IO vs IV Vancomycin in Tourniquetless TKA

Status unconfirmed · Phase 4

Conditions studied: Infection, Surgical Site

In brief

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

Key facts

Study ID

NCT05705843

Run by

The Methodist Hospital Research Institute

People needed

40

Starts

2023-01-25

Expected to finish

2024-01-25

Last updated by the study team

2023-01-31

Who can join

Age: 19 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Houston Methodist Hospital Outpatient Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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