Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2026-01-02 @ 10:58 AM
Study NCT ID:
NCT02950532
Status:
COMPLETED
Last Update Posted:
2020-08-13
First Post:
2016-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016103', 'term': 'Spinal Fractures'}, {'id': 'D013124', 'term': 'Spinal Injuries'}, {'id': 'D007738', 'term': 'Kyphosis'}], 'ancestors': [{'id': 'D019567', 'term': 'Back Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-11', 'studyFirstSubmitDate': '2016-10-18', 'studyFirstSubmitQcDate': '2016-10-28', 'lastUpdatePostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Accuracy of CT scan measurements', 'timeFrame': 'CT scans, MRI and x-rays were taken on admission into hospital after the patient got a thoracolumbar fracture. These images will be retrospectively analyzed (eligible images are from the date of the fracture up to 3 days after the event).', 'description': 'Accuracy describes how closely the measured value is to the true value and is an indicator of systematic errors. The accuracy of measurements of each CT scan parameter will be compared between the participating sites.'}, {'measure': 'Inter-rater reliability', 'timeFrame': 'CT scans, MRI and x-rays were taken on admission into hospital after the patient got a thoracolumbar fracture. These images will be retrospectively analyzed (eligible images are from the date of the fracture up to 3 days after the event).', 'description': 'The inter-rater reliability is defined as the percent agreement between the measurements of the different parameters by the different observers. The CT scans and radiographs (if available) distributed to the participating sites will be measured at each site by all participating MDs within each team or at least by one trained PI.'}], 'primaryOutcomes': [{'measure': 'Sensitivity of Local kyphosis (LK) and/or Inter-spinous distanceI (SD)', 'timeFrame': 'CT scans, MRI and x-rays were taken on admission into hospital after the patient got a thoracolumbar fracture. These images will be retrospectively analyzed (eligible images are from the date of the fracture up to 3 days after the event).', 'description': 'Sensitivity of LK and/or ISD Is defined as the proportion of patients with PLC injury correctly diagnosed by an increase in LK and/or ISD difference compared to MRI. The Specificity si defined as the proportion of patients with PLC injury correctly diagnosed by an increase in LK and/or ISD difference compared to MRI. The gold standard is a diagnostic test and it is the best accepted test that is assumed to be able to determine the true disease state. It is considered as the reference method or the best test available.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity and specificity of superior-inferior end plate angle (SIEA)', 'timeFrame': 'CT scans, MRI and x-rays were taken on admission into hospital after the patient got a thoracolumbar fracture. These images will be retrospectively analyzed (eligible images are from the date of the fracture up to 3 days after the event).', 'description': 'Is defined as the proportion of patients with PLC injury correctly diagnosed by a increase in SIEA compared to MRI.'}, {'measure': 'Sensitivity and specificity of vertebral body height (BH)', 'timeFrame': 'CT scans, MRI and x-rays were taken on admission into hospital after the patient got a thoracolumbar fracture. These images will be retrospectively analyzed (eligible images are from the date of the fracture up to 3 days after the event).', 'description': 'Is defined as the proportion of patients with PLC injury correctly diagnosed by an decrease in BH compared to MRI.'}, {'measure': 'Sensitivity and specificity of inter-pedicular distance (IPD)', 'timeFrame': 'CT scans, MRI and x-rays were taken on admission into hospital after the patient got a thoracolumbar fracture. These images will be retrospectively analyzed (eligible images are from the date of the fracture up to 3 days after the event).', 'description': 'Is defined as the proportion of patients with PLC injury correctly diagnosed by a increase in IPD compared to MRI.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Posterior ligamentous complex', 'Thoracolumbar fractures', 'Interspinous distance', 'Local kyphosis'], 'conditions': ['Spinal Deformity', 'Spinal Fractures', 'Spinal Injuries', 'Kyphosis']}, 'descriptionModule': {'briefSummary': 'The objective of this investigation is to confirm the results obtained in a pilot study showing that certain radiological parameters based on computed tomography (CT) scans seem to reliably detect posterior ligament complex (PLC) injury without the need for Magnetic Resonance Imaging (MRI)', 'detailedDescription': 'Integrity of posterior ligament complex (PLC) has an important bearing on the treatment strategies for thoracolumbar (TL) fractures. Magnetic Resonance Imaging (MRI) is the gold standard to confirm PLC injury. The routine use of MRI has its limitations especially since in most trauma centers MRI is not the primary assessment for TL fractures due to reduced availability, increased cost and its adverse applicability in trauma setting and in case of a polytrauma. In contrast computed tomography (CT) scans are an integral part of trauma evaluation protocols, are accurate in spine fracture diagnosis and are performed in less time, making them suitable to assess polytrauma scenarios. In a recent pilot study, a number of radiological parameters based on CT scans have shown to reliably detect PLC injury when compared to MRI. The aim of the study is to reconfirm and validate these CT based parameters to assess PLC injury compared to MRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The participating study sites will retrospectively identify all eligible patients in the medical charts (i.e. who meet all of the inclusion and none of the exclusion criteria). If required by local regulations, patients choosing to participate will sign and date an informed consent form (ICF).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 60 years\n* A3/A4 TL fracture between T11-L2 with or without PLC injury\n* Pre-treatment CT scan and MRI. Radiographs (if available)\n* Signed Informed consent, if required by EC/IRB\n\nExclusion Criteria:\n\n* Pathological fractures\n* Multilevel contiguous and non-contiguous injuries\n* Fractures with obvious spinous process split indicating tension band failure such as AO type B1 injuries\n* Fractures with translation injuries or dislocations such as AO type C injuries'}, 'identificationModule': {'nctId': 'NCT02950532', 'acronym': 'PAM', 'briefTitle': 'Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures', 'organization': {'class': 'OTHER', 'fullName': 'AO Innovation Translation Center'}, 'officialTitle': 'Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures (T11-L2): A Diagnostic Test Study to Analyze Sensitivity and Specificity', 'orgStudyIdInfo': {'id': 'AOCID_PAM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Retrospective radiological evaluation in cases presenting A3 or A4 TL burst fractures (AOSpine classification) between T11 to L2 with or without suspected PLC injury', 'interventionNames': ['Other: Retrospective radiological evaluation']}], 'interventions': [{'name': 'Retrospective radiological evaluation', 'type': 'OTHER', 'description': 'Radiological evaluation will be performed in already existing imaging exams. Superior-inferior end plate angle (SIEA), vertebral body height (BH), local kyphosis (LK), inter-spinous distance (ISD) and inter-pedicular distance (IPD) will be measured in CT scans and radiographs (if available). PLC injury will be determinated with the gold standard method (MRI).', 'armGroupLabels': ['Cases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310003', 'city': 'Hangzhou', 'country': 'China', 'facility': 'The 1st Affiliated Hospital of Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '71526', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut Universtiy Hospitals', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}, {'zip': '641 011', 'city': 'Coimbatore', 'country': 'India', 'facility': 'Ganga Hospital', 'geoPoint': {'lat': 11.00555, 'lon': 76.96612}}, {'zip': '118765', 'city': 'Uijeongbu-si', 'country': 'South Korea', 'facility': "Uijeongbu St. Mary's Hospital", 'geoPoint': {'lat': 37.7415, 'lon': 127.0474}}, {'zip': 'BT12 6BA', 'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'Royal Victoria Hospital', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}], 'overallOfficials': [{'name': 'Shanmuganathan Rajasekaran, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ganga Hospital'}, {'name': 'Test Testing, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'TESTING'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AO Clinical Investigation and Publishing Documentation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}