Clinical trial NCT04042233: Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol
Official title: Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prosthetic Joint Infection
Vancomycin
Joint Diseases
Keywords: total hip arthroplasty
vancomycin
intraosseous vancomycin
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 23
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to evaluate a novel vancomycin intraosseous administration protocol vs a standard IV vancomycin administration protocol for primary total hip arthroplasty patients.

Detailed description: Patients are randomized to one of two groups.

GROUP A - Will receive IV antibiotics (cefepime \& vancomycin) are started in pre-op approximately 1 hour prior to incision vancomycin dose weight-based at approximately 15mg/kg, generally 1000-1750mg in 500 milliliters (mL) normal saline (NS).

GROUP B - Will have IV cefepime started in pre-op within 1 hour of incision. Intraosseous (IO) administration of vancomycin (500mg in 250 milliliters NS) will be administered in the OR after sterile prep and draping has occurred. Injection will take place into the greater trochanter (within a pre-specified region).

Both Groups will be monitored during surgery and immediately post-operatively for adverse injection reactions (i.e. Red Man Syndrome). Both groups will otherwise follow identical post-operative protocols (including post-operative antibiotic administration).

TISSUE SAMPLES Five (5) tissue samples will be taken from each patient, 2 soft tissue samples and 3 bone samples will be taken throughout the course of the procedure.

One blood sample will be taken in both groups intraoperatively at the time of initiation of closure.

These samples will immediately be sent to a lab for analysis.

Eligibility criteria: Inclusion Criteria:

* Patient is undergoing a primary total hip arthroplasty
* Patient gives informed consent to participate in the study.
* Age Range \>18

Exclusion Criteria:

* Previous surgery on the hip (including hip scopes)
* BMI above 35
* Contraindication to receiving vancomycin or cefepime (allergy, medical issue, etc)
* Inability to locate the greater trochanter or administer the IO infusion
* Refusal to participate
* Diabetes
* Immunocompromised or immunosuppressed patients (HIV, Hep C, End stage renal disease, dialysis, transplant, chemo/radiation treatment in last 6 months, medications).

Primary outcomes:
measure: Systemic Vancomycin Level - Start of Case
timeFrame: approximately 10 minutes before incision
measure: Systemic Vancomycin Level - End of Case
timeFrame: end of surgical case
measure: Vancomycin Concentration of Pulvinar Soft Tissue
timeFrame: intraoperative
measure: Vancomycin Concentration of Intramedullary Bone
timeFrame: intraoperative
Secondary outcomes:
measure: Soft Tissue Vancomycin Level - Start of Case
timeFrame: at start of case within 15 minutes after incision
measure: Femur Vancomycin Concentration Level
timeFrame: intraoperative
measure: Acetabulum Vancomycin Level
timeFrame: intraoperative
measure: 30-Day Complications
timeFrame: From the administration of antibiotics perioperatively to 30 days post op.
measure: 90-Day Complications
timeFrame: From the administration of antibiotics perioperatively to 90 days post op.
measure: Soft Tissue Vancomycin Level - End of Case
timeFrame: right before wound closure is initiated at the end of the case
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Terry A Clyburn, MD
role: PRINCIPAL_INVESTIGATOR
References: