Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-28 @ 12:15 AM
Study NCT ID:
NCT06238934
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-02
First Post:
2024-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Knee Osteoarthritis With Bone Marrow Aspirate Matrix: Prospective, Randomized Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-26', 'studyFirstSubmitDate': '2024-01-26', 'studyFirstSubmitQcDate': '2024-01-26', 'lastUpdatePostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Society Score', 'timeFrame': 'before infiltration, 1 month after first infiltration, three months, six months and one year after infiltration'}, {'measure': 'Western Ontario and Mcmaster (WOMAC) score', 'timeFrame': 'before infiltration, 1 month after first infiltration, three months, six months and one year after infiltration'}, {'measure': 'Visual analog scale for pain', 'timeFrame': 'before infiltration, 1 month after first infiltration, three months after infiltration, six months and one year after infiltration'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osteoarthritis', 'knee', 'hyaluronic acid', 'bone marrow aspirate', 'bone marrow aspirate matrix'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Knee osteoarthritis (KOA) first manifests itself as a molecular derangement followed by anatomical and/or physiological changes. Conservative treatment of osteoarthritis should be the first approach to patients with this disease. The interest in biological therapies, including viscosupplementation and cell therapy, involves the recent update in knowledge about the pathophysiology of OA and its natural history. The aim of the present study is to compare the clinical results of intra-articular hyaluronic acid infiltration (IHA), bone marrow aspirate (BMA) and BMA matrix in the treatment of knee osteoarthritis. The sample will consist of 90 patients with osteoarthritis of the knee followed up at the INTO, who will be divided into three groups: group A, treatment with BMA; group B, treatment with IHA ; and group C, treatment with BMA matrix. Patients will be submitted to clinical, subjective functional and radiographic evaluation by an observer independent of the one who applied the selected treatment, at moments before application and 3 months, 6 months and 12 months after application. We believe that treatment with BMA and the BMA matrix have a better effect in improving symptoms and for a longer period of time than treatment with hyaluronic acid.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBilateral knee OA according to the American College of Rheumatology criteria Kellgren-Lawrence ≤ III in both knees Full range of movement (0 a 120°).\n\nExclusion Criteria:\n\n1\\) history of trauma, infection or previous surgery in the affected limb two years before procedure (2)limb malalignment: varus\\> 10° or valgus \\>15° (3) corticosteroids 3 months before the procedure (4) viscosupplementation 12 months before procedure (5) inflammatory, rheumatological or autoimmune disease (6) body mass index \\>35 kg/m2 (7) use of immunosuppresors or anticoagulants (8) active tumor (9) haematological disorder (10) Hip OA \\> Tonnis grade 3 (11) history of transmissible disease (12) patients unable for positioning for the procedure (13) patients living outside Rio de Janeiro metropolitan area'}, 'identificationModule': {'nctId': 'NCT06238934', 'briefTitle': 'Treatment of Knee Osteoarthritis With Bone Marrow Aspirate Matrix: Prospective, Randomized Trial', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Instituto Nacional de Traumatologia e Ortopedia'}, 'officialTitle': 'Treatment of Knee Osteoarthritis With Bone Marrow Aspirate Matrix: Prospective, Randomized Trial', 'orgStudyIdInfo': {'id': '74952423.1.0000.5273'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Bone marrow aspirate matrix', 'interventionNames': ['Biological: Bone marrow aspirate matrix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Bone marrow aspirate', 'interventionNames': ['Biological: Bone marrow aspirate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C', 'description': 'Hyaluronic acid', 'interventionNames': ['Device: Hyaluronic acid']}], 'interventions': [{'name': 'Bone marrow aspirate matrix', 'type': 'BIOLOGICAL', 'description': 'Bone marrow aspirate \\* Hyaluronic acid', 'armGroupLabels': ['Group A']}, {'name': 'Bone marrow aspirate', 'type': 'BIOLOGICAL', 'description': 'Bone marrow aspirate', 'armGroupLabels': ['Group B']}, {'name': 'Hyaluronic acid', 'type': 'DEVICE', 'description': 'Hyaluronic acid', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20940-070', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'contacts': [{'name': 'Eduardo B de Sousa, MD, PhD', 'role': 'CONTACT', 'email': 'eduardobranco.joelho@gmail.com', 'phone': '21998913144'}, {'name': 'Phelippe Augusto V Maia, MD, MSC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sandra T Minamoto, MD,MSC', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Instituto Nacional de Traumatologia e Ortopedia', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Nacional de Traumatologia e Ortopedia', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopaedic surgeon', 'investigatorFullName': 'Eduardo Branco de Sousa', 'investigatorAffiliation': 'Instituto Nacional de Traumatologia e Ortopedia'}}}}