Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 11:10 PM
Study NCT ID:
NCT00393393
Status:
UNKNOWN
Last Update Posted:
2006-10-27
First Post:
2006-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness Study of Hylan G-F 20 to Preserve Cartilage in Osteoarthritis of the Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-10', 'completionDateStruct': {'date': '2006-01'}, 'lastUpdateSubmitDate': '2006-10-26', 'studyFirstSubmitDate': '2006-10-26', 'studyFirstSubmitQcDate': '2006-10-26', 'lastUpdatePostDateStruct': {'date': '2006-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cartilage volume as assessed by magnetic resonance imaging'}]}, 'conditionsModule': {'keywords': ['osteoarthritis', 'knee', 'hylan'], 'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '21861935', 'type': 'DERIVED', 'citation': 'Wang Y, Hall S, Hanna F, Wluka AE, Grant G, Marks P, Feletar M, Cicuttini FM. Effects of Hylan G-F 20 supplementation on cartilage preservation detected by magnetic resonance imaging in osteoarthritis of the knee: a two-year single-blind clinical trial. BMC Musculoskelet Disord. 2011 Aug 24;12:195. doi: 10.1186/1471-2474-12-195.'}]}, 'descriptionModule': {'briefSummary': 'That Hylan G-F 20 may act to protect cartilage from the expected degree of degradation over a 12 month period in subjects with moderate to marked osteoarthritis of the knee', 'detailedDescription': 'Two courses of Hylan G-F 20 ( Synvisc) administered by intra-articular injection at 6 monthly intervals. MRI examinations of the knee for estimation of cartilage volume prior to treatment, before second course and at 12 months in 40 subjects with Grade 2/3 osteoarthritis of knee . A further 40 subjects with similar degree of osteoarthritis of knee who do not receive Hylan G-F therapy will be assessed by MRI in identical manner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* grade 2 or 3 osteoarthritis knee age 18 - 80 pain score VAS \\>39 mm on 100mm scale\n\nExclusion Criteria:\n\n* surgery in prior 12 months significant valgus deformity recent trauma use of opioid analgesia unstable medical condition recent corticosteroid injection morbid obesity'}, 'identificationModule': {'nctId': 'NCT00393393', 'briefTitle': 'Effectiveness Study of Hylan G-F 20 to Preserve Cartilage in Osteoarthritis of the Knee', 'organization': {'class': 'OTHER', 'fullName': 'Cabrini Medical Centre'}, 'officialTitle': 'A Single-Blind Prospective Parallel Control Group Pilot Study to Assess the Effect of Hylan G-F 20 (Synvisc) Supplementation on Cartilage Preservation in Osteoarthritis of the Knee', 'orgStudyIdInfo': {'id': '05-11-07-05'}}, 'armsInterventionsModule': {'interventions': [{'name': 'intra-articular injection of Hylan G-F 20', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3144', 'city': 'Malvern', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'stephen hall, MBBS, FRACP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emeritus Research', 'geoPoint': {'lat': -37.86259, 'lon': 145.02811}}], 'centralContacts': [{'name': 'stephen hall, MBBS, FRACP', 'role': 'CONTACT', 'email': 'drshall@ozemail.com.au', 'phone': '613 9509 6166'}, {'name': 'marie feletar, MBBS, FRACP', 'role': 'CONTACT', 'email': 'mfeletar@westnet.com.au', 'phone': '613 9509 6166'}], 'overallOfficials': [{'name': 'stephen hall, MBBS, FRACP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cabrini Medical Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cabrini Medical Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genzyme, a Sanofi Company', 'class': 'INDUSTRY'}]}}}