Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-01-04 @ 11:15 PM
Study NCT ID:
NCT02133794
Status:
UNKNOWN
Last Update Posted:
2014-05-08
First Post:
2014-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tomosynthesis Use in Detecting Subtle Occult Hip Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008327', 'term': 'Mammography'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-05-06', 'studyFirstSubmitDate': '2014-04-23', 'studyFirstSubmitQcDate': '2014-05-06', 'lastUpdatePostDateStruct': {'date': '2014-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with hip fracture detected with tomosynthesis versus x-ray alone.', 'timeFrame': 'Participants will be followed up to 3 months post tomosynthesis exam.'}], 'secondaryOutcomes': [{'measure': 'ER wait time', 'timeFrame': 'End of study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hip fracture', 'Tomosynthesis', 'X-ray', 'Emergency room'], 'conditions': ['Hip Fracture']}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to determine if using tomosynthesis, in conjunction with x-ray, is better at detecting hip fractures than using x-ray alone. The goal of this study will be to include the use of tomosynthesis with x-ray as usual practice when a patient comes to the emergency room with symptoms of a hip fracture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged \\> 18 years who/se:\n* Present at the ER with a possible hip fracture and\n* Have a negative x-ray for a hip fracture\n* Physician has a high clinical suspicion of a hip fracture\n* Provide provision of informed consent\n\nExclusion Criteria:\n\n* Hip prosthesis on the same side of the suspected hip fracture\n* Other serious medical illness that is likely to interfere with study participation\n* Significant psychiatric illness, senility, dementia, alcohol or substance abuse, which could impair the ability to provide informed consent and to adhere to the trial procedures\n* Pregnant or suspected pregnancy'}, 'identificationModule': {'nctId': 'NCT02133794', 'briefTitle': 'Tomosynthesis Use in Detecting Subtle Occult Hip Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Medical Imaging Informatics Research Centre at McMaster'}, 'officialTitle': 'Tomosynthesis Use in Detecting Subtle Occult Hip Fractures', 'orgStudyIdInfo': {'id': 'Parasu-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tomosynthesis', 'interventionNames': ['Device: Tomosynthesis']}], 'interventions': [{'name': 'Tomosynthesis', 'type': 'DEVICE', 'otherNames': ['GE Discovery 650'], 'armGroupLabels': ['Tomosynthesis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Naveen Parasu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Juravinski Hospital', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Imaging Informatics Research Centre at McMaster', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Naveen Parasu', 'investigatorFullName': 'Naveen Parasu', 'investigatorAffiliation': 'Medical Imaging Informatics Research Centre at McMaster'}}}}