A novel low-profile external skeletal fixator for type IIIB open tibial fractures: A biomechanical and clinical pilot study.

BACKGROUND: Although external fixator is standard for managing staged treatment of open tibial fracture, the main disadvantage of this device is too bulky to be tolerated by most patients for longtime use. The purposes of this pilot study were to compare the biomechanical properties of a novel low-profile external fixator (LP-ESF) with a traditional ESF and also to evaluate its performance in patients with Gustilo type IIIb tibial open fractures. METHODS: A prospective clinical pilot study started from January 2015 to December 2017, and 18 patients with Gustilo type IIIb open tibial fractures underwent the fixation with a novel LP-ESF system. The biomechanical properties of the LP-ESF were compared with the Synthes External Fixation System according to the standard ASTM F1541-02. These patients were divided into two groups according to the size of bony defect. The postoperative clinical outcomes were subsequently collected. RESULTS: The biomechanical properties of the LP-ESF were comparable with those of Synthes External Fixation System and had an improved the axial/torsional stiffness and ultimate strength. In the clinical study, all patients with LP-ESF had fracture union. The duration of application of LP-ESF was 3.5 to 18 months until fracture union. In 10 of 18 patients, their fractures were immobilized with the LP-ESF until bone union, and no pin tract infection and no chronic osteomyelitis were recorded. The 36-Item Short Form Health Survey life quality and health survey were good to excellent in these patients. Notably, the LP-ESF allowed a patient with severe bone and soft-tissue defects to preserve the leg and joints function. CONCLUSION: In this study, we found that the novel LP-ESFs had improved clinical outcomes. The long-term LP-ESF application seems to be tolerable in our patients. This novel approach permits better controls in deep infection and faster healing of fractures, and thus may provide a viable alternative treatment for Gustilo type IIIb open tibial fractures.