NCT03506347

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 24, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

September 24, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2019

Completed
11 months until next milestone

Results Posted

Study results publicly available

December 17, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

April 17, 2018

Results QC Date

December 2, 2019

Last Update Submit

January 23, 2020

Conditions

Arthropathy of Knee Joint

Outcome Measures

Primary Outcomes (2)

  • Vancomycin Concentration in Fat

    Mean vancomycin concentration in fat measured in ug/g at surgical closure

    Approximately 60 minutes post surgical incision

  • Vancomycin Concentration in Bone

    Mean vancomycin concentration in bone measured in ug/g at surgical closure

    Approximately 60 minutes post surgical incision

Study Arms (2)

Vancomycin 15mg/kg IV

ACTIVE COMPARATOR

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.

Drug: Vancomycin

Vancomycin 500mg Intraosseous

EXPERIMENTAL

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.

Drug: Vancomycin

Interventions

VancomycinDRUG

Antibiotic

Also known as: Vancocin
Vancomycin 15mg/kg IVVancomycin 500mg Intraosseous

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary Total Knee Arthroplasty for osteoarthritis Informed consent given

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Publications (1)

  • Spangehl MJ, Clarke HD, Moore GA, Zhang M, Probst NE, Young SW. Higher Tissue Concentrations of Vancomycin Achieved With Low-Dose Intraosseous Injection Versus Intravenous Despite Limited Tourniquet Duration in Primary Total Knee Arthroplasty: A Randomized Trial. J Arthroplasty. 2022 May;37(5):857-863. doi: 10.1016/j.arth.2022.01.057. Epub 2022 Jan 26.

    PMID: 35091036DERIVED

Related Links

MeSH Terms

Interventions

Vancomycin

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Dr. Mark Spangehl
Organization
Mayo Clinic
Spangehl.Mark@mayo.edu
480-342-2948

Study Officials

  • Mark J Spangehl

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 17, 2018

First Posted

April 24, 2018

Study Start

September 24, 2018

Primary Completion

January 17, 2019

Study Completion

January 17, 2019

Last Updated

January 27, 2020

Results First Posted

December 17, 2019

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)