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Not yet recruiting NCT07621094

Intraosseous Antibiotics for Osseointegration

No phase Interventional Osseointegration Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: intraosseous antibiotic delivery.
Who it may be relevant to
Registry conditions: Osseointegration Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

The purpose of this research study is to learn about the characteristics of infection in osseointegration patients. This research study will also study how safe and effective it is to use antibiotics inside the bone.

Detailed description

The goal of this multi-center prospective trial is to assess the characteristics of infection among patients with osseointegrated prosthesis and the safety and effectiveness of intraosseous antibiotic delivery.

Participants will enroll in an observational arm. Participants who require surgery for infection may enroll in an interventional arm assessing the safety and feasibility of intraosseous antibiotic administration as a potential treatment for infection.

Interventions

  • Procedure intraosseous antibiotic delivery
    After debridement, patients will receive intraosseous (IO) vancomycin 500mg in 150ml of normal saline during surgery. The solution will be prepared by the hospital pharmacy and administered via an IO cannula. The cannula will be placed proximal to the intramedullary fixture. In cases where a tourniquet can be utilized proximal to the IO cannula, the antibiotic is delivered as a bolus. Tourniquet must be up for 1 hour after installation of the IO cases where the residual limb is too short to allo

Primary outcome measures

  • Number of Patients Who Develop Wound Dehiscence [Time frame: Week 2]
  • Number of Patients Who Develop Wound Dehiscence [Time frame: Week 6]
  • Number of Patients Who Develop Wound Dehiscence [Time frame: Month 3]
  • Number of Patients Who Develop Wound Dehiscence [Time frame: Month 6]
  • Number of Patients Who Develop Wound Dehiscence [Time frame: Month 12]
  • Number of Patients Who Develop Superficial Infection [Time frame: Week 2]
  • Number of Patients Who Develop Superficial Infection [Time frame: Week 6]
  • Number of Patients Who Develop Superficial Infection [Time frame: Month 3]
  • Number of Patients Who Develop Superficial Infection [Time frame: Month 6]
  • Number of Patients Who Develop Superficial Infection [Time frame: Month 12]
Secondary outcome measures (5)
  • Patient-Reported Outcomes Measurement Information System (PROMIS -29) [Time frame: 2-weeks, 6-weeks, 3-months, 6-months, 12-months]
  • Veterans RAND 12 (VR-12) Health Survey - Physical Component Score [Time frame: 2-weeks, 6-weeks, 3-months, 6-months, 12-months]
  • Veterans Rand 12 (VR12) Health Survey - Mental Component Score [Time frame: 2 weeks, 6-weeks, 3-months, 6-months, 12-months]
  • Pain - Numeric Rating Scale [Time frame: 2-weeks, 6-weeks, 3-months, 6-months, 12-months]
  • Pain - Brief Pain Inventory (BPI) [Time frame: 2-weeks, 6-weeks, 3-months, 6-months, 12-months]

Eligibility criteria

Inclusion criteria

  • Treated with osseointegration for transfemoral, transhumeral, or transtibial amputation and presenting with concern for surgical site infection
  • >18 years of age

Exclusion criteria

  • Unable to follow up at site for 1 year
  • Patients that speak neither English nor Spanish
  • <18 years of age

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 5 centers
  • University of Colorado Anschutz Medical Campus — Aurora
  • Hospital for Special Surgery — New York
  • Atrium Health Carolinas Medical Center — Charlotte
  • University of Pennsylvania Perelman School of Medicine — Philadelphia
  • UT Health San Antonio — San Antonio

Identifiers

NCT: NCT07621094 · IRB00147620 · 40010222

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗