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.
Infections, Infected Wound, Nonunion of Fracture, Injury Leg, Amputation, Internal Fixation; Complications, Infection or Inflammation, Fracture, Lower Extremity Fracture, Antibiotic Side Effect
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.
PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
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Indiana University, Indianapolis, Indiana, United States, 46202
University of Maryland , MD Department of Orthopaedics, Baltimore, Maryland, United States, 21201
Hennepin Health, Minneapolis, Minnesota, United States, 55487
NYU Langone Medical Center, New York, New York, United States, 10003
Atrium Health, Carolinas Medical Center, Charlotte, North Carolina, United States, 28207
Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, United States, 27106
Penn State University M.S. Hershey Medical Center, Hershey, Pennsylvania, United States, 17033
Vanderbilt Medical Center, Nashville, Tennessee, United States, 37203
University of Texas Health Science Center at Houston, Houston, Texas, United States, 77030
University of Washington Harborview Medical Center, Seattle, Washington, United States, 98195
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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18 Years to
ALL
No
Major Extremity Trauma Research Consortium,
William Obremskey, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt Medical Center
Renan Castillo, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins Bloomberg School of Public Health
2026-09-29