Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-26 @ 1:44 PM
Study NCT ID:
NCT04597567
Status:
UNKNOWN
Last Update Posted:
2020-10-22
First Post:
2020-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcome of Implant Removal Versus Retention After Posterior Fixation of Thoracolumbar Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2022-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-16', 'studyFirstSubmitDate': '2020-10-16', 'studyFirstSubmitQcDate': '2020-10-16', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EQ-5D-5L questionnaire', 'timeFrame': 'Baseline', 'description': 'Measuring the quality of life after metal removal'}], 'secondaryOutcomes': [{'measure': 'Oswestry disability index', 'timeFrame': 'Baseline', 'description': 'Measuring the quality of life after metal removal or without removal'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metal removal'], 'conditions': ['Thoracolumbar']}, 'referencesModule': {'references': [{'pmid': '16814787', 'type': 'BACKGROUND', 'citation': 'Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.'}]}, 'descriptionModule': {'briefSummary': 'Comparing clinical outcome between patients who underwent metal removal and those who retained the metal'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-60 years\n* Posterior fixation\n* Six to nine months after fixation\n* Neurologically free patient\n* Fracture consolidation detected by ct\n* Types A3\\&A4 fractures\n\nExclusion Criteria:\n\n* unstable fractures B\\&C\n* pathological fractures\n* multilevel fractures\n* poly trauma patients'}, 'identificationModule': {'nctId': 'NCT04597567', 'briefTitle': 'Clinical Outcome of Implant Removal Versus Retention After Posterior Fixation of Thoracolumbar Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Clinical Outcome of Implant Removal Versus Retention After Posterior Fixation of Thoracolumbar Spine Fractures', 'orgStudyIdInfo': {'id': 'Metal removal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metal removal', 'interventionNames': ['Procedure: Metal removal']}, {'type': 'NO_INTERVENTION', 'label': 'Metal retention'}], 'interventions': [{'name': 'Metal removal', 'type': 'PROCEDURE', 'description': 'Implant removal after fracture consolidation after posterior fixation of thoracolumbar spine fractures', 'armGroupLabels': ['Metal removal']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mahmoud Samir, Physician', 'role': 'CONTACT', 'email': 'mahmoudsamir9463@gmail.com', 'phone': '01125098684'}, {'name': 'Mahmoud Fouad, Phd', 'role': 'CONTACT', 'email': 'Dr.m.fouad@gmail.com', 'phone': '0114227270'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Mahmoud Samir Mondy', 'investigatorAffiliation': 'Assiut University'}}}}