Regional Prophylactic Vancomycin in Revision Total Knee Replacement

Overview

The purpose of this study is to determine whether or not giving a lower dose of antibiotics (Vancomycin) in the area where it is needed (the knee joint) is more effective at preventing infection than the current standard dose which is given intravenously (IV) through a wrist vein.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2015

Detailed Description

Patients were assigned to one of two groups by chance (like a coin toss): – GROUP 1 – Received 500mg of vancomycin into the tibia (shin) bone of the leg being operated on. – GROUP 2 – Received 1g of vancomycin, which is the amount normally given to patients. For both groups, the revision knee replacement will then be carried out as normal. OTHER ANTIBIOTICS All patients received cefazolin IV (an antibiotic used to prevent infection) prior to the beginning of surgery to ensure effective preventive antibiotics. The patient will also received 3 postoperative doses of cefazolin over a 24-hour period (4 doses in total). This is standard of care for all total knee replacement surgeries. TISSUE SAMPLES – Ten (10) tissue samples were taken during the surgery, consisting of both bone and fat beneath the skin. Each sample were very small, around the size of a pinhead. – In addition, a drain sample was taken from the knee joint drain fluid to measure vancomycin concentration the morning following surgery. – These samples were frozen and sent to a lab for analysis.

Interventions

  • Drug: Vancomycin

Arms, Groups and Cohorts

  • Experimental: Vancomycin 500mg intraosseous
    • Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
  • Active Comparator: Vancomycin 1g IV
    • Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.

Clinical Trial Outcome Measures

Primary Measures

  • Mean Concentration of Vancomycin in Subcutaneous Fat
    • Time Frame: Baseline to 24 hours
    • During the procedure, subcutaneous fat samples (approximately 0.5 cm^3) were taken at regular intervals until skin closure. Vancomycin concentrations were determined by liquid chromatography coupled with tandem mass spectrometry. Times are given as minutes post surgical incision.
  • Mean Concentration of Vancomycin in Bone Samples
    • Time Frame: baseline to 24 hours
    • During the procedure, bone samples (approximately 0.5 cm^3) were taken at regular intervals were taken at regular intervals until skin closure. All bone samples were taken from the femur, distant from the tibial intraosseous injection site. Vancomycin concentrations were determined by liquid chromatography coupled with tandem mass spectrometry. Times are given as minutes post surgical incision.

Participating in This Clinical Trial

Inclusion Criteria

  • Revision total knee arthroplasty – Informed consent given Exclusion Criteria:

  • Current treatment with IV Vancomycin within the preceding 7 days – Previous hypersensitivity to vancomycin – Significant cardiac or respiratory abnormality – Contraindications to using the intraosseous vascular access system (EZ-IO) – Sepsis

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Collaborator
    • Vidacare Corporation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mark J. Spangehl, M.D., PI – Mayo Clinic
  • Overall Official(s)
    • Mark Spangehl, MD, Principal Investigator, Mayo Clinic

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