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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

Tracking Information
First Submitted Date March 12, 2010
First Posted Date March 15, 2010
Last Update Posted Date June 12, 2012
Study Start Date February 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 12, 2010)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Bracing During Infantile Scoliosis: Airways Study
Official Title Bracing During Infantile Scoliosis: Airways Study by Acoustic Method, EOS™ Acquisition and Noninvasive Respiratory Muscles Assessment
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™)

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children with evolutive juvenile thoracic scoliosis requiring either a Milwaukee or a Cheneaux brace
Condition Scoliosis
Intervention
  • 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.
Study Groups/Cohorts
  • Milwaukee brace
    Children with an infantile scoliosis requiring Milwaukee bracing
    Interventions:
    • Device: Acoustic reflection method evaluation
    • Radiation: EOS™
    • Other: Non invasive respiratory muscle assessment
  • Cheneaux brace
    Children with an infantile scoliosis requiring Cheaneaux bracing
    Interventions:
    • Device: Acoustic reflection method evaluation
    • Radiation: EOS™
    • Other: Non invasive respiratory muscle assessment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 11, 2012)
15
Original Estimated Enrollment
 (submitted: March 12, 2010)
30
Actual Study Completion Date June 2011
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01087034
Other Study ID Numbers MA-SInf
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr Nicolas LEBOULANGER, Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau
Study Sponsor Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau
Collaborators Ecole Nationale Supérieure des Arts et Metiers
Investigators
Principal Investigator: Nicolas LEBOULANGER, MD Assistance Publique - Hôpitaux de Paris
Study Director: Brigitte FAUROUX, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau
Verification Date June 2012