Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-28 @ 5:39 AM
Study NCT ID:
NCT01370057
Status:
TERMINATED
Last Update Posted:
2017-07-21
First Post:
2011-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Thoraco-lumbo-sacral Orthoses (TLSOs) in the Treatment of Adolescent Idiopathic Scoliosis (AIS)
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Failure of Subject Recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-18', 'studyFirstSubmitDate': '2011-05-20', 'studyFirstSubmitQcDate': '2011-06-08', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Curve progression', 'timeFrame': 'Till cessation of growth or progression of curve severity to 50 degrees or more, patient will be followed once every 6 months, an average follow up of 3 years is expected', 'description': 'Curve progression to Cobb angle of 50 degrees or more'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adolescent Idiopathic Scoliosis', 'Scoliosis', 'AIS', 'Brace', 'TLSO'], 'conditions': ['Scoliosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the risk of curve progression in Adolescent Idiopathic Scoliosis for subjects treated with bracing as compared to those without bracing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed Diagnosis of AIS\n* Age ≥10, ≤15 years old\n* Risser 0, 1 or 2\n* Primary Cobb angle between 20 and 40 degrees (inclusive)\n* Apex (of at least one of the primary curves) caudal to T7\n* Pre-menarchal OR post-menarchal by ≤1 year\n* Physical and mental ability to adhere to bracing protocol\n\nExclusion Criteria:\n\n* Diagnosis of other musculoskeletal or developmental illnesses possibly responsible for the curvature\n* A history of previous surgical or orthotic treatment\n* Inability to read and understand Chinese'}, 'identificationModule': {'nctId': 'NCT01370057', 'briefTitle': 'The Use of Thoraco-lumbo-sacral Orthoses (TLSOs) in the Treatment of Adolescent Idiopathic Scoliosis (AIS)', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'The Use of TLSOs in the Treatment of Adolescent Idiopathic Scoliosis: A Prospective, Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'BRAIST HK PROTOCOL VER1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Treatment with bracing', 'interventionNames': ['Device: Thoraco-lumbo-sacral Orthosis']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Watchful waiting without bracing'}], 'interventions': [{'name': 'Thoraco-lumbo-sacral Orthosis', 'type': 'DEVICE', 'otherNames': ['The Thoraco-lumbo-sacral Orthosis is fabricated at Prosthetic & Orthotic Department at our research facility(Prince of Wales Hospital, Hong Kong SAR, China)'], 'description': 'Treatment with Thoraco-lumbo-sacral Orthosis for Adolescent Idiopathic Scoliosis', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'China', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'CHENG Chun-yiu Jack', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}