Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
Study NCT ID:
NCT04905394
Status:
COMPLETED
Last Update Posted:
2021-05-27
First Post:
2021-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Radiological Outcomes of Subchondroplasty in the Treatment of Bone Marrow Edema of the Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-26', 'studyFirstSubmitDate': '2021-05-18', 'studyFirstSubmitQcDate': '2021-05-26', 'lastUpdatePostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain reduction', 'timeFrame': '6 months', 'description': 'Pain reduction of 4 points in numeric rating score'}], 'secondaryOutcomes': [{'measure': 'Radiological evaluation', 'timeFrame': '6 months', 'description': 'Evaluation of osteoarthritis progression in the knee on x-rays according to Kellgren\\&Lawrence classification'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Marrow Edema']}, 'referencesModule': {'references': [{'pmid': '37213661', 'type': 'DERIVED', 'citation': 'Randelli P, Compagnoni R, Ferrua P, Ricci M, La Verde L, Mekky AF, De Silvestri A, Menon A. Efficacy of Subchondroplasty in the Treatment of Pain Associated With Bone Marrow Lesions in the Osteoarthritic Knee. Orthop J Sports Med. 2023 May 16;11(5):23259671231163528. doi: 10.1177/23259671231163528. eCollection 2023 May.'}]}, 'descriptionModule': {'briefSummary': 'Bone marrow lesions (BMLs) of the knee are common subchondral defects, often associated with pain and functional limitation. Subchondroplasty is a percutaneous procedure in which calcium phosphate is injected inside BML areas, ensuring stability and promoting the deposition of new bone. Primary outcome of this study was to obtain a reduction of the Numeric Rating Scale score of 4 points or more at 6 months follow-up in more than 75% of patients. The secondary outcome was to evaluate the osteoarthritic and bone marrow structure evolution in the months after the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Atraumatic knee pain for at least 3 months;\n* Failure of conservative treatment (including NSAIDs, physical therapy, intra- articular injection with steroids or hyaluronic acid and bisphosphonates);\n* Mild to moderate osteoarthritis (Kellgren-Lawrence18 grade ≤ 3)\n* BML on a loading area at MRI imaging (femoral condyles and/or tibial plateau)\n\nExclusion Criteria:\n\n* Knee pain and functional limitation related to other causes like osteonecrosis\n* Fractures or inflammatory arthritis\n* Ligamentous instabilities\n* Malalignment on the coronal axis greater than 10 degrees in varus/valgus\n* Severe tri-compartmental arthritis (Kellgren-Lawrence grade 4)'}, 'identificationModule': {'nctId': 'NCT04905394', 'briefTitle': 'Clinical and Radiological Outcomes of Subchondroplasty in the Treatment of Bone Marrow Edema of the Knee', 'organization': {'class': 'OTHER', 'fullName': 'University of Milan'}, 'officialTitle': 'Short Term Clinical and Radiological Outcomes of Subchondroplasty in the Treatment of Bone Marrow Edema of the Knee', 'orgStudyIdInfo': {'id': 'SubCond'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment with subchondroplasty for bone edema in the knee', 'description': 'Patients treated with subchondroplasty for bone edema of the knee', 'interventionNames': ['Procedure: subchondroplasty']}], 'interventions': [{'name': 'subchondroplasty', 'type': 'PROCEDURE', 'description': "subchondroplasty is an innovative percutaneous procedure in which calcium phosphate, biocompatible material similar to the native bone apatite with osteoinductive properties, is injected inside BML areas. The purpose of subchondroplasty is the patient's symptoms relief, improving the mechanical strength of subchondral bone, stimulating bone remodeling to avoid bone sagging, and slow down the arthritic degenerative process to postpone arthroplasty.", 'armGroupLabels': ['Treatment with subchondroplasty for bone edema in the knee']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Gaetano Pini hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'pietro randelli, prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Milan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Researcher will not share data with other organizations'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pietro Randelli, MD', 'investigatorAffiliation': 'University of Milan'}}}}