Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2026-04-21 @ 2:53 PM
Study NCT ID:
NCT02338258
Status:
UNKNOWN
Last Update Posted:
2015-01-14
First Post:
2014-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study of the Nonunion of Long Tubular Bone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-11', 'studyFirstSubmitDate': '2014-12-26', 'studyFirstSubmitQcDate': '2015-01-11', 'lastUpdatePostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The healing rate', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diaphyses']}, 'descriptionModule': {'briefSummary': 'The purpose of the study to supplied the diagnostic and treatment criteria of the nonunion of the long tubular bone after treatment of Intramedallery nailing'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient who had the nonunion of long tubular bone\n2. The patient who was the age of 14 \\~ 65 years old.\n3. The patient who complete the follow-up conditions.\n4. The patient who has independent behavior ability.\n5. The patient who volunteered for signed informed consent\n\nExclusion Criteria:\n\n1. Infectious nonunion of the long turubar bone\n2. Pathological fracture.\n3. The immune system disease.\n4. Cancer'}, 'identificationModule': {'nctId': 'NCT02338258', 'briefTitle': 'The Study of the Nonunion of Long Tubular Bone', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Jishuitan Hospital'}, 'officialTitle': 'The Prospective、Randomized、Comparative Clinical Study About the Two Operation Methods Between Anti-rotational Plate Group and Exchanged Intramedullary Nailgroup to Treat the Nonunion of Long Tubular Bone After Intramedullary Nail Fixation', 'orgStudyIdInfo': {'id': 'Z141107002514086'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The Anti-rotational plate group', 'description': 'The method was used to control the rotational unstabilization at the fracture site', 'interventionNames': ['Device: Anti-rotational plate', 'Device: Exchanged Intramedullary nailing']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Exchanged Intramedullary nailing group', 'description': 'the method Provided the axial and rotational stability', 'interventionNames': ['Device: Exchanged Intramedullary nailing']}], 'interventions': [{'name': 'Anti-rotational plate', 'type': 'DEVICE', 'armGroupLabels': ['The Anti-rotational plate group']}, {'name': 'Exchanged Intramedullary nailing', 'type': 'DEVICE', 'armGroupLabels': ['Exchanged Intramedullary nailing group', 'The Anti-rotational plate group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '730000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xianzhi XZ Ma, MD', 'role': 'CONTACT', 'email': '870248900@qq.com', 'phone': '+8615201542942'}], 'facility': 'The orthopaedic Trauma center of Jishuitan Hospital in Beijing', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Bosong BS zhang, MD', 'role': 'CONTACT', 'email': 'zhangbosong@sina.com', 'phone': '+8613621219567', 'phoneExt': '+86'}], 'overallOfficials': [{'name': 'Bosong Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jishuitan hospital in Beijing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Jishuitan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorFullName': 'Xianzhi Ma', 'investigatorAffiliation': 'Beijing Jishuitan Hospital'}}}}