Comparing two methods of antibiotic delivery during knee surgery
Intraosseous Vancomycin and Cefazolin vs Intravenous Administration in Primary Total Knee Arthroplasty
PHASE1; PHASE2 · The Methodist Hospital Research Institute · NCT06640491
This study is testing whether giving antibiotics directly into the bone during knee surgery works better than the usual method of giving them through an IV to help reduce complications after surgery.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Methodist Hospital Research Institute (other) |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06640491 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of intraosseous (IO) versus intravenous (IV) administration of antibiotics, specifically vancomycin and cefazolin, in patients undergoing primary total knee arthroplasty (TKA). Participants will be randomly assigned to receive either the standard IV treatment or the experimental IO treatment. The study will assess whether IO administration reduces perioperative exposure risks and if there are differences in post-operative complication rates between the two methods. Conducted at Houston Methodist Hospital, this trial seeks to improve antibiotic delivery methods in surgical settings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for elective primary total knee arthroplasty.
Not a fit: Patients with contraindications to vancomycin or cefazolin, or those with a BMI over 40, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and reduced complications for patients undergoing knee surgery.
How similar studies have performed: While the approach of IO antibiotic administration is less common, similar studies have shown promise in other surgical contexts, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient is scheduled to undergo an elective primary total knee arthroplasty. * Patient is able to understand the study design and intervention and gives informed consent to participate in the study. * Patient is 18 years or older. Exclusion Criteria: * Contraindication to receiving vancomycin or cefazolin. * Body mass index (BMI) \> 40. * Uncontrolled Diabetes (defined as A1c \> 7.5%). * Patient received or is scheduled to receive IV vancomycin or cefazolin within 7 days prior to their planned procedure. * Any hardware, condition, or anatomic status that prevents the tibial tubercle from being a viable intraosseous injection site. * Refusal to participate * Any condition, in the opinion of the primary investigator, that deems the participant unsuitable for participation in the research study.
Where this trial is running
Houston, Texas
- Houston Methodist Hospital — Houston, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Thomas Sullivan
- Email: tsullivan@houstonmethodist.org
- Phone: 346-238-1603
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Total Knee Arthroplasty