Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
Study NCT ID:
NCT01979666
Status:
TERMINATED
Last Update Posted:
2024-04-02
First Post:
2013-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nitrate Patch Use as Treatment of Knee AVN
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010020', 'term': 'Osteonecrosis'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'Failure to recruit patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-31', 'studyFirstSubmitDate': '2013-11-03', 'studyFirstSubmitQcDate': '2013-11-07', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in bone substrate edema', 'timeFrame': '6 weeks', 'description': 'the area and percent of the knee which the edema involves'}], 'secondaryOutcomes': [{'measure': 'other MRI changes', 'timeFrame': '6 weeks', 'description': 'reduction of subchondral fracture resolution of accompanied findings presence of femoral head or condyle flattening'}, {'measure': 'analgesics use', 'timeFrame': '6 weeks', 'description': "according to the patient's self report"}, {'measure': 'pain severity', 'timeFrame': '6 weeks', 'description': 'according to a visual analouge scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Knee AVN, Nitrates'], 'conditions': ['Necrosis, Avascular, of Bone']}, 'descriptionModule': {'briefSummary': 'The pathogenesis of AVN includes a defective blood supply to the knee joint. Local nitrates induce peripheral vasodilation and may improve blood supply to the affected tissue.\n\nThis study aims to test whether the use of a nicotine patch may accelerate the healing process from AVN of the knee.', 'detailedDescription': 'The main purpose of this study is to examine whether treatment with a local nitrate patch will improve MRI findings and clinical outcomes in patients with AVN of the knee.\n\nThis is a double-blind prospective study that will include 50 adult volunteers, randomly assigned to a "nitrate" group that will be given a nitrate patch, and a "placebo" group that will be given a placebo patch.\n\nThe following outcomes will be measured:\n\n* MRI findings before and after the patch treatment\n* Use of analgesics\n* Subjective pain relief.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients (18-80 y.o)\n* diagnosis of AVN according to MRI\n\nExclusion Criteria:\n\n* Terminal illness\n* Cognitive impairment / any condition disturbing informed concent.\n* Nitrate intolerance\n* Patients using Cyclic GMP inhibitiors'}, 'identificationModule': {'nctId': 'NCT01979666', 'briefTitle': 'Nitrate Patch Use as Treatment of Knee AVN', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'the Effect of a Nitrate Patch on the Healing Process of AVN of the Knee', 'orgStudyIdInfo': {'id': 'SHEBA-12-9707-AL-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'description': 'the patients that will get a nitrate patch', 'interventionNames': ['Drug: nitrate patch', 'Device: MRI scan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'the patients that will get the placebo patch', 'interventionNames': ['Drug: placebo patch', 'Device: MRI scan']}], 'interventions': [{'name': 'nitrate patch', 'type': 'DRUG', 'description': 'patients in the study group will get a nitrate patch', 'armGroupLabels': ['study group']}, {'name': 'placebo patch', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'control group patients will get a placebo patch', 'armGroupLabels': ['control group']}, {'name': 'MRI scan', 'type': 'DEVICE', 'otherNames': ['MRI'], 'description': 'MRI scan after 6 weeks of treatment', 'armGroupLabels': ['control group', 'study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'overallOfficials': [{'name': 'avi livneh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}, {'name': 'arik asman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'head of internal medicine ward F', 'investigatorFullName': 'Prof.Avi Livneh', 'investigatorAffiliation': 'Sheba Medical Center'}}}}