the EOS™ system)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau

Collaborators

Ecole Nationale Supérieure des Arts et Metiers

Investigators

  • Study Director: Brigitte Fauroux, MD, PhD, Assistance Publique - Hôpitaux de Paris
  • Principal Investigator: Nicolas LEBOULANGER, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

March 12, 2010

First Submitted That Met QC Criteria

March 12, 2010

First Posted (Estimate)

March 15, 2010

Study Record Updates

Last Update Posted (Estimate)

June 12, 2012

Last Update Submitted That Met QC Criteria

June 11, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA-SInf

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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