Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-02-26 @ 12:03 PM
Study NCT ID:
NCT03211650
Status:
COMPLETED
Last Update Posted:
2021-06-14
First Post:
2017-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Hyaluronic Acid and Platelet-rich Plasma Combination in 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'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-10', 'studyFirstSubmitDate': '2017-07-06', 'studyFirstSubmitQcDate': '2017-07-06', 'lastUpdatePostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WOMAC score', 'timeFrame': '6 months after the first intra-articular injection', 'description': 'Comparison of WOMAC total score among three treatment arms'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of intra-articular injections of combined hyaluronic acid and platelet-rich plasma in knee degenerative joint disease in improving joint function and reducing pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Knee pain for 4 months;\n* Knee degenerative sign evaluated with X-ray with a Kellgren-Lawrence grade inferior to 3;\n* Patients able to understand the study conditions and willing to participate for its entire duration;\n* Patients who signed written informed consent.\n\nExclusion criteria:\n\n* Severe knee osteoarthritis of grade 4;\n* Diabetes mellitus;\n* Rheumatoid arthritis;\n* Ongoing malignancies;\n* Certified allergic reactions towards the administered drugs ;\n* Malalignment of mechanical axis of the lower limb (varus \\> 10 °, valgus \\> 10 °);\n* Coagulopathies;\n* Severe cardiovascular diseases;\n* Ongoing infections;\n* Immunodepression;\n* Anticoagulants or anti-platelet agents;\n* Haemoglobin \\< 11 g/dl;\n* Platelet count \\< 150,000/mm\\^3\n* Drug addiction;\n* Alcoholism;\n* Psychiatric disease;\n* Pregnancy or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT03211650', 'briefTitle': 'Efficacy of Hyaluronic Acid and Platelet-rich Plasma Combination in Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of Milan'}, 'officialTitle': 'Efficacy of Intra-articular Injection of Combined Hyaluronic Acid and Platelet-rich Plasma in Knee Degenerative Joint Disease', 'orgStudyIdInfo': {'id': 'ACP-HA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hyaluronic acid + platelet-rich plasma', 'description': 'Intra-articular injections of hyaluronic acid combined with platelet-rich plasma', 'interventionNames': ['Drug: hyaluronic Acid + platelet-rich plasma']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'platelet-rich plasma', 'description': 'Intra-articular injections of platelet-rich plasma', 'interventionNames': ['Drug: platelet-rich plasma']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'hyaluronic acid', 'description': 'Intra-articular injections of hyaluronic acid', 'interventionNames': ['Drug: hyaluronic acid']}], 'interventions': [{'name': 'hyaluronic Acid + platelet-rich plasma', 'type': 'DRUG', 'otherNames': ['Cellular Matrix/A-CP HA Kit'], 'description': 'Intra-articular injections of hyaluronic acid combined with platelet-rich plasma', 'armGroupLabels': ['hyaluronic acid + platelet-rich plasma']}, {'name': 'hyaluronic acid', 'type': 'DRUG', 'otherNames': ['ArthroVisc40'], 'description': 'Intra-articular injections of hyaluronic acid', 'armGroupLabels': ['hyaluronic acid']}, {'name': 'platelet-rich plasma', 'type': 'DRUG', 'otherNames': ['RegenKit-BCT-1'], 'description': 'Intra-articular injections of platelet-rich plasma', 'armGroupLabels': ['platelet-rich plasma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'state': 'Milan', 'country': 'Italy', 'facility': 'U.O.C. 1a Divisione, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20097', 'city': 'San Donato Milanese', 'state': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Policlinico San Donato', 'geoPoint': {'lat': 45.41047, 'lon': 9.26838}}], 'overallOfficials': [{'name': 'Pietro Randelli, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Regen Lab SA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'Pietro Randelli, MD', 'investigatorAffiliation': 'University of Milan'}}}}