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Completed

NCT Number: NCT04042233

Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Houston Methodist Hospital

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Experimental Intraosseous vancomycin 500mg in 250 mL NS

Drug

500mg of Vancomycin in 250 mL of normal saline will be injected into a pre-specified region of the greater trochanter during primary total hip arthroplasty.

Standard IV administration of vancomycin

Drug

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 mL NS).

Primary outcomes

  1. Systemic Vancomycin Level - Start of Case

    Time frame: approximately 10 minutes before incision

    vancomycin blood level before the time of incision - typically taken approximately 10 minutes before incision.

  2. Systemic Vancomycin Level - End of Case

    Time frame: end of surgical case

  3. Vancomycin Concentration of Pulvinar Soft Tissue

    Time frame: intraoperative

    vancomycin concentration (ug/mL) of pulvinar soft tissue. Vancomycin tissue concentration measured by high performance liquid chromotagraphy.

  4. Vancomycin Concentration of Intramedullary Bone

    Time frame: intraoperative

    Vancomycin Concentration of Intramedullary Bone in units ug/mL. Vancomycin tissue concentration measured by high performance liquid chromotagraphy.

Secondary outcomes

  1. Soft Tissue Vancomycin Level - Start of Case

    Time frame: at start of case within 15 minutes after incision

    at start , soft tissue. Vancomycin tissue concentration (ug/mL) measured by high performance liquid chromatography.

  2. Femur Vancomycin Concentration Level

    Time frame: intraoperative

    Intraoperative femur bone sample measured for vancomycin concentration (ug/mL). Vancomycin tissue concentration measured by high performance liquid chromatography.

  3. Acetabulum Vancomycin Level

    Time frame: intraoperative

    Intra-operative Acetabulum bone vancomycin concentrations (ug/mL) measured by high performance liquid chromatography.

  4. 30-Day Complications

    Time frame: From the administration of antibiotics perioperatively to 30 days post op.

    Complications 30 days post surgery eg. infection.

  5. 90-Day Complications

    Time frame: From the administration of antibiotics perioperatively to 90 days post op.

    Complications 90 days post surgery eg. infection

  6. Soft Tissue Vancomycin Level - End of Case

    Time frame: right before wound closure is initiated at the end of the case

    soft tissue taken at end of case, right before wound closure is initiated. Vancomycin tissue concentration (ug/mL) measured by high performance liquid chromatography.

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 1, 2019
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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