Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-01-08 @ 11:48 AM
Study NCT ID:
NCT04042233
Status:
COMPLETED
Last Update Posted:
2025-03-13
First Post:
2019-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007592', 'term': 'Joint Diseases'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tsullivan@houstonmethodist.org', 'phone': '2817254460', 'title': 'Thomas Sullivan', 'organization': 'Houston Methodist Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '90 days', 'eventGroups': [{'id': 'EG000', 'title': 'IV Group', 'description': 'IV group', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'IO Group', 'description': 'IO', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'serosanguinous drainag', 'notes': 'Patient had small part of distal incision with serosanguinous drainage 8 days post-op. By day 16 day post-op) the incision had stopped draining w/ no overlying erythema etc at any point.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Fall', 'notes': '17 days post-op patient fell off some steps outside their home. Fall was mechanical in nature. Patient unable to weight bear afterwards. XR showed Vancouver B2 fracture. Patient underwent revision THA. After careful review, deemed unrelated AE.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectal Bleeding', 'notes': 'Patient went to ED for rectal bleeding.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Systemic Vancomycin Level - Start of Case', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Group', 'description': 'IV group'}, {'id': 'OG001', 'title': 'IO Group', 'description': 'IO'}], 'classes': [{'categories': [{'measurements': [{'value': '27.98', 'spread': '13.67', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'approximately 10 minutes before incision', 'description': 'vancomycin blood level before the time of incision - typically taken approximately 10 minutes before incision.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Systemic Vancomycin Level - End of Case', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Group', 'description': 'IV group'}, {'id': 'OG001', 'title': 'IO Group', 'description': 'IO'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'spread': '7.34', 'groupId': 'OG000'}, {'value': '5.75', 'spread': '2.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'end of surgical case', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Vancomycin Concentration of Pulvinar Soft Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Group', 'description': 'IV group'}, {'id': 'OG001', 'title': 'IO Group', 'description': 'IO'}], 'classes': [{'categories': [{'measurements': [{'value': '61.58', 'spread': '46.64', 'groupId': 'OG000'}, {'value': '71.79', 'spread': '48.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'intraoperative', 'description': 'vancomycin concentration (ug/mL) of pulvinar soft tissue. Vancomycin tissue concentration measured by high performance liquid chromotagraphy.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Vancomycin Concentration of Intramedullary Bone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Group', 'description': 'IV group'}, {'id': 'OG001', 'title': 'IO Group', 'description': 'IO'}], 'classes': [{'categories': [{'measurements': [{'value': '33.93', 'spread': '26.86', 'groupId': 'OG000'}, {'value': '59.39', 'spread': '28.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'intraoperative', 'description': 'Vancomycin Concentration of Intramedullary Bone in units ug/mL. Vancomycin tissue concentration measured by high performance liquid chromotagraphy.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Soft Tissue Vancomycin Level - Start of Case', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Group', 'description': 'IV group'}, {'id': 'OG001', 'title': 'IO Group', 'description': 'IO'}], 'classes': [{'categories': [{'measurements': [{'value': '63.77', 'spread': '33.70', 'groupId': 'OG000'}, {'value': '69.08', 'spread': '37.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at start of case within 15 minutes after incision', 'description': 'at start , soft tissue. Vancomycin tissue concentration (ug/mL) measured by high performance liquid chromatography.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Femur Vancomycin Concentration Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Group', 'description': 'IV group'}, {'id': 'OG001', 'title': 'IO Group', 'description': 'IO'}], 'classes': [{'categories': [{'measurements': [{'value': '20.90', 'spread': '20.81', 'groupId': 'OG000'}, {'value': '41.45', 'spread': '29.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'intraoperative', 'description': 'Intraoperative femur bone sample measured for vancomycin concentration (ug/mL). Vancomycin tissue concentration measured by high performance liquid chromatography.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Acetabulum Vancomycin Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Group', 'description': 'IV group'}, {'id': 'OG001', 'title': 'IO Group', 'description': 'IO'}], 'classes': [{'categories': [{'measurements': [{'value': '67.97', 'spread': '24.82', 'groupId': 'OG000'}, {'value': '130.88', 'spread': '45.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'intraoperative', 'description': 'Intra-operative Acetabulum bone vancomycin concentrations (ug/mL) measured by high performance liquid chromatography.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '30-Day Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Group', 'description': 'IV group'}, {'id': 'OG001', 'title': 'IO Group', 'description': 'IO'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the administration of antibiotics perioperatively to 30 days post op.', 'description': 'Complications 30 days post surgery eg. infection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '90-Day Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Group', 'description': 'IV group'}, {'id': 'OG001', 'title': 'IO Group', 'description': 'IO'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the administration of antibiotics perioperatively to 90 days post op.', 'description': 'Complications 90 days post surgery eg. infection', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Soft Tissue Vancomycin Level - End of Case', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Group', 'description': 'IV group'}, {'id': 'OG001', 'title': 'IO Group', 'description': 'IO'}], 'classes': [{'categories': [{'measurements': [{'value': '57.14', 'spread': '29.49', 'groupId': 'OG000'}, {'value': '78.22', 'spread': '26.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'right before wound closure is initiated at the end of the case', 'description': 'soft tissue taken at end of case, right before wound closure is initiated. Vancomycin tissue concentration (ug/mL) measured by high performance liquid chromatography.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IV Administration of Vancomycin', 'description': 'Standard IV vancomycin administration protocol.\n\nStandard IV administration of vancomycin: IV antibiotics (cefepime \\& vancomycin) are started in pre-op approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg, generally 1000-1750mg in 500 mL NS).'}, {'id': 'FG001', 'title': 'IO Vancomycin 500mg in 250 mL NS', 'description': 'Experimental Intraosseous administration protocol.\n\nExperimental Intraosseous vancomycin 500mg in 250 mL NS: 500mg of Vancomycin in 250 mL of normal saline will be injected into a pre-specified region of the greater trochanter during primary total hip arthroplasty.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': '1st sample used for calibration of vancomycin tissue/bone concentration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IV Administration of Vancomycin', 'description': 'Standard IV vancomycin administration protocol.\n\nStandard IV administration of vancomycin: IV antibiotics (cefepime \\& vancomycin) are started in pre-op approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg, generally 1000-1750mg in 500 mL NS).'}, {'id': 'BG001', 'title': 'IO Vancomycin 500mg in 250 mL NS', 'description': 'Experimental Intraosseous administration protocol.\n\nExperimental Intraosseous vancomycin 500mg in 250 mL NS: 500mg of Vancomycin in 250 mL of normal saline will be injected into a pre-specified region of the greater trochanter during primary total hip arthroplasty.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.51', 'spread': '5.99', 'groupId': 'BG000'}, {'value': '67.89', 'spread': '4.10', 'groupId': 'BG001'}, {'value': '68.31', 'spread': '4.81', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'The American Society of Anesthesiologists (ASA) physical status classification', 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '0.52', 'groupId': 'BG000'}, {'value': '2.4', 'spread': '0.52', 'groupId': 'BG001'}, {'value': '2.5', 'spread': '0.51', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "ASA I A person in good health. ASA II A mild but well-managed or treated condition ASA III A serious condition that has an impact on a person's overall health. ASA IV A severe condition that's life-threatening. ASA V A life-threatening condition that needs immediate surgery to increase survival odds.\n\nASA VI A deceased person who is an organ donor.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '27.36', 'spread': '4.68', 'groupId': 'BG000'}, {'value': '27.85', 'spread': '4.88', 'groupId': 'BG001'}, {'value': '27.6', 'spread': '4.66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2022-04-25', 'size': 190000, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-05T12:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2019-07-30', 'resultsFirstSubmitDate': '2024-03-11', 'studyFirstSubmitQcDate': '2019-07-31', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-06', 'studyFirstPostDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systemic Vancomycin Level - Start of Case', 'timeFrame': 'approximately 10 minutes before incision', 'description': 'vancomycin blood level before the time of incision - typically taken approximately 10 minutes before incision.'}, {'measure': 'Systemic Vancomycin Level - End of Case', 'timeFrame': 'end of surgical case'}, {'measure': 'Vancomycin Concentration of Pulvinar Soft Tissue', 'timeFrame': 'intraoperative', 'description': 'vancomycin concentration (ug/mL) of pulvinar soft tissue. Vancomycin tissue concentration measured by high performance liquid chromotagraphy.'}, {'measure': 'Vancomycin Concentration of Intramedullary Bone', 'timeFrame': 'intraoperative', 'description': 'Vancomycin Concentration of Intramedullary Bone in units ug/mL. Vancomycin tissue concentration measured by high performance liquid chromotagraphy.'}], 'secondaryOutcomes': [{'measure': 'Soft Tissue Vancomycin Level - Start of Case', 'timeFrame': 'at start of case within 15 minutes after incision', 'description': 'at start , soft tissue. Vancomycin tissue concentration (ug/mL) measured by high performance liquid chromatography.'}, {'measure': 'Femur Vancomycin Concentration Level', 'timeFrame': 'intraoperative', 'description': 'Intraoperative femur bone sample measured for vancomycin concentration (ug/mL). Vancomycin tissue concentration measured by high performance liquid chromatography.'}, {'measure': 'Acetabulum Vancomycin Level', 'timeFrame': 'intraoperative', 'description': 'Intra-operative Acetabulum bone vancomycin concentrations (ug/mL) measured by high performance liquid chromatography.'}, {'measure': '30-Day Complications', 'timeFrame': 'From the administration of antibiotics perioperatively to 30 days post op.', 'description': 'Complications 30 days post surgery eg. infection.'}, {'measure': '90-Day Complications', 'timeFrame': 'From the administration of antibiotics perioperatively to 90 days post op.', 'description': 'Complications 90 days post surgery eg. infection'}, {'measure': 'Soft Tissue Vancomycin Level - End of Case', 'timeFrame': 'right before wound closure is initiated at the end of the case', 'description': 'soft tissue taken at end of case, right before wound closure is initiated. Vancomycin tissue concentration (ug/mL) measured by high performance liquid chromatography.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['total hip arthroplasty', 'vancomycin', 'intraosseous vancomycin'], 'conditions': ['Prosthetic Joint Infection', 'Vancomycin', 'Joint Diseases']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate a novel vancomycin intraosseous administration protocol vs a standard IV vancomycin administration protocol for primary total hip arthroplasty patients.', 'detailedDescription': 'Patients are randomized to one of two groups.\n\nGROUP A - Will receive IV antibiotics (cefepime \\& vancomycin) are started in pre-op approximately 1 hour prior to incision vancomycin dose weight-based at approximately 15mg/kg, generally 1000-1750mg in 500 milliliters (mL) normal saline (NS).\n\nGROUP B - Will have IV cefepime started in pre-op within 1 hour of incision. Intraosseous (IO) administration of vancomycin (500mg in 250 milliliters NS) will be administered in the OR after sterile prep and draping has occurred. Injection will take place into the greater trochanter (within a pre-specified region).\n\nBoth Groups will be monitored during surgery and immediately post-operatively for adverse injection reactions (i.e. Red Man Syndrome). Both groups will otherwise follow identical post-operative protocols (including post-operative antibiotic administration).\n\nTISSUE SAMPLES Five (5) tissue samples will be taken from each patient, 2 soft tissue samples and 3 bone samples will be taken throughout the course of the procedure.\n\nOne blood sample will be taken in both groups intraoperatively at the time of initiation of closure.\n\nThese samples will immediately be sent to a lab for analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is undergoing a primary total hip arthroplasty\n* Patient gives informed consent to participate in the study.\n* Age Range \\>18\n\nExclusion Criteria:\n\n* Previous surgery on the hip (including hip scopes)\n* BMI above 35\n* Contraindication to receiving vancomycin or cefepime (allergy, medical issue, etc)\n* Inability to locate the greater trochanter or administer the IO infusion\n* Refusal to participate\n* Diabetes\n* Immunocompromised or immunosuppressed patients (HIV, Hep C, End stage renal disease, dialysis, transplant, chemo/radiation treatment in last 6 months, medications).'}, 'identificationModule': {'nctId': 'NCT04042233', 'briefTitle': 'Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol', 'organization': {'class': 'OTHER', 'fullName': 'The Methodist Hospital Research Institute'}, 'officialTitle': 'Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol', 'orgStudyIdInfo': {'id': 'Pro00022651'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IV administration of vancomycin', 'description': 'Standard IV vancomycin administration protocol.', 'interventionNames': ['Drug: Standard IV administration of vancomycin']}, {'type': 'EXPERIMENTAL', 'label': 'IO Vancomycin 500mg in 250 mL NS', 'description': 'Experimental Intraosseous administration protocol.', 'interventionNames': ['Drug: Experimental Intraosseous vancomycin 500mg in 250 mL NS']}], 'interventions': [{'name': 'Experimental Intraosseous vancomycin 500mg in 250 mL NS', 'type': 'DRUG', 'description': '500mg of Vancomycin in 250 mL of normal saline will be injected into a pre-specified region of the greater trochanter during primary total hip arthroplasty.', 'armGroupLabels': ['IO Vancomycin 500mg in 250 mL NS']}, {'name': 'Standard IV administration of vancomycin', 'type': 'DRUG', 'description': 'IV antibiotics (cefepime \\& vancomycin) are started in pre-op approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg, generally 1000-1750mg in 500 mL NS).', 'armGroupLabels': ['IV administration of vancomycin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Terry A Clyburn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Methodist Hospital Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Methodist Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Terry Clyburn', 'investigatorAffiliation': 'The Methodist Hospital Research Institute'}}}}