IO vs IV Vancomycin in Tourniquetless TKA

Sponsor

The Methodist Hospital Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05705843

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Purpose of this study is to compare the efficacy of intravenous and intraosseous antibiotic administration techniques during tourniquetless total knee arthroplasty.

Condition or Disease	Intervention/Treatment	Phase
Infection, Surgical Site	Drug: Intraosseous Vancomycin Injection Drug: Intravenous Vancomycin	Phase 4

Detailed Description

Primary Objective: Comparable levels of vancomycin will be found in distal femur, proximal tibia, and periarticular soft tissues, as well as in systemic levels, between the intravenous and intraosseous administration groups.

Secondary Objective: Compare 30- and 90-day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) versus the interventional group (intraosseous administration of vancomycin). The research team hypothesizes that there will be no difference in complication (infection) rates between groups

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This study is a prospective, randomized, single-blinded, controlled trial. The anticipated total number of participants in this study is 20 patients in each treatment arm: 20 patients will be given IV Vancomycin, 20 patients will be given IO vancomycin. This sample size is based on previous studies examining vancomycin concentration in primary TKA between IO vs IVThis study is a prospective, randomized, single-blinded, controlled trial. The anticipated total number of participants in this study is 20 patients in each treatment arm: 20 patients will be given IV Vancomycin, 20 patients will be given IO vancomycin. This sample size is based on previous studies examining vancomycin concentration in primary TKA between IO vs IV

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Participant will be blinded to their mode of vancomycin administration. Lab will be blinded to which group subject samples come from when doing concentration level testing.

Primary Purpose:

Prevention

Official Title:

Intraosseous Vancomycin vs Intravenous Vancomycin in Tourniquetless Primary Total Knee Arthroplasty

Anticipated Study Start Date :

Jan 25, 2023

Anticipated Primary Completion Date :

Jan 25, 2024

Anticipated Study Completion Date :

Jan 25, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intravenous Vancomycin Administration Patients will receive the Houston Methodist Hospital orthopedic surgery standard of care pre-operative antibiotic regimen for primary total knee arthroplasty patients. This includes IV antibiotics (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg [12,13] generally 1000-1750mg in 500mL NS).	Drug: Intravenous Vancomycin IV Vancomycin will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg generally 1000-1750mg in 500mL NS).
Experimental: Intraosseous Vancomycin Administration IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision. IV Vancomycin will not be administered preoperatively in this group. IO vancomycin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the OR after sterile prep and draping has occurred prior to skin incision (500mg in 150mL NS). Injection will take place into the tibial tubercle (within a pre-specified region) immediately prior to incision.	Drug: Intraosseous Vancomycin Injection • IO vancomycin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the OR after sterile prep and draping has occurred prior to skin incision (500mg in 150mL NS).

Arm

Intervention/Treatment

Active Comparator: Intravenous Vancomycin Administration

Patients will receive the Houston Methodist Hospital orthopedic surgery standard of care pre-operative antibiotic regimen for primary total knee arthroplasty patients. This includes IV antibiotics (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg [12,13] generally 1000-1750mg in 500mL NS).

Drug: Intravenous Vancomycin

IV Vancomycin will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg generally 1000-1750mg in 500mL NS).

Experimental: Intraosseous Vancomycin Administration

IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision. IV Vancomycin will not be administered preoperatively in this group. IO vancomycin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the OR after sterile prep and draping has occurred prior to skin incision (500mg in 150mL NS). Injection will take place into the tibial tubercle (within a pre-specified region) immediately prior to incision.

Drug: Intraosseous Vancomycin Injection

• IO vancomycin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the OR after sterile prep and draping has occurred prior to skin incision (500mg in 150mL NS).

Outcome Measures

Primary Outcome Measures

Vancomycin Bone/Tissue Concentrations [immediate post-op]
Compare levels of vancomycin will be found in distal femur, proximal tibia, and periarticular soft tissues,
Systemic Vancomycin Concentrations [will be recorded day of surgery]
Compare systemic vancomycin levels between the intravenous and intraosseous vancomycin administration groups.

Secondary Outcome Measures

30 day & 90 day post-operative complication rates [30 days post-op, 90 days post-op]
Monitor charts and clinic visits during the study subject's standard of care postoperative visit schedule and monitor for adverse events including periprosthetic joint infection and wound issues.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient is undergoing a primary total knee arthroplasty.
Patient is able to understand the study design and intervention and gives informed consent to participate in the study. No LAR consents will be utilized for this study.
Age >18 years.
Total knee arthroplasty performed without the use of a tourniquet.

Exclusion Criteria:

Previous surgery on the knee (including arthroscopic knee surgery)
BMI above 35
Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).
Inability to locate the tibial tubercle or administer the IO infusion
Refusal to participate
Uncontrolled Diabetes Mellitus type 1 or 2, defined as Hemoglobin A1C >7.5.
Immunocompromised or immunosuppressed patients (HIV, Hep C, End-Stage Renal Disease, dialysis, transplant, chemo/radiation treatment in last 6 months, and immunosuppresive medications)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Houston Methodist Hospital Outpatient Center	Houston	Texas	United States	77030

Sponsors and Collaborators

The Methodist Hospital Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Timothy S. Brown, Principal Investigator, The Methodist Hospital Research Institute

ClinicalTrials.gov Identifier:

NCT05705843

Other Study ID Numbers:

PRO00035759

First Posted:

Jan 31, 2023

Last Update Posted:

Jan 31, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Timothy S. Brown, Principal Investigator, The Methodist Hospital Research Institute

Vancomycin

Total Knee Arthroplasty

Tourniquetless

Additional relevant MeSH terms:

Surgical Wound Infection

Vancomycin

Study Results

No Results Posted as of Jan 31, 2023