[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07633418":3,"trial-entities:NCT07633418":84,"trial-summary:NCT07633418":88},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":40,"sex":41,"minimum_age":42,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":43,"std_ages":47,"locations":50,"central_contacts":69,"overall_officials":71,"references":72,"see_also_links":83},"NCT07633418","804904","IO Vancomycin Administration in TKA","Systemic Vancomycin Levels in Intraosseous Administration During Total Knee Arthroplasty","NOT_YET_RECRUITING","2029-04-29","2026-05","2026-06-08","2026-06-01","University of California, San Diego","OTHER",false,"This is a prospective, single-center, open-label study evaluating systemic vancomycin levels following preoperative intraosseous administration in patients undergoing primary unilateral total knee arthroplasty. Eligible participants will receive preoperative intraosseous vancomycin (500 mg in 100 mL saline) as part of standard perioperative infection prophylaxis. The study is open-label due to the nature of the intervention. Blood samples will be collected at predefined time points intraoperatively to measure serum vancomycin concentrations. Patients will be randomized to either a tourniquet or no tourniquet for these blood draws.",null,[19],"Total Knee Arthroplasty",[],"INTERVENTIONAL","PREVENTION",[24],"PHASE4",{"count":26,"type":27},30,"ESTIMATED",[29],{"type":30,"name":31,"description":6,"armGroupLabels":32},"DRUG","Intraosseous Vamcomycin Administration",[33,34],"Non tourniquet IO Vancomycin","Tourniquet IO Vancomycin",[36],{"measure":37,"description":38,"timeFrame":39},"Serum Vancomycin Levels","Serum Vancomycin Levels following IO Vancomycin administration","From administration up to 30 minutes post-administration.",[],"ALL","18 Years",{"inclusion":44,"exclusion":45,"raw_text":46},[],[],"Inclusion Criteria:\n\n1. Is a patient over the age of 18 receiving treatment at UC San Diego\n2. Is undergoing primary unilateral total knee arthroplasty\n3. Is able to provide consent\n4. Is candidate for IO administration of Vancomycin\n\nExclusion Criteria:\n\n1. Has had a previous surgery on the knee of interest (with the exception of arthroscopy)\n2. Has a BMI \\>35\n3. Has a contraindication to receiving vancomycin, cefepime, or cefazolin (i.e. allergy)\n4. Has diabetes with A1c \\>7.5% (unless with controlled fructosamine)\n5. Is immunocompromised\u002Fimmunosuppressed (i.e. due to HIV, hepatitis C, end-stage renal disease, post-transplant status, chemotherapy or radiation therapy within 6 months of surgery, immunomodulating medications)\n6. Has a history of active infection\n7. Inability to provide consent\n8. Prisoner\n9. Pregnant women",[48,49],"ADULT","OLDER_ADULT",[51],{"facility":52,"city":53,"state":54,"zip":55,"country":56,"contacts":57,"geoPoint":66},"UC San Diego","San Diego","California","92093","United States",[58,63],{"name":59,"role":60,"phone":61,"email":62},"Dominic Baun","CONTACT","858-534-8268","jbaun@health.ucsd.edu",{"name":64,"role":65},"Scott Ball, MD","PRINCIPAL_INVESTIGATOR",{"lat":67,"lon":68},32.71571,-117.16472,[70],{"name":59,"role":60,"phone":61,"email":62},[],[73,77,80],{"pmid":74,"type":75,"citation":76},"34084697","BACKGROUND","Olsen Kipp J, Hanberg P, Slater J, Moller Nielsen L, Storgaard Jakobsen S, Stilling M, Bue M. Vancomycin bone and tissue concentrations following tibial intraosseous administration - evaluated in a porcine model. J Bone Jt Infect. 2021 Feb 12;6(4):99-106. doi: 10.5194\u002Fjbji-6-99-2021. eCollection 2021.",{"pmid":78,"type":75,"citation":79},"37714404","Hu M, Zhang Y, Yang X, Wang Y, Xu H, Xiang S. Intraarticular vancomycin decreased the risk of acute postoperative periprosthetic joint infection without increasing complication in primary total joint arthroplasty-a prospective study. Int J Infect Dis. 2023 Nov;136:64-69. doi: 10.1016\u002Fj.ijid.2023.09.004. Epub 2023 Sep 14.",{"pmid":81,"type":75,"citation":82},"40339929","McNamara CA, Wininger AE, Sullivan TC, Brown TS, Clyburn TA, Incavo SJ, Park KJ. The AAHKS Best Podium Presentation Research Award: Intraosseous Vancomycin Reduces the Rate of Periprosthetic Joint Infection Following Aseptic Revision Total Knee Arthroplasty. J Arthroplasty. 2025 Sep;40(S19):S28-S32. doi: 10.1016\u002Fj.arth.2025.04.060. Epub 2025 May 6.",[],{"nct_id":4,"conditions":85,"biomarkers":87},[86],"Total Knee Replacement",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]