Bracing During Infantile Scoliosis: Airways Study

Completed

• Conditions: Scoliosis
• Interventions: Device: Acoustic reflection method evaluation; Radiation: EOS™; Other: Non invasive respiratory muscle assessment

• Registration Number: NCT01087034
• Lead Sponsor: 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™)

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-12
• Study First Submitted QC: 2010-03-12
• Study First Posted: 2010-03-15
• Primary Completion: 2010-07
• Study Completion: 2011-06
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-11
• Last Update Posted: 2012-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cheneaux brace	Non invasive respiratory muscle assessment	Children with an infantile scoliosis requiring Cheaneaux bracing
Milwaukee brace	Non invasive respiratory muscle assessment	Children with an infantile scoliosis requiring Milwaukee bracing
Cheneaux brace	EOS™	Children with an infantile scoliosis requiring Cheaneaux bracing
Milwaukee brace	Acoustic reflection method evaluation	Children with an infantile scoliosis requiring Milwaukee bracing
Milwaukee brace	EOS™	Children with an infantile scoliosis requiring Milwaukee bracing
Cheneaux brace	Acoustic reflection method evaluation	Children with an infantile scoliosis requiring Cheaneaux bracing

Primary Outcome Measures

Name	Time	Method
Impact of bracing on airways	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)

Trial Locations

Locations (2)

Armand Trousseau University Hospital; 🇫🇷 Paris, France

Ecole Nationale Supérieure des Arts et Metiers; 🇫🇷 Paris, France