Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-01-22 @ 9:25 AM
Study NCT ID:
NCT02433704
Status:
WITHDRAWN
Last Update Posted:
2017-07-28
First Post:
2015-04-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Antibiotic Dosing for Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002437', 'term': 'Cefazolin'}], 'ancestors': [{'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Difficulty with enrollment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-27', 'studyFirstSubmitDate': '2015-04-10', 'studyFirstSubmitQcDate': '2015-05-04', 'lastUpdatePostDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of acute surgical site infection', 'timeFrame': 'defined as within 3 weeks after the surgical procedure'}], 'secondaryOutcomes': [{'measure': 'correlation of clinical comorbidities to acute infection rates', 'timeFrame': '1 year post surgical intervention'}, {'measure': 'number of complications', 'timeFrame': '1 year post surgical intervention'}, {'measure': 'tourniquet time', 'timeFrame': 'during procedure, up to approximately 2.5 hours'}, {'measure': 'blood loss', 'timeFrame': 'during procedure, up to approximately 2.5 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Infection of Total Knee Replacement']}, 'descriptionModule': {'briefSummary': 'To directly compare acute infection rates in patients undergoing total knee replacement with intraosseous regional administration or systemic intravenous administration of prophylactic antibiotics.', 'detailedDescription': 'Subjects will be prospectively enrolled into the Intraosseous Regional Administration (IORA) group, and the investigators will use historical controls for the Systemic Intravenous Administration (SIA) group, to include a matched group of patients from 6 months prior to enrollment. SIA group will receive systemic dosing of cefazolin within one hour of the incision, which is the current standard of care. IORA group will receive intraosseous dosing after the tourniquet is inflated to 300-350mm/Hg. Cefazolin 1 gram will be given through an intraosseous cannula, placed into the medial aspect of the proximal tibia, after draping and before skin incision. The cefazolin will be administered as a bolus in 200 mL of normal saline. Incision will be made immediately after infusion. Subjects in both groups will receive routine care following the procedure. Primary outcome will be acute surgical site infection, which is defined as within 3 weeks after the surgical procedure. Secondary outcomes will include correlation of clinical comorbidities to the primary outcome, report complications, and compare surgery specific information (tourniquet time, blood loss).\n\nSubjects with a penicillin allergy will receive a 200mg cefazolin test dose via a systemic intravenous route, which is the current standard of care. If no adverse reaction is observed, then the investigators will proceed with administration of 1g cefazolin via the intraosseus route.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n•primary diagnoses of osteoarthritis\n\nExclusion Criteria:\n\n* history of compartment syndrome\n* allergy to an antibiotic in the study\n* venous stasis\n* peripheral vascular disease'}, 'identificationModule': {'nctId': 'NCT02433704', 'briefTitle': 'Preoperative Antibiotic Dosing for Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Preoperative Antibiotic Dosing for Total Knee Arthroplasty: Intraosseous Versus Systemic Infusion', 'orgStudyIdInfo': {'id': 'Pro00061712'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intraosseous Administration', 'description': 'Cefazolin 1 gram will be given through an intraosseous cannula, placed into the medial aspect of the proximal tibia, after draping and before skin incision. The cefazolin will be administered as a bolus in 200 mL of normal saline.', 'interventionNames': ['Device: New Intraosseous', 'Drug: Cefazolin']}, {'type': 'NO_INTERVENTION', 'label': 'Systemic Intravenous Administration', 'description': 'Historical controls will be used and will have received systemic dosing of cefazolin within one hour of the incision.'}], 'interventions': [{'name': 'New Intraosseous', 'type': 'DEVICE', 'description': 'Intraosseous administration of prophylactic antibiotics', 'armGroupLabels': ['Intraosseous Administration']}, {'name': 'Cefazolin', 'type': 'DRUG', 'description': 'Cefazolin 1 gram will be given through an intraosseous cannula, placed into the medial aspect of the proximal tibia, after draping and before skin incision. The cefazolin will be administered as a bolus in 200 mL of normal saline.', 'armGroupLabels': ['Intraosseous Administration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27703', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Medical Plaza Page Road', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Samuel Wellman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}