Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2025-12-28 @ 12:15 AM
Study NCT ID:
NCT03876795
Status:
COMPLETED
Last Update Posted:
2023-04-19
First Post:
2019-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Effectiveness of Combined Intra-articular and Intra-osseus Injection VS a Single Intra-articular Injection of Bone Marrow Concentrate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'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': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-18', 'studyFirstSubmitDate': '2019-03-12', 'studyFirstSubmitQcDate': '2019-03-14', 'lastUpdatePostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score trend over time', 'timeFrame': 'basal 2,6,12 months after treatment', 'description': 'WOMAC is a validated score, designed to highlight the problems of patients with lower limb pathologies, in particular in terms of pain, stiffness and functionality. The score will be completed by the patient, possibly in the presence of an investigator, and simple guidelines for self-compilation will be provided.'}], 'secondaryOutcomes': [{'measure': 'IKDC Subjective Knee Evaluation Form (IKDC)', 'timeFrame': '2,6,12 months', 'description': 'IKDC is a validated score used in the evaluation of symptoms, function and sport activity in patients suffering of knee diseases, such as meniscal or ligamentous damage, osteoarthritis. The Subjective Knee Form provides the best method of overall assessment of the most significant symptoms and disabilities for a population that has undergone cartilage repair treatments.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bone Marrow Comcentrate', 'intra-articular', 'intra-osseus'], 'conditions': ['Osteoarthritis, Knee']}, 'referencesModule': {'references': [{'pmid': '36468635', 'type': 'DERIVED', 'citation': 'Silva S, Andriolo L, Boffa A, Di Martino A, Reale D, Vara G, Miceli M, Cavallo C, Grigolo B, Zaffagnini S, Filardo G. Prospective double-blind randomised controlled trial protocol comparing bone marrow aspirate concentrate intra-articular injection combined with subchondral injection versus intra-articular injection alone for the treatment of symptomatic knee osteoarthritis. BMJ Open. 2022 Sep 8;12(9):e062632. doi: 10.1136/bmjopen-2022-062632.'}]}, 'descriptionModule': {'briefSummary': 'Osteoarthritis (OA) is one of the most common diseases resulting in large burdens on society.\n\nAmong the emerging treatments, Bone Marrow Concentrate (BMC) intra-articular injections are a promising regenerative approach. However, they offer only a temporary benefit since they target synovial and chondral tissues but fail to address the osteochondral interface, which plays a key role in the onset and progression of joint degeneration.\n\nThis project will investigate the efficacy of combined BMC injections, targeting both intra-articular tissues and subchondral bone, to treat OA in a Randomized Controlled Trial (RCT).', 'detailedDescription': 'The main aim is to evaluate in a RCT the potential of a new combined BMC treatment for OA, through the use of scores for the clinical outcome, the study of imaging and biological samples for tissue regeneration and systemic effects, and the identification of BMC and patient characteristics predictive of better results.\n\nAll patients will undergo an arthroscopic procedure to debride degenerated tissues (this can offer a temporary benefit but not long lasting results) before BMC intra-articular injection. Half patients will receive also the injection of BMC at the subchondral level (bone samples obtained to allow BMC placement will be sent to the Lab).\n\nThe same minimally invasive incisions will be used for all patients, ensuring patient blinding. Evaluations, performed by medical staff not involved in the treatment to ensure double blinding, will document subjective clinical improvement, functional measurements, biomarker study, and imaging with the use of modern 3TMRI and qCT technology. BMC characterization and patient features will be analysed to identify factors predictive of a better outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female patients, aged between 40 and 70;\n2. Arthrosis of the medial compartment (grade 2-3 according to the Kellgren-Lawrence score\\> 4 months);\n3. Failure after at least 6 months of conservative treatment (drug therapy with NSAIDs and painkillers, hyaluronic acid infiltration, corticosteroid infiltration, PRP);\n4. Patients' ability and consent to participate in clinical and radiological follow-up;\n5. Signature of informed consent.\n\nExclusion Criteria:\n\n1. Patients with trauma in the 6 months prior to surgery;\n2. Patients with maligncy;\n3. Patients suffering from rheumatic diseases;\n4. Patients suffering from non-compensated diabetes;\n5. Patients suffering from uncompensated thyroid metabolic disorders;\n6. Patients abusing alcoholic beverages, drugs or drugs;\n7. Patients with axial deviations\\> 5 °;\n8. Body Mass Index\\> 35;\n9. Patients treated with joint infiltrations in the previous 6 months;\n10. Patients treated with surgery at the same knee in the previous 12 months."}, 'identificationModule': {'nctId': 'NCT03876795', 'acronym': 'INTERFACE', 'briefTitle': 'Evaluation of Effectiveness of Combined Intra-articular and Intra-osseus Injection VS a Single Intra-articular Injection of Bone Marrow Concentrate', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Evaluation of Effectiveness of Combined Intra-articular and Intra-osseus Injection VS a Single Intra-articular Injection of Bone Marrow Concentrate for the Treatment of Osteoarthritis in the Knee. (INTERFACE) Double Blind, Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'INTERFACE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Single intra-articular Bone Marrow Concentrate injection', 'description': 'Single intra-articular Bone Marrow Concentrate injection in the knee', 'interventionNames': ['Biological: Bone Marrow Concentrate']}, {'type': 'EXPERIMENTAL', 'label': 'combined Bone Marrow Concentrate injection', 'description': 'combined Bone Marrow Concentrate injection (intra-articular and intra-osseus)', 'interventionNames': ['Biological: Bone Marrow Concentrate']}], 'interventions': [{'name': 'Bone Marrow Concentrate', 'type': 'BIOLOGICAL', 'description': 'Bone Marrow Concentrate injection', 'armGroupLabels': ['Single intra-articular Bone Marrow Concentrate injection', 'combined Bone Marrow Concentrate injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40136', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Rizzoli Orthopaedic Institute', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}