JMIR Publications

ABSTRACT

Background:

The management of infected metaphyseal nonunion of the tibia is devastating, especially when associated with significant bone loss, poor soft tissues, draining sinuses, axial deformity, knee or ankle joint stiffness, limb discrepancy and multi-resisted pathogens. A systematic review, performed recently by the primary investigators (PROSPERO ID: CRD42020205781), but not yet published, yielded the lack of studies in the field and the huge heterogeneity of the presented results. We found several bias and controversies such as no clear definition of the exact part of the tibia where the non-union was located, what was the pathogen causing the fracture related infection (FRI), the number of previous interventions and time to presentation, the exact type of treatment methods including the use of muscle flaps or bone grafting. Time to final union as functional score consist of another important but missing data.

Methods:

This prospective clinical trial study, with minimum follow-up time 36 months, focuses on effectiveness of the Ilizarov method after radical nonunion debridement and targeted antibiotic therapy in patients presented with infected metaphyseal tibial nonunions. The primary outcomes would be the definite healing of nonunion and the infection-free results. Secondary outcomes would be limb alignment and discrepancy, alteration in patient’s quality of life and functional results. Power analysis was calculated and was found to require a minimum of 11 patients to obtain statistical power but we aim to include at least 25 patients in the study. Discussion: The lack of control group, the heterogeneity of patients regarding the number of previous surgeries, the involved pathogens, the length of treatment, the proper antibiotic treatment for eradication of the infection composed important limitation of this study. However, its strongest advantage is the prospective design with adequate number of participants as opposed to what already exists in literature. Trial Registration: The study has been registered retrospectively in ISRCTN with registration number ISRCTN30905788 (January 25th, 2022) under the name “Infection and non-union of the upper and lower part of the shinbone: treatment with the Ilizarov method” (SePseT Ilizarov) and all patients will be informed and will signed the consent form (https://doi.org/10.1186/ISRCTN30905788).