Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2026-02-25 @ 5:52 PM
Study NCT ID:
NCT02856828
Status:
TERMINATED
Last Update Posted:
2019-10-15
First Post:
2016-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Novel Use of an Enhanced Fluoroscopic Imaging Device to Reduce Radiation Exposure and Operative Time During Intramedullary Nailing of Hip Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rachel.reilly@duke.edu', 'phone': '919-668-0291', 'title': 'Dr. Rachel Reilly', 'organization': 'Duke University Health Systems'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Only two radiation dosimeters were purchased. Therefore, there is no radiation exposure data for the secondary surgeon.'}}, 'adverseEventsModule': {'timeFrame': 'During surgery and post-operative time of hospital admission, approximately 2 days', 'eventGroups': [{'id': 'EG000', 'title': 'Digital Image Enhancement (DIE) Group', 'description': 'A novel digital image enhancement technology will be used intraoperatively\n\nDIE: digital image enhancement', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Standard intraoperative imaging will be used intraoperatively', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital Image Enhancement (DIE) Group', 'description': 'The radiation exposure to the patient in the digital image enhancement group.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The radiation exposure to the patient in the standard intraoperative imaging group.'}], 'classes': [{'title': 'Participant 1', 'categories': [{'measurements': [{'value': '5.12', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Participant was in the DIE Group.', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Participant was in the Control Group.', 'groupId': 'OG000'}, {'value': '12.9', 'groupId': 'OG001'}]}]}, {'title': 'Participant 3', 'categories': [{'measurements': [{'value': '9.79', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Participant was in the DIE Group.', 'groupId': 'OG001'}]}]}, {'title': 'Participant 4', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Participant was in the Control Group.', 'groupId': 'OG000'}, {'value': '7.93', 'groupId': 'OG001'}]}]}, {'title': 'Participant 5', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Participant was in the Control Group.', 'groupId': 'OG000'}, {'value': '15.41', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'intraoperatively', 'unitOfMeasure': 'mGy', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital Image Enhancement (DIE) Group', 'description': 'The radiation exposure to the primary surgeon of the participants from the novel digital image enhancement group.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The radiation exposure of the primary surgeon of the participants in the standard intraoperative imaging group.'}], 'classes': [{'title': 'Primary Surgeon 1', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'This participant was not in the control group.', 'groupId': 'OG001'}]}]}, {'title': 'Primary Surgeon 2', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This participant was not in the Digital Image Enhancement group.', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Primary Surgeon 3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'This participant was not in the control group.', 'groupId': 'OG001'}]}]}, {'title': 'Primary Surgeon 4', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This participant was not in the Digital Image Enhancement group.', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Primary Surgeon 5', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This participant was not in the Digital Image Enhancement group.', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'intraoperatively', 'unitOfMeasure': 'mrem', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Radiation Exposure to Scrub Tech During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital Image Enhancement (DIE) Group', 'description': 'The radiation exposure to the surgical technician of the participants from the novel digital image enhancement group.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The radiation exposure of the surgical technician of the participants in the standard intraoperative imaging group.'}], 'classes': [{'title': 'Surgical Technician 1', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'This participant was not in the Control group.', 'groupId': 'OG001'}]}]}, {'title': 'Surgical Technician 2', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This participant was not in the Digital Image Enhancement group.', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Surgical Technician 3', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'This participant was not in the Control group.', 'groupId': 'OG001'}]}]}, {'title': 'Surgical Technician 4', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This participant was not in the Digital Image Enhancement group.', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Surgical Technician 5', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This participant was not in the Digital Image Enhancement group.', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'intraoperatively', 'unitOfMeasure': 'mrem', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Image Quality and Reproducibility of Desired Images', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Image Quality of the Digital Image Enhancement (DIE) Group', 'description': 'The image quality, on a scale of 1-10 with 10 being the best quality, obtained for the novel digital image enhancement technology that was used intraoperatively.\n\nDIE: digital image enhancement'}, {'id': 'OG001', 'title': 'Image Quality of the Control Group', 'description': 'The image quality, on a scale of 1-10 with 10 being the best quality, obtained for the standard intraoperative imaging that was used intraoperatively.'}], 'classes': [{'title': 'Participant 1 Image', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'This participant was not in the Control group.', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2 Image', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This participant was not in the Digital Image Enhancement group.', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Participant 3 Image', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'This participant was not in the Control group.', 'groupId': 'OG001'}]}]}, {'title': 'Participant 4 Image', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This participant was not in the Digital Image Enhancement group.', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Participant 5 Image', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This participant was not in the Digital Image Enhancement group.', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'intraoperatively', 'description': 'Measured by questionnaire related to image quality. Quality scale of 1-10, 1 being poor image quality and 10 being excellent image quality.', 'unitOfMeasure': 'Quality Scale of 1-10, 10 being the best', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Operative Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital Image Enhancement (DIE) Group', 'description': 'Operative time of the participants in the Digital Image Enhancement Group.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Operative time of the participants in the Standard Intraoperative Group.'}], 'classes': [{'title': 'Participant 1', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'This participant was not in the Control group.', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This participant was not in the Digital Image Enhancement group.', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}, {'title': 'Participant 3', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'This participant was not in the Control group.', 'groupId': 'OG001'}]}]}, {'title': 'Participant 4', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This participant was not in the Digital Image Enhancement group.', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'Participant 5', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This participant was not in the Digital Image Enhancement group.', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'intraoperatively', 'unitOfMeasure': 'minutes', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Digital Image Enhancement (DIE) Group', 'description': 'A novel digital image enhancement technology will be used intraoperatively\n\nDIE: digital image enhancement'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Standard intraoperative imaging will be used intraoperatively'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Digital Image Enhancement (DIE) Group', 'description': 'A novel digital image enhancement technology will be used intraoperatively\n\nDIE: digital image enhancement'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Standard intraoperative imaging will be used intraoperatively'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Hip fracture patients only, not surgeons'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-09-29', 'size': 234552, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-09-12T14:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Closed due to slow enrollment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'dispFirstSubmitDate': '2019-04-05', 'completionDateStruct': {'date': '2018-02-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-04', 'studyFirstSubmitDate': '2016-07-28', 'dispFirstSubmitQcDate': '2019-04-05', 'resultsFirstSubmitDate': '2019-09-12', 'studyFirstSubmitQcDate': '2016-08-02', 'dispFirstPostDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-12', 'studyFirstPostDateStruct': {'date': '2016-08-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge', 'timeFrame': 'intraoperatively'}, {'measure': 'Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge', 'timeFrame': 'intraoperatively'}, {'measure': 'Radiation Exposure to Scrub Tech During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge', 'timeFrame': 'intraoperatively'}], 'secondaryOutcomes': [{'measure': 'Image Quality and Reproducibility of Desired Images', 'timeFrame': 'intraoperatively', 'description': 'Measured by questionnaire related to image quality. Quality scale of 1-10, 1 being poor image quality and 10 being excellent image quality.'}, {'measure': 'Operative Time', 'timeFrame': 'intraoperatively'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Radiation Exposure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of a novel digital image enhancement (DIE) technology in reducing the radiation exposure to both the patient and surgical staff during standard intramedullary nail placement for treatment of hip fractures. Secondarily, to evaluate whether the image quality and reproducibility of desired images can be improved with use of the DIE technology. Finally, to evaluate whether DIE technology reduces total operative time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* closed hip fracture requiring intramedullary nailing\n\nExclusion Criteria:\n\n* age \\<18 years'}, 'identificationModule': {'nctId': 'NCT02856828', 'briefTitle': 'Novel Use of an Enhanced Fluoroscopic Imaging Device to Reduce Radiation Exposure and Operative Time During Intramedullary Nailing of Hip Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Novel Use of an Enhanced Fluoroscopic Imaging Device to Reduce Radiation Exposure and Operative Time During Intramedullary Nailing of Hip Fractures', 'orgStudyIdInfo': {'id': 'Pro00074745'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital Image Enhancement (DIE) Group', 'description': 'A novel digital image enhancement technology will be used intraoperatively', 'interventionNames': ['Device: DIE']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Standard intraoperative imaging will be used intraoperatively'}], 'interventions': [{'name': 'DIE', 'type': 'DEVICE', 'description': 'digital image enhancement', 'armGroupLabels': ['Digital Image Enhancement (DIE) Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}