Vancomycin given into the joint, into bone, or by IV during total knee replacement
A Prospective, Randomized Parallel Group Study of the Efficacy of Vancomycin Administered Through Intraarticular Injection Versus Intraosseous Injection Versus Intravenous Infusion in Patients Undergoing Total Knee Arthroplasty
This trial will test whether a single dose of vancomycin injected into the knee joint before a primary total knee replacement protects against infection as well as vancomycin given into bone or by IV for adults treated at UC San Diego.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT07282782 on ClinicalTrials.gov |
What this trial studies
This randomized, parallel-group, phase 4 study at UC San Diego compares three methods of preoperative vancomycin prophylaxis—intraarticular injection, intraosseous injection, and intravenous infusion—in adults undergoing primary unilateral total knee arthroplasty. Participants are randomized to one of the three arms and receive vancomycin before surgery; intraosseous administration requires an additional puncture and specialized device. The trial excludes patients with prior knee surgery (except arthroscopy), BMI >35, vancomycin/cefepime/cefazolin contraindications, uncontrolled diabetes, immunosuppression, chronic kidney disease, or active infections. Investigators hypothesize that intraarticular injection will be non-inferior to intraosseous injection while reducing wounds, procedure time, and cost.
Who should consider this trial
Good fit: Adults (≥18 years) receiving care at UC San Diego Health who are scheduled for primary unilateral total knee arthroplasty, can provide consent, and meet medical eligibility criteria are appropriate candidates.
Not a fit: Those who are excluded—such as people with prior knee surgery (other than arthroscopy), BMI >35, uncontrolled diabetes, immunosuppression, chronic kidney disease, or vancomycin allergy—would not be eligible and therefore would not benefit from participation in this protocol.
Why it matters
Potential benefit: If successful, patients could receive similar protection from infection with a simpler intraarticular injection instead of an extra bone injection, potentially reducing wounds, time, and cost.
How similar studies have performed: Intravenous and intraosseous vancomycin have established use for perioperative prophylaxis, but randomized head-to-head comparisons that include intraarticular injection are limited, so this direct comparison is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any patient over the age of 18 years of age receiving treatment at UC San Diego Health * Undergoing primary unilateral TKA * Ability to provide consent Exclusion Criteria: * previous surgery on the knee (with the exception of arthroscopy) * BMI \> 35 * contraindication to receiving vancomycin, cefepime or cefazolin (ie, allergy, etc) * diabetics with A1c\>7.5% (unless controlled fructosamine) * immunocompromised or immunosuppressed patients (HIV, Hepatitis C, end stage renal disease (ESRD), post transplant, chemotherapy or radiation therapy within 6 months of surgery, immunomodulating meducations) * no history of active infections * no history of chronic kidney disease
Where this trial is running
San Diego, California
- University of California, San Diego — San Diego, California, United States (Recruiting)
Study contacts
- Study coordinator: Dominic Baun
- Email: jbaun@health.ucsd.edu
- Phone: 858-534-8268
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.