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Regional Prophylactic Vancomycin in Revision Total Knee Replacement

NCT ID: NCT02020031

Last Updated: 2016-11-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-06-30

Brief Summary

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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

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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.

Conditions

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Arthropathy of Knee Joint

Keywords

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Revision knee joint

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Vancomycin

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Vancomycin

Intervention Type DRUG

Interventions

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Vancomycin

Intervention Type DRUG

Other Intervention Names

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Vancocin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vidacare Corporation

INDUSTRY

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mark J. Spangehl, M.D.

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark Spangehl, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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13-004988

Identifier Type: -

Identifier Source: org_study_id