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.

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.

Hip fractures constitute the most debilitating complication of osteoporosis with a steadily increasing incidence in an aging population. Intramedullary nailing of osteoporotic proximal femoral fractures can be challenging because of poor implant anchorage in the femoral head. Recently, cement augmentation of PFNA blades with Polymethylmethycrylate (PMMA) has shown promising results by enhancing the cutout resistance in proximal femoral fractures. The aim of this biomechanical study was to assess the impact of cement augmentation on the fixation strength of TFNA blades and screws within the femoral head, and compare its effect with head elements placed in a center or antero–posterior off–center positions.

Eight groups were formed out of 96 polyurethane foam specimens with low density, simulating isolated femoral heads with severe osteoporotic bone. The specimens in each group were implanted with either non–augmented or PMMA–augmented TFNA blades or screws in a center or antero–posterior off–center position, 7 mm anterior or 7 mm posterior. They were mechanically tested in a setup simulating an unstable pertrochanteric fracture with lack of postero–medial support and load sharing at the fracture gap. All specimens underwent progressively increasing cyclic loading until catastrophic construct failure. Varus–valgus and head rotation angles were monitored by an inclinometer mounted on the head. A varus collapse of 5° or a 10° head rotation were defined as the clinically relevant failure criterion.

Load at failure for specimens with augmented TFNA head elements (screw center: 3799 N ± 326 (mean ± SD); blade center: 3228 N ± 478; screw off–center: 2680 N ± 182; blade off–center: 2591 N ± 244) was significantly higher compared to the respective non–augmented specimens (blade center: 1489 N ± 41; screw center: 1593 N ± 120; blade off–center: 1018 N ± 48; screw off–center: 515 N ± 73), p<0.001. In both non–augmented and augmented specimens, the failure load in center position was significantly higher compared to the respective off–center position, regardless of head element, p<0.001. Non–augmented TFNA blades in off–center position revealed significantly higher load at failure versus non–augmented screws in off–center position, p<0.001.

Cement augmentation clearly enhances fixation stability of TFNA blades and screws. Non–augmented blades outperformed screws in antero–posterior off–center position. Positioning of TFNA blades in the femoral head is more forgiving than TFNA screws in terms of failure load. Augmentation with TFNA has not been approved by FDA.