[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545649":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":44,"responsibleParty":67,"collaborators":26,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":26,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":26,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"The Methodist Hospital Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intravenous Vancomycin","ACTIVE_COMPARATOR","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\u002Fkg generally 1000-1750mg in 500mL normal saline (NS))",[13],"Drug: Intravenous Vancomycin",{"label":15,"type":16,"description":17,"interventionNames":18},"Intraosseous Vancomycin","EXPERIMENTAL","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.",[19],"Drug: Intraosseous Vancomycin Injection",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Intraosseous Vancomycin Injection","* 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.",[15],null,{"type":22,"name":9,"description":28,"armGroupLabels":29,"otherNames":26},"• 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\u002Fkg generally 1000-1750mg in 500mL normal saline (NS))",[9],[31],{"name":32,"affiliation":5,"role":33},"Jason S Ahuero, MD","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},"Thomas C Sullivan, BS","CONTACT","346-238-1603","tsullivan@houstonmethodist.org",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},"Blesson Varghese, BS","713-441-3814","bvarghese6@houstonmethodist.org",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Houston Methodist Hospital","RECRUITING","Houston","Texas","77030","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-95.36327,29.76328,{"lat":57,"lon":56},[60,61,62,65],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},{"name":32,"role":33,"phone":26,"phoneExt":26,"email":26},{"name":63,"role":64,"phone":26,"phoneExt":26,"email":26},"Kevin Varner, MD","SUB_INVESTIGATOR",{"name":66,"role":64,"phone":26,"phoneExt":26,"email":26},"Kwan J Park, MD",{"type":33,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Jason S. Ahuero","Orthopedic Surgeon","100545649","phase-4-intraosseous-vs-intravenous-vancomycin-administration-in-total-ankle-arthroplasty-100545649",false,"NCT06384651","Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty","IOTAA","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\u002Fradiation treatment in last 6 months, medications).\n* Vulnerable populations","ALL","18 Years",{"count":80,"type":81},40,"ESTIMATED","INTERVENTIONAL",[84],"PHASE4","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.",[87,88],"Infections","Ankle Arthritis","2025-01-22",{"date":91,"type":92},"2025-01-24","ACTUAL",{"date":94,"type":92},"2024-12-03",{"date":96,"type":81},"2027-12",{"name":5,"class":6},1]