Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-01 @ 6:45 AM
Study NCT ID:
NCT06384651
Status:
RECRUITING
Last Update Posted:
2025-01-24
First Post:
2024-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'single blind patient is blinded. Surgeon is not blinded. Lab technician measuring tissue concentrations are blinded. Research coordinator is not blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a prospective, randomized, single-blinded, controlled trial. 20 patients in each treatment arm: 20 patients will be given IV vancomycin, 20 patients will be given IO vancomycin'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-22', 'studyFirstSubmitDate': '2024-04-02', 'studyFirstSubmitQcDate': '2024-04-24', 'lastUpdatePostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systemic Sample Vancomycin Tissue Concentration - Start of Case', 'timeFrame': 'perioperatively'}, {'measure': 'Systemic Sample Vancomycin Tissue Concentration - End of Case', 'timeFrame': 'perioperatively'}, {'measure': 'Capsule or Synovium Sample Vancomycin Tissue Concentration', 'timeFrame': 'immediately after the procedure'}, {'measure': 'Distal Tibia Sample Vancomycin Tissue Concentration', 'timeFrame': 'immediately after the procedure'}, {'measure': 'Talar Bone Sample Vancomycin Tissue Concentration', 'timeFrame': 'immediately after the procedure'}], 'secondaryOutcomes': [{'measure': '90 day post-operative wound complication and infection rates', 'timeFrame': '90 days after the procedure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infections', 'Ankle Arthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare two different antibiotic regimens and techniques during total ankle arthroplasty (TAA).\n\nPrimary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic samples between patient groups.\n\nSecondary Objective: Compare 30 day and 90 day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) vs the interventional group (intraosseous administration of vancomycin). The investigators hypothesize that there will be no difference in complication (infection) rates between groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Patient is undergoing total ankle arthroplasty.\n* Patient is able to give informed consent to participate in the study. LAR consents will not be utilized for this study\n* Age Range \\>18\n\nExclusion Criteria\n\n* Previous lower extremity surgery that in the opinion of the principal investigator or qualified research personnel precludes the participant from safely participating on the study.\n* BMI \\> 40.\n* Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).\n* Inability to administer the IO infusion.\n* Patient refusal to participate.\n* Uncontrolled Diabetes Mellitus type 1 or 2, defined as Hemoglobin A1C \\>7.5.\n* Immunocompromised or immunosuppressed patients (HIV, Hep C, end stage renal disease, dialysis, transplant, chemo/radiation treatment in last 6 months, medications).\n* Vulnerable populations'}, 'identificationModule': {'nctId': 'NCT06384651', 'acronym': 'IOTAA', 'briefTitle': 'Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'The Methodist Hospital Research Institute'}, 'officialTitle': 'Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty', 'orgStudyIdInfo': {'id': 'PRO00037789'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous Vancomycin', 'description': "Patients will receive the orthopedic surgeon's standard of care pre-operative antibiotic regimen for TAA patients. This includes IV antibiotics (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg generally 1000-1750mg in 500mL normal saline (NS))", 'interventionNames': ['Drug: Intravenous Vancomycin']}, {'type': 'EXPERIMENTAL', 'label': 'Intraosseous Vancomycin', 'description': "IV antibiotics per physician's standard of care: Typically ancef or cefepime is started in pre-op within 1 hour of incision. IV Vancomycin will not be given preoperatively in this group.\n\nIO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).\n\nIO Injection will take place into the medial malleolus.", 'interventionNames': ['Drug: Intraosseous Vancomycin Injection']}], 'interventions': [{'name': 'Intraosseous Vancomycin Injection', 'type': 'DRUG', 'description': '* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).\n* IO Injection will take place into the medial malleolus.', 'armGroupLabels': ['Intraosseous Vancomycin']}, {'name': 'Intravenous Vancomycin', 'type': 'DRUG', 'description': "• Patients will receive the orthopedic surgeon's standard of care pre-operative antibiotic regimen for TAA patients. This includes IV antibiotics (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg generally 1000-1750mg in 500mL normal saline (NS))", 'armGroupLabels': ['Intravenous Vancomycin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Thomas C Sullivan, BS', 'role': 'CONTACT', 'email': 'tsullivan@houstonmethodist.org', 'phone': '346-238-1603'}, {'name': 'Jason S Ahuero, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kevin Varner, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kwan J Park, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Houston Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Thomas C Sullivan, BS', 'role': 'CONTACT', 'email': 'tsullivan@houstonmethodist.org', 'phone': '346-238-1603'}, {'name': 'Blesson Varghese, BS', 'role': 'CONTACT', 'email': 'bvarghese6@houstonmethodist.org', 'phone': '713-441-3814'}], 'overallOfficials': [{'name': 'Jason S Ahuero, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Methodist Hospital Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Methodist Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopedic Surgeon', 'investigatorFullName': 'Jason S. Ahuero', 'investigatorAffiliation': 'The Methodist Hospital Research Institute'}}}}