Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT06238804
Status:
WITHDRAWN
Last Update Posted:
2024-04-09
First Post:
2024-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characteristic Analysis and Surgical Exploration for Acetabular Roof Fractures: Multicenter Retrospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Due to limited funding, the study is now being withdrawn.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-07', 'studyFirstSubmitDate': '2024-01-23', 'studyFirstSubmitQcDate': '2024-01-31', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative outcome', 'timeFrame': '4 months', 'description': "Merle d'Aubigné score, fracture healing, reduction quality, etc"}], 'secondaryOutcomes': [{'measure': 'complication', 'timeFrame': '1 month', 'description': 'wound infection, iatrogenic injury of vessels and nerves, etc'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acetabular Fracture']}, 'descriptionModule': {'briefSummary': 'Acetabular roof was a crucial structure for maintaining the stability of hip joint; however, its important role was not especially emphasized in the Letournel-Judet classification system. Acetabular roof was segmented into the roof column and roof wall in Three-column classification and fracture in this area alone was defined as A3 injury. Radiographic data and functional outcome of A3 injury patients were reviewed to explore the characteristics and surgical strategy.', 'detailedDescription': 'Fracture data, surgical incision, operation time, blood loss, fracture healing， Reduction quality，functional outcome，and relevant complications'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients met the inclusion criteria were collected in this study.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-80 years, acute (\\<14 days) closed roof column/wall acetabular fractures (A3.1, A3.2 or A3.3) in Three-column classification, normal activity of the affected hip before the injury, received surgical reduction and internal fixation\n\nExclusion Criteria:\n\n* open fractures, pathologic fractures, limited range of motion (ROM) of the hip joint before the injury, conservative treatment, risk factors affecting bone healing (such as smoking and metabolic diseases) and noncompletion of the two-year follow-up'}, 'identificationModule': {'nctId': 'NCT06238804', 'acronym': 'CASEARF', 'briefTitle': 'Characteristic Analysis and Surgical Exploration for Acetabular Roof Fractures: Multicenter Retrospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Hebei Medical University Third Hospital'}, 'officialTitle': 'Characteristic Analysis and Surgical Exploration for Acetabular Roof Fractures: Multicenter Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'ZRP2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'fracture types', 'description': 'A3.1, A3.2, A3.3', 'interventionNames': ['Procedure: KL, Iliofemoral, Ilioinguinal, Iliac fossa and combined approaches']}], 'interventions': [{'name': 'KL, Iliofemoral, Ilioinguinal, Iliac fossa and combined approaches', 'type': 'PROCEDURE', 'otherNames': ['Fracture types'], 'description': 'A3.1, A3.2, A3.3', 'armGroupLabels': ['fracture types']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050051', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'Hebei Medical University Third Hospital', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}], 'overallOfficials': [{'name': 'Zhiyong Hou, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hebei Medical University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hebei Medical University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Ruipeng Zhang', 'investigatorAffiliation': 'Hebei Medical University Third Hospital'}}}}