Actively Recruiting
PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
Led by Major Extremity Trauma Research Consortium · Updated on 2026-02-02
250
Participants Needed
13
Research Sites
226 weeks
Total Duration
On this page
Sponsors
M
Major Extremity Trauma Research Consortium
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.
CONDITIONS
Official Title
PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Nonunion of a fracture previously treated with fixation, defined as unplanned surgery to promote healing more than 3 months after last fixation
- Infection diagnosed by fracture-related infection (FRI) criteria or CDC criteria, including possible culture-negative infection as determined by the surgeon
- Scheduled for at least 6 weeks of systemic antibiotic treatment
You will not qualify if you...
- High risk of amputation as determined by the initial physician
- Participation in other investigational therapy within 1 month before or planned within 12 months after infection treatment
- Being incarcerated or institutionalized
- Unable to attend required follow-up visits or having medical conditions preventing general anesthesia
- Prior chronic infection at the fracture site before fixation
- Pathological fractures caused by cancer
- History of Paget's Disease
- Unwillingness or inability to provide consent
- Inability to complete at least 12 months of follow-up after infection treatment
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Trial Site Locations
Total: 13 locations
1
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
2
University of Maryland , MD Department of Orthopaedics
Baltimore, Maryland, United States, 21201
Actively Recruiting
3
Sinai Hospital Baltimore
Baltimore, Maryland, United States, 21215
Not Yet Recruiting
4
Hennepin Health
Minneapolis, Minnesota, United States, 55487
Actively Recruiting
5
Jamaica Hospital Medical Center
Queens, New York, United States, 11418
Not Yet Recruiting
6
Atrium Health, Carolinas Medical Center
Charlotte, North Carolina, United States, 28207
Not Yet Recruiting
7
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27106
Actively Recruiting
8
University of Okalahoma College of Medicine
Oklahoma City, Oklahoma, United States, 73104
Not Yet Recruiting
9
Penn State University M.S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
10
Vanderbilt Medical Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
11
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Not Yet Recruiting
12
University of Washington Harborview Medical Center
Seattle, Washington, United States, 98195
Actively Recruiting
13
University of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
W
William Obremskey, MD
CONTACT
K
Karen Trochez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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