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Bracing During Infantile Scoliosis: Airways Study (MASI)

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ClinicalTrials.gov Identifier: NCT01087034
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : June 12, 2012
Sponsor:
Collaborator:
Ecole Nationale Supérieure des Arts et Metiers
Information provided by (Responsible Party):
Dr Nicolas LEBOULANGER, Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau

Brief Summary:

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™)


Condition or disease Intervention/treatment
Scoliosis Device: Acoustic reflection method evaluation Radiation: EOS™ Other: Non invasive respiratory muscle assessment

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bracing During Infantile Scoliosis: Airways Study by Acoustic Method, EOS™ Acquisition and Noninvasive Respiratory Muscles Assessment
Study Start Date : February 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

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.




Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with evolutive juvenile thoracic scoliosis requiring either a Milwaukee or a Cheneaux brace
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087034


Locations
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France
Armand Trousseau University Hospital
Paris, France, 75012
Ecole Nationale Supérieure des Arts et Metiers
Paris, France, 75013
Sponsors and Collaborators
Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau
Ecole Nationale Supérieure des Arts et Metiers
Investigators
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Principal Investigator: Nicolas LEBOULANGER, MD Assistance Publique - Hôpitaux de Paris
Study Director: Brigitte FAUROUX, MD, PhD Assistance Publique - Hôpitaux de Paris
Publications:
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Responsible Party: Dr Nicolas LEBOULANGER, Dr, Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau
ClinicalTrials.gov Identifier: NCT01087034    
Other Study ID Numbers: MA-SInf
First Posted: March 15, 2010    Key Record Dates
Last Update Posted: June 12, 2012
Last Verified: June 2012
Keywords provided by Dr Nicolas LEBOULANGER, Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau:
Infantile scoliosis
bracing
acoustic reflection method
EOS™
noninvasive
upper airways
thoracic penetration index
Idiopathic juvenile evolutive thoracic scoliosis
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases