Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-03

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to compare two different antibiotic regimens and techniques during total ankle arthroplasty (TAA).

Primary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic samples between patient groups.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Drug Delivery Devices for Osteomyelitis

NCT02968693

Osteomyelitis

COMPLETED

Prospective Cohort Study on Antibiotic Course and Efficacy After Two-stage Revision in PJI.

NCT05284318

Periprosthetic Joint Infection Anti-Bacterial Agents

RECRUITING

A RCT for Y-Knot All-suture Anchor in Ankle Ligaments Injury Repair

NCT04310956

Ligament Injury

COMPLETED NA

Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation

NCT05989243

Transtibial Amputation Transfemoral Amputation

RECRUITING

Comparing Clinical Outcomes of Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries

NCT05729542

Ankle Injuries Syndesmotic Injuries Ankle Fractures

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infections Ankle Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a prospective, randomized, single-blinded, controlled trial. 20 patients in each treatment arm: 20 patients will be given IV vancomycin, 20 patients will be given IO vancomycin

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

single blind patient is blinded. Surgeon is not blinded. Lab technician measuring tissue concentrations are blinded. Research coordinator is not blinded.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intravenous Vancomycin

Patients will receive the orthopedic surgeon's standard of care pre-operative antibiotic regimen for TAA 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 generally 1000-1750mg in 500mL normal saline (NS))

Group Type ACTIVE_COMPARATOR

Intravenous Vancomycin

Intervention Type DRUG

• Patients will receive the orthopedic surgeon's standard of care pre-operative antibiotic regimen for TAA 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 generally 1000-1750mg in 500mL normal saline (NS))

Intraosseous Vancomycin

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 given preoperatively in this group.

IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).

IO Injection will take place into the medial malleolus.

Group Type EXPERIMENTAL

Intraosseous Vancomycin Injection

Intervention Type DRUG

* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
* IO Injection will take place into the medial malleolus.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intraosseous Vancomycin Injection

* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
* IO Injection will take place into the medial malleolus.

Intervention Type DRUG

Intravenous Vancomycin

• Patients will receive the orthopedic surgeon's standard of care pre-operative antibiotic regimen for TAA 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 generally 1000-1750mg in 500mL normal saline (NS))

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient is undergoing total ankle arthroplasty.
* Patient is able to give informed consent to participate in the study. LAR consents will not be utilized for this study
* Age Range \>18

Exclusion Criteria

* Previous lower extremity surgery that in the opinion of the principal investigator or qualified research personnel precludes the participant from safely participating on the study.
* BMI \> 40.
* Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).
* Inability to administer the IO infusion.
* Patient 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, medications).
* Vulnerable populations

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No