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Enrolling by Invitation

NCT Number: NCT07549542

Efficacy and Safety of Intraosseous Antibiotic Prophylaxis in Total Hip Replacement

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

Enrolling by Invitation

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Key information

Conditions

Antibiotic Prophylaxis Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Robert Wood Johnson University Hospital Somerset

Somerset, New Jersey, 08876, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CeFAZolin 1000 MG

Drug

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

Saline (0.9%, sterile, for infusion)

Drug

normal saline

Primary outcomes

  1. Cefazolin Concentration

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

    Cefazolin concentration in local tissues and serum

Secondary outcomes

  1. Post-operative complications

    Time frame: time of surgery to 90 days from surgery

    Any post-operative complications, potentially related to the intra-osseous ancef or otherwise

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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