Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 8:53 PM
Study NCT ID:
NCT07329361
Status:
RECRUITING
Last Update Posted:
2026-01-09
First Post:
2025-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Intra-articular Injections of Frozen Platelet-Rich Plasma in Patients With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-26', 'studyFirstSubmitDate': '2025-12-10', 'studyFirstSubmitQcDate': '2025-12-26', 'lastUpdatePostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'KOOS - Knee Injury and Osteoarthritis Outcome Score', 'timeFrame': '6 months', 'description': 'From 0 (worst outcome) to 100 (best outcome)'}], 'secondaryOutcomes': [{'measure': 'KOOS - Knee Injury and Osteoarthritis Outcome Score', 'timeFrame': '2 months', 'description': 'From 0 (worst outcome) to 100 (best outcome)'}, {'measure': 'VAS - Visual Analog Scale', 'timeFrame': '2 months', 'description': 'From 0 (best outcome) to 10 (worst outcome)'}, {'measure': 'VAS - Visual Analog Scale', 'timeFrame': '6 months', 'description': 'From 0 (best outcome) to 10 (worst outcome)'}, {'measure': 'Lequesne Index', 'timeFrame': '2 months', 'description': 'A patient-completed questionnaire used to measure the severity of osteoarthritis assessing pain and function.\n\nFrom 0 (best outcome) to 24 (worst outcome)'}, {'measure': 'Lequesne Index', 'timeFrame': '6 months', 'description': 'A patient-completed questionnaire used to measure the severity of osteoarthritis assessing pain and function.\n\nFrom 0 (best outcome) to 24 (worst outcome)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthristis']}, 'descriptionModule': {'briefSummary': 'Evaluation of intra-articular injections in knee osteoarthritis using frozen-stored PRP. Compared with intra-articular injections of PRP applied at the time of collection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both sexes.\n* Aged between 40 and 85 years old.\n* Diagnosed with osteoarthritis through clinical radiological examination.\n* Joint pain equal to or less than 75 points on the KOOS (pain).\n* Radiological severity grades 1, 2, and 3 according to the Ahlbäck scale.\n* Indication for intra-articular PRP infiltration.\n* Body Mass Index values between 20 and 35.\n* Negative serological tests for syphilis, HIV, HBV, and HCV.\n* Possibility of observation during the follow-up period.\n* Signature of informed consent.\n\nExclusion Criteria:\n\n* Body mass index \\>35\n* Diagnosed polyarticular disease.\n* Previous arthroscopy in the last year.\n* Severe mechanical deformity.\n* Intra-articular hyaluronic acid injection in the last 12 months.\n* Intra-articular corticosteroid or PRP injection in the last 6 months.\n* Systemic autoimmune rheumatic disease (connective tissue diseases and systemic necrotizing vasculitis).\n* Anemia or other hematological disorders.\n* Positive serological tests for SYPHILIS, HIV, HBV, and HCV.\n* Undergoing immunosuppressive treatments.\n* Poorly controlled diabetes mellitus.\n* Patients allergic to paracetamol.\n* Pregnancy or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT07329361', 'briefTitle': 'Efficacy and Safety of Intra-articular Injections of Frozen Platelet-Rich Plasma in Patients With Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'MiKS Hospital'}, 'officialTitle': 'Efficacy and Safety of Intra-articular Injections of Frozen Platelet-Rich Plasma in Patients With Knee Osteoarthritis: Randomized Control Trial', 'orgStudyIdInfo': {'id': 'UCA-17/EC/25/CON'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Frozen Platelet-Rich Plasma', 'interventionNames': ['Other: Platelet Rich Plasma']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Platelet-Rich Plasma', 'interventionNames': ['Other: Platelet Rich Plasma']}], 'interventions': [{'name': 'Platelet Rich Plasma', 'type': 'OTHER', 'description': 'Platelet-rich plasma stored by freezing', 'armGroupLabels': ['Frozen Platelet-Rich Plasma']}, {'name': 'Platelet Rich Plasma', 'type': 'OTHER', 'description': 'Fresh Platelet-Rich Plasma', 'armGroupLabels': ['Platelet-Rich Plasma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01010', 'city': 'Vitoria-Gasteiz', 'state': 'Araba/Álava', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Diego Delgado', 'role': 'CONTACT', 'email': 'diego.delgado@hospitalmiks.com', 'phone': '0034 945 25 20 77'}], 'facility': 'Arthroscopic Surgery Unit, MiKS Hosptial', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MiKS Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}