Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-28 @ 4:46 AM
Study NCT ID:
NCT04165902
Status:
UNKNOWN
Last Update Posted:
2019-11-19
First Post:
2019-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Additional Effects of Steroid and Dextrose to Hyaluronic Acid on 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006820', 'term': 'Hyaluronic Acid'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-11-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-17', 'studyFirstSubmitDate': '2019-11-10', 'studyFirstSubmitQcDate': '2019-11-13', 'lastUpdatePostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Western Ontario and McMaster Universities Osteoarthritis index', 'timeFrame': 'changes of scores from baseline to at one week, one month, 3 months and 6 months after 3 times of injections; score range: 0-100, higher scores mean a worse outcome', 'description': 'assess knee osteoarthritis related performance'}], 'secondaryOutcomes': [{'measure': 'Balance', 'timeFrame': 'changes of scores from baseling to at one week, one month, 3 months and 6 months after 3 times of injections; score range 0-4, higher scores mean a better outcome', 'description': 'Berg Balance scale'}, {'measure': 'physical functional performance-walking', 'timeFrame': 'change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections', 'description': '10 meters normal and fast walking speed'}, {'measure': 'physical functional performance-stairs climbing', 'timeFrame': 'change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections', 'description': 'time for up and down stairs'}, {'measure': 'physical functional performance-chair raising', 'timeFrame': 'change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections', 'description': '5 repeated chair-rising time'}, {'measure': 'physical functional performance-balance', 'timeFrame': 'change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections', 'description': 'timed up and go test'}, {'measure': 'Knee Injury and Osteoarthritis Outcome Score', 'timeFrame': 'changes of scores from baseline to at one week, one month, 3 months and 6 months after 3 times of injections; score range 0-100, higher scores mean at better outcome', 'description': 'assess osteoarthritis of knee related function'}, {'measure': 'Doppler resistance index', 'timeFrame': 'changes of scores from baseline to at one week after 1 time of injection and two weeks after 2 times of injection; the lower values indicate a low blood vessel resistance', 'description': 'assess knee blood vessel resistance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['knee osteoarthritis, hyaluronic acid, steroid, dextrose'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Using double-blind, randomized controlled design to compare the immediate, short-term and intermediate-term additional therapeutic effects of ultrasound-guided corticosteroid injection and dextrose injection of hyaluronic acid injection on patients with knee osteoarthritis, under the basis of International Classification of Functioning, Disability, and Health.', 'detailedDescription': "A total of 60 patients will be collected. The participants will be randomized into two groups, including hyaluronic acid combined corticosteroid group and hyaluronic acid combined dextrose group. The balance, physical activity (10 meters normal and fast walk, up and downstairs, and 5 repeated chair-rising time, timed up and go test), functional performance and knee-related quality of life (Western Ontario and McMaster Universities Osteoarthritis index、Knee Injury and Osteoarthritis Outcome Score) will be evaluated. All the evaluations will be re-evaluated at one week after injection, one month after injection, three months after injection, and six months after injection. Subjects and evaluators will be both blinded to the group's classification during the whole course of study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of knee osteoarthritis can walk for 15 meters Kellgren-Lawerence grade 2 or greater than 2 can follow up for 6 months\n\nExclusion Criteria:\n\n* major diseases will affect balance, such as stroke, infectious diseases, rheumatoid arthritis, dizziness, or vertigo fractures malignance pregnancy or prepare to pregnant received knee injections in the past 6 months previous operation of knee joints'}, 'identificationModule': {'nctId': 'NCT04165902', 'briefTitle': 'Additional Effects of Steroid and Dextrose 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 108-2314-B-341-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'steroid plus hyaluronic acid', 'description': 'steroid plus hyaluronic acid injection, one time per week, for 3 weeks', 'interventionNames': ['Drug: compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dextrose plus hyaluronic acid', 'description': 'dextrose plus hyaluronic acid injection, one time per week, for 3 weeks', 'interventionNames': ['Drug: compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritis']}], 'interventions': [{'name': 'compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritis', 'type': 'DRUG', 'description': 'compare the immediate effect (one week after 3 times of injections), short-term effects (one month and three months after 3 times of injections), and midterm effect (6 months after 3 times of injections).', 'armGroupLabels': ['dextrose plus hyaluronic acid', 'steroid plus hyaluronic acid']}]}, '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': '886-2984161201'}], 'overallOfficials': [{'name': 'Ru-Lan Hsieh, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Shin Kong Wu Ho-Su Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shin Kong Wu Ho-Su Memorial Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD', 'investigatorFullName': 'Ru-Lan Hsieh', 'investigatorAffiliation': 'Taipei Medical University'}}}}