Efficacy and Safety of Intraosseous Antibiotic Prophylaxis in Total Hip Replacement

NCT07549542 | Enrolling By Invitation Phase 4 FDA Drug

• 3 other identifiers: PRO2026000363PC 110-25IRB00004311
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Antibiotic Prophylaxis Surgery

Keywords

Antibiotic prophylaxis; intraosseous antibiotics; intraosseous ancef

Outcome Measures

Primary Outcomes (1)

• Cefazolin Concentration

  Cefazolin concentration in local tissues and serum

  From administration of intra-osseous ancef to 4 hours post-operatively

Secondary Outcomes (1)

• Post-operative complications

  time of surgery to 90 days from surgery

Study Arms (2)

Intraosseous Ancef

EXPERIMENTAL

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; Drug: Saline (0.9%, sterile, for infusion)

Intraosseous Saline

PLACEBO COMPARATOR

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)

Interventions

CeFAZolin 1000 MG DRUG

1 gram of ancef will be administered intra-osseously into the patient's operative side greater trochanter

Intraosseous Ancef

Saline (0.9%, sterile, for infusion) DRUG

normal saline

Intraosseous Ancef; Intraosseous Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Robert Wood Johnson University Hospital Somerset

Somerset, New Jersey, 08876, United States

Location

Related Publications (3)

• 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.

  PMID: 37902891 BACKGROUND

• 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.

  PMID: 22773397 BACKGROUND

• 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.

  PMID: 37088221 BACKGROUND

MeSH Terms

Interventions

Cefazolin; Sodium Chloride

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Randomized control trial with intraosseous ancef group and placebo (saline) group with goal of determining antibiotic concentrations in local tissues and serum

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 24, 2026
• Study Start: October 20, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)