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Bracing During Infantile Scoliosis: Airways Study (MASI)

C

Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau

Status

Completed

Conditions

Scoliosis

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT01087034
MA-SInf

Details and patient eligibility

About

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™)

Enrollment

15 patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

15 participants in 2 patient groups

Milwaukee brace
Description:
Children with an infantile scoliosis requiring Milwaukee bracing
Treatment:
Other: Non invasive respiratory muscle assessment
Radiation: EOS™
Device: Acoustic reflection method evaluation
Cheneaux brace
Description:
Children with an infantile scoliosis requiring Cheaneaux bracing
Treatment:
Other: Non invasive respiratory muscle assessment
Radiation: EOS™
Device: Acoustic reflection method evaluation

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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