Intraosseous Antibiotic Prophylaxis for Total Hip Replacement
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method of delivering antibiotics during hip replacement surgery to enhance the medicine's effectiveness. Researchers aim to determine if administering the antibiotic cefazolin directly into the bone, in addition to the usual IV method, increases the drug's presence in the bloodstream and tissues. Participants will receive either the new bone-based antibiotic method or a placebo, along with standard care, and will provide blood and tissue samples. The trial seeks adults scheduled for their first hip replacement who are already set to receive standard antibiotic care. As a Phase 4 trial, this research focuses on understanding how an already FDA-approved and effective treatment can benefit more patients.
Do I have to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. However, since the trial involves standard antibiotic treatment before surgery, it's best to discuss your current medications with the trial team to ensure there are no interactions.
What is the safety track record for cefazolin?
Research has shown that cefazolin, an antibiotic used to prevent infections during surgery, is generally safe for patients. Studies have found that patients who received cefazolin during total hip replacements experienced fewer infections compared to those who received a placebo. Specifically, one study showed the infection rate dropped from 3.3% with a placebo to 0.9% with cefazolin.
Most people tolerate cefazolin well, meaning it usually doesn't cause problems. Some patients might experience mild reactions like nausea or a skin rash, but serious side effects are rare. The FDA has approved this antibiotic for use in surgeries, supporting its safety.
While less information exists specifically about using cefazolin inside the bone, similar methods with other antibiotics have proven safe and effective. Although intraosseous cefazolin is still under study, existing data on cefazolin and similar methods suggest it is safe to use.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about intraosseous antibiotic prophylaxis because it offers a new method for preventing infection in total hip replacements. Unlike standard intravenous antibiotic delivery, this method administers cefazolin directly into the bone (greater trochanter), potentially increasing the concentration of the antibiotic at the surgical site and improving its effectiveness. This targeted delivery could reduce the risk of infections more effectively than traditional methods, providing a significant advantage in surgical outcomes.
What evidence suggests that intraosseous cefazolin is effective for improving antibiotic levels in total hip replacement?
This trial will compare intraosseous delivery of cefazolin with a saline placebo for infection prevention in total hip replacement surgeries. Studies have shown that cefazolin reduces infections after hip replacements. In one study, infections decreased from 3.3% with a placebo to 0.9% with cefazolin. Research suggests that delivering cefazolin directly into the bone (intraosseous delivery) might increase its levels in the body and tissues, potentially offering better protection against infections during surgery. Patients who received cefazolin this way had higher drug levels in their blood compared to standard methods. Overall, cefazolin is trusted for preventing infections in hip surgeries, and new methods like intraosseous delivery are being explored to enhance its effectiveness.12356
Are You a Good Fit for This Trial?
This trial is for adults (18 or older) scheduled for their first total hip replacement surgery who will receive standard IV antibiotics before surgery.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard intravenous cefazolin and either intraosseous cefazolin or placebo before surgery
Post-operative Monitoring
Blood and tissue samples are collected to measure cefazolin concentration
Follow-up
Participants complete routine postoperative follow-up and outcome assessment
What Are the Treatments Tested in This Trial?
Interventions
- Cefazolin
Trial Overview
The study compares giving an extra dose of the antibiotic cefazolin directly into the bone during hip replacement, along with standard IV cefazolin, versus a placebo injection plus standard IV cefazolin. The goal is to see if this method improves antibiotic levels and outcomes.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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
50cc sterile injectable normal saline will be administered intra-osseously into the patient's operative side greater trochanter prior to incision
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rutgers, The State University of New Jersey
Lead Sponsor
Citations
Efficacy and Safety of Intraosseous Antibiotic Prophylaxis ...
The goal of this clinical trial is to learn if intraosseous antibiotic (cefazolin) administration can improve antibiotic levels in adults undergoing primary ...
CEFAZOLIN PROPHYLACTIC EFFICACY ON PROSTHETIC ...
Cefazolin administration within 24 h of primary THA may be appropriate for perioperative deep PJI. Level of Evidence II; Retrospective study . Keywords: ...
Efficacy and Safety of Intraosseous Antibiotic Prophylaxis ...
The study design is a prospective, randomized control trial designed to compare the efficacy and safety of intraosseous (IO) antibiotic prophylaxis in patients ...
A Systematic Review and Meta-Analysis
Cefazolin. Prosthetic Joint Infection. Introduction. Total joint arthroplasty is the most effective method for treating various advanced joint ...
Efficacy and Safety of Intraosseous Versus Intravenous ... - PMC
Long-term results of prophylactic cefazolin versus placebo in total hip replacement. Lancet. 1987;329:860. doi: 10.1016/S0140-6736(87)91635 ...
Intraosseous Antibiotic Prophylaxis for Total Hip ...
The goal of this clinical trial is to learn if intraosseous antibiotic (cefazolin) administration can improve antibiotic levels in adults ...
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