Ignite Creation Date:
2025-12-24 @ 12:54 PM
Ignite Modification Date:
2025-12-28 @ 5:35 AM
Study NCT ID:
NCT05742061
Status:
UNKNOWN
Last Update Posted:
2023-02-23
First Post:
2023-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-articular Platelet Rich Plasma vs Corticosteroid in Treatment of Knee Osteoarthritis Patients
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': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-21', 'studyFirstSubmitDate': '2023-02-01', 'studyFirstSubmitQcDate': '2023-02-21', 'lastUpdatePostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of knee pain, stiffness and physical function prior knee injection', 'timeFrame': 'Assessment will be done just before injection', 'description': 'Assessment through the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. The final score for the WOMAC was determined by adding the aggregate scores for pain, stiffness, and function. Scores range from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status.'}, {'measure': 'Assessment of knee pain, stiffness and physical function 2 weeks after injection', 'timeFrame': '2 weeks after injection', 'description': 'Assessment through WOMAC score'}, {'measure': 'Assessment of knee pain, stiffness and physical function 6 weeks after injection', 'timeFrame': '6 weeks after injection', 'description': 'Assessment through WOMAC score'}, {'measure': 'Assessment of knee pain, stiffness and physical function 12 weeks after injection', 'timeFrame': '12 weeks after injection', 'description': 'Assessment through WOMAC score'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis Knee', 'Corticosteroid', 'Platelet Rich Plasma']}, 'descriptionModule': {'briefSummary': 'Knee osteoarthritis is the most common type of osteoarthritis in the lower extremity and constitutes 23% of all arthritis cases, about 13% of females and 10% of males aged above 60 years have symptomatic knee OA. Intra-articular corticosteroids (IACs) are a frequently-used treatment regimen for pain relief from symptomatic knee OA as it inhibits inflammation and reduces prostaglandin synthesis. Platelet-rich plasma (PRP) is an autologous blood product containing a high percentage of various growth factors (GFs), such as fibroblast growth factor, epidermal growth factor, vascular endothelial growth factor, transforming growth factor-β and platelet-derived growth factor. The aim of this study is to compare effect of intra-articular injection of platelet rich plasma versus corticosteroid in treatment of primary knee osteoarthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'genderBased': True, 'genderDescription': 'Patients 40-70 years of age suffering from knee OA', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 40-70 years of age suffering from knee OA with Kellgren Lawrence grade II or III on standing antero-posterior and lateral knee radiographs.\n* Patients diagnosed according to ACR classification criteria.\n\nExclusion Criteria:\n\n* Systemic diseases as Patients having diabetes mellitus,Cardiovascular diseases or coagulopathies.\n* Those receiving treatment with anticoagulant , anti\\_platelet medications or systemic corticosteroid 10 days before injection or recent use of NSAIDs.\n* Pregnant and breast feeding females.\n* Patients have hemoglobin values \\<10 g/dl or platelet values\\<150,000/ml.'}, 'identificationModule': {'nctId': 'NCT05742061', 'briefTitle': 'Intra-articular Platelet Rich Plasma vs Corticosteroid in Treatment of Knee Osteoarthritis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Intra-articular Platelet Rich Plasma vs Corticosteroid in Treatment of Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'MS 54-1-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'OA group injected by corticosteroid', 'description': 'Group l include 50 patients who will be injected with one intra\\_articular injection of 2 ml of methylprednisolone acetate 40 mg/ml mixed with 2ml of lidocaine', 'interventionNames': ['Drug: Corticosteroid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OA group injected by Platelet Rich Plasma', 'description': 'Group lI include 50 patients who will be injected with a single 5 ml intra\\_articular injection of PRP prepared in our hospital', 'interventionNames': ['Other: Platelet Rich Plasma']}], 'interventions': [{'name': 'Corticosteroid', 'type': 'DRUG', 'description': 'The injection will be given at a site near the superolateral pole of patella in the suprapatellar pouch under aseptic conditions and the patient will be advised to take one day of rest after injection and apply ice to the area if there are any signs of inflammation.', 'armGroupLabels': ['OA group injected by corticosteroid']}, {'name': 'Platelet Rich Plasma', 'type': 'OTHER', 'description': 'PRP preparation :- 20 ml of venous blood will be drawn from the antecubital vein using an 18G needle to avoid traumatizing platelets and will be collected in a sterile tube containing 2 ml of Sodium Citrate anticoagulant. Approximately 2 ml of whole blood will be separated for a complete blood count.The blood with anticoagulant will centrifuged at 4000 rpm for 6-10 minutes to separate erythrocytes and then at 4000 rpm for 6-10 min to concentrate platelets.The final product was 4-5 ml of PRP containing leukocytes with platelet concentration of 3-5 times the average normal value.', 'armGroupLabels': ['OA group injected by Platelet Rich Plasma']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Arwa S. Amer, MD', 'role': 'CONTACT', 'email': 'arwa.amer@fmed.bu.edu.eg', 'phone': '01550465282'}, {'name': 'Benha University', 'role': 'CONTACT', 'email': 'info@bu.edu.eg', 'phone': '0133213517'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Rheumatology, Rehabilitation and Physical Medicine', 'investigatorFullName': 'Arwa El Sayed Abdel Rahman', 'investigatorAffiliation': 'Benha University'}}}}