Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT03562260
Status:
UNKNOWN
Last Update Posted:
2018-07-02
First Post:
2018-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bipolar Surgical Release in Congenital Muscular Torticollis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C535425', 'term': 'Congenital torticollis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'only 1 group in children who received the bipolar release'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2019-08-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-28', 'studyFirstSubmitDate': '2018-05-21', 'studyFirstSubmitQcDate': '2018-06-07', 'lastUpdatePostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ImageJ scoring system', 'timeFrame': 'no torticollis after 1 year of surgery', 'description': 'measurement from pictures of head and face compared to normal children score 1-3 in 5 measurement in total score of 15 as interval scale score has 4 grade 13-15 is excellent results score 10-12 good result 7-9 fair less than 6 score is poor result after surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Congenital Muscular Torticollis']}, 'referencesModule': {'references': [{'pmid': '3760169', 'type': 'BACKGROUND', 'citation': 'Lee EH, Kang YK, Bose K. Surgical correction of muscular torticollis in the older child. J Pediatr Orthop. 1986 Sep-Oct;6(5):585-9. doi: 10.1097/01241398-198609000-00011.'}, {'pmid': '21629376', 'type': 'BACKGROUND', 'citation': 'Sudesh P, Bali K, Mootha AK, Dhillon MS. Results of bipolar release in the treatment of congenital muscular torticolis in patients older than 10 years of age. J Child Orthop. 2010 Jun;4(3):227-32. doi: 10.1007/s11832-010-0254-x. Epub 2010 Mar 26.'}, {'pmid': '18591606', 'type': 'BACKGROUND', 'citation': 'Shim JS, Jang HP. Operative treatment of congenital torticollis. J Bone Joint Surg Br. 2008 Jul;90(7):934-9. doi: 10.1302/0301-620X.90B7.20339.'}]}, 'descriptionModule': {'briefSummary': 'The congenital muscular torticollis is common disease in children.The indication for surgery is the children have persist deformity after 1 year old.Many surgical treatment had proposed such as unipolar release and bipolar release.By author experience the bipolar release had better results from complete cut the muscle both origin and insertion.This study wants to study the results of treatment in term of recurrence of the deformity.', 'detailedDescription': 'the study perform in children with congenital muscular torticollis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. all children age ranged from 5-15 years old who received the surgical treatment by bipolar release in the hospital.\n\nExclusion Criteria:\n\n* 1\\. no history of surgery at the neck 2. no history of congenital anomalies and syndrome that effect the neck'}, 'identificationModule': {'nctId': 'NCT03562260', 'briefTitle': 'Bipolar Surgical Release in Congenital Muscular Torticollis', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Result of Bipolar Surgical Release in Congenital Muscular Torticollis', 'orgStudyIdInfo': {'id': 'si049/2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'children who had bipolar release', 'description': 'children who had bipolar release are included', 'interventionNames': ['Procedure: bipolar release']}], 'interventions': [{'name': 'bipolar release', 'type': 'PROCEDURE', 'description': 'the bipolar release is the surgery that cut the origin and insertion of the sternocleidomastoid muscle that cause the torticollis from its contracture', 'armGroupLabels': ['children who had bipolar release']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Prof.Dr.Kamolporn kaewpornsawan, MD.', 'role': 'CONTACT', 'email': 'kamolporn.kae@mahidol.ac.th', 'phone': '(66)024197968', 'phoneExt': '127'}], 'facility': 'Prof.Dr.Kamolporn Kaewpornsawan', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Prof.Dr.Kamolporn Kaewpornsawan, MD', 'role': 'CONTACT', 'email': 'kamolporn.kae@mahidol.ac.th', 'phone': '660814984227'}], 'overallOfficials': [{'name': 'Prof.Dr.Kamolporn Kaewpornsawan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Orthopaedic Surgery,Faculty of Medicine,Siriraj Hospital,Mahidol University,Bangkok,Thailand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no sharing IPD data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}