Regional Prophylactic Vancomycin in Revision Total Knee Replacement

Condition(s) targeted: Revision, Knee Joint

Intervention: Vancomycin (Drug); Vancomycin (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
Mark Spangehl, MD, Principal Investigator, Affiliation: Mayo Clinic

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.

Official title: Regional Prophylactic Vancomycin in Revision Total Knee Replacement

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Compare average level of concentration between the two groups.

Detailed description: Patients will be assigned to one of two groups by chance (like a coin toss):

- GROUP 1 - Will receive 500mg of vancomycin into the tibia (shin) bone of the leg being

operated on.

- GROUP 2 - Will receive 1g of vancomycin, which is the amount normally given to

patients. This will be into the wrist vein (IV). The patient nor the Principal Investigator can choose the study group. Patients will have an equal chance of being assigned to either group. GROUP 1: Vancomycin will be injected into blood vessels that are inside the bone of the leg being operated on. This is a common technique used in intensive care units and emergency departments. This method allows a lower dose of vancomycin to be used. GROUP 2: Vancomycin will be given as standard of care into an arm vein (IV), where it travels around the entire body through the bloodstream. For both groups, the revision knee replacement will then be carried out as normal. OTHER ANTIBIOTICS All patients will receive cefazolin IV (an antibiotic used to prevent infection) prior to the beginning of surgery to ensure effective preventive antibiotics. The patient will also receive 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 will be taken during the surgery, consisting of both bone and

fat beneath the skin. Each sample is very small, around the size of a pinhead. Where possible the samples will be taken from tissue that is normally discarded during a normal knee replacement procedure. Otherwise the samples will be taken from areas that will not compromise the structure or function of the knee and are already exposed for normal surgical procedures.

- In addition, a drain sample will be taken from the knee joint drain fluid to measure

vancomycin concentration the morning following surgery.

- These samples are frozen and sent to a lab for analysis. Patients will not be notified

of the results, as they are for research purposes only and will not affect clinical care.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 intraosseous vascular access using the EZ-IO (from VIDACARE)

- Sepsis

Mayo Clinic, Phoenix, Arizona 85054, United States; Recruiting
Debbie L Ryan, CRC, Phone: 480-342-1208, Email: ryan.debra29@mayo.edu
Andre R Watkins, CRC, Phone: 480-342-0349, Email: watkins.andre@mayo.edu
Henry D Clarke, M.D., Sub-Investigator

Starting date: December 2013
Last updated: April 12, 2015