Efficacy and Safety of Intraosseous Antibiotic Prophylaxis in Total Hip Replacement: A Prospective Randomized Controlled Trial
ClinicalTrials.gov Studies
Summary
A new Phase 4 clinical trial (NCT07549542) has been registered on ClinicalTrials.gov, evaluating whether intraosseous administration of cefazolin improves antibiotic concentrations in blood and tissue compared with standard intravenous cefazolin alone in adults undergoing primary total hip replacement. The trial, listed as "Kind: PHASE4" with an April 24, 2026 date, will enroll participants receiving either intraosseous cefazolin plus standard IV cefazolin or placebo plus standard IV cefazolin. Healthcare providers and clinical investigators involved in orthopedic surgery should monitor this trial's findings, as positive results could inform future antibiotic prophylaxis protocols for joint replacement procedures.
“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.”
About this source
ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.
What changed
This ClinicalTrials.gov registration documents a new prospective randomized controlled trial examining whether intraosseous cefazolin administration increases antibiotic concentrations in blood and tissue compared with standard intravenous cefazolin alone in adults undergoing primary total hip replacement. Participants will receive either intraosseous cefazolin or placebo in addition to standard IV cefazolin before surgery. The trial includes blood sampling, intraoperative tissue collection, and 90-day postoperative follow-up.
Healthcare institutions performing orthopedic joint replacement surgery and clinical investigators specializing in surgical site infection prevention should monitor enrollment and outcome data from this Phase 4 study. If intraosseous administration demonstrates superior antibiotic penetration, the findings could influence prophylaxis protocols and clinical practice guidelines for total joint arthroplasty.
Archived snapshot
Apr 25, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Efficacy and Safety of Intraosseous Antibiotic Prophylaxis in Total Hip Replacement: A Prospective Randomized Controlled Trial
Phase 4 NCT07549542 Kind: PHASE4 Apr 24, 2026
Abstract
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
Interventions: CeFAZolin 1000 MG, Saline (0.9%, sterile, for infusion)
Related changes
Get daily alerts for ClinicalTrials.gov Studies
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from NIH.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when ClinicalTrials.gov Studies publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.