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

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

INTRODUCTION. Intramedullary nail fixation has been used for successful treatment of long bone fracture such as humerus, tibia and femur. We look at the experience of our trauma unit in treating long bone fracture using the AO approved Expert femoral/tibial nail and proximal femoral nail antirotation (PFNA). We look at the union and complication rates in patients treated with AO approved nailing system for pertrochanteric, femoral and tibial shaft fracture. METHODS. We carried out retrospective case notes review of patients that underwent femoral and tibial nailing during the period of study- October 2007 to August 2009. All patients were treated using the AO approved nailing system. We identified all trauma patients that underwent femoral and tibial nailing through the trauma register. Further information was then obtained by going through medical notes and reviewing all followed-up X-rays stored within the online radiology system. RESULTS. 149 patients, 85 male and 64 female were included into the study. 150 procedures were carried out during period of study as 1 patient underwent conversion of lateral entry femoral nail to PFNA due to refracture. Patients' age ranged from 14-96 with mean of 55. 140 patients had isolated long bone fracture (either femur or tibia) compared to 9 patients with multiple bone fractures. Our unit performed 64 Expert tibial nail, 36 PFNA, 31 Expert lateral entry femoral nail and 19 Expert retrograde femoral nail during period of study. 13 patients treated with intramedullary nail sustained open fracture, 9 of them were compound tibial fracture compared to 4 compound femoral fractures. All patients were followed-up between 2 to 24 months or until death. 9 out of 17 patients that died in this study had diagnosis of tumour. Complication rates were 17% for Expert tibial nail (1 patient with valgus deformity, peroneal nerve palsy and delayed union, 3 with delayed union, 4 with broken locking screw, 2 with wound infection and 1 with abscess over wound site), 4% for lateral/retrograde femoral nail (1 each for pulmonary embolism and broken locking screw) and 4% for PFNA (1 each for delayed union and deep vein thrombosis). The overall complication rates were 10% from this study. DISCUSSION & CONCLUSIONS. We conclude that the AO approved nailing system used for treating pertrochanteric, femoral and tibial fractures were effective with high union rate. The overall complication rates were 10% from this study. Complication rates for tibial nail were as high as 17% compared to 4% for femoral nail or PFNA. The complication rates for PFNA in our study were lower compared to 29% in PFN that was reported in one literature

The treatment of fractures of the proximal tibia is complex and makes great demands on the implants used. Our study aimed to identify what levels of primary stability could be achieved with various forms of osteosynthesis in the treatment of diaphyseal fractures of the proximal tibia. Pairs of human tibiae were investigated. An unstable fracture was simulated by creating a defect at the metaphyseal-diaphyseal junction. Six implants were tested in a uniaxial testing device (Instron) using the quasi-static and displacement-controlled modes and the force-displacement curve was recorded. The movements of each fragment and of the implant were recorded video-optically (MacReflex, Qualysis). Axial deviations were evaluated at 300 N. The results show that the nailing systems tolerated the highest forces. The lowest axial deviations in varus and valgus were also found for the nailing systems; the highest axial deviations were recorded for the buttress plate and the less invasive stabilising system (LISS). In terms of rotational displacement the LISS was better than the buttress plate. In summary, it was found that higher loads were better tolerated by centrally placed load carriers than by eccentrically placed ones. In the case of the latter, it appears advantageous to use additive procedures for medial buttressing in the early phase

Background. A large proportion of the expense incurred due to hip fractures arises due to secondary factors such as duration of hospital stay and additional theatre time due to surgical complications. Studies have shown that the use of intramedullary (IM) nail fixation presents a statistically higher risk of re-fracture than plating, which has been attributed to the stress riser at the end of the nail. It is not clear, however, if this situation also applies to unstable fractures, for which plating has a higher fixation failure rate. Moreover, biomechanical studies to date have not considered newer designs of IM nails which have been specifically designed to better distribute weight-bearing loads. This aim of this experimental study was to evaluate the re-fracture risk produced by a newer type of nailing system compared to an equivalent plate. Methods. Experimental testing was conducted using fourth generation Sawbones composite femurs and X-Bolt IM hip nail (n=4) and fracture plate (n=4) implants. An unstable pertrochanteric fracture pattern was used (AO classification: 31-A1 / 31-A2). Loading was applied along the peak loading vector experienced during walking, up to a maximum load of 500N. The risk of re-fracture was evaluated from equivalent strains measured using four rosette strain gauges on the surface of the bone at known stress riser locations. Results. Strain gauge readings determined that the equivalent strains in the femoral diaphysis were approximately 25% larger for the nail than the plate (p < 0.005). The strain levels at the location coinciding with the end of the plate were also larger for the nail, but not significantly (p > 0.26). Conclusions. Although the risk of re-fracture for displaced tronchantaric fractures was found to be larger for nailing than plating, measured strains were substantially lower than the failure strain of cortical bone (even when scaled for full weight-bearing loads of 1800N). This indicates that fracture risk is not present in either implant for bone of healthy quality, but may still become problematic in highly osteoporotic patients. Level of Evidence. IIb - Evidence from at least one well designed experimental trial

Shortness of an extremity due to different causes is an issue that may adversely affect human life functional and psychologically. In this study, in the light of previous studies, it is aimed to develop a new expandable intramedullary system, providing lengthening in order to remove previous problems and complications and to annihilate leg length discrepancies at present and future without second surgical intervention as far as possibble by lenghtening the intramedullary nail. To this end, a new electromechanically activated intramedullary nail has been designed and generated. The intramedullary nail was designed to perform extremity lengthening electro-mechanically. The 3D design of the system is performed with computer software and the rapid and metal prototype of the system has been produced. The intramedullary nail system is comprised of three main units; Mechanical transmission unit, Electronic unit, Lengthening unit. The nail system is designed to function both mechanically and electronically complying with the requirement. This also provides an advantage that if any one (mechanic or electronic) fails, the lengthening process can continue with the other. Compression tests are applied in order to evaluate the strength of the system. The deformation values of the parts are recorded and stress values of each parts were calculated. The new system needs only 300N loading for mechanical lengthening. When 800N is considered as average human weight, the implant must withstand minumum 2400N load. Considering the safety conditions, we applied 4000N load on the new system. At 4000N, the whole system shows only 1.465 mm deformation which is less than the gap between the two bone parts. Also, when the system is implanted inside the bone, the loads are distributed proportionally between the bone and the implant. So, except for extraordinary conditions, the newly developed system is highly rigid and safe. In each applied method, lots of complications whether general or method-specific are seen. When the methods like Albizzia, ISKD and FITBONE avaliable and widely used today are examined separately, complications specific to these methods can be clearly observed [1–12]. Bliskunov Nail, Albizzia Nail and ISKD [13–18] have mechanical working principles and in these systems, lengthening process is obtained by rotational movement of the extremity. This rotational movement causes complications like pain, dislocation and uncontrolled lengthening [11,13,16,19–21]. In our newly developed system, only axial stimulation is needed for the activation of the mechanism. This is one of the advantages of our system. Both the mechanical unit and the electronical units are designed to be extended 0.1 mm at each activation. This means that the optimal amount of distraction (1mm/day) can be achieved in a controlled way. In other systems, the distraction amount can not be fully controlled and complications seen on other systems [1, 6, 8–10], like distruption of callus due to the excessive distraction and nonunion of the bone can be encountered. The success of the system at practice will be examined with in-vivo animal experiments and according to the results, it will be ready for use on human by performing necessary restorations