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

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:

• 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.

Participants will:

• Receive standard intravenous cefazolin before surgery and either intraosseous cefazolin or placebo
• Provide blood samples before and after antibiotic administration
• Have small tissue samples collected during surgery
• Complete routine postoperative follow-up and outcome assessment for 90 days

Study Overview

• Status: Enrolling by invitation
• Conditions: Antibiotic Prophylaxis Surgery
• Intervention / Treatment: Drug: CeFAZolin 1000 MG; Drug: Saline (0.9%, sterile, for infusion)

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Somerset, New Jersey, United States, 08876
      • Robert Wood Johnson University Hospital Somerset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years
• Scheduled to undergo primary total hip arthroplasty
• Receiving standard institutional antibiotic prophylaxis with IV bolus cefazolin prior to surgery

Exclusion Criteria:

• Reduced renal function (GFR < 30)
• Reduced liver function (AST/ALT > 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/or spoken English
• Undergoing revision total hip arthroplasty

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intraosseous Ancef; 50cc mixture of sterile injectable normal saline and one gram of ancef will be administered intra-osseously into the patient's operative side greater trochanter prior to incision	Drug: CeFAZolin 1000 MG; 1 gram of ancef will be administered intra-osseously into the patient's operative side greater trochanter; Drug: Saline (0.9%, sterile, for infusion); normal saline
Placebo Comparator: Intraosseous Saline; 50cc sterile injectable normal saline will be administered intra-osseously into the patient's operative side greater trochanter prior to incision	Drug: Saline (0.9%, sterile, for infusion); normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cefazolin Concentration	Cefazolin concentration in local tissues and serum	From administration of intra-osseous ancef to 4 hours post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative complications	Any post-operative complications, potentially related to the intra-osseous ancef or otherwise	time of surgery to 90 days from surgery

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey

Publications and helpful links

General Publications

• 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/s11999-012-2469-2.
• 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/s00402-023-05108-1. Epub 2023 Oct 30.
• 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/j.arth.2023.04.028. Epub 2023 Apr 23.

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Antibiotic prophylaxis; intraosseous antibiotics; intraosseous ancef
• Additional Relevant MeSH Terms: Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Amides; Inorganic Chemicals; Chlorine Compounds; beta-Lactams; Lactams; Cephalosporins; Thiazines; Sodium Compounds; Chlorides; Hydrochloric Acid; Cefazolin; Sodium Chloride
• Other Study ID Numbers: PRO2026000363; PC 110-25 (Other Grant/Funding Number: New Jersey Health Foundation); IRB00004311 (Other Grant/Funding Number: IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes