Introduction and Objective. Intramedullary nails are frequently used for treatment of unstable distal tibia fractures. However, insufficient fixation of the distal fragment could result in delayed healing, malunion or nonunion. The quality of fixation may be adversely affected by the design of both the nail and locking screws, as well as by the fracture pattern and bone density. Recently, a novel concept for angular stable nailing has been developed that maintains the principle of relative stability and introduces improvements expected to reduce nail toggling, screw migration and secondary loss of reduction. It incorporates polyether ether ketone (PEEK) inlays integrated in the distal and proximal canal portions of the nail for angular stable screw locking. The nail can be used with new standard locking screws and low-profile retaining locking screws, both designed to enhance cortical fixation. The low-profile screws are with threaded head, anchoring in the bone and increasing the surface contact area due to the head's increased diameter. The objective of this study was to investigate the biomechanical competence of the novel angular stable intramedullary nail concept for treatment of unstable distal tibia fractures, compared with four other nail designs in an artificial bone model under dynamic loading. Materials and Methods. The distal 70 mm of thirty artificial tibiae (Synbone) were assigned to 5 groups for distal locking using either four different commercially available nails – group 1: Expert Tibia Nail (DePuy Synthes); group 2: TRIGEN META-NAIL with Internal Hex Captured Screws (Smith & Nephew); group 3: T2 Alpha with Locking Screws (Stryker); group 4: Natural Nail System featuring StabiliZe Technology (Zimmer) – or the novel angular stable TN-Advanced nail with low-profile screws (group 5, DePuy Synthes). The distal locking in all groups was performed using 2 mediolateral screws. All specimens were biomechanically tested under quasi-static and progressively increasing combined cyclic axial and torsional loading in internal rotation until failure, with monitoring by means of motion tracking. Results. Initial nail toggling of the distal tibia fragment in group 5 was significantly lower as compared with group 3 in varus (p=0.04) or with groups 2 and 4 in flexion (p≤0.02). In addition, the toggling in varus was significantly lower in group 1 versus group 4 (p<0.01). Moreover, during dynamic loading, within the course of the first 10,000 cycles the movements of the distal fragment in terms of varus, flexion, internal rotation, as well as axial and shear displacements at the fracture site, were all significantly lower in group 5 compared with group 4 (p<0.01). Additionally, group 5 demonstrated significantly lower values for flexion versus groups 2 and 3 (p≤0.04), for internal rotation versus group 1 (p=0.03), and for axial displacement versus group 3 (p=0.03). A trend to significantly lower values was detected in group 5 versus group 1 for varus, flexion and shear displacement – with p ranging between 0.05 and 0.07 – and versus group 3 for shear displacement (p=0.07). Cycles to failure were highest in group 5 with a significant difference to group 4 (p<0.01). Conclusions. From a biomechanical perspective, the novel angular stable intramedullary nail concept with integrated PEEK inlays and low-profile screws provides ameliorated resistance against nail toggling and loss of reduction under static and dynamic loading compared with other commercially available intramedullary nails used for fixation of unstable distal tibia fractures

Unstable distal tibia fractures are challenging injuries requiring surgical treatment. Intramedullary nails are frequently used; however, distal fragment fixation problems may arise, leading to delayed healing, malunion or nonunion. Recently, a novel angle-stable locking nail design has been developed that maintains the principle of relative construct stability, but introduces improvements expected to reduce nail toggling, screw migration and secondary loss of reduction, without the requirement for additional intraoperative procedures. The aim of this study was to investigate the biomechanical competence of a novel angle-stable intramedullary nail concept for treatment of unstable distal tibia fractures, compared to a conventional nail in a human cadaveric model under dynamic loading. Ten pairs of fresh-frozen human cadaveric tibiae with a simulated AO/OTA 42-A3.1 fracture were assigned to 2 groups for reamed intramedullary nailing using either a conventional (non-angle-stable) Expert Tibia Nail with 3 distal screws (Group 1) or the novel Tibia Nail Advanced system with 2 distal angle-stable locking low-profile screws (Group 2). The specimens were biomechanically tested under conditions including quasi-static and progressively increasing combined cyclic axial and torsional loading in internal rotation until failure of the bone-implant construct, with monitoring by means of motion tracking. Initial axial construct stiffness, although being higher in Group 2, did not significantly differ between the 2 nail systems, p=0.29. In contrast, initial torsional construct stiffness was significantly higher in Group 2 compared to Group 1, p=0.04. Initial nail toggling of the distal tibia fragment in varus and flexion was lower in Group 2 compared to Group 1, being significant in flexion, p=0.91 and p=0.03, respectively. After 5000 cycles, interfragmentary movements in terms of varus, flexion, internal rotation, axial displacement and shear displacement at the fracture site were all lower in Group 2 compared to Group 1, with flexion and shear displacement being significant, p=0.14, p=0.04, p=0.25, p=0.11 and p=0.04, respectively. Cycles to failure until both interfragmentary 5° varus and 5° flexion were significantly higher in Group 2 compared to Group 1, p=0.04. From a biomechanical perspective, the novel angle-stable intramedullary nail concept has the potential of achieving a higher initial axial and torsional relative stability and maintaining it with a better resistance towards loss of reduction under dynamic loading, while reducing the number of distal locking screws, compared to conventional locking in intramedullary nailed unstable distal tibia fractures