Actively Recruiting
PO Versus 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
56 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
Researchers are evaluating the differences in treating infected nonunion of fractures after internal fixation using oral (PO) versus intravenous (IV) antibiotics. This Phase III randomized control trial will include 250 patients aged 18 years or older who have an infected nonunion with a segmental defect less than one centimeter. The study aims to compare the effectiveness of oral antibiotic therapy to traditional IV antibiotics, combined with proper surgical care, in preventing re-hospitalization and treatment failure within one year. Participants will be randomly assigned to receive either oral antibiotics or IV antibiotics for six weeks after hospital discharge. Both groups will receive standard care including operative debridement, soft tissue wound coverage, and regular clinical follow-ups. Laboratory tests for inflammatory markers will be done at 2 and 6 weeks, with radiographic assessments at 6 weeks and 3 months or until bone healing is confirmed. The study will also evaluate treatment compliance, medical costs, number of surgeries, complications, and hospitalization duration. Throughout the study, patients will be assessed at baseline and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after discharge. Researchers will monitor rates of re-hospitalization, treatment failure including re-infection and nonunion, amputation, and patient adherence to antibiotics. Outcomes will be determined by a blinded panel using predefined criteria. The total follow-up period is one year, ensuring thorough evaluation of treatment results and patient recovery.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Nonunion of a fracture previously treated with fixation, defined as unplanned surgery to promote union more than 3 months after last fixation
- Infection at the fracture site confirmed by specific criteria or surgeon diagnosis
- Scheduled for systemic antibiotic treatment for at least 6 weeks
- Able to attend follow-up visits for at least 12 months after infection treatment
You will not qualify if you...
- High risk of amputation as determined by the managing physician
- Receiving other investigational therapies within one month before or planned within 12 months after infection treatment
- Incarcerated or institutionalized individuals
- Unable to return for follow-up visits or unable to undergo general anesthesia due to medical conditions
- Prior history of chronic infection at the fracture site before fixation
- Pathological fractures caused by cancer
- History of Paget's Disease
- Unwilling or unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - 6 weeks
Participants receive either oral (PO) or intravenous (IV) antibiotics for infected nonunion of fractures for up to 6 weeks following hospitalization and surgical debridement.
Visits at 2 weeks and 6 weeks for laboratory evaluation and clinical follow-up
Duration - 12 months
Participants are monitored for up to 12 months after treatment to assess hospital re-admissions, treatment failure, infection recurrence, nonunion, amputation rates, and compliance with antibiotic treatment.
Clinical follow-up visits at 3 months, 6 months, and 12 months; radiographic follow-up at 6 weeks and 3 months or until bone union
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
K
Karen Trochez
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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