Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2026-01-27 @ 8:36 AM
Study NCT ID:
NCT02958761
Status:
COMPLETED
Last Update Posted:
2016-11-09
First Post:
2016-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Knee Arthrosis With Platelet-derived Growth Factors vs. Hyaluronic Acid.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-01-31', 'releaseDate': '2016-12-06'}, {'resetDate': '2017-05-08', 'releaseDate': '2017-03-28'}, {'resetDate': '2018-04-04', 'releaseDate': '2018-03-06'}], 'estimatedResultsFirstSubmitDate': '2016-12-06'}}, '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'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-08', 'studyFirstSubmitDate': '2016-10-29', 'studyFirstSubmitQcDate': '2016-11-07', 'lastUpdatePostDateStruct': {'date': '2016-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy (as determined by improvement at MRI 6 months after the first injection) of intraarticular injections of platelet lysate', 'timeFrame': 'Six months after the last infiltration', 'description': 'Each knee was improvement, from baseline, by at least one degree the maximum MRI score (Shahriaree Classification System - modified) at 6 month'}], 'secondaryOutcomes': [{'measure': 'WOMAC functional scale', 'timeFrame': 'At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year', 'description': 'multilevel generalized linear models (for panel-data) with interaction between time and treatment group'}, {'measure': 'Lysholm functional scale', 'timeFrame': 'At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year', 'description': 'multilevel generalized linear models (for panel-data) with interaction between time and treatment group'}, {'measure': 'Tegner Knee functional scale', 'timeFrame': 'At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year', 'description': 'multilevel generalized linear models (for panel-data) with interaction between time and treatment group'}, {'measure': 'AKS functional scale', 'timeFrame': 'At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year', 'description': 'multilevel generalized linear models (for panel-data) with interaction between time and treatment group'}, {'measure': 'Lequesne functional scale', 'timeFrame': 'At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year', 'description': 'multilevel generalized linear models (for panel-data) with interaction between time and treatment group'}, {'measure': 'VAS for pain', 'timeFrame': 'At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year', 'description': 'multilevel generalized linear models (for panel-data) with interaction between time and treatment group'}, {'measure': 'Adverse event', 'timeFrame': '1 year', 'description': 'number of patients and knees with adverse event (any); anticipated potential adverse events were infection, anaphylaxis, hematoma'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['knee arthrosis', 'platelet-derived growth factors'], 'conditions': ['Knee Osteoarthrosis']}, 'descriptionModule': {'briefSummary': 'Primary aim of this trial was to assess efficacy three intraarticular injections of platelet lysate when compared to hyaluronic acid. Additional objectives were to compare the treatment groups in terms of a number of functional scales and of number of adverse events.', 'detailedDescription': 'Intra-articular injections of hyaluronic acid are effective in improving symptoms and slow disease progression, but are not able to revert the damage mechanism and trigger cartilage healing.\n\nGrowth factors included in PRP could stimulate cartilage repair, normalize synovial fluid viscoelasticity, induce a correction in tissue damage, improve articular function, control pain and ameliorate quality of life.\n\nPrimary aim of this trial was to assess, among patients with grade II/III osteoarthrosis of the knee, efficacy (as determined by improvement at MRI 6 months after the first injection) of three intraarticular injections of platelet lysate when compared to hyaluronic acid. Additional objectives were to compare the treatment groups in terms of a number of functional scales (WOMAC, Lysholm, Tegner Knee, Scale, AKS, Lequesne, VAS) and of number of adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* grade II/III OA of the knee demonstrated at MRI17,18, according to Shahriaree Classification System - modified\n* no previous OA treatment with local hyaluronic acid or steroid injections\n* ife expectancy \\>1 year\n* no ongoing pregnancy\n* ability to understand and complete clinical and functional scales Lysholm, WOMAC, AKS, VAS\n* written consent.'}, 'identificationModule': {'nctId': 'NCT02958761', 'briefTitle': 'Treatment of Knee Arthrosis With Platelet-derived Growth Factors vs. Hyaluronic Acid.', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}, 'officialTitle': 'Treatment of Knee Arthrosis: Platelet-derived Growth Factors vs. Hyaluronic Acid. A Phase II-III Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '28914/2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Platelet-rich plasma', 'description': 'Patients in the intervention group will receive three autologous PRP plus calcium gluconate (as activator) intraarticular injections at 4-week intervals. Briefly, at the Immunohaematology and Transfusion Service, on each scheduled visit 20 ml of autologous whole blood will be sampled from each patient, 2 ml ACD-A will be added directly the syringe as anticoagulant; finally the vial will be gently centrifuged at 900rpm for 7 minutes. Platelet-rich plasma was collected. The PRP vials plus activator will be immediately shipped to the rehabilitation unit, where intraarticular injection will be performed by an experienced physiatrist.', 'interventionNames': ['Biological: intraarticular injections of platelet lysate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'hyaluronic acid', 'description': 'Patients in the control group will receive three intraarticular hyaluronic acid (20 mg/2 mL; Hyalgan, Fidia, Abano Terme, Italy) injections at the same intervals, by the same study staff.', 'interventionNames': ['Drug: hyaluronic acid']}], 'interventions': [{'name': 'intraarticular injections of platelet lysate', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Platelet-rich plasma']}, {'name': 'hyaluronic acid', 'type': 'DRUG', 'description': 'intraarticular hyaluronic acid (20 mg/2 mL; Hyalgan, Fidia, Abano Terme, Italy) injections at the same intervals', 'armGroupLabels': ['hyaluronic acid']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Claudio Lisi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Claudio Lisi', 'investigatorAffiliation': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-12-06', 'type': 'RELEASE'}, {'date': '2017-01-31', 'type': 'RESET'}, {'date': '2017-03-28', 'type': 'RELEASE'}, {'date': '2017-05-08', 'type': 'RESET'}, {'date': '2018-03-06', 'type': 'RELEASE'}, {'date': '2018-04-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Claudio Lisi, MD, Fondazione IRCCS Policlinico San Matteo di Pavia'}}}}