Bracing During Infantile Scoliosis: Airways Study

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™)

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Key information

Conditions

Scoliosis Bone Diseases Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Armand Trousseau University Hospital, Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acoustic reflection method evaluation

Device

Evaluation of airways by acoustic relection method, with and without the bracing device

EOS™

Radiation

Scoliosis and thoracic penetration index evaluation by EOS™ acquisition, with and without the bracing device

Non invasive respiratory muscle assessment

Other

Non invasive respiratory muscles assessment, with and without the bracing device.

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau

Other

Collaborators

Ecole Nationale Supérieure des Arts et Metiers

Registry information

Official study title

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

Acronym: MASI

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2011
First posted: Mar 15, 2010
Registry last updated: Jun 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed