Objectives. The Sliding Hip Screw (SHS) is commonly used to treat trochanteric hip fractures. Fixation failure is a devastating complication requiring complex revision surgery. One mode of fixation failure is lag screw cut-out which is greatest in unstable fracture patterns and when the tip-apex distance of the lag screw is > 25 mm. The X-Bolt Dynamic Hip Plating System (X-Bolt Orthopaedics, Dublin, Ireland) is a new device which aims to reduce this risk of cut-out. However, some surgeons have reported difficulty minimising the tip-apex distance with subsequent concerns that this may lead to an increased risk of cut-out. Patients and Methods. We measured the tip-apex distance from the intra-operative radiographs of 93 unstable trochanteric hip fractures enrolled in a randomised controlled trial (Warwick Hip Trauma Evaluation, WHiTE One trial). Participants were treated with either the sliding hip screw or the X-Bolt dynamic hip plating system. We also recorded the incidence of cut-out in both groups, at a median follow-up time of 17 months. Results. There was a significantly increased tip-apex distance with the use of the X-Bolt (mean difference 3.7mm (95% confidence interval 1.58 to 5.73); SHS mean 17.1 mm, X-Bolt mean 20.8; p = 0.001. However, this was not associated with an increased incidence of cut-out at a median follow-up time of 17 months, with three cut-outs (6%) in the SHS group and 0 (0%) in the X-Bolt group. Conclusion. The X-Bolt is a safe implant with no increased risk for cut-out. Concerns about minimising the tip-apex distance may be justified but do not appear to be clinically important. Cite this article: M. A. Fernandez, A. Aquilina, J. Achten, N. Parsons, M. L. Costa, X. L. Griffin. The tip-apex distance in the X-Bolt dynamic plating system. Bone Joint Res 2017;6:–207. DOI: 10.1302/2046-3758.64.BJR-2015-0016.R2

Introduction. Lag screw cut-out following fixation of unstable intertrochanteric fractures in osteoporotic bone remains an unsolved challenge. A novel new device is the X-Bolt which is an expanding type bolt that may offer superior fixation in osteoporotic bone compared to the standard DHS screw type device. Aims. The aim of this study was to test if there was a difference in cut-out using the X-Bolt implant compared with the standard DHS system. Methods. Specimens of low density surrogate bone (5pcf) were inserted into a simplified biomechanical fracture model and had either an X-Bolt or DHS implant inserted. There were eight samples in each group. The fracture model was tested with an incremental cyclical loading programme in a Material Test System. Displacement, cycle count and force exerted were continuously recorded until cut-out of the implant. Results. All of the specimens failed by varus collapse with superior cut-out and resulted in an automatic stop of the MTS. Specimens with the X-Bolt implant inserted lasted longer on cyclical count and withstood a greater force at cut-out compared with DHS specimens. The mean number of cycles to cutout in the DHS specimens was 4345 and in specimens with the X-Bolt inserted was 6898. The mean force at which cutout occurred in the DHS group was 1.025kN and in specimens with the X-Bolt inserted was 1.275kN. A statistically significant difference was observed with a P-value of 0.005 and a power of 87.2% with respect to cycle count and a P-value of 0.008 and power 84.8% with respect to force exerted at failure when comparing between the two groups. Conclusion. This study shows that the X-Bolt device demonstrated superior cut-out resistance and withstood greater loads compared to the DHS in low density surrogate bone in an unstable fracture model under cyclical axial loading

Aims. Surgical treatment of hip fracture is challenging; the bone is porotic and fixation failure can be catastrophic. Novel implants are available which may yield superior clinical outcomes. This study compared the clinical effectiveness of the novel X-Bolt Hip System (XHS) with the sliding hip screw (SHS) for the treatment of fragility hip fractures. Methods. We conducted a multicentre, superiority, randomized controlled trial. Patients aged 60 years and older with a trochanteric hip fracture were recruited in ten acute UK NHS hospitals. Participants were randomly allocated to fixation of their fracture with XHS or SHS. A total of 1,128 participants were randomized with 564 participants allocated to each group. Participants and outcome assessors were blind to treatment allocation. The primary outcome was the EuroQol five-dimension five-level health status (EQ-5D-5L) utility at four months. The minimum clinically important difference in utility was pre-specified at 0.075. Secondary outcomes were EQ-5D-5L utility at 12 months, mortality, residential status, mobility, revision surgery, and radiological measures. Results. Overall, 437 and 443 participants were analyzed in the primary intention-to-treat analysis in XHS and SHS treatment groups respectively. There was a mean difference of 0.029 in adjusted utility index in favour of XHS with no evidence of a difference between treatment groups (95% confidence interval -0.013 to 0.070; p = 0.175). There was no evidence of any differences between treatment groups in any of the secondary outcomes. The pattern and overall risk of adverse events associated with both treatments was similar. Conclusion. Any difference in four-month health-related quality of life between the XHS and SHS is small and not clinically important. There was no evidence of a difference in the safety profile of the two treatments; both were associated with lower risks of revision surgery than previously reported. Cite this article: Bone Joint J 2021;103-B(2):256–263

Aims. The aim of this study was to inform a definitive trial which could determine the clinical effectiveness of the X-Bolt Dynamic Hip Plating System compared with the sliding hip screw for patients with complex pertrochanteric fragility fractures of the femur. Patients and Methods. This was a single centre, participant blinded, randomised, standard-of-care controlled pilot trial. Patients aged 60 years and over with AO/ASIF A2 and A3 type femoral pertrochanteric fractures were eligible. Results. The primary outcome was the EuroQoL 5 Dimension Score (EQ-5D-3L) at one year following index fixation. A total of 100 participants were recruited, and primary outcome data were available for 88 patients following losses to follow-up and withdrawals. The mean difference in EQ-5D was 0.03 (95% confidence interval -0.17, 0.120; p = 0.720.) There were no significant differences in any of the secondary outcomes measures. The recruitment and follow-up rates from this feasibility study were as predicted. Conclusion. A definitive trial with 90% power to find a clinically important difference in EQ-5D would require 964 participants based upon the data from this study. We plan to start recruitment to this trial in Spring 2016. Take home message: A definitive trial of X-Bolt Dynamic Hip Plating System is feasible and should be conducted now in order to quantify the clinical effectiveness of this novel implant. Cite this article: Bone Joint J 2016;98-B:686–9

Fractures of the proximal femur are one of the greatest challenges facing the medical community, constituting a heavy socioeconomic burden worldwide. Controversy exists regarding the optimal treatment for patients with unstable trochanteric proximal femoral fractures. The recognised treatment alternatives are extramedullary fixation usually with a sliding hip screw and intramedullary fixation with a cephalomedullary nail. Current evidence suggests that best results and lowest complication rates occur using a sliding hip screw. Complications in these difficult fractures are relatively common regardless of type of treatment. We believe that a novel device, the X-Bolt dynamic plating system, may offer superior fixation over a sliding hip screw with lower reoperation risk and better function. We therefore propose to investigate the clinical effectiveness of the X-bolt dynamic plating system compared with standard sliding hip screw fixation within the framework of a the larger WHiTE (Warwick Hip Trauma Evaluation) Comprehensive Cohort Study. Cite this article: Bone Joint Res 2013;2:206–9

Femoral head collapse is a possible complication after surgical treatment of femoral neck fractures. The purpose of this study was to examine whether implantation of a Sliding Hip Screw (SHS) or an X-Bolt could increase the risk of femoral head collapse. Similar to traditional hip screws, the X-Bolt is implanted through the femoral neck; however, it uses an expanding cross-shape to improve rotational stability. The risk of collapse was investigated alongside patient factors, such as osteonecrosis. This numerical study assessed the risk of femoral head collapse using linear eigenvalue buckling (an established method [1]), and also from the maximum von Mises stress within the cortical bone. The femoral head was loaded using the pressures reported by Yoshida et al. for a patient sitting down (reported to put the femoral head at greatest risk of collapse [2]), with a peak pressure of 9.4 MPa and an average pressure of 1.59 MPa. The femur was fixed in all degrees of freedom at a plane through the femoral neck. The X-Bolt and SHS were implanted in accordance with the operative techniques. The femoral head and implants were meshed with quadratic tetrahedral elements, and cortical bone was meshed with triangular thin shell elements. A converged mesh seeding density of 1.2 mm was used. All models were create and solved using ABAQUS finite element software (version 6.12, Simulia, Dassault Systèmes, France). The influence of implant type and presence was examined alongside a variety of patient factors:. Osteonecrosis, modelled as a cone of bone of varying angle, and varying modulus values. Cortical thinning. Reduced cortical modulus. Femoral head size. Twenty-two finite element models were run for each implant condition (intact; implanted with the X-Bolt; implanted with a SHS), resulting in a total of 66 models. The finite element models were validated using experimental tests performed on five 4. th. generation composite Sawbones femurs (Malmö, Sweden), and verified against previously published results [1]. No significant difference was found between the X-Bolt and the SHS, for either critical buckling pressure (p=0.964), or the maximum von Mises stress (p=0.274), indicating no difference in the risk of femoral head collapse. The maximum von Mises stress (and therefore the risk of collapse) within the cortical bone was significantly higher for the intact femoral head compared to both implants (X-Bolt: p=0.048, SHS: p=0.002). Of the factors examined, necrosis of the femoral head caused the greatest increase in risk. The study by Volokh et al. [1] concluded that deterioration of the cancellous bone underneath the cortical shell can greatly increase the risk of femoral head collapse, and the results of the present study support this finding. Interestingly the presence of either an X-Bolt or SHS implant appeared to reduce the risk of femoral head collapse

Objectives. Fractures of the proximal femur are a common clinical problem, and a number of orthopaedic devices are available for the treatment of such fractures. The objective of this study was to assess the rotational stability, a common failure predictor, of three different rotational control design philosophies: a screw, a helical blade and a deployable crucifix. Methods. Devices were compared in terms of the mechanical work (W) required to rotate the implant by 6° in a bone substitute material. The substitute material used was Sawbones polyurethane foam of three different densities (0.08 g/cm. 3. , 0.16 g/cm. 3. and 0.24 g/cm. 3. ). Each torsion test comprised a steady ramp of 1°/minute up to an angular displacement of 10°. Results. The deployable crucifix design (X-Bolt), was more torsionally stable, compared to both the dynamic hip screw (DHS, p = 0.008) and helical blade (DHS Blade, p= 0.008) designs in bone substitute material representative of osteoporotic bone (0.16 g/cm. 3. polyurethane foam). In 0.08 g/cm. 3. density substrate, the crucifix design (X-Bolt) had a higher resistance to torsion than the screw (DHS, p = 0.008). There were no significant differences (p = 0.101) between the implants in 0.24 g/cm. 3. density bone substitute. Conclusions. Our findings indicate that the clinical standard proximal fracture fixator design, the screw (DHS), was the least effective at resisting torsional load, and a novel crucifix design (X-Bolt), was the most effective design in resisting torsional load in bone substitute material with density representative of osteoporotic bone. At other densities the torsional stability was also higher for the X-Bolt, although not consistently significant by statistical analysis. Cite this article: J. D. Gosiewski, T. P. Holsgrove, H. S. Gill. The efficacy of rotational control designs in promoting torsional stability of hip fracture fixation. Bone Joint Res 2017;6:270–276. DOI: 10.1302/2046-3758.65.BJR-2017-0287.R1

Femoral head collapse due to avascular necrosis (AVN) is a relatively rare occurrence following intertrochanteric fractures; however, with over thirty-thousand intertrochanteric fractures per year in England and Wales alone, and an incidence of up to 1.16%, it is still significant. Often patients are treated with a hip fixation device, such as a sliding hip screw or X-Bolt. This study aimed to investigate the influence of three factors on the likelihood of head collapse: (1) implant type; (2) the size of the femoral head; and (3) the size of the AVN lesion. Finite element (FE) models of an intact femur, and femurs implanted with two common hip fixation designs, the Compression Hip Screw (Smith & Nephew) and the X-Bolt (X-Bolt Orthopaedics), were developed. Experimental validation of the FE models on 4. th. generation Sawbones composite femurs (n=5) found the peak failure loads predicted by the implanted model was accurate to within 14%. Following validation on Sawbones, the material modulus (E) was updated to represent cancellous (E=500MPa) and cortical (E=1GPa) bone, and the influence of implant design, head size, and AVN was examined. Four head sizes were compared: mean male (48.4 mm) and female (42.2 mm) head sizes ± two standard deviations. A conical representation of an AVN lesion with a lower modulus (1MPa) was created, and four different radii were studied. The risk of head collapse was assessed from (1) the critical buckling pressure and (2) the peak failure stress. The likelihood of head collapse was reduced by implantation of either fixation device. Smaller head sizes and greater AVN lesion size increased the risk of femoral head collapse. These results indicate the treatment of intertrochanteric fractures with a hip fixation device does not increase the risk of head collapse; however, patient factors such as small head size and AVN severity significantly increase the risk

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

Despite the vast quantities of published artificial intelligence (AI) algorithms that target trauma and orthopaedic applications, very few progress to inform clinical practice. One key reason for this is the lack of a clear pathway from development to deployment. In order to assist with this process, we have developed the Clinical Practice Integration of Artificial Intelligence (CPI-AI) framework – a five-stage approach to the clinical practice adoption of AI in the setting of trauma and orthopaedics, based on the IDEAL principles (https://www.ideal-collaboration.net/). Adherence to the framework would provide a robust evidence-based mechanism for developing trust in AI applications, where the underlying algorithms are unlikely to be fully understood by clinical teams.

Cite this article: Bone Joint Res 2024;13(9):507–512.