Regional Prophylactic Vancomycin in Revision Total Knee Replacement

Phase 2

Completed

• Conditions: Arthropathy of Knee Joint
• Interventions: Drug: Vancomycin

• Registration Number: NCT02020031
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-18
• Study First Submitted QC: 2013-12-18
• Study First Posted: 2013-12-24
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-10
• Results First Submitted: 2016-10-04
• Results First Submitted QC: 2016-10-04
• Last Update Submitted: 2016-10-04
• Results First Posted: 2016-11-25
• Last Update Posted: 2016-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mean Concentration of Vancomycin in Subcutaneous Fat	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	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Phoenix, Arizona, United States