Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT01050894
Status:
COMPLETED
Last Update Posted:
2017-03-21
First Post:
2010-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of Anti-inflammatory Cytokines in Whole Blood in Osteoarthritis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-17', 'studyFirstSubmitDate': '2010-01-14', 'studyFirstSubmitQcDate': '2010-01-15', 'lastUpdatePostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure anti-inflammatory cytokines', 'timeFrame': 'immediately after processing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['osteoarthritis'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This is a feasibility study to determine if anti-inflammatory cytokines can be concentrated from patients with osteoarthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with evidence of osteoarthritis.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* radiographic evidence of osteoarthritis\n* signed informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* \\< 18 years of age\n* blood clotting disorder or active hematologic cancer\n* undergoing chemotherapy\n* history of rheumatoid arthritis\n* septic joint or fracture\n* active infection or history of chronic infection\n* use of cytokine blocking drugs with the last 6 months\n* intra-articular steroid or hyaluronic acid (HA) injection within last 6 months'}, 'identificationModule': {'nctId': 'NCT01050894', 'briefTitle': 'Feasibility Study of Anti-inflammatory Cytokines in Whole Blood in Osteoarthritis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'A Feasibility Study to Determine the Up-regulation of Anti-inflammatory Cytokines in Whole Blood From Patients With Osteoarthritis', 'orgStudyIdInfo': {'id': 'APS-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'osteoarthritis patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4646237', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'OrthoIndy', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40506', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Orthopaedic Surgery, Kentucky Clinic', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '43221', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Sports Medicine Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}