[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07549542":3,"trial-entities:NCT07549542":99,"trial-summary:NCT07549542":103},{"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":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":43,"secondary_outcomes":48,"sex":53,"minimum_age":54,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":55,"std_ages":72,"locations":75,"central_contacts":85,"overall_officials":86,"references":87,"see_also_links":98},"NCT07549542","PRO2026000363","Efficacy and Safety of Intraosseous Antibiotic Prophylaxis in Total Hip Replacement","Efficacy and Safety of Intraosseous Antibiotic Prophylaxis in Total Hip Replacement: A Prospective Randomized Controlled Trial","ENROLLING_BY_INVITATION","2026-11","2026-04","2026-04-29","2025-10-20","Rutgers, The State University of New Jersey","OTHER",false,"The goal of this clinical trial is to learn if intraosseous antibiotic (cefazolin) administration can improve antibiotic levels in adults undergoing primary total hip replacement. The main question it aims to answer is:\n\n• Does intraosseous cefazolin increase antibiotic concentrations in blood and tissue compared with standard intravenous cefazolin alone? Researchers will compare patients receiving intraosseous cefazolin plus standard intravenous cefazolin to those receiving placebo injection plus standard intravenous cefazolin to see if local antibiotic delivery improves outcomes.\n\nParticipants will:\n\n* Receive standard intravenous cefazolin before surgery and either intraosseous cefazolin or placebo\n* Provide blood samples before and after antibiotic administration\n* Have small tissue samples collected during surgery\n* Complete routine postoperative follow-up and outcome assessment for 90 days",null,[19],"Antibiotic Prophylaxis Surgery",[21,22,23],"Antibiotic prophylaxis","intraosseous antibiotics","intraosseous ancef","INTERVENTIONAL","BASIC_SCIENCE",[27],"PHASE4",{"count":29,"type":30},25,"ESTIMATED",[32,38],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","CeFAZolin 1000 MG","1 gram of ancef will be administered intra-osseously into the patient's operative side greater trochanter",[37],"Intraosseous Ancef",{"type":33,"name":39,"description":40,"armGroupLabels":41},"Saline (0.9%, sterile, for infusion)","normal saline",[37,42],"Intraosseous Saline",[44],{"measure":45,"description":46,"timeFrame":47},"Cefazolin Concentration","Cefazolin concentration in local tissues and serum","From administration of intra-osseous ancef to 4 hours post-operatively",[49],{"measure":50,"description":51,"timeFrame":52},"Post-operative complications","Any post-operative complications, potentially related to the intra-osseous ancef or otherwise","time of surgery to 90 days from surgery","ALL","18 Years",{"inclusion":56,"exclusion":60,"raw_text":71},[57,58,59],"Age ≥ 18 years","Scheduled to undergo primary total hip arthroplasty","Receiving standard institutional antibiotic prophylaxis with IV bolus cefazolin prior to surgery",[61,62,63,64,65,66,67,68,69,70],"Reduced renal function (GFR \\\u003C 30)","Reduced liver function (AST\u002FALT \\> 3× upper limit of normal)","Weight \\> 120 kg","Undergoing bilateral total hip arthroplasty","Documented cefazolin anaphylaxis","Active joint infection","History of diabetes","Inflammatory arthropathies","Inability to understand written and\u002For spoken English","Undergoing revision total hip arthroplasty","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Scheduled to undergo primary total hip arthroplasty\n* Receiving standard institutional antibiotic prophylaxis with IV bolus cefazolin prior to surgery\n\nExclusion Criteria:\n\n* Reduced renal function (GFR \\\u003C 30)\n* Reduced liver function (AST\u002FALT \\> 3× upper limit of normal)\n* Weight \\> 120 kg\n* Undergoing bilateral total hip arthroplasty\n* Documented cefazolin anaphylaxis\n* Active joint infection\n* History of diabetes\n* Inflammatory arthropathies\n* Inability to understand written and\u002For spoken English\n* Undergoing revision total hip arthroplasty",[73,74],"ADULT","OLDER_ADULT",[76],{"facility":77,"city":78,"state":79,"zip":80,"country":81,"geoPoint":82},"Robert Wood Johnson University Hospital Somerset","Somerset","New Jersey","08876","United States",{"lat":83,"lon":84},40.4976,-74.48849,[],[],[88,92,95],{"pmid":89,"type":90,"citation":91},"37902891","BACKGROUND","Zhang J, Chen G, Yu X, Liu Y, Li Z, Zhang X, Zhong Q, Xu R. Higher cefazolin concentrations in synovial fluid with intraosseous regional prophylaxis in knee arthroplasty: a randomized controlled trial. Arch Orthop Trauma Surg. 2024 Sep;144(9):4069-4075. doi: 10.1007\u002Fs00402-023-05108-1. Epub 2023 Oct 30.",{"pmid":93,"type":90,"citation":94},"22773397","Young SW, Zhang M, Freeman JT, Vince KG, Coleman B. Higher cefazolin concentrations with intraosseous regional prophylaxis in TKA. Clin Orthop Relat Res. 2013 Jan;471(1):244-9. doi: 10.1007\u002Fs11999-012-2469-2.",{"pmid":96,"type":90,"citation":97},"37088221","Harper KD, Park KJ, Brozovich AA, Sullivan TC, Serpelloni S, Taraballi F, Incavo SJ, Clyburn TA. Otto Aufranc Award: Intraosseous Vancomycin in Total Hip Arthroplasty - Superior Tissue Concentrations and Improved Efficiency. J Arthroplasty. 2023 Jul;38(7S):S11-S15. doi: 10.1016\u002Fj.arth.2023.04.028. Epub 2023 Apr 23.",[],{"nct_id":4,"conditions":100,"biomarkers":102},[101],"Total replacement of hip",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]