Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-31 @ 3:42 PM
Study NCT ID:
NCT01087034
Status:
COMPLETED
Last Update Posted:
2012-06-12
First Post:
2010-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bracing During Infantile Scoliosis: Airways Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-11', 'studyFirstSubmitDate': '2010-03-12', 'studyFirstSubmitQcDate': '2010-03-12', 'lastUpdatePostDateStruct': {'date': '2012-06-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of bracing on airways', 'timeFrame': '6 months', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Infantile scoliosis', 'bracing', 'acoustic reflection method', 'EOS™', 'noninvasive', 'upper airways', 'thoracic penetration index', 'Idiopathic juvenile evolutive thoracic scoliosis'], 'conditions': ['Scoliosis']}, 'referencesModule': {'references': [{'pmid': '9457181', 'type': 'BACKGROUND', '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.'}, {'pmid': '18582707', 'type': 'BACKGROUND', '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.'}, {'pmid': '18812914', 'type': 'BACKGROUND', '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.'}, {'pmid': '7314016', 'type': 'BACKGROUND', '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.'}, {'pmid': '16200029', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe EOS™ device allows a double incidence, full body, and low-dose X-ray acquisition with thoracic 3D reconstruction.\n\nThe 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™)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with evolutive juvenile thoracic scoliosis requiring either a Milwaukee or a Cheneaux brace', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children with evolutive juvenile thoracic scoliosis\n* with a Cobb angle ≥ 30°\n* requiring either a Milwaukee or a Cheneaux brace\n* in a stable respiratory state\n\nExclusion Criteria:\n\n* history of spine surgery'}, 'identificationModule': {'nctId': 'NCT01087034', 'acronym': 'MASI', 'briefTitle': 'Bracing During Infantile Scoliosis: Airways Study', 'organization': {'class': 'OTHER', 'fullName': "Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau"}, 'officialTitle': 'Bracing During Infantile Scoliosis: Airways Study by Acoustic Method, EOS™ Acquisition and Noninvasive Respiratory Muscles Assessment', 'orgStudyIdInfo': {'id': 'MA-SInf'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Milwaukee brace', 'description': 'Children with an infantile scoliosis requiring Milwaukee bracing', 'interventionNames': ['Device: Acoustic reflection method evaluation', 'Radiation: EOS™', 'Other: Non invasive respiratory muscle assessment']}, {'label': 'Cheneaux brace', 'description': 'Children with an infantile scoliosis requiring Cheaneaux bracing', 'interventionNames': ['Device: Acoustic reflection method evaluation', 'Radiation: EOS™', 'Other: Non invasive respiratory muscle assessment']}], 'interventions': [{'name': 'Acoustic reflection method evaluation', 'type': 'DEVICE', 'description': 'Evaluation of airways by acoustic relection method, with and without the bracing device', 'armGroupLabels': ['Cheneaux brace', 'Milwaukee brace']}, {'name': 'EOS™', 'type': 'RADIATION', 'description': 'Scoliosis and thoracic penetration index evaluation by EOS™ acquisition, with and without the bracing device', 'armGroupLabels': ['Cheneaux brace', 'Milwaukee brace']}, {'name': 'Non invasive respiratory muscle assessment', 'type': 'OTHER', 'description': 'Non invasive respiratory muscles assessment, with and without the bracing device.', 'armGroupLabels': ['Cheneaux brace', 'Milwaukee brace']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Armand Trousseau University Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Ecole Nationale Supérieure des Arts et Metiers', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Nicolas LEBOULANGER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Brigitte FAUROUX, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau", 'class': 'OTHER'}, 'collaborators': [{'name': 'Ecole Nationale Supérieure des Arts et Metiers', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Dr Nicolas LEBOULANGER', 'investigatorAffiliation': "Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau"}}}}