Comparing two methods of antibiotic delivery during knee surgery
Official title: Intraosseous Vancomycin and Cefazolin vs Intravenous Administration in Primary Total Knee Arthroplasty
Run by The Methodist Hospital Research Institute · NCT06640491 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | The Methodist Hospital Research Institute Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | May 15, 2025 |
| Main results expected | December 1, 2030 |
| Study ends | December 1, 2035 |
| Registry record updated | May 18, 2025 |
| Trial ID | NCT06640491 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older scheduled for elective primary total knee arthroplasty.
✕Probably not a fit
Patients with contraindications to vancomycin or cefazolin, or those with a BMI over 40, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While the approach of IO antibiotic administration is less common, similar studies have shown promise in other surgical contexts, suggesting potential for success.
Who can join: the full rules
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 it's running
-
Houston Methodist Hospital
Houston, Texas, United States Recruiting
Study contacts
- Study coordinator: Thomas Sullivan
- Email: tsullivan@houstonmethodist.org
- Phone: 346-238-1603
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Mind mapping-based education to help after knee replacement
A group of adults having total knee replacement will receive mind-mapping education in addition to standard care to see if it helps with pain, fear of movement, and readiness to leave the hospital.
-
DoACs vs LMWH for blood flow after knee replacement
This study tests whether rivaroxaban, apixaban, or LMWH work differently to support blood flow in the legs after total knee replacement in adults.
-
Branched chain amino acids after knee replacement to help muscle
This trial tests whether giving Livact after knee replacement helps preserve muscle and function in adults with sarcopenia.
-
Cryotherapy to Cut Opioid Use After Knee Replacement
This trial tests whether compressive cryotherapy with a Game Ready device can lower opioid use and improve recovery after total knee replacement in adults 60–80.
-
Early cognitive changes after same-day hip or knee replacement
This study tests whether older adults (65 or older, 70 per description) who have same-day discharge after hip or knee replacement show changes in cognitive test performance from before surgery to the first day after surgery.
-
Preoperative Genicular Nerve Block for Knee Replacement
This study tests whether giving a genicular nerve block before knee replacement can reduce pain after surgery and lower opioid use.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.