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Regional Prophylactic Vancomycin in Revision Total Knee Replacement (VIDACARE)

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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

Tracking Information
First Submitted Date  ICMJE December 18, 2013
First Posted Date  ICMJE December 24, 2013
Results First Submitted Date  ICMJE October 4, 2016
Results First Posted Date  ICMJE November 25, 2016
Last Update Posted Date November 25, 2016
Study Start Date  ICMJE December 2013
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2016)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 18, 2013)
Compare average level of concentration between the two groups. [ Time Frame: Baseline to 24 hours ]
Shapiro-Wilk test will be used to assess the normality of the residuals.
Change History Complete list of historical versions of study NCT02020031 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Regional Prophylactic Vancomycin in Revision Total Knee Replacement
Official Title  ICMJE Regional Prophylactic Vancomycin in Revision Total Knee Replacement
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Arthropathy of Knee Joint
Intervention  ICMJE Drug: Vancomycin
Other Name: Vancocin
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Vancomycin
  • 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.
    Intervention: Drug: Vancomycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2015)
22
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2013)
20
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02020031
Other Study ID Numbers  ICMJE 13-004988
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mark J. Spangehl, M.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Vidacare Corporation
Investigators  ICMJE
Principal Investigator: Mark Spangehl, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP