Bracing During Infantile Scoliosis: Airways Study (MASI)

• ClinicalTrials.gov Identifier: NCT01087034
• Recruitment Status: Completed
• First Posted: March 15, 2010
• Last Update Posted: June 12, 2012
• Sponsor: Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau
• Collaborator: Ecole Nationale Supérieure des Arts et Metiers
• Information provided by (Responsible Party): Dr Nicolas LEBOULANGER, Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau

Tracking Information

• First Submitted Date: March 12, 2010
• First Posted Date: March 15, 2010
• Last Update Posted Date: June 12, 2012
• Study Start Date: February 2010
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 12, 2010)

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)

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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 Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Children with evolutive juvenile thoracic scoliosis requiring either a Milwaukee or a Cheneaux brace
• Condition: 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.

Study Groups/Cohorts

• Milwaukee brace
  Children with an infantile scoliosis requiring Milwaukee bracing
  Interventions:

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

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

Publications *

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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 11, 2012): 15
• Original Estimated Enrollment (submitted: March 12, 2010): 30
• Actual Study Completion Date: June 2011
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01087034
• Other Study ID Numbers: MA-SInf
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr Nicolas LEBOULANGER, Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau
• Study Sponsor: Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau
• Collaborators: Ecole Nationale Supérieure des Arts et Metiers

Investigators

• Principal Investigator: Nicolas LEBOULANGER, MD; Assistance Publique - Hôpitaux de Paris
• Study Director: Brigitte FAUROUX, MD, PhD; Assistance Publique - Hôpitaux de Paris

• PRS Account: Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau
• Verification Date: June 2012