Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol

NCT04042233 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Pro00022651
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate a novel vancomycin intraosseous administration protocol vs a standard IV vancomycin administration protocol for primary total hip arthroplasty patients.

Conditions

Prosthetic Joint Infection; Vancomycin; Joint Diseases

Keywords

total hip arthroplasty; vancomycin; intraosseous vancomycin

Outcome Measures

Primary Outcomes (4)

• Systemic Vancomycin Level - Start of Case

  vancomycin blood level before the time of incision - typically taken approximately 10 minutes before incision.

  approximately 10 minutes before incision

• Systemic Vancomycin Level - End of Case

  end of surgical case

• Vancomycin Concentration of Pulvinar Soft Tissue

  vancomycin concentration (ug/mL) of pulvinar soft tissue. Vancomycin tissue concentration measured by high performance liquid chromotagraphy.

  intraoperative

• Vancomycin Concentration of Intramedullary Bone

  Vancomycin Concentration of Intramedullary Bone in units ug/mL. Vancomycin tissue concentration measured by high performance liquid chromotagraphy.

  intraoperative

Secondary Outcomes (6)

• Soft Tissue Vancomycin Level - Start of Case

  at start of case within 15 minutes after incision

• Femur Vancomycin Concentration Level

  intraoperative

• Acetabulum Vancomycin Level

  intraoperative

• 30-Day Complications

  From the administration of antibiotics perioperatively to 30 days post op.

• 90-Day Complications

  From the administration of antibiotics perioperatively to 90 days post op.

Study Arms (2)

IV administration of vancomycin

ACTIVE COMPARATOR

Standard IV vancomycin administration protocol.

Drug: Standard IV administration of vancomycin

IO Vancomycin 500mg in 250 mL NS

EXPERIMENTAL

Experimental Intraosseous administration protocol.

Drug: Experimental Intraosseous vancomycin 500mg in 250 mL NS

Interventions

Experimental Intraosseous vancomycin 500mg in 250 mL NS DRUG

500mg of Vancomycin in 250 mL of normal saline will be injected into a pre-specified region of the greater trochanter during primary total hip arthroplasty.

IO Vancomycin 500mg in 250 mL NS

Standard IV administration of vancomycin DRUG

IV antibiotics (cefepime \& vancomycin) are started in pre-op approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg, generally 1000-1750mg in 500 mL NS).

IV administration of vancomycin

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is undergoing a primary total hip arthroplasty
• Patient gives informed consent to participate in the study.
• Age Range \>18

You may not qualify if:

• Previous surgery on the hip (including hip scopes)
• BMI above 35
• Contraindication to receiving vancomycin or cefepime (allergy, medical issue, etc)
• Inability to locate the greater trochanter or administer the IO infusion
• Refusal to participate
• Diabetes
• Immunocompromised or immunosuppressed patients (HIV, Hep C, End stage renal disease, dialysis, transplant, chemo/radiation treatment in last 6 months, medications).

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Results Point of Contact

• Title: Thomas Sullivan
• Organization: Houston Methodist Hospital

tsullivan@houstonmethodist.org

2817254460

Study Officials

• Terry A Clyburn, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 1, 2019
• Study Start: December 31, 2019
• Primary Completion: May 25, 2022
• Study Completion: September 1, 2022
• Last Updated: March 13, 2025
• Results First Posted: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)