[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573581":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":51,"collaborators":25,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":25,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":25,"enrollmentInfo":64,"targetDuration":25,"studyType":67,"phases":68,"briefSummary":71,"conditions":72,"keywords":25,"overallStatus":74,"whyStopped":25,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"The Methodist Hospital Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intraosseous Vancomycin","EXPERIMENTAL","Participants in this group will receive other antibiotics according to the Houston Methodist Hospital orthopedic surgeon's standard of care regimen, which typically involves ancef or cefepime being administered in pre-op within 1 hour of the incision. IO Vancomycin will be administered in the OR after incision (500mg in 100-150mL normal saline (NS)), and the injection will be placed into the posterior ilium.",[13],"Drug: Intraosseous Vancomycin",{"label":15,"type":16,"description":17,"interventionNames":18},"Intravenous Vancomycin","ACTIVE_COMPARATOR","Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for lumbar fusion patients. This includes IV antibiotics (typically ancef or cefepime and vancomycin), which 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 NS).",[19],"Drug: Intravenous Vancomycin",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","The intervention is specific to the method of administration that will be used when giving the dose of antibiotic vancomycin which is done to prevent infection following surgery.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"This is the standard method of giving the antibiotic vancomycin to patients undergoing surgery across many specialties in order to prevent infection.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Emily Vidal","CONTACT","346-238-4675","evidal@houstonmethodist.org",[36],{"facility":37,"status":25,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Houston Methodist Hospital","Houston","Texas","77030","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-95.36327,29.76328,{"lat":47,"lon":46},[50],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Mark Prasarn","Orthopedic Surgeon","100573581","phase-2-io-vancomycin-spine-100573581",false,"NCT06748144","IO Vancomycin Spine","Intraosseous vs. Intravenous Vancomycin Administration in Spine Surgery","Inclusion Criteria:\n\n* Patient is undergoing open posterior instrumented spinal fusion (PSIF) or transforaminal lumbar interbody fusion (TLIF)\n* Patient is able to give informed consent to participate on the study. LAR consents will not be utilized for this study\n* Age Range \\>18\n\nExclusion Criteria:\n\n* Previous spine surgery if surgeon deems it will affect 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* Refusal to participate\n* Diabetes as defined as uncontrolled A1C \\> 7.5 and eGFR \\\u003C59\n* Immunocompromised or immunosuppressed patients (HIV, Hep C, ESRD, dialysis, transplant, chemo\u002Fradiation treatment in last 6 months, medications)\n* No vulnerable populations","ALL","18 Years",{"count":65,"type":66},30,"ESTIMATED","INTERVENTIONAL",[69,70],"PHASE2","PHASE3","The goal of this research is to learn if injecting the antibiotic vancomycin directly into the bone marrow (intraosseous) or IO) during a lumbar (spinal) fusion surgery, is as effective or better than the standard method of giving it vancomycin through a vein (intravenous) or IV) during lumbar fusion surgery.",[73],"Lumbar Fusion Surgery","NOT_YET_RECRUITING","2026-03-24",{"date":77,"type":78},"2026-03-25","ACTUAL",{"date":80,"type":66},"2026-05",{"date":82,"type":66},"2030-04",{"name":5,"class":6},1]