[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06384651":3,"trial-entities:NCT06384651":110,"trial-summary:NCT06384651":115},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":39,"secondary_outcomes":52,"sex":56,"minimum_age":57,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":58,"std_ages":73,"locations":76,"central_contacts":100,"overall_officials":106,"references":108,"see_also_links":109},"NCT06384651","PRO00037789","Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty","RECRUITING","2027-12","2025-01","2025-01-24","2024-12-03","The Methodist Hospital Research Institute","OTHER",false,"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.",null,[18,19],"Infections","Ankle Arthritis",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE4",{"count":26,"type":27},40,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"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.",[34],"Intraosseous Vancomycin",{"type":30,"name":36,"description":37,"armGroupLabels":38},"Intravenous Vancomycin","• 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))",[36],[40,43,45,48,50],{"measure":41,"timeFrame":42},"Systemic Sample Vancomycin Tissue Concentration - Start of Case","perioperatively",{"measure":44,"timeFrame":42},"Systemic Sample Vancomycin Tissue Concentration - End of Case",{"measure":46,"timeFrame":47},"Capsule or Synovium Sample Vancomycin Tissue Concentration","immediately after the procedure",{"measure":49,"timeFrame":47},"Distal Tibia Sample Vancomycin Tissue Concentration",{"measure":51,"timeFrame":47},"Talar Bone Sample Vancomycin Tissue Concentration",[53],{"measure":54,"timeFrame":55},"90 day post-operative wound complication and infection rates","90 days after the procedure","ALL","18 Years",{"inclusion":59,"exclusion":63,"raw_text":72},[60,61,62],"Patient is undergoing total ankle arthroplasty.","Patient is able to give informed consent to participate in the study. LAR consents will not be utilized for this study","Age Range \\>18",[64,65,66,67,68,69,70,71],"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.","BMI \\> 40.","Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).","Inability to administer the IO infusion.","Patient refusal to participate.","Uncontrolled Diabetes Mellitus type 1 or 2, defined as Hemoglobin A1C \\>7.5.","Immunocompromised or immunosuppressed patients (HIV, Hep C, end stage renal disease, dialysis, transplant, chemo\u002Fradiation treatment in last 6 months, medications).","Vulnerable populations","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",[74,75],"ADULT","OLDER_ADULT",[77],{"facility":78,"status":7,"city":79,"state":80,"zip":81,"country":82,"contacts":83,"geoPoint":97},"Houston Methodist Hospital","Houston","Texas","77030","United States",[84,89,92,95],{"name":85,"role":86,"phone":87,"email":88},"Thomas C Sullivan, BS","CONTACT","346-238-1603","tsullivan@houstonmethodist.org",{"name":90,"role":91},"Jason S Ahuero, MD","PRINCIPAL_INVESTIGATOR",{"name":93,"role":94},"Kevin Varner, MD","SUB_INVESTIGATOR",{"name":96,"role":94},"Kwan J Park, MD",{"lat":98,"lon":99},29.76328,-95.36327,[101,102],{"name":85,"role":86,"phone":87,"email":88},{"name":103,"role":86,"phone":104,"email":105},"Blesson Varghese, BS","713-441-3814","bvarghese6@houstonmethodist.org",[107],{"name":90,"affiliation":12,"role":91},[],[],{"nct_id":4,"conditions":111,"biomarkers":114},[112,113],"Infection","Osteoarthritis of ankle",[],{"nct_id":4,"found":116,"summary":117,"prompt_version":127},true,{"design":118,"status":119,"heading":120,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This is an interventional study comparing two different ways to give antibiotics during surgery, involving 40 participants.","completed","Vancomycin Administration in Total Ankle Arthroplasty","This study is comparing two ways to give an antibiotic called vancomycin during total ankle replacement surgery. One group of patients will receive vancomycin through a standard IV (into a vein). The other group will receive vancomycin directly into the bone in the ankle (intraosseous injection). Researchers want to see if both methods deliver similar amounts of vancomycin to the bone, soft tissue, and throughout the body. They also want to compare infection rates 30 and 90 days after surgery between the two groups. You may be able to join if you are at least 18 years old and are having total ankle replacement surgery. The study is currently recruiting 40 participants.","Your post-operative complication rates (infection) will be compared at 30 and 90 days after surgery.",112,"You would receive vancomycin either intravenously or through an intraosseous injection during your total ankle replacement surgery. Tissue and blood samples will be taken during and immediately after the procedure.","Not stated in the trial record.",[],"v2"]