Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-02-24 @ 10:20 PM
Study NCT ID:
NCT06797960
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-29
First Post:
2025-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Intra Articular Injection of Platelet Rich Fibrin Versus Hyaluronic Acid As Means of Pain Relief in Patients with Moderate Degree 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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2025-01-21', 'studyFirstSubmitQcDate': '2025-01-28', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain relief as measured by VAS score', 'timeFrame': '3 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Randomised controlled trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I, II.\n* Moderate knee osteoarthritis\n\nExclusion Criteria:\n\n* Neurological patients.\n* Patients with uncontrolled co morbidities'}, 'identificationModule': {'nctId': 'NCT06797960', 'briefTitle': 'Ultrasound Guided Intra Articular Injection of Platelet Rich Fibrin Versus Hyaluronic Acid As Means of Pain Relief in Patients with Moderate Degree Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Fayoum University'}, 'officialTitle': 'ANALGESIC EFFECT of ULTRASOUND GUIDED INTRA- ARTICULAR INJECTION of PLATELET RICH FIBRIN VERSUS INJECTION of HYALURONIC ACID in PATIENTS with MODERATE KNEE OSTEOARTHRITIS. a RANDOMIZED CONTROLLED STUDY', 'orgStudyIdInfo': {'id': 'M757'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PRF group', 'interventionNames': ['Device: Ultra sound guided Injection of PRF intra articularly']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hyaluronic acid group', 'interventionNames': ['Drug: Intra articular injection of HA']}], 'interventions': [{'name': 'Ultra sound guided Injection of PRF intra articularly', 'type': 'DEVICE', 'description': 'Intra articular injection of PRF', 'armGroupLabels': ['PRF group']}, {'name': 'Intra articular injection of HA', 'type': 'DRUG', 'description': 'Intra articular injection of HA', 'armGroupLabels': ['Hyaluronic acid group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Islam Shaban Shaban', 'role': 'CONTACT', 'phone': '00201008757498'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fayoum University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Islam Shaban Shaban', 'investigatorAffiliation': 'Fayoum University'}}}}