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Enrolling by invitation NCT07549542

Efficacy and Safety of Intraosseous Antibiotic Prophylaxis in Total Hip Replacement

Phase IV Interventional Antibiotic Prophylaxis Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CeFAZolin 1000 MG, Saline (0.9%, sterile, for infusion).
Who it may be relevant to
Registry conditions: Antibiotic Prophylaxis Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Intraosseous Antibiotic Prophylaxis in Total Hip Replacement: A Prospective Randomized Controlled Trial

Overview

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

Interventions

  • 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

Primary outcome measures

  • Cefazolin Concentration [Time frame: From administration of intra-osseous ancef to 4 hours post-operatively]
Secondary outcome measures (1)
  • Post-operative complications [Time frame: time of surgery to 90 days from surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Robert Wood Johnson University Hospital Somerset — Somerset

Publications

  • 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
  • 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
  • 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

Identifiers

NCT: NCT07549542 · PRO2026000363 · PC 110-25 · IRB00004311

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗