Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03506347
Other study ID # 17-007853
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date September 24, 2018
Est. completion date January 17, 2019

Study information

Verified date January 2020
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 obtaining adequate tissue levels of the antibiotic than the current standard dose which is given intravenously (IV) through a wrist vein. The use of intraosseous regional administration (IORA) of vancomycin requires the use of a tourniquet for the duration of the procedure. Many surgeons prefer to perform the surgery with tourniquet use minimised or without a tourniquet at all. The aim of this study is to evaluate whether IORA vancomycin can achieve effective tissue concentrations with tourniquet use minimised.


Description:

Patients are assigned to one of two groups by chance (like a coin toss):

GROUP A - Will receive 15mg/kg based on actual body weight (maximum of 2g) of vancomycin via the systemic route at a rate of 15mg/kg as per hospital guidelines. Systemic IV vancomycin is given via a forearm vein, given over an infusion timed to finish immediately prior to surgery.

GROUP B - Will have the limb exsanguinated and an above knee tourniquet inflated to 300 mmHg. Immediately following tourniquet inflation, Group B will receive 500mg of vancomycin, via an EZ-IO intraosseous cannula. The vancomycin would be administered in 150ml of saline solution. The intraosseous cannula would be placed into the epiphysis of the proximal tibia. The tourniquet will be left inflated for 10 minutes following completion of the IORA injection then deflated.

Both Groups will receive weight-based dose of systemic cefazolin ( or alternative antibiotic if allergic to cefazolin 15 minutes prior to inflation of tourniquet. This ensures all patients in the study receive effective antibiotic prophylaxis regardless of randomization. Both groups of patients would then undergo routine prep and draping For both groups, Total knee replacement would then be carried out as normal and the tourniquet will be inflated for cementation of the implants.

TISSUE SAMPLES Ten (10) tissue samples will be taken from each patient, 6 'fat' samples and 4 'bone' samples. Each sample is very small, around the size of a pinhead. Bone samples will be taken from the femur only to ensure no direct contamination from the site of injection (tibia) In addition, drain samples will be taken from the intra-articular drain site to measure vancomycin concentration the morning following surgery.

Three blood samples will be taken in both groups, intraoperatively, in recovery, and the following morning.

These samples are frozen and sent to a lab for analysis.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date January 17, 2019
Est. primary completion date January 17, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria

Primary Total Knee Arthroplasty for osteoarthritis Informed consent given

Exclusion Criteria

Current or treatment with IV Vancomycin within preceding 7 days Previous hypersensitivity to vancomycin Significant cardiac or respiratory abnormality Patient has contraindications to IO vascular access using the EZ-IO

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Vancomycin
Antibiotic

Locations

Country Name City State
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Vancomycin Concentration in Fat Mean vancomycin concentration in fat measured in ug/g at surgical closure Approximately 60 minutes post surgical incision
Primary Vancomycin Concentration in Bone Mean vancomycin concentration in bone measured in ug/g at surgical closure Approximately 60 minutes post surgical incision
See also
  Status Clinical Trial Phase
Recruiting NCT01198340 - Evaluation of Optimal Dose of Local Anesthetics for Patient Controlled Continuous Femoral Nerve Block N/A
Completed NCT03364088 - Outcome After Total Knee Arthroplasty Under General or Spinal Anesthesia N/A
Suspended NCT03601728 - A Personalized Prehabilitation Intervention In Elective Joint Replacement Surgery N/A
Completed NCT03647709 - Opioid-free Accelerated Recovery Total Knee Arthroplasty
Recruiting NCT03339323 - The Effect of Exercise Training on Muscle Mass in Patients With Total Knee Arthroplasty N/A
Completed NCT03668756 - Comparison of Computer-Assisted Navigation and Conventional Instrumentation for Bilateral Total Knee Arthroplasty
Completed NCT01548664 - The Utilization of Nintendo Wii™ in Outpatient Rehabilitation Following Total Knee Replacement Phase 2
Completed NCT01309035 - Total Knee Arthroplasty - Accelerated Recovery Without Tourniquet N/A
Completed NCT01364194 - Local Infiltration With Bupivacaine to Increase Quality of Post-operative Pain Control in Total Knee Replacement Phase 4
Recruiting NCT05504577 - Kaolin-based Hemostatic Gauze in Total Knee Arthroplasty Phase 4
Completed NCT01907178 - Postoperative Pain Management in Hospital and Following Discharge From Hospital. N/A
Completed NCT03044028 - Neuromuscular Electrical Stimulation (NMES) for Improving Outcomes Following Total Knee Arthroplasty (TKA) N/A
Completed NCT00967161 - Motion Analysis of EMP Knee Versus Posterior Stabilized Knee Arthroplasty for Osteoarthritis N/A
Completed NCT01333189 - Improving Function After Knee Arthroplasty With Weight-Bearing Biofeedback N/A
Completed NCT06124651 - Comparison of Cruciate Retaining and Posterior Stabilized Total Knee Arthroplasty N/A
Recruiting NCT04814082 - Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee Arthroplasty N/A
Completed NCT05266027 - Naldebain for Pain Management After Knee Arthroplasty Phase 4

External Links