PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation

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.

Inclusion Criteria:Nonunion of a fracture that has previously undergone fixation. A Nonunion is defined as unplanned surgery with the primary purpose to promote union based on clinical/radiographic evidence >3 months after last fixationInfection as determined by eitherFRI criteriaCDC criteria (without the timeframe) This includes the possibility of culture negative, but determined to be infection by treating surgeonSystemic antibiotic treatment regimen scheduled for at least 6 weeksExclusion Criteria:Patients with a high risk of amputation based on the initial managing physicianPatients undergoing treatment of any other investigational therapy within the month preceding infection treatment or planned within the 12 months following infection treatmentIncarcerated or institutionalized patientsPatients who are unable to return for required follow-up visits and/or medical co-morbidities which preclude treatment with a general anestheticPatients with a prior history of chronic infection at the index site before fracture fixationPatients with pathological fractures from a neoplastic processHistory of Paget's DiseaseThe patient, or a designated proxy, unwilling to provide consentThe patient must be available for follow-up for at least 12 months following infection treatment