Clinical trial NCT05705843: IO vs IV Vancomycin in Tourniquetless TKA
Official title: Intraosseous Vancomycin vs Intravenous Vancomycin in Tourniquetless Primary Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infection, Surgical Site
Keywords: Vancomycin
Total Knee Arthroplasty
Tourniquetless
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a prospective, randomized, single-blinded, controlled trial. The anticipated total number of participants in this study is 20 patients in each treatment arm: 20 patients will be given IV Vancomycin, 20 patients will be given IO vancomycin. This sample size is based on previous studies examining vancomycin concentration in primary TKA between IO vs IV
Primary purpose: PREVENTION

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 criteria: 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)

Primary outcomes:
measure: Vancomycin Bone/Tissue Concentrations
timeFrame: immediate post-op
measure: Systemic Vancomycin Concentrations
timeFrame: will be recorded day of surgery
Secondary outcomes:
measure: 30 day & 90 day post-operative complication rates
timeFrame: 30 days post-op, 90 days post-op
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital Outpatient Center
state: Texas
Study officials:
References: