Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT05440032
Status:
RECRUITING
Last Update Posted:
2024-01-30
First Post:
2022-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LE as a Marker for Periprosthetic Joint Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-29', 'studyFirstSubmitDate': '2022-06-27', 'studyFirstSubmitQcDate': '2022-06-27', 'lastUpdatePostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Qualitative agreement (Positive, Intermediate, or Negative) between the semi-quantitative electrochemical LE test and Roche Chemstrip® LE test (Negative, Trace, 1+, or 2+)', 'timeFrame': 'Within one hour of fluid aspiration'}], 'secondaryOutcomes': [{'measure': 'Correlation of leukocyte esterase and synovial white blood cell count', 'timeFrame': 'Within 30 days of surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Prosthetic-joint Infection']}, 'descriptionModule': {'briefSummary': 'Testing and comparison of a novel point-of-care electrochemical assay to detect and help diagnose periprosthetic joint infection on the hip and knee to the standard of care test', 'detailedDescription': 'The primary objective of this study is to assess the equivalence of a semi-quantitative electrochemical leukocyte esterase test system and off-label use of the Roche Chemstrip leukocyte esterase (LE) test for the diagnosis of periprosthetic joint infection (PJI) in synovial fluid from hip and knee joints. In this study, the qualitative outcome of each of the two methodologies for detecting leukocyte esterase enzyme will be compared. The hypothesis of this study is that the two tests will demonstrate equivalence. The leukocyte esterase enzyme level will also be compared to synovial white blood cell count, which will be considered as a secondary reference.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects undergoing planned aseptic revision surgery to replace part or all of their hip or knee implant or subjects undergoing planned revision for infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age greater than 18 years\n2. Willing and able to sign the informed consent document\n3. Subjects presenting with presumed aseptic failure of a prosthetic joint and expected to undergo revision arthroplasty, or subjects presenting with presumed PJI and expected to undergo either DAIR or radical implant resection, and subjects being investigated for PJI having joint aspiration outside of the operating room who may or may not require surgical intervention.\n\nExclusion Criteria:\n\n1. Subjects with known active crystalline deposition disease (e.g. gout)\n2. Subjects with adverse local tissue reaction (ALTR) as a result of corrosion of components or metal-on-metal bearing surface in the hip\n3. Subjects with active inflammatory arthropathy (e.g. rheumatoid arthritis)\n4. Subjects undergoing a second-stage re-implantation procedure for PJI\n5. Subjects in which standard of care assessments, at a minimum serology (ESR and CRP) and synovial fluid analysis (synovial WBC count, neutrophil percentage, and culture), cannot be performed.\n6. Subjects in whom there is an insufficient amount of synovial fluid to perform the required investigational tests.'}, 'identificationModule': {'nctId': 'NCT05440032', 'briefTitle': 'LE as a Marker for Periprosthetic Joint Infection', 'organization': {'class': 'NETWORK', 'fullName': 'Center for Innovation and Research Organization'}, 'officialTitle': 'Electrochemical Test of Leukocyte Esterase as a Marker for Periprosthetic Joint Infection', 'orgStudyIdInfo': {'id': 'LE001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Synovial fluid testing with semi-quantitative leukocyte esterase test strip', 'description': 'Using a drop of synovial fluid, sample will be analyzed via the point-of-care device to measure amount of leukocyte esterase in the sample', 'interventionNames': ['Diagnostic Test: Semi-quantitative electrochemical leukocyte esterse test strip']}, {'label': 'Synovial fluid testing with Roche Chemstrip', 'description': 'Using a drop of synovial fluid, sample will be analyzed via a urine test-strip to measure amount of leukocyte esterase in the sample', 'interventionNames': ['Diagnostic Test: Roche Chemstrip']}], 'interventions': [{'name': 'Semi-quantitative electrochemical leukocyte esterse test strip', 'type': 'DIAGNOSTIC_TEST', 'description': 'Electrochemical assay to detect level of leukocyte esterase in sample', 'armGroupLabels': ['Synovial fluid testing with semi-quantitative leukocyte esterase test strip']}, {'name': 'Roche Chemstrip', 'type': 'DIAGNOSTIC_TEST', 'description': 'Urinalysis chemstrip', 'armGroupLabels': ['Synovial fluid testing with Roche Chemstrip']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80210', 'city': 'Denver', 'state': 'Colorado', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Research Manager', 'role': 'CONTACT', 'phone': '303-260-2940'}], 'facility': 'Colorado Joint Replacement', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Research Coordinator', 'role': 'CONTACT'}], 'facility': 'Cleveland Clinic Florida', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Research Coordinator', 'role': 'CONTACT', 'phone': '502-587-8222', 'phoneExt': '65585'}], 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Research Manager', 'role': 'CONTACT', 'phone': '212-598-6245'}], 'facility': 'New York University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14618', 'city': 'Rochester', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Research Manager', 'role': 'CONTACT', 'phone': '585-341-9303'}], 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '43054', 'city': 'New Albany', 'state': 'Ohio', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Research Coordinator', 'role': 'CONTACT', 'phone': '614-964-0348'}], 'facility': 'JIS Orthopaedics', 'geoPoint': {'lat': 40.08117, 'lon': -82.80879}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Research Coordinator', 'role': 'CONTACT', 'phone': '267-339-3613'}], 'facility': 'Rothman Orthopaedic Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Research Manager', 'role': 'CONTACT', 'phone': '304-293-2485'}], 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'centralContacts': [{'name': 'Tiffany Morrison', 'role': 'CONTACT', 'email': 'tiffany@parvizisurgical.com', 'phone': '717-856-1202'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center for Innovation and Research Organization', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}