Bracing During Infantile Scoliosis: Airways Study

NCT01087034 | Completed

• 1 other identifier: MA-SInf
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 2

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™)

Conditions

Scoliosis

Keywords

Infantile scoliosis; bracing; acoustic reflection method; EOS™; noninvasive; upper airways; thoracic penetration index; Idiopathic juvenile evolutive thoracic scoliosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Milwaukee brace

Children with an infantile scoliosis requiring Milwaukee bracing

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

Cheneaux brace

Children with an infantile scoliosis requiring Cheaneaux bracing

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

Interventions

Acoustic reflection method evaluation DEVICE

Evaluation of airways by acoustic relection method, with and without the bracing device

Cheneaux brace; Milwaukee brace

EOS™ RADIATION

Scoliosis and thoracic penetration index evaluation by EOS™ acquisition, with and without the bracing device

Cheneaux brace; Milwaukee brace

Non invasive respiratory muscle assessment OTHER

Non invasive respiratory muscles assessment, with and without the bracing device.

Cheneaux brace; Milwaukee brace

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with evolutive juvenile thoracic scoliosis requiring either a Milwaukee or a Cheneaux brace

You may qualify if:

• children with evolutive juvenile thoracic scoliosis
• with a Cobb angle ≥ 30°
• requiring either a Milwaukee or a Cheneaux brace
• in a stable respiratory state

You may not qualify if:

• history of spine surgery

Sponsors & Collaborators

• Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau: lead
• Ecole Nationale Supérieure des Arts et Metiers: collaborator

Study Sites (2)

Armand Trousseau University Hospital

Paris, 75012, France

Location

Ecole Nationale Supérieure des Arts et Metiers

Paris, 75013, France

Location

Related Publications (5)

• 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.

  PMID: 9457181 BACKGROUND

• 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.

  PMID: 18582707 BACKGROUND

• 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.

  PMID: 18812914 BACKGROUND

• 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.

  PMID: 7314016 BACKGROUND

• 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.

  PMID: 16200029 BACKGROUND

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Nicolas LEBOULANGER, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Brigitte FAUROUX, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 12, 2010
• First Posted: March 15, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: June 1, 2011
• Last Updated: June 12, 2012

Record last verified: 2012-06

Locations

FR (2)