Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT05145504
Status:
COMPLETED
Last Update Posted:
2023-08-02
First Post:
2021-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of IL-6 in Synovial Fluid in Obese and Normal Weight Patients Suffering From Gonarthrosis During PTA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-31', 'studyFirstSubmitDate': '2021-11-25', 'studyFirstSubmitQcDate': '2021-11-25', 'lastUpdatePostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate whether the IL-6 concentration in the synovial fluid of obese patients is 100% higher than the IL-6 concentration of the synovial fluid in normal weight patients', 'timeFrame': '1 day'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['IL-6 Concentration in the Synovial Fluid of Obese Patients is 100% Higher Than the IL-6 Concentration of the Synovial Fluid in Normal Weight Patients']}, 'descriptionModule': {'briefSummary': 'Evaluate the concentration of IL-6 in the synovial fluid of obese patients suffering from gonarthrosis during knee arthroplasty surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population is made up of obese and normal weight patients, of age, undergoing knee replacement surgery for gonarthrosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 55 and 85 years inclusive,\n* Normal weight patients with BMI 18-24.9 included\n* Obese patients with BMI ≥ 30\n* Patients suffering from gonarthrosis awaiting knee arthroplasty surgery\n* Patients awaiting knee replacement surgery\n* Patients who agree to sign informed consent\n\nExclusion Criteria:\n\n* Patients under 55 years of age.\n* Patients over 85 years of age\n* Patients suffering from diabetes mellitus\n* Patients who are unable to understand\n* Patients with severe neurological disorders or severe disability\n* Rheumatoid arthritis patients\n* Cancer patients\n* Patients on immunosuppressive therapy'}, 'identificationModule': {'nctId': 'NCT05145504', 'acronym': 'IL6PG', 'briefTitle': 'Evaluation of IL-6 in Synovial Fluid in Obese and Normal Weight Patients Suffering From Gonarthrosis During PTA', 'organization': {'class': 'OTHER', 'fullName': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio"}, 'officialTitle': 'Evaluation of Biomarker IL-6 in Synovial Fluid in Obese and Normal Weight Patients Suffering From Gonarthrosis During Knee Arthroplasty Surgery.', 'orgStudyIdInfo': {'id': 'IL6PG'}}, 'armsInterventionsModule': {'armGroups': [{'label': '20 obese patients, with BMI ≥ 30', 'interventionNames': ['Diagnostic Test: Evaluation of IL-6 biomarkers in synovial fluid']}, {'label': '20 normal weight patients with BMI between 18.5 - 24.9 inclusive', 'interventionNames': ['Diagnostic Test: Evaluation of IL-6 biomarkers in synovial fluid']}], 'interventions': [{'name': 'Evaluation of IL-6 biomarkers in synovial fluid', 'type': 'DIAGNOSTIC_TEST', 'description': 'Evaluation of IL-6 biomarkers in synovial fluid in obese and normal weight patients with gonarthrosis', 'armGroupLabels': ['20 normal weight patients with BMI between 18.5 - 24.9 inclusive', '20 obese patients, with BMI ≥ 30']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20161', 'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Istituto Ortopedico Galeazzi', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}