Clinical trial NCT01087034: Bracing During Infantile Scoliosis: Airways Study
Official title: Bracing During Infantile Scoliosis: Airways Study by Acoustic Method, EOS™ Acquisition and Noninvasive Respiratory Muscles Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scoliosis
Keywords: Infantile scoliosis
bracing
acoustic reflection method
EOS™
noninvasive
upper airways
thoracic penetration index
Idiopathic juvenile evolutive thoracic scoliosis
Lead sponsor: Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau
Sponsor class: OTHER
Collaborators: name: Ecole Nationale Supérieure des Arts et Metiers
First posted: 2010-03-15
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with evolutive juvenile thoracic scoliosis requiring either a Milwaukee or a Cheneaux brace

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™)


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

Primary outcomes:
measure: Impact of bracing on airways
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Armand Trousseau University Hospital
city: Paris
country: France
facility: Ecole Nationale Supérieure des Arts et Metiers
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Nicolas LEBOULANGER, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Brigitte FAUROUX, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Donnelly LF, Bisset GS 3rd. Airway compression in children with abnormal thoracic configuration. Radiology. 1998 Feb;206(2):323-6. doi: 10.1148/radiology.206.2.9457181.
citation: Dubousset J, Charpak G, Skalli W, de Guise J, Kalifa G, Wicart P. [Skeletal and spinal imaging with EOS system]. Arch Pediatr. 2008 Jun;15(5):665-6. doi: 10.1016/S0929-693X(08)71868-2. No abstract available. French.
citation: Heary RF, Bono CM, Kumar S. Bracing for scoliosis. Neurosurgery. 2008 Sep;63(3 Suppl):125-30. doi: 10.1227/01.NEU.0000320387.93907.97.
citation: Jones RS, Kennedy JD, Hasham F, Owen R, Taylor JF. Mechanical inefficiency of the thoracic cage in scoliosis. Thorax. 1981 Jun;36(6):456-61. doi: 10.1136/thx.36.6.456.
citation: Margonato V, Fronte F, Rainero G, Merati G, Veicsteinas A. Effects of short term cast wearing on respiratory and cardiac responses to submaximal and maximal exercise in adolescents with idiopathic scoliosis. Eura Medicophys. 2005 Jun;41(2):135-40.