Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT05159258
Status:
COMPLETED
Last Update Posted:
2021-12-16
First Post:
2021-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Morphological Analysis and Classification of Posterior Malleolar Fractures Based on CT Scans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064386', 'term': 'Ankle Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D016512', 'term': 'Ankle Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-02', 'studyFirstSubmitDate': '2021-11-18', 'studyFirstSubmitQcDate': '2021-12-02', 'lastUpdatePostDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'posterior malleolar fracture classification', 'timeFrame': '2013-2019', 'description': 'Haraguchi, Bartonicek and Mason \\& Molloy classification'}, {'measure': 'area of posterior malleolar fragment', 'timeFrame': '2013-2019'}, {'measure': 'area of remaining stable plafond', 'timeFrame': '2013-2019'}, {'measure': 'length of remaining fibular notch', 'timeFrame': '2013-2019'}, {'measure': 'length of involving fibular notch', 'timeFrame': '2013-2019'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ankle fractures', 'Posterior malleolar fractures', 'Classification', 'Mechanism'], 'conditions': ['Morphological Analysis and Classification', 'Posterior Malleolar Fractures', 'CT Scans']}, 'descriptionModule': {'briefSummary': 'The study was to propose a classification system of posterior malleolar fractures by fracture lines with the use of CT scans, including 3D CT reconstruction, which can better understand morphological characteristics, analyze the mechanism and guide the surgeon to choose optimal approach and fixation.', 'detailedDescription': 'The investigators retrospectively analyzed consecutive patients with ankle fractures from January 2013 and December 2019 . Participants were included with OTA/AO type 44 fractures involving posterior malleolus and CT scans. The exclusion criteria were: (1) previous ankle surgery; (2) pathological fractures; (3) previous deformity in ankle joint; (4) age ≤16 years old. Finally, A total of 128 patients were included in this study. 128 consecutive participants with posterior malleolar fractures from January 2013 and December 2019. CT data were loaded into Mimics software (V20.0, Materialize), in which 3D CT reconstruction, morphological analysis and data measurements were made. Statistical analysis was performed using the Statistical Packages for Social Sciences V23.0 (SPSS, Chicago, IL, USA). Mann-Whitney U test were used. P value of \\< 0.05 was considered statistically significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'OTA/AO type 44 fractures involving posterior malleolus', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* OTA/AO type 44 fractures involving posterior malleolus and CT scans\n\nExclusion Criteria:\n\n* Previous ankle surgery\n* Pathological fractures\n* Previous deformity in ankle joint\n* Age ≤16 years old'}, 'identificationModule': {'nctId': 'NCT05159258', 'briefTitle': 'Morphological Analysis and Classification of Posterior Malleolar Fractures Based on CT Scans', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Morphological Analysis and Classification of Posterior Malleolar Fractures Based on CT Scans', 'orgStudyIdInfo': {'id': 'MACPMFCTscans'}}, 'armsInterventionsModule': {'interventions': [{'type': 'OTHER'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'The results of the study are publicly available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Hailin Xu', 'investigatorAffiliation': "Peking University People's Hospital"}}}}