Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty

Phase 4

Recruiting

• Conditions: Infections; Ankle Arthritis
• Interventions: Drug: Intravenous Vancomycin; Drug: Intraosseous Vancomycin Injection

• Registration Number: NCT06384651
• Lead Sponsor: The Methodist Hospital Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-13
• Status Verified: 2024-04
• Study First Submitted: 2024-04-02
• Study First Submitted QC: 2024-04-24
• Last Update Submitted: 2024-04-24
• Study First Posted: 2024-04-25
• Last Update Posted: 2024-04-25
• Primary Completion: 2027-04
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous Vancomycin	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))
Intraosseous Vancomycin	Intraosseous Vancomycin Injection	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.

Primary Outcome Measures

Name	Time	Method
Systemic Sample Vancomycin Tissue Concentration - End of Case	perioperatively
Systemic Sample Vancomycin Tissue Concentration - Start of Case	perioperatively
Capsule or Synovium Sample Vancomycin Tissue Concentration	immediately after the procedure
Talar Bone Sample Vancomycin Tissue Concentration	immediately after the procedure
Distal Tibia Sample Vancomycin Tissue Concentration	immediately after the procedure

Secondary Outcome Measures

Name	Time	Method
90 day post-operative wound complication and infection rates	90 days after the procedure

Trial Locations

Locations (1)

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States