Efficacy and Safety of Intraosseous Antibiotic Prophylaxis in Total Hip Replacement

Conditions

• Antibiotic Prophylaxis Surgery

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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

Key Dates

Start date

Oct 20, 2025

Status verified

Apr 2026

Primary completion

Oct 31, 2026

Completion

Nov 30, 2026

Study Design

Enrollment

25 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• 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
• 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

Primary Outcome Measure

Cefazolin Concentration [ Time Frame: From administration of intra-osseous ancef to 4 hours post-operatively ]

Locations (1)

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