Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-04-18 @ 12:50 PM
Study NCT ID:
NCT03244969
Status:
WITHDRAWN
Last Update Posted:
2021-09-05
First Post:
2017-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone Healing Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Study was registered in another clinicaltrials.gov entry', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-31', 'studyFirstSubmitDate': '2017-08-07', 'studyFirstSubmitQcDate': '2017-08-07', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Granulation tissue formation', 'timeFrame': '23 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hematoma fracture, angiogenesis, bone formation'], 'conditions': ['Bone Fracture']}, 'descriptionModule': {'briefSummary': 'The aim of the research is to identify structural tissue changes in the early fracture hematomas.', 'detailedDescription': 'The fracture hematomas obtained during reconstructive bone surgery from patients with bone fractures will be examined. Histological methods and ultra-thin sections for electron microscopy will be used to identify structural tissue changes in the granulation tissue in different period of time after bone fracture. Immunohistochemical analysis will be performed to estimate the dynamic of proliferation, differentiation and cell migration during granulation and reticulofibrosis bone tissues development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with fractures of the upper and lower extremities underwent surgical bone recunstruction.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with fractures of the upper and lower extremities\n* Patients for whom the surgical bone reconstruction are indicated'}, 'identificationModule': {'nctId': 'NCT03244969', 'briefTitle': 'Bone Healing Study', 'organization': {'class': 'OTHER', 'fullName': 'Kazan Federal University'}, 'officialTitle': 'Study of the Granulation Tissue Formation in the Early Fracture Hematoma', 'orgStudyIdInfo': {'id': 'hematoma-2017'}}, 'contactsLocationsModule': {'locations': [{'zip': '119333', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Igor Plaksa', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kazan Federal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'aspirant of the morphology department', 'investigatorFullName': 'Mikhail Mavlikeev', 'investigatorAffiliation': 'Kazan Federal University'}}}}