Background: There is a large assortment of modalities for the surgical treatment/management of distal radius fractures (DRFs), where the most widely used is the fixed-angle volar plating (VLP) system, which, sometimes, is referred to as the "surgical modality of choice". While outcomes with each modality are usually good to excellent, each has its share of shortcomings and complications. Thus, there is scope for improvements to existing modalities and/or introduction of new ones. Study Purpose: We introduce a novel modality, namely, the prototype of an intramedullary injectable bioresorbable polymer-bioresorbable balloon osteosynthesis (IPBO) system, and investigated its plausibility. Experimental Procedures: The biomechanical performance of a construct comprising a synthetic distal radius (fourth-generation Sawbones ® ) on which a simulated fracture was created (4-mm wide osteotomy positioned 25 mm from the most distal end of the radius) and fixated with a placement of the IPBO system (SIPBO Construct) was compared to that when the fixation was with an approved Ti-6Al-4V alloy VLP system (SVLP Construct), under a clinically-relevant compressive loading protocol. Performance involved determination of quantitative parameters of the construct (initial longitudinal stiffness (ICLS), final longitudinal stiffness (FCLS), and load-to-failure (P f )) and observation and recording of features of the construct at the fracture point. We also determined the quantitative parameters for the intact synthetic distal radius (control). Results: For each of the quantitative parameters, the range of values for SIPBO Construct was within that for SVLP Construct, suggesting that the IPBO System is a plausible modality. Also, for SIPBO Construct, failure occurred within the polymer zone, whereas, for SVLP Con-
310struct, some failure features were fracture of the cortical wall and of the dorsal proximal fragments. Conclusion: The findings suggest that the IPBO system is plausible. As such, it merits further study; for example, determination of the influence of fracture gap fill ratio (defined as the proportion of the fracture gap that is filled by the expanding balloon as the polymer is injected into the balloon) on a large collection of quantitative biomechanical parameters.
Complications and shortcomings of volar plating, which is very widely used for surgical treatment of distal radius fractures, are well known. Thus, there is scope for alternative innovative surgical methods. In the present work, we used the finite element analysis method to compare the biomechanical performance of a model of a construct comprising a simulated distal radius fracture considered fixated using a notional intramedullary injectable bioresorbable polymer-bioresorbable balloon osteosynthesis system ("fixator") versus using a commercially-available volar locking plate (VP). The biomechanical parameters determined were longitudinal stiffness and factor of safety under each of the applied loads. For the fixator model, 1) each of the biomechanical parameters was markedly influenced by fracture gap fill ratio (FGFR) (defined as the proportion of the volume of the fracture gap that is considered occupied by the expanded polymer-filled balloon) but not by modulus of elasticity assigned to the polymer; 2) with FGFR = 100%, stiffness was comparable to that of the Ti-6Al-4V alloy VP construct model; and 3) stiffness was within the range of literature values for stiffness of constructs comprising simulated fractures in fresh cadaveric distal radii fixated using metal volar locking plate. These results suggest that the fixator may be an alternative modality to metal volar plating and, as such, deserves further evaluation.
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