Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT07115602
Status:
COMPLETED
Last Update Posted:
2025-08-11
First Post:
2025-07-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Methodology to Transfer High Volumes of Data for Distant Expert Radiographic Evaluation of Pelvic Ring Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2025-07-16', 'studyFirstSubmitQcDate': '2025-08-06', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arbeitsgemeinschaft für Osteosynthesefragen / Orthopaedic Trauma Association (AO/OTA) classification', 'timeFrame': 'From enrollment to the end of primary injury evaluation at day 1', 'description': 'Each expert determines the AO/OTA classification of the pelvic ring injury presented by the patient (total = 28 pelvic ring injuries in 28 patients) following a 3 steps sequential imaging evaluation:\n\n1. Review of computed tomography images alone;\n2. Addition of a standard anteroposterior pelvic radiograph with a pelvic binder;\n3. Addition of a standard anteroposterior pelvic radiograph without a pelvic binder.\n\nEach one of the 3 provided classifications is recorded and compared to determine if standard anteroposterior pelvic radiographs (with and without a pelvic binder) add value to the information gained with computed tomography images alone in terms of injury classification.'}, {'measure': 'Young and Burgess classification', 'timeFrame': 'From enrollment to the end of primary injury evaluation at day 1', 'description': 'Each expert determines the Young and Burgess classification of the pelvic ring injury presented by the patient (total = 28 pelvic ring injuries in 28 patients) following a 3 steps sequential imaging evaluation: 1) Review of computed tomography images alone; 2) Addition of a standard anteroposterior pelvic radiograph with a pelvic binder; 3) Addition of a standard anteroposterior pelvic radiograph without a pelvic binder. Each one of the 3 provided classifications is recorded and compared to determine if standard anteroposterior pelvic radiographs (with and without a pelvic binder) add value to the information gained with computed tomography images alone in terms of injury classification.'}, {'measure': 'Pelvic ring mechanical stability assessment', 'timeFrame': 'From enrollment to the end of primary injury evaluation at day 1', 'description': 'Each expert determines the mechanical stability of the pelvic ring injury (pelvic ring fully stable, pelvic ring horizontally unstable, pelvic ring fully unstable) presented by the patient (total = 28 pelvic ring injuries in 28 patients) following a 3 steps sequential imaging evaluation: 1) Review of computed tomography images alone; 2) Addition of a standard anteroposterior pelvic radiograph with a pelvic binder; 3) Addition of a standard anteroposterior pelvic radiograph without a pelvic binder. Each one of the 3 provided assessments is recorded and compared to determine if standard anteroposterior pelvic radiographs (with and without a pelvic binder) add value to the information gained with computed tomography images alone in terms of mechanical stability assessment.'}, {'measure': 'Surgical fixation plan', 'timeFrame': 'From enrollment to the end of primary injury evaluation at day 1', 'description': 'Each expert determines the surgical fixation plan (no fixation needed, anterior fixation only, posterior fixation only, lumboelvic fixation only, anterior and posterior fixation, anterior and lumbopelvic fixation) for the pelvic ring injury presented by the patient (total = 28 pelvic ring injuries in 28 patients) following a 3 steps sequential imaging evaluation: 1) Review of computed tomography images alone; 2) Addition of a standard anteroposterior pelvic radiograph with a pelvic binder; 3) Addition of a standard anteroposterior pelvic radiograph without a pelvic binder. Each one of the 3 provided plans is recorded and compared to determine if standard anteroposterior pelvic radiographs (with and without a pelvic binder) add value to the information gained with computed tomography images alone in terms of surgical fixation planning.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['classification', 'assessment', 'computed tomography', 'stability', 'pelvic belt', 'pelvic ring injury', 'standard anteroposterior radiograph'], 'conditions': ['Pelvic Ring Injury']}, 'descriptionModule': {'briefSummary': 'The aim of this retrospective cohort study based on a prospectively filled registry was to determine whether standard anteroposterior pelvic radiographs with and without pelvic binder provide valuable information on pelvic ring injury anatomy and stability when compared to computed tomography images alone. The ultimate goal was to improve the management of these injuries in both emergency and definitive treatment.', 'detailedDescription': 'At the core of the study was a stepwise pelvic imaging evaluation of pelvic ring injury patients by a panel of international pelvic trauma experts. The assessment was conducted in 3 sequential steps:\n\n1. Review of computed tomography images alone.\n2. Addition of a standard anteroposterior pelvic radiograph with a pelvic binder.\n3. Addition of a standard anteroposterior pelvic radiograph without a pelvic binder.\n\nAt each step, experts independently classified the injury (Arbeitsgemeinschaft für Osteosynthsesfragen / Orthopaedic Trauma Association and Young and Burgess classifications), assessed mechanical stability and recommended definitive treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult pelvic ring injury patients operatively treated within 3 weeks from injury', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1\\) admission to the author's institution between January 2012 and December 2023;\n* 2\\) high-energy pelvic ring injury involving a non-pathologic pelvis (i.e., no prior injury, pathology, or surgery compromising image interpretation), surgically treated within three weeks of injury;\n* 3\\) age ≥18 years at the time of trauma.\n\nExclusion Criteria:\n\n* 1\\) imaging acquired after any kind of surgical stabilization (i.e. emergent external fixation), which could bias injury assessment;\n* 2\\) incomplete imaging dataset, defined as the absence of any of the following: pelvic computed tomography, standard anteroposterior pelvic radiograph with pelvic binder, and standard anteroposterior pelvic radiograph without pelvic binder;\n* 3\\) poor image quality, including incomplete pelvic coverage, computed tomography slice thickness \\>2 mm, motion artifacts, or incompatibility with the image viewer used for the study;\n* 4\\) documented (written or verbal) refusal to participate."}, 'identificationModule': {'nctId': 'NCT07115602', 'briefTitle': 'Methodology to Transfer High Volumes of Data for Distant Expert Radiographic Evaluation of Pelvic Ring Injuries', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Retrospective Multi-expert Diagnostic Imaging Evaluation of Pelvic Ring Injuries: Methodology for Transferring Large DICOM Data Volumes to Remote Experts, and Survey Designed to Isolate Information Obtained From Different Imaging Modalities', 'orgStudyIdInfo': {'id': 'VMOO_MDThesis_M_&_M'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pelvic ring injury patients with operative management within 3 weeks from injury', 'description': 'Pelvic ring injury patients with operative management within 3 weeks from injury'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '01.01.2025 for 6 months', 'ipdSharing': 'YES', 'description': 'De-identified radiographic images of the pelvis (computed tomography scanners, standard anteroposterior radiographs with and without pelvic binder)', 'accessCriteria': 'A panel of 8 international pelvic trauma experts was assembled based on their demonstrated expertise in the field and active involvement in relevant academic societies. These 8 experts will receive de-identified radiographic images to classifiy the injuries, evaluate pelvic stability and propose a treatment plan. No other patient data will be shared with the experts.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Axel Gamulin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr Axel GAMULIN, MD, PD, CC, FMH, Senior Staff Surgeon', 'investigatorFullName': 'Axel Gamulin', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}