Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT04980105
Status:
UNKNOWN
Last Update Posted:
2021-07-28
First Post:
2021-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intra-articular Injections of Platelet-rich Plasma, Hyaluronic Acid, or Corticosteroids for 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'}, {'id': 'D000077555', 'term': 'Methylprednisolone Acetate'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A total of 150 participants fulfilling the inclusion criteria, patients were randomly assigned into three groups by a computer-based protocol. The patients were separated into three groups according to the type of treatment administered.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-17', 'studyFirstSubmitDate': '2021-07-07', 'studyFirstSubmitQcDate': '2021-07-17', 'lastUpdatePostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Timed Up and Go test (TUG)', 'timeFrame': '18th months', 'description': "The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees"}, {'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': '18th months', 'description': "The VAS uses a straight 10 centimeter line with one end being 'no pain' and on the other end the 'worst imaginable pain'. The patient chooses a spot on the line then places a perpendicular line to indicate their pain level"}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'To assess if there are any differences among platelet-rich plasma, hyaluronic acid, and corticosteroid knee intra-articular injection regarding function and pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged 35-65 years old\n* Patient with knee pain that had been continuing for at least 12 months with no relief using anti-inflammatory medications and that deteriorated with weight-bearing\n* Knee osteoarthritis that classified as mild-moderate or moderate-severe (Kellgren-Lawrence Grade 2, 3, or 4)\n\nExclusion Criteria:\n\n* Age \\> 65 years\n* The recent history of knee trauma\n* Autoimmune rheumatic diseases\n* Accompanying severe hip OA\n* Thrombocytopenia or other blood diseases\n* Immunosuppressive or anticoagulant treatment\n* The invasive procedure applied to the knee\n* Intra-articular steroid injection to the knee within the previous 12 months\n* Previous joint infection\n* Uncontrolled systemic diseases such as diabetes or hypertension, and cancer\n* Excessive varus/valgus knee deformity'}, 'identificationModule': {'nctId': 'NCT04980105', 'briefTitle': 'Intra-articular Injections of Platelet-rich Plasma, Hyaluronic Acid, or Corticosteroids for Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of Wasit'}, 'officialTitle': 'Intra-articular Injections of Platelet-rich Plasma, Hyaluronic Acid, or Corticosteroids for Knee Osteoarthritis, Which is Better? A Prospective Study of a Single-blind Randomized Control Trial RCT From the Iraqi Population', 'orgStudyIdInfo': {'id': 'UOW/MS102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Platelet-rich plasma arm', 'interventionNames': ['Biological: Platelet-rich plasma']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hyaluronic acid arm', 'interventionNames': ['Drug: Hyaluronic acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Methylprednisolone acetate arm', 'interventionNames': ['Drug: Methylprednisolone acetate injectable suspension (DEPO-MEDROL®)']}], 'interventions': [{'name': 'Platelet-rich plasma', 'type': 'BIOLOGICAL', 'description': 'Two intra-articular injections of autologous platelets-rich plasma (PRP) in two weeks intervals between the first and the second injection.', 'armGroupLabels': ['Platelet-rich plasma arm']}, {'name': 'Hyaluronic acid', 'type': 'DRUG', 'description': 'Two intraarticular injections of hyaluronic acid (60 mg) in two weeks intervals between the first and the second injection', 'armGroupLabels': ['Hyaluronic acid arm']}, {'name': 'Methylprednisolone acetate injectable suspension (DEPO-MEDROL®)', 'type': 'DRUG', 'description': 'Single methylprednisolone acetate intraarticular injection (DEPO-MEDROL® pfizer 80 mg) mixed with 3cc of (xylocaine 2% concentration)', 'armGroupLabels': ['Methylprednisolone acetate arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wāsiţ', 'country': 'Iraq', 'facility': 'University of Wasit', 'geoPoint': {'lat': 32.38333, 'lon': 45.225}}], 'overallOfficials': [{'name': 'Usama A Al-Sari, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UOW'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wasit', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Lecturer of Rheumatology M.B.,Ch.B, MSc , PhD', 'investigatorFullName': 'Usama Al-Sari', 'investigatorAffiliation': 'University of Wasit'}}}}