Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-03 @ 4:49 PM
Study NCT ID:
NCT01365260
Status:
COMPLETED
Last Update Posted:
2012-12-05
First Post:
2011-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of an Injectable Medical Device to Treat Knee Osteoarthritis
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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-04', 'studyFirstSubmitDate': '2011-05-31', 'studyFirstSubmitQcDate': '2011-06-02', 'lastUpdatePostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with an acute inflammatory reaction in the injected knee', 'timeFrame': 'up to 7 days', 'description': 'An acute inflammatory reaction in more than 5% of the participants will be considered as manifestation of treatment related intolerance'}, {'measure': 'Change from baseline in blood count', 'timeFrame': '3 days and 7 days'}, {'measure': 'Number of participants with adverse events', 'timeFrame': 'Up to 90 days after the treatment'}], 'secondaryOutcomes': [{'measure': 'Maximum global pain in the target knee', 'timeFrame': 'Days -21, 0, 1, 3, 7, 14, 30, 90th', 'description': 'Measured by Visual Analogue Scale for pain (VAS)'}, {'measure': 'The Western Ontario and McMaster University OA index (WOMAC)', 'timeFrame': 'Days 0, 7, 14, 30, 90'}, {'measure': 'The patient global assessment of treatment by Likert-scale questionnaire', 'timeFrame': 'Days 0, 7, 14, 30, 90'}, {'measure': 'The patients acceptance of symptoms state (PASS)', 'timeFrame': 'Days 7, 14, 30, 90'}, {'measure': 'Omeract-ORASI responders index', 'timeFrame': 'Days 7, 14, 30'}, {'measure': 'The number of tablets of rescue medications used between visits', 'timeFrame': 'During the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether MM-II is effective in the treatment of osteoarthritis, in direct comparison with an approved hyaluronic acid preparation.', 'detailedDescription': 'Osteoarthritis (OA) is the commonest form of joint disease, characterized by articular cartilage degradation with an accompanying periarticular bone response and a synovial membrane inflammation. Clinical manifestations of OA in the knee include pain in and around the joint, stiffness of the joint after rest, crepitus on motion and limited joint. MM-II medical device was designed to reduce wear and lower friction in knees of osteoarthritis patients by creating a lubricating layer onto cartilage surfaces upon injection. The purpose of this study is to determine whether a medical device MM-II is effective in the treatment of osteoarthritis, in direct comparison with an approved hyaluronic acid preparation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Symptomatic unilateral knee tibiofemoral OA\n* Radiographic evidence of knee OA of Kellgren-Lawrence Grade II or III in one or both knees on a recent 3 months time X-Ray\n* Knee pain within the last 24 hours before assessment more than 40mm on VAS\n* Pain on most days in the last month\n\nExclusion Criteria:\n\n* Knee pain equal or more than 80mm on a 100mm VAS.\n* Pain in the contra lateral knee; more than 30mm on a 100 VAS.\n* Concomitant inflammatory joint disease (e.g. gout, rheumatoid arthritis, history of Reiter's syndrome, psoriatic arthritis and ankylosing spondylitis.\n* Any condition that may interfere with the measure of pain in the targeted knee\n* Concomitant meaningful synovial fluid effusion\n* Post trauma OA\n* Gross ligamentous instability of the knee"}, 'identificationModule': {'nctId': 'NCT01365260', 'briefTitle': 'Safety and Efficacy of an Injectable Medical Device to Treat Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Moebius Medical Ltd.'}, 'officialTitle': 'A Double-Blind, Randomized, Feasibility Controlled Study to Assess the Safety and Efficacy of MM-II, an Injectable Intraarticular Medical Device, Intended to the Treatment of Symptomatic Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'MM-002'}, 'secondaryIdInfos': [{'id': '0196-11-HMO', 'type': 'OTHER', 'domain': 'Hadassah Medical Center'}, {'id': 'HTA 5960', 'type': 'OTHER', 'domain': 'Israel Ministry of Health'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MM-II', 'interventionNames': ['Device: MM-II']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DurolaneTM', 'description': 'hyaluronic acid', 'interventionNames': ['Device: DurolaneTM']}], 'interventions': [{'name': 'MM-II', 'type': 'DEVICE', 'description': 'Single intraarticular (knee) injection of MM-II', 'armGroupLabels': ['MM-II']}, {'name': 'DurolaneTM', 'type': 'DEVICE', 'otherNames': ['hyaluronic acid'], 'description': 'Single intraarticular (knee) injection of DurolaneTM', 'armGroupLabels': ['DurolaneTM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Mount Scopus Hospital', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Leonid (Arieh) Kandel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Mount Scopus Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Moebius Medical Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}