Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT01544712
Status:
COMPLETED
Last Update Posted:
2012-03-06
First Post:
2012-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Controlled Study of Stage 3 Osteonecrosis Treatment by Bone Marrow
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-05', 'studyFirstSubmitDate': '2012-02-22', 'studyFirstSubmitQcDate': '2012-03-05', 'lastUpdatePostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reduction of total prosthesis', 'timeFrame': '24, 60 months', 'description': 'Need to undergo a surgical treatment total prosthesis'}], 'secondaryOutcomes': [{'measure': 'Pain reduction', 'timeFrame': '24, 60 months', 'description': 'Visual analogue scale'}, {'measure': 'functional status', 'timeFrame': '24, 60 months', 'description': 'Lequesne and WOMAC scores'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['osteonecrosis', 'cell-based therapy', 'bone marrow', 'mesenchymal stem cell', 'hip', 'core decompression'], 'conditions': ['Non Traumatic Osteonecrosis of the Femoral Head (Hip)']}, 'referencesModule': {'references': [{'pmid': '28988340', 'type': 'DERIVED', 'citation': 'Hauzeur JP, De Maertelaer V, Baudoux E, Malaise M, Beguin Y, Gangji V. Inefficacy of autologous bone marrow concentrate in stage three osteonecrosis: a randomized controlled double-blind trial. Int Orthop. 2018 Jul;42(7):1429-1435. doi: 10.1007/s00264-017-3650-8. Epub 2017 Oct 7.'}]}, 'descriptionModule': {'briefSummary': 'In stage 3 Osteonecrosis (ON) of the femoral head, a beneficial effect of bone marrow grafting was reported with a reduction of the functional evolution and the necessity of a total prosthesis placement in a non-controlled retrospective trial. Based on this experience, the investigators would like to start a randomized controlled double blind study on the effect of autologous implantation of autologous bone marrow cells into the necrotic lesion of stage 3 ON of the femoral head.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients who have a non traumatic ON of the femoral head\n2. Stage 3 ON (subchondral fracture).\n3. Age \\> 18 years\n4. Be able and willing to participate in the study\n\nExclusion Criteria:\n\n1. evidence of malignant disorder in the past five years\n2. Patient unable to undergo a MRI.\n3. Patient who is positive for an HIV, hepatitis B or C infection.'}, 'identificationModule': {'nctId': 'NCT01544712', 'briefTitle': 'Controlled Study of Stage 3 Osteonecrosis Treatment by Bone Marrow', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Treatment of Stage 3 Osteonecrosis of the Femoral Head by Autologous Transplantation of Bone Marrow Cells: a Randomized, Controlled Double Blind Study', 'orgStudyIdInfo': {'id': 'Ref 2004/08 st 3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Core decompression', 'interventionNames': ['Procedure: core decompression of the femoral head']}, {'type': 'EXPERIMENTAL', 'label': 'Bone marrow', 'description': 'core decompression plus autologous concentrated bone marrow', 'interventionNames': ['Procedure: core decompression with autologous bone marrow implantation']}], 'interventions': [{'name': 'core decompression with autologous bone marrow implantation', 'type': 'PROCEDURE', 'description': 'core biopsy with injection of 40 ml concentrated autologous bone marrow.', 'armGroupLabels': ['Bone marrow']}, {'name': 'core decompression of the femoral head', 'type': 'PROCEDURE', 'description': 'core biopsy with injection of 40 ml saline solution in place of bone marrow.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'state': 'Liège', 'country': 'Belgium', 'facility': 'University of Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Jean-Philippe Hauzeur', 'investigatorAffiliation': 'University of Liege'}}}}