Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-03-06 @ 8:51 PM
Study NCT ID:
NCT01950858
Status:
UNKNOWN
Last Update Posted:
2013-09-26
First Post:
2013-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyper Baric Oxygen Therapy (HBOT) for Spontaneous Osteonecrosis of the Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-09-19', 'studyFirstSubmitDate': '2013-08-28', 'studyFirstSubmitQcDate': '2013-09-19', 'lastUpdatePostDateStruct': {'date': '2013-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': '6 weeks', 'description': 'Pain Reduction'}, {'measure': 'Safety', 'timeFrame': 'end of HBOT', 'description': 'Number of Participants with Adverse Events during HBOT'}], 'secondaryOutcomes': [{'measure': 'Reduction In AVN size by MRI', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spontaneous Osteonecrosis of the Knee']}, 'descriptionModule': {'briefSummary': 'safety and efficacy of Hyper Baric Oxygen (HBO) in patients presenting with spontaneous osteonecrosis of the knee'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age40-85 years\n* Diagnosis of Spontaneous osteonecrosis of the knee (SONK)in last month, Stage 1 or 2 by MRI.\n\nExclusion Criteria:\n\n* Hyperbaric treatment (HBOT) in the last 2 years.\n* Any contraindication for HBOT\n* Pregnancy.\n* Inability to sign inform consent\n* Any contraindication for MRI'}, 'identificationModule': {'nctId': 'NCT01950858', 'briefTitle': 'Hyper Baric Oxygen Therapy (HBOT) for Spontaneous Osteonecrosis of the Knee', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'Safety and Efficacy of Hyper Baric Oxygen Therapy (HBOT) in Patients Presenting With Spontaneous Osteonecrosis of the Knee', 'orgStudyIdInfo': {'id': '91/12*1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biological', 'description': '6 weeks of HBO treatment as well as non weight bearing', 'interventionNames': ['Biological: Weight reduction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'non weight bearing', 'interventionNames': ['Biological: Weight reduction']}], 'interventions': [{'name': 'Weight reduction', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Biological', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70300', 'city': 'Ẕerifin', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Yiftah Beer, MD', 'role': 'CONTACT', 'email': 'yiftah.beer@gmail.com', 'phone': '972-8-9779432'}], 'facility': 'Assaf-Harofeh Medical Center', 'geoPoint': {'lat': 31.95731, 'lon': 34.84852}}], 'centralContacts': [{'name': 'Yiftah Beer, MD', 'role': 'CONTACT', 'email': 'yiftah.beer@gmail.com', 'phone': '972-8-9779432'}], 'overallOfficials': [{'name': 'Shai Efrati, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assaf-Harofeh Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Yiftah Beer', 'investigatorFullName': 'Assaf Harofeh MC', 'investigatorAffiliation': 'Assaf-Harofeh Medical Center'}}}}