Intraosseous Antibiotics for Osseointegration
Part of paid clinical trials in Aurora, Colorado.
- Sponsor
- Wake Forest University Health Sciences
- Study ID
- NCT07621094
- Status
- Not Yet Recruiting
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Conditions
- Osseointegration Infection
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- intraosseous antibiotic delivery — PROCEDUREAfter 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 allow tourniquet (pneumatic or elastic) proximal to the IO cannula, the intraosseous antibiotic must be infused at a rate not to exceed 10mg/min or less. This can be accomplished by connecting intravenous tubing to the antibiotic mixture and the IO cannula. In cases without a tourniquet, IO infusion should begin during the irrigation phase and continue through the complete closure of the wound, since it requires a significant amount of time 50-60 min.
Study Details
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.
Key Dates
- Start date
- Sep 30, 2026
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2030
- Completion
- Dec 31, 2031
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- No Intervention: ObservationalPatients that do not require surgery for infection
- Experimental: Intraosseous Antibiotics for OsseointegrationPatients that require surgery for infection
Primary Outcome Measure
Number of Patients Who Develop Wound Dehiscence [ Time Frame: Week 2 ]
Central Contacts
- Christine Churchill, MA704-355-6947
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | Danielle Melton, MD (PRINCIPAL_INVESTIGATOR) |
| Hospital for Special Surgery | New York | New York | 10021 | S. Robert Rozbruch, MD (PRINCIPAL_INVESTIGATOR) |
| Atrium Health Carolinas Medical Center | Charlotte | North Carolina | 28203 | Joseph R Hsu, MD (PRINCIPAL_INVESTIGATOR) |
| University of Pennsylvania Perelman School of Medicine | Philadelphia | Pennsylvania | 19104 | Benjamin Potter, MD (PRINCIPAL_INVESTIGATOR) |
| UT Health San Antonio | San Antonio | Texas | 78229 | Joseph Alderete, MD (PRINCIPAL_INVESTIGATOR) |