---
title: IO vs IV Vancomycin in Tourniquetless TKA
nct_id: NCT05705843
overall_status: UNKNOWN
phase: PHASE4
sponsor: The Methodist Hospital Research Institute
study_type: INTERVENTIONAL
primary_condition: Infection, Surgical Site
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05705843.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05705843"
ct_last_update_post_date: 2023-01-31
last_seen_at: "2026-05-12T06:46:54.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# IO vs IV Vancomycin in Tourniquetless TKA

**Official Title:** Intraosseous Vancomycin vs Intravenous Vancomycin in Tourniquetless Primary Total Knee Arthroplasty

**NCT ID:** [NCT05705843](https://clinicaltrials.gov/study/NCT05705843)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 40
- **Lead Sponsor:** The Methodist Hospital Research Institute
- **Conditions:** Infection, Surgical Site
- **Start Date:** 2023-01-25
- **Completion Date:** 2024-01-25
- **CT.gov Last Update:** 2023-01-31

## Brief Summary

Purpose of this study is to compare the efficacy of intravenous and intraosseous antibiotic administration techniques during tourniquetless total knee arthroplasty.

## Detailed Description

Primary Objective: Comparable levels of vancomycin will be found in distal femur, proximal tibia, and periarticular soft tissues, as well as in systemic levels, between the intravenous and intraosseous administration groups.

Secondary Objective: Compare 30- and 90-day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) versus the interventional group (intraosseous administration of vancomycin). The research team hypothesizes that there will be no difference in complication (infection) rates between groups

## Eligibility

- **Minimum age:** 19 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Patient is undergoing a primary total knee arthroplasty.
* Patient is able to understand the study design and intervention and gives informed consent to participate in the study. No LAR consents will be utilized for this study.
* Age \>18 years.
* Total knee arthroplasty performed without the use of a tourniquet.

Exclusion Criteria:

* Previous surgery on the knee (including arthroscopic knee surgery)
* BMI above 35
* Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).
* Inability to locate the tibial tubercle or administer the IO infusion
* Refusal to participate
* Uncontrolled Diabetes Mellitus type 1 or 2, defined as Hemoglobin A1C \>7.5.
* Immunocompromised or immunosuppressed patients (HIV, Hep C, End-Stage Renal Disease, dialysis, transplant, chemo/radiation treatment in last 6 months, and immunosuppresive medications)
```

## Arms

- **Intravenous Vancomycin Administration** (ACTIVE_COMPARATOR) — Patients will receive the Houston Methodist Hospital orthopedic surgery standard of care pre-operative antibiotic regimen for primary total knee arthroplasty patients. This includes IV antibiotics (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[12,13\] generally 1000-1750mg in 500mL NS).
- **Intraosseous Vancomycin Administration** (EXPERIMENTAL) — * IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision. IV Vancomycin will not be administered preoperatively in this group.
* IO vancomycin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the OR after sterile prep and draping has occurred prior to skin incision (500mg in 150mL NS).
* Injection will take place into the tibial tubercle (within a pre-specified region) immediately prior to incision.

## Interventions

- **Intraosseous Vancomycin Injection** (DRUG) — • IO vancomycin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the OR after sterile prep and draping has occurred prior to skin incision (500mg in 150mL NS).
- **Intravenous Vancomycin** (DRUG) — IV Vancomycin will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg generally 1000-1750mg in 500mL NS).

## Primary Outcomes

- **Vancomycin Bone/Tissue Concentrations** _(time frame: immediate post-op)_ — Compare levels of vancomycin will be found in distal femur, proximal tibia, and periarticular soft tissues,
- **Systemic Vancomycin Concentrations** _(time frame: will be recorded day of surgery)_ — Compare systemic vancomycin levels between the intravenous and intraosseous vancomycin administration groups.

## Secondary Outcomes

- **30 day & 90 day post-operative complication rates** _(time frame: 30 days post-op, 90 days post-op)_

## Locations (1)

- Houston Methodist Hospital Outpatient Center, Houston, Texas, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.houston methodist hospital outpatient center|houston|texas|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT05705843*  
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