Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-03-02 @ 3:19 AM
Study NCT ID:
NCT03086759
Status:
COMPLETED
Last Update Posted:
2019-01-18
First Post:
2017-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-Articular Platelet Rich Plasm Use in Osteoarthritis of Knee.
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': 'C005900', 'term': 'triamcinolone hexacetonide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-16', 'studyFirstSubmitDate': '2017-03-16', 'studyFirstSubmitQcDate': '2017-03-21', 'lastUpdatePostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain', 'timeFrame': 'Baseline, after 4, 8, 12 and 48 weeks', 'description': 'Evaluated using a visual analogue scale'}], 'secondaryOutcomes': [{'measure': 'Change in joint edema', 'timeFrame': 'Baseline, after 4, 8, 12 and 48 weeks', 'description': 'Evaluated using a visual analogue scale'}, {'measure': 'Change in range of motion', 'timeFrame': 'Baseline, after 4, 8, 12 and 48 weeks', 'description': 'Evaluated using goniometry'}, {'measure': 'Change in a clinical improvement scale', 'timeFrame': 'Baseline, after 4, 8, 12 and 48 weeks', 'description': 'Evaluated using an improvement scale'}, {'measure': 'Change in quality of life', 'timeFrame': 'Baseline, after 4, 8, 12 and 48 weeks', 'description': 'Using the SF-36 questionnaire'}, {'measure': 'Change in functional capacity', 'timeFrame': 'Baseline, after 4, 8, 12 and 48 weeks', 'description': 'Using the WOMAC questionnaire'}, {'measure': 'Change in functional capacity', 'timeFrame': 'Baseline, after 4, 8, 12 and 56 weeks', 'description': 'Using the M Lequesne questionnaire'}, {'measure': 'Change in functional capacity', 'timeFrame': 'Baseline, after 4, 8, 12 and 48 weeks', 'description': 'Using the six minute walk test'}, {'measure': 'Change in functional capacity', 'timeFrame': 'Baseline, after 4, 8, 12 and 48 weeks', 'description': 'Using the time to up and go test'}, {'measure': 'Changing in quantitative and semiquantitative measurement of synovial hypertrophy and semiquantitative Power Doppler', 'timeFrame': 'Baseline, after 4, 8, 12 and 48 weeks', 'description': 'Using an ultrasound exam'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Osteoarthritis of the knee is a very prevalent disease. However, there are few therapeutic options for its patients. Platelet-rich plasma is a treatment option for chronic pain. If proven to be effective in its intra-articular use, Platelet-rich plasma may help in the treatment of these patients.\n\nGoal:\n\nPrimary objective: To compare effectiveness in improving pain and function and the medium-term tolerance (12 weeks) of intra-articular injection of Platelet-rich plasma versus intraarticular injection of triamcinolone hexacetonide in patients with symptomatic primary knee osteoarthritis.\n\nSecondary objective: To compare the medium-term effectiveness of intra-articular injection of Platelet-rich plasma versus intra-articular injection of triamcinolone hexacetonide to improve synovial hypertrophy and quality of life in these patients.\n\nMethods: A prospective randomized controlled double-blind study with three groups (each with n = 33) of patients with symptomatic osteoarthritis of knees who will receive intra-articular infiltration in a single moment. Patients will be allocated to one of three groups: 1) Platelet-rich plasma group: patients who will receive plasma; 2) triamcinolone hexacetonide Group: patients who will receive 40mg of triamcinolone hexacetonide; And 3) Isotonic saline solution group: patients who will receive isotonic saline solution. The patients will be evaluated by "blind" evaluators in 4 assessment times up to 12 weeks of follow-up through clinical assessment instruments (rest and movement pain, joint edema, goniometry, clinical improvement scale, quality of life questionnaire as the SF36), functional (Womac questionnaire, M. Lequesne Functional Knee Index, 6 min walk test, Time up and go test), and ultrasound test (quantitative and semiquantitative measurement of synovial hypertrophy and semiquantitative Power Doppler).\n\nStatistics: The following statistical tests will be used according to the need: Student\'s t test, Mann-whitney, Pearson\'s chi-square test and ANOVA for repeated measures. A statistical significance of 5% will be considered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary knee osteoarthritis\n* degree II and II in Kellgren \\& Lawrence classification\n* pain duration: more than three months\n* pain in the visual analogue scale between 4 and 8cm\n* agree in participate and sign the consent form\n\nExclusion Criteria:\n\n* secondary knee osteoarthritis\n* skin lesion in knee\n* intraarticular joint injection in the previous three months\n* steroids use in the previous 30 days\n* degree I or IV in Kellgren \\& Lawrence classification\n* inflammatory arthritis, gout and pseudo-gout\n* cancer\n* previous surgery in knee\n* cardiovascular and respiratory disease that change functional status\n* pregnancy and breastfeed\n* coagulation disturb\n* bacterial infection\n* handicapped\n* NSAIDs and Platelet anticoagulant in the previous month'}, 'identificationModule': {'nctId': 'NCT03086759', 'briefTitle': 'Intra-Articular Platelet Rich Plasm Use in Osteoarthritis of Knee.', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Intra-Articular Use of Platelet Rich Plasma Versus Corticosteroid: A Clinical Trials in Osteoarthritis of Knee.', 'orgStudyIdInfo': {'id': 'CEP UNIFESP 842 167/2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Platelet rich plasm group', 'interventionNames': ['Procedure: platelet rich plasm']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Triamcinolone Hexacetonide group', 'interventionNames': ['Drug: Triamcinolone Hexacetonide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Isotonic Saline Solution group', 'interventionNames': ['Procedure: Isotonic Saline Solution']}], 'interventions': [{'name': 'platelet rich plasm', 'type': 'PROCEDURE', 'description': 'intra-articular infiltration with platelet rich plasm', 'armGroupLabels': ['Platelet rich plasm group']}, {'name': 'Triamcinolone Hexacetonide', 'type': 'DRUG', 'description': 'intra-articular infiltration withTriamcinolone Hexacetonide', 'armGroupLabels': ['Triamcinolone Hexacetonide group']}, {'name': 'Isotonic Saline Solution', 'type': 'PROCEDURE', 'description': 'intra-articular infiltration with Isotonic Saline Solution', 'armGroupLabels': ['Isotonic Saline Solution group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04023900', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade Federal de Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jose Carlos Nunes Tamashiro', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}