Bracing During Infantile Scoliosis: Airways Study

Scoliosis Clinical Trial

— MASI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01087034
• Other study ID #: MA-SInf
• Status: Completed
• Phase: N/A
• First received: March 12, 2010
• Last updated: June 11, 2012
• Start date: February 2010
• Est. completion date: June 2011

Study information

• Verified date: June 2012
• Source: Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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™)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Scoliosis

Intervention

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.

Locations

Country	Name	City	State
France	Armand Trousseau University Hospital	Paris
France	Ecole Nationale Supérieure des Arts et Metiers	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau	Ecole Nationale Supérieure des Arts et Metiers

Country where clinical trial is conducted

France, 

References & Publications (5)

Donnelly LF, Bisset GS 3rd. Airway compression in children with abnormal thoracic configuration. Radiology. 1998 Feb;206(2):323-6. — View 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. French. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of bracing on airways	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)	6 months	No