Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-01-08 @ 6:01 AM
Study NCT ID:
NCT03167333
Status:
UNKNOWN
Last Update Posted:
2020-02-11
First Post:
2017-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Synovitis in 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-09', 'studyFirstSubmitDate': '2017-05-18', 'studyFirstSubmitQcDate': '2017-05-24', 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual analog scale(VAS)', 'timeFrame': 'before injection at baseline'}, {'measure': 'visual analog scale(VAS)', 'timeFrame': '4 weeks(first evaluation)'}, {'measure': 'visual analog scale(VAS)', 'timeFrame': '12 weeks(secondary evaluation)'}, {'measure': 'The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)', 'timeFrame': 'before injection at baseline'}, {'measure': 'The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)', 'timeFrame': '4 weeks(first evaluation)'}, {'measure': 'The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)', 'timeFrame': '12 weeks(secondary evaluation)'}], 'secondaryOutcomes': [{'measure': 'Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed simultaneously.', 'timeFrame': 'before injection at baseline'}, {'measure': 'Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed', 'timeFrame': '4 weeks(first evaluation)'}, {'measure': 'Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed', 'timeFrame': '12 weeks(secondary evaluation)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Synovitis of Knee', 'Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'To determine whether platelet-rich-plasma (PRP) or HA (hyaluronic acid)injection into synovitis in osteoarthritis(OA) knee can achieve improvement in knee function and reduce synovitis.', 'detailedDescription': 'Methods:\n\nsixty patients with OA knee having unilateral or bilateral synovitis validated by ultrasound (N=40) were studied. All the patients were randomized to receive PRP (N=40) or Hyaluronic acid(HA)(N=40) injection twice at 2-week intervals; Clinical assessments were performed using a visual analog scale(VAS) and The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index) before injection at baseline, 4 weeks(first evaluation) and 12 weeks(secondary evaluation). Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed simultaneously.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with OA knee according to ACR guideline\n\n 1. stiffness less than 30min\n 2. cracking sound during activity\n 3. more than 30min pain for last 2 months\n 4. non-bed ridden patients\n 5. no structure abnormality\n 6. synovitis was proved by US\n\nExclusion Criteria:\n\n1\\. OA knee secondary to other disease 2 . more than 10 years after diagnosing OA 3. under knee surgery within 3 months 4. autoimmune disease 5. refuses inform/consent process'}, 'identificationModule': {'nctId': 'NCT03167333', 'briefTitle': 'The Role of Synovitis in Osteoarthritis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': 'Does Synovitis Affect Treatment Efficacy in Intra-articular Injection Therapy to Osteoarthritis', 'orgStudyIdInfo': {'id': '2017-03-009B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRP group', 'description': 'the patients received PRP(platelet-rich-plasma) injection twice at 2-week intervals', 'interventionNames': ['Drug: platelet rich plasma']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HA group', 'description': 'the patients received HA(hyaluronic acid) injection twice at 2-week intervals', 'interventionNames': ['Drug: Hyaluronic acid']}], 'interventions': [{'name': 'platelet rich plasma', 'type': 'DRUG', 'description': 'The amount of PPR was about 4-5 cc', 'armGroupLabels': ['PRP group']}, {'name': 'Hyaluronic acid', 'type': 'DRUG', 'description': 'HA was 2.5cc', 'armGroupLabels': ['HA group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '886', 'city': 'Hualien City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chien-Chih Wang', 'role': 'CONTACT', 'email': 'candycandywang@gmail.com', 'phone': '886 958738258'}], 'facility': 'Taipei veteran general hospital yuli branch', 'geoPoint': {'lat': 23.97694, 'lon': 121.60444}}], 'centralContacts': [{'name': 'Chien-CHIh Wang, MD', 'role': 'CONTACT', 'email': 'candycandywang@gmail.com', 'phone': '886-958738258'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}