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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Arthropathy of Knee Joint
Intervention Drug: Vancomycin
Enrollment 22
Recruitment Details Subjects were enrolled between January 2014 and April 2015 at Mayo Clinic in Arizona.
Pre-assignment Details  
Arm/Group Title Vancomycin 500mg Intraosseous Vancomycin 1g IV
Hide Arm/Group Description 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 is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
Period Title: Overall Study
Started 11 11
Completed 10 10
Not Completed 1 1
Reason Not Completed
Physician Decision             1             1
Arm/Group Title Vancomycin 500mg Intraosseous Vancomycin 1g IV Total
Hide Arm/Group Description 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 is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation. Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
Although 22 subjects were enrolled, 2 subjects were withdrawn from the study following an intra-operative decision not to proceed with a full revision. Baseline demographics are provided for the subjects who completed the study.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
69.3
(43 to 83)
67.4
(54 to 82)
68.4
(43 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
7
  70.0%
5
  50.0%
12
  60.0%
Male
3
  30.0%
5
  50.0%
8
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Mean Concentration of Vancomycin in Subcutaneous Fat
Hide Description 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.
Time Frame Baseline to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vancomycin 500mg Intraosseous Vancomycin 1g IV
Hide Arm/Group Description:
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 is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: µg/g
At approximately 3 minutes 94.1  (69.0) 3.2  (1.8)
At approximately 30 minutes 88.3  (131) 5.0  (2.9)
At approximately 50 minutes 69.4  (50) 4.2  (2.5)
At approximately 115 minutes 173  (445) 4.7  (2.6)
At approximately 150 minutes 249  (639) 4.0  (2.2)
At approximately 180 minutes 18.2  (11.6) 3.6  (2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vancomycin 500mg Intraosseous, Vancomycin 1g IV
Comments Comparison at approximately 3 minutes, adjusted by BMI, age, and length of surgical procedure.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vancomycin 500mg Intraosseous, Vancomycin 1g IV
Comments Comparison at approximately 30 minutes, adjusted by BMI, age, and length of surgical procedure.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vancomycin 500mg Intraosseous, Vancomycin 1g IV
Comments Comparison at approximately 50 minutes, adjusted by BMI, age, and length of surgical procedure.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vancomycin 500mg Intraosseous, Vancomycin 1g IV
Comments Comparison at approximately 115 minutes, adjusted by BMI, age, and length of surgical procedure.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vancomycin 500mg Intraosseous, Vancomycin 1g IV
Comments Comparison at approximately 150 minutes, adjusted by BMI, age, and length of surgical procedure.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vancomycin 500mg Intraosseous, Vancomycin 1g IV
Comments Comparison at approximately 180 minutes, adjusted by BMI, age, and length of surgical procedure.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Mean Concentration of Vancomycin in Bone Samples
Hide Description 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.
Time Frame baseline to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vancomycin 500mg Intraosseous Vancomycin 1g IV
Hide Arm/Group Description:
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 is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: µg/g
At approximately 30 minutes 90.7  (77) 7.9  (5.7)
At approximately 50 minutes 193  (191) 8.6  (5.9)
At approximately 115 minutes 59.8  (63) 5.0  (2.3)
At approximately 145 minutes 62.9  (62) 7.1  (4.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vancomycin 500mg Intraosseous Vancomycin 1g IV
Hide Arm/Group Description 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 is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
All-Cause Mortality
Vancomycin 500mg Intraosseous Vancomycin 1g IV
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Vancomycin 500mg Intraosseous Vancomycin 1g IV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/10 (40.00%)      0/10 (0.00%)    
Blood and lymphatic system disorders     
Acute blood loss anemia   1/10 (10.00%)  1 0/10 (0.00%)  0
Postoperative hypoxemia  [1]  1/10 (10.00%)  1 0/10 (0.00%)  0
Nervous system disorders     
Foot drop of left leg   1/10 (10.00%)  1 0/10 (0.00%)  0
Left peroneal neuropathy   1/10 (10.00%)  2 0/10 (0.00%)  0
Renal and urinary disorders     
Acute renal failure with olgiurea   1/10 (10.00%)  1 0/10 (0.00%)  0
Surgical and medical procedures     
Intraoperative opiate overdose  [2]  1/10 (10.00%)  1 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Secondary to acute asthma exacerbation; pulmonary embolism ruled out.
[2]
Required postoperative infusion of Narcan
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vancomycin 500mg Intraosseous Vancomycin 1g IV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/10 (50.00%)      3/10 (30.00%)    
Blood and lymphatic system disorders     
Hypotension   1/10 (10.00%)  1 0/10 (0.00%)  0
Hyponatremia   1/10 (10.00%)  1 0/10 (0.00%)  0
Hypovolemic hyponatremia   1/10 (10.00%)  1 0/10 (0.00%)  0
Cardiac disorders     
Intermittent atrial tachycardia   1/10 (10.00%)  1 0/10 (0.00%)  0
Premature ventricular complexes   0/10 (0.00%)  0 1/10 (10.00%)  1
General disorders     
Elevated temperature post surgery   2/10 (20.00%)  2 0/10 (0.00%)  0
Swelling below eyes  [1]  1/10 (10.00%)  1 0/10 (0.00%)  0
Psychiatric disorders     
Altered mental state   1/10 (10.00%)  1 0/10 (0.00%)  0
Renal and urinary disorders     
Acute urinary retention   0/10 (0.00%)  0 1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders     
Pulmonary bronchitis  [2]  1/10 (10.00%)  1 0/10 (0.00%)  0
Surgical and medical procedures     
Procedure turned into a brief operation and not full revision  [3]  0/10 (0.00%)  0 1/10 (10.00%)  1
Replacement of thoracic pulse generator  [4]  1/10 (10.00%)  1 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Possibly due to intraoperative fluid volume and positioning
[2]
With oxygen desaturation with leg swelling
[3]
Patient withdrawn and study collection terminated
[4]
Device could not be started up after patient's knee surgery. Patient has history of cervical enteropathic syndrome.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Mark J. Spanghel
Organization: Mayo Clinic
Phone: 480-301-5685
EMail: Spangehl.Mark@mayo.edu
Layout table for additonal information
Responsible Party: Mark J. Spangehl, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT02020031     History of Changes
Other Study ID Numbers: 13-004988
First Submitted: December 18, 2013
First Posted: December 24, 2013
Results First Submitted: October 4, 2016
Results First Posted: November 25, 2016
Last Update Posted: November 25, 2016