Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Regional Prophylactic Vancomycin in Revision Total Knee Replacement (VIDACARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02020031
Recruitment Status : Completed
First Posted : December 24, 2013
Results First Posted : November 25, 2016
Last Update Posted : November 25, 2016
Sponsor:
Collaborator:
Vidacare Corporation
Information provided by (Responsible Party):
Mark J. Spangehl, M.D., Mayo Clinic

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Arthropathy of Knee Joint Drug: Vancomycin Phase 2 Phase 3

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Regional Prophylactic Vancomycin in Revision Total Knee Replacement
Study Start Date : December 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 Drug: Vancomycin
Other Name: Vancocin
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.
 Drug: Vancomycin
Other Name: Vancocin


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 using the intraosseous vascular access system (EZ-IO)
  • Sepsis
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020031


Locations
Layout table for location information
United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
Sponsors and Collaborators
Mayo Clinic
Vidacare Corporation
Investigators
Layout table for investigator information
Principal Investigator: Mark Spangehl, MD Mayo Clinic
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Mark J. Spangehl, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02020031     History of Changes
Other Study ID Numbers: 13-004988
First Posted: December 24, 2013    Key Record Dates
Results First Posted: November 25, 2016
Last Update Posted: November 25, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Mark J. Spangehl, M.D., Mayo Clinic:
Revision knee joint
Additional relevant MeSH terms:
Layout table for MeSH terms
Joint Diseases
Musculoskeletal Diseases
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents