Trial record 2 of 3 for:    "spondylocostal dysostosis" [DISEASE] OR NCT00001754 [ID-NUMBER] OR NCT00854828 [ID-NUMBER] OR NCT01087034 [ID-NUMBER]

Bracing During Infantile Scoliosis: Airways Study (MASI)

This study has been completed.
Sponsor:
Collaborator:
Ecole Nationale Supérieure des Arts et Metiers
Information provided by (Responsible Party):
Dr Nicolas LEBOULANGER, Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau
ClinicalTrials.gov Identifier:
NCT01087034
First received: March 12, 2010
Last updated: June 11, 2012
Last verified: June 2012
  Purpose

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 Intervention
Scoliosis
Device: Acoustic reflection method evaluation
Radiation: EOS™
Other: Non invasive respiratory muscle assessment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bracing During Infantile Scoliosis: Airways Study by Acoustic Method, EOS™ Acquisition and Noninvasive Respiratory Muscles Assessment

Resource links provided by NLM:


Further study details as provided by Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau:

Primary Outcome Measures:
  • Impact of bracing on airways [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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)


Enrollment: 15
Study Start Date: February 2010
Study Completion Date: June 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01087034

Locations
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
Principal Investigator: Nicolas LEBOULANGER, MD Assistance Publique - Hôpitaux de Paris
Study Director: Brigitte FAUROUX, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Responsible Party: Dr Nicolas LEBOULANGER, Dr, Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau
ClinicalTrials.gov Identifier: NCT01087034     History of Changes
Other Study ID Numbers: MA-SInf
Study First Received: March 12, 2010
Last Updated: June 11, 2012
Health Authority: France: Ministry of Health

Keywords provided by 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:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 18, 2014