Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-02-25 @ 5:12 AM
Study NCT ID:
NCT04154202
Status:
UNKNOWN
Last Update Posted:
2019-11-06
First Post:
2019-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of NM/CT 870 DR Camera in the Diagnosis of Joint Prosthesis and Tibial Open Reduction and Internal Fixation (ORIF) Complications.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2021-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-04', 'studyFirstSubmitDate': '2019-10-29', 'studyFirstSubmitQcDate': '2019-11-04', 'lastUpdatePostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the role of NM imaging in the diagnosis work up of joint prosthesis and tibial ORIF complications by using GE NM/CT 870 DR camera and its accompanied tools..', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Infection']}, 'descriptionModule': {'briefSummary': "This is a prospective study. Patients' cohort is composed of 70 consecutive post joint replacement and post tibial ORIF patients, referred by their orthopedic surgeon to the Nuclear Medicine institute of Tel Aviv Sourasky Medical Center in the diagnostic work up of post operative bone infection and or mechanical loosening.\n\nThe proposed study will be presented to the ethical committee of the medical center and will be started once approved."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Three months or more post joint replacement, or post tibial ORIF, or last surgical intervention adult patients suspected of bone infection and or mechanical loosening.\n\nExclusion Criteria:\n\n1. Patients younger than 18 years;\n2. Shorter than 3 month surgical intervention at the suspected area; Newly diagnosed (\\<3 months) fractures around the prosthesis;\n3. Pathological fractures (e.g. Metastatic).'}, 'identificationModule': {'nctId': 'NCT04154202', 'briefTitle': 'The Role of NM/CT 870 DR Camera in the Diagnosis of Joint Prosthesis and Tibial Open Reduction and Internal Fixation (ORIF) Complications.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'The Role of NM/CT 870 DR Camera in the Diagnosis of Joint Prosthesis and Tibial Open Reduction and Internal Fixation (ORIF) Complications.', 'orgStudyIdInfo': {'id': 'TASMC-19-ES-0468-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bone inaction patients', 'description': 'Three months or more post joint replacement, or post tibial ORIF, or last surgical intervention adult patients suspected of bone infection and or mechanical loosening.', 'interventionNames': ['Other: Bone Scan']}], 'interventions': [{'name': 'Bone Scan', 'type': 'OTHER', 'description': 'Bone Scan: three-phase planar Bone Scan and a SPECT/CT \\[perfusion, blood pool and SPECT/CT of the relevant region of interest (ROI), and a whole-body planar late bone scan\\].', 'armGroupLabels': ['Bone inaction patients']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}