Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-25 @ 2:06 PM
Study NCT ID:
NCT02949466
Status:
UNKNOWN
Last Update Posted:
2016-11-01
First Post:
2016-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Additional Effects of Triamcinolone to Hyaluronic Acid on Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-29', 'studyFirstSubmitDate': '2016-10-25', 'studyFirstSubmitQcDate': '2016-10-28', 'lastUpdatePostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional performance assessed with the Western Ontario and McMaster Universities Osteoarthritis Index', 'timeFrame': 'changes from baseline to at after one week, one month, three months, and six months of completion of injections', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index'}], 'secondaryOutcomes': [{'measure': '10 meter walk test', 'timeFrame': 'changes from baseline to at after one week, one month, three months, and six months of completion of injections', 'description': '10 meter walk as fast as possible'}, {'measure': 'Quality of life assessed with the Knee Injury and Osteoarthritis Outcome Score', 'timeFrame': 'changes from baseline to at after one week, one month, three months, and six months of completion of injections', 'description': 'Knee Injury and Osteoarthritis Outcome Score'}, {'measure': '5 times rapid chair rising test', 'timeFrame': 'changes from baseline to at after one week, one month, three months, and six months of completion of injections', 'description': 'rapid chair rising for 5 times as fast as possible'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['knee osteoarthritis', 'triamcinolone', 'therapeutic effects'], 'conditions': ['Physical Activity', 'Functional Performance']}, 'referencesModule': {'references': [{'pmid': '34958762', 'type': 'DERIVED', 'citation': 'Wang CP, Lee WC, Hsieh RL. Effects of Repeated Co-Injections of Corticosteroids and Hyaluronic Acid on Knee Osteoarthritis: A Prospective, Double-Blind Randomized Controlled Trial. Am J Med. 2022 May;135(5):641-649. doi: 10.1016/j.amjmed.2021.11.016. Epub 2021 Dec 24.'}]}, 'descriptionModule': {'briefSummary': 'Using a double-blind, randomized controlled design to investigate the additional therapeutic effects of 3 times of combined triamcinolone and hyaluronic acid injections to 3 times of hyaluronic acid injections to patients with knee osteoarthritis.', 'detailedDescription': 'A total of 56 patients will be enrolled and randomized into two groups, including 3 times of triamcinolone combined hyaluronic acid injections group and 3 times of hyaluronic acid injections group.\n\nThe triamcinolone combined hyaluronic acid injections group will receive 3 times of triamcinolone combined hyaluronic acid injection per week in three weeks; the hyaluronic acid group will receive hyaluronic acid injection in three weeks.\n\nPhysical activities and functional performance will be evaluated at before injection, at after one week, one month, three months, and six months of completion of 3 times of injections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* knee osteoarthritis with Kellgren/Lawrence grade II or III\n\nExclusion Criteria:\n\n* who have neurological deficit, such as stroke who have implant in knee'}, 'identificationModule': {'nctId': 'NCT02949466', 'briefTitle': 'Additional Effects of Triamcinolone to Hyaluronic Acid on Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University'}, 'officialTitle': 'Additional Therapeutic Effects of Triamcinolone to Hyaluronic Acid on Knee Osteoarthritis: A Double Blind, Randomized-controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'MOST 105-2314-B-341-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'triamcinolone and hyaluronic acid group', 'description': 'combined triamcinolone (Triamcinolone 10 mg 1cc) and hyaluronic acid (2 cc) injections: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined triamcinolone and hyaluronic acid injections to hyaluronic acid injections', 'interventionNames': ['Drug: Triamcinolone', 'Device: Hyaluronic acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'hyaluronic acid group', 'description': 'hyaluronic acid (2cc) injection: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined triamcinolone and hyaluronic acid injections to hyaluronic acid injections', 'interventionNames': ['Device: Hyaluronic acid']}], 'interventions': [{'name': 'Triamcinolone', 'type': 'DRUG', 'otherNames': ['corticosteroids'], 'description': 'compare the additional therapeutic effects of triamcinolone combined with hyaluronic acid injections to hyaluronic acid injections only to patients with knee osteoarthritis', 'armGroupLabels': ['triamcinolone and hyaluronic acid group']}, {'name': 'Hyaluronic acid', 'type': 'DEVICE', 'description': 'compare the additional therapeutic effects of triamcinolone combined with hyaluronic acid injections to hyaluronic acid injections only to patients with knee osteoarthritis', 'armGroupLabels': ['hyaluronic acid group', 'triamcinolone and hyaluronic acid group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '111-01', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Shin Kong Wu Ho-Su Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Ru-Lan Hsieh, MD', 'role': 'CONTACT', 'email': 'M001052@ms.skh.org.tw', 'phone': '886-2-28332211', 'phoneExt': '2538;2531'}, {'name': 'Ru-Lan Hsieh, MD', 'role': 'CONTACT', 'email': 'rulan@tmu.edu.tw', 'phone': '886-2-28332211', 'phoneExt': '2538;2531'}], 'overallOfficials': [{'name': 'Ru-Lan Hsieh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shin Kong Wu Ho-Su Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ru-Lan Hsieh', 'investigatorAffiliation': 'Taipei Medical University'}}}}