Regional Prophylactic Vancomycin in Revision Total Knee Replacement

NCT02020031 | Completed Phase 2 Results

• 1 other identifier: 13-004988
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthropathy of Knee Joint

Keywords

Revision knee joint

Outcome Measures

Primary Outcomes (2)

• Mean Concentration of Vancomycin in Subcutaneous Fat

  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.

  Baseline to 24 hours

• Mean Concentration of Vancomycin in Bone Samples

  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.

  baseline to 24 hours

Study Arms (2)

Vancomycin 500mg intraosseous

EXPERIMENTAL

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

Vancomycin 1g IV

ACTIVE COMPARATOR

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

Interventions

Vancomycin DRUG

Also known as: Vancocin

Vancomycin 1g IV; Vancomycin 500mg intraosseous

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Revision total knee arthroplasty
• Informed consent given

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Vidacare Corporation: collaborator

Study Sites (1)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

MeSH Terms

Interventions

Vancomycin

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Mark J. Spanghel
• Organization: Mayo Clinic

Spangehl.Mark@mayo.edu

480-301-5685

Study Officials

• Mark Spangehl, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: December 24, 2013
• Study Start: December 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 25, 2016
• Results First Posted: November 25, 2016

Record last verified: 2016-10

Locations

US (1)