Ignite Creation Date:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2026-01-01 @ 7:23 AM
Study NCT ID:
NCT05579795
Status:
UNKNOWN
Last Update Posted:
2022-11-03
First Post:
2022-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Management and Outcome of Tethered Cord Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009436', 'term': 'Neural Tube Defects'}], 'ancestors': [{'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-11-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2024-12-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-01', 'studyFirstSubmitDate': '2022-10-03', 'studyFirstSubmitQcDate': '2022-10-11', 'lastUpdatePostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor power', 'timeFrame': 'Two years', 'description': 'Outcome of Detethering of the Tethered spinal cord according to Motor power of the lower limbs 5 grades 0: No visible muscle contraction\n\n1. Visible muscle contraction with no or trace movement\n2. Limb movement, but not against gravity\n3. Movement against gravity but not resistance\n4. Movement against at least some resistance supplied by the examiner\n5. Full strength'}, {'measure': 'Sensations', 'timeFrame': 'Two years', 'description': 'Outcome of Detethering of the Tethered spinal cord according to the sensations of lower limbs , is there decreased sensations of lower limbs and if improved or not'}, {'measure': "Sphincter's function", 'timeFrame': 'Two years', 'description': 'Outcome of Detethering of the Tethered spinal cord according to is there urinary incontinence or stool incontinence and if improved or not'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tethered Cord Syndrome']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess surgical management and outcome of Tethered cord syndrome', 'detailedDescription': 'Tethered cord syndrome (TCS) is a developmental abnormality of the neuroaxis which is usually diagnosed in childhood. The actual tethering has been attributed to a variety of pathologic entities, including a thickened tight filum terminale , intradural lipomas with or without a connecting extradural component, intradural fibrous adhesions, diastematomyelia, and adherence of the neural placode following previous closure of a myelomeningocele. However, sufficient differences in the mode of onset, clinical manifestations, and outcome exist between pediatric and adolescent patients with tethered cord to warrant a more detailed analysis of the adult syndrome. The most problematic technical consideration in surgery for the release of the tethered cord is how to preserve functioning neural elements and rebuild the dural sac to avoid CSF leak. The purpose of this study is to review causes of Tethered cord, clinical presentation, diagnostic tools, treatment options and outcome in school-aged children, adolescents, and young adults with Tethered cord.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Males and Females below 16 years old with Tethered cord syndome', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Tethered cord syndrome presenting at our institute\n* Patients with spinal dysraphism\n* Lipomyelomeningocele with Tethered cord\n* patients presented with neurological deficit after lipomyelomeningocele repair due to Tethered cord\n* patients presented with neurological deficit after myelomeningocele repair due to Tethered cord\n* Diastematomyelia with Tethered cord - Tethered cord due to filum terminale.\n* Tethered cord due to fibrous adhesions\n\nExclusion Criteria:\n\n* Asymptomatic Patients with Tethered cord discovered accidentally'}, 'identificationModule': {'nctId': 'NCT05579795', 'briefTitle': 'Surgical Management and Outcome of Tethered Cord Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Tethered Cord Syndrome: Surgical Management and Outcome', 'orgStudyIdInfo': {'id': 'Tethered Cord Syndrome'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Detethering of the spinal cord', 'type': 'PROCEDURE', 'description': 'Release of the tethered spinal cord'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Amr Gamal Hussein, GP', 'role': 'CONTACT', 'email': 'amrgamalz@yahoo.com', 'phone': '01067651618', 'phoneExt': '+2'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'two years', 'ipdSharing': 'YES', 'description': 'The aim of this study is to assess surgical management and outcome of Tethered cord syndrome.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amr Gamal Hussein Mohamed', 'investigatorAffiliation': 'Assiut University'}}}}