Osteosynthesis aims to maintain fracture reduction until bone healing occurs, which is not achieved in case of mechanical fixation failure. One form of failure is plastic plate bending due to overloading, occurring in up to 17% of midshaft fracture cases and often necessitating reoperation. This study aimed to replicate in-vivo conditions in a cadaveric experiment and to validate a finite element (FE) simulation to predict plastic plate bending.

Six cadaveric bones were used to replicate an established ovine tibial osteotomy model with locking plates in-vitro with two implant materials (titanium, steel) and three fracture gap sizes (30, 60, 80 mm). The constructs were tested monotonically until plastic plate deformation under axial compression. Specimen-specific FE models were created from CT images. Implant material properties were determined using uniaxial tensile testing of dog bone shaped samples. The experimental tests were replicated in the simulations. Stiffness, yield, and maximum loads were compared between the experiment and FE models.

Implant material properties (Young's modulus and yield stress) for steel and titanium were 184 GPa and 875 MPa, and 105 GPa and 761 MPa, respectively. Yield and maximum loads of constructs ranged between 469–491 N and 652–683 N, and 759–995 N and 1252–1600 N for steel and titanium fixations, respectively. FE models accurately and quantitatively correctly predicted experimental results for stiffness (R2=0.96), yield (R2=0.97), and ultimate load (R2=0.97).

FE simulations accurately predicted plastic plate bending in osteosynthesis constructs. Construct behavior was predominantly driven by the implant itself, highlighting the importance of modelling correct material properties of metal. The validated FE models could predict subject-specific load bearing capacity of osteosyntheses in vivo in preclinical or clinical studies.

Acknowledgements: This study was supported by the AO Foundation via the AOTRAUMA Network (Grant No.: AR2021_03).

In absence of available quantitative measures, the assessment of fracture healing based on clinical examination and X-rays remains a subjective matter. Lacking reliable information on the state of healing, rehabilitation is hardly individualized and mostly follows non evidence-based protocols building on common guidelines and personal experience. Measurement of fracture stiffness has been demonstrated as a valid outcome measure for the maturity of the repair tissue but so far has not found its way to clinical application outside the research space. However, with the recent technological advancements and trends towards digital health care, this seems about to change with new generations of instrumented implants – often unfortunately termed “smart implants” – being developed as medical devices.

The AO Fracture Monitor is a novel, active, implantable sensor system designed to provide an objective measure for the assessment of fracture healing progression (1). It consists of an implantable sensor that is attached to conventional locking plates and continuously measures implant load during physiological weight bearing. Data is recorded and processed in real-time on the implant, from where it is wirelessly transmitted to a cloud application via the patient's smartphone. Thus, the system allows for timely, remote and X-ray free provision of feedback upon the mechanical competence of the repair tissue to support therapeutic decision making and individualized aftercare.

The device has been developed according to medical device standards and underwent extensive verification and validation, including an in-vivo study in an ovine tibial osteotomy model, that confirmed the device's capability to depict the course of fracture healing as well as its long-term technical performance. Currently a multi-center clinical investigation is underway to demonstrate clinical safety of the novel implant system. Rendering the progression of bone fracture healing assessable, the AO Fracture Monitor carries potential to enhance today's postoperative care of fracture patients.

Freehand distal interlocking of intramedullary nails remains a challenging task. If not performed correctly it can be a time consuming and radiation expensive procedure. Recently, the AO Research Institute developed a new training device for Digitally Enhanced Hands-on Surgical Training (DEHST) that features practical skills training augmented with digital technologies, potentially improving surgical skills needed for distal interlocking. Aim of the study: To evaluate weather training with DEHST enhances the performance of novices without surgical experience in free-hand distal nail interlocking compared to a non-trained group of novices.

20 novices were assigned in two groups and performed distal interlocking of a tibia nail in an artificial bone model. Group 1: DEHST trained novices (virtual locking of five nail holes during one hour of training). Group 2: untrained novices without DEHST training. Time, number of x-rays, nail hole roundness, critical events and success rates were compared between the groups.

Time to complete the task (sec.) and x-ray exposure (µGcm2) were significantly lower in Group1 414.7 (290–615) and 17.8 (9.8–26.4) compared to Group2 623.4 (339–1215) and 32.6 (16.1–55.3); p=0.041 and 0.003. Perfect circle roundness (%) was 95.0 (91.1–98.0) in Group 1 and 80.8 (70.1–88.9) in Group 2; p<0.001. In Group 1 90% of the participants achieved successful completion of the task (hit the nail with the drill), whereas only 60% of the participants in group 2 achieved this; p=0.121.

Training with DEHST significantly enhances the performance of novices without surgical experience in distal interlocking of intramedullary nails. Besides radiation exposure and operation time the com-plication rate during the operation can be significantly reduced.

Secondary bone healing is impacted by the extent of interfragmentary motion at the fracture site. It provides mechanical stimulus that is required for the formation of fracture callus. In clinical settings, interfragmentary motion is induced by physiological loading of the broken bone – for example, by weight-bearing. However, there is no consensus about when mechanical stimuli should be applied to achieve fast and robust healing response. Therefore, this study aims to identify the effect of the immediate and delayed application of mechanical stimuli on secondary bone healing.

A partial tibial osteotomy was created in twelve Swiss White Alpine sheep and stabilized using an active external fixator that induced well-controlled interfragmentary motion in form of a strain gradient. Animals were randomly assigned into two groups which mimicked early (immediate group) and late (delayed group) weight-bearing. The immediate group received daily stimulation (1000 cycles/day) from the first day post-op and the delayed group from the 22nd day post-op. Healing progression was evaluated by measurements of the stiffness of the repair tissue during mechanical stimulation and by quantifying callus area on weekly radiographs. At the end of the five weeks period, callus volume was measured on the post-mortem high-resolution computer tomography (HRCT) scan.

Stiffness of the repair tissue (p<0.05) and callus progression (p<0.01) on weekly radiographs were significantly larger for the immediate group compared to the delayed group. The callus volume measured on the HRCT was nearly 3.2 times larger for the immediate group than for the delayed group (p<0.01).

This study demonstrates that the absence of immediate mechanical stimuli delays callus formation, and that mechanical stimulation already applied in the early post-op phase promotes bone healing.

Aim

Debridement, Antibiotics, Irrigation, and implant Retention (DAIR) is a surgical treatment protocol suitable for some patients with fracture related infection (FRI). Clinically relevant pre-clinical models of DAIR are scarce and none have been developed in large animals. Therefore, this project aimed to develop a large animal model for FRI including a DAIR approach and compare outcomes after 2 or 5 weeks of infection.

Despite past advances of implant technologies, complication rates of fixations remain high at challenging sites such as the proximal humerus [1]. These may not only be owed to the implant itself but also to dissatisfactory surgical execution of fracture reduction and implant positioning. Therefore, the aim of this study was to quantify the instrumentation accuracy of a highly standardised and guided procedure and its influence on the biomechanical outcome and predicted failure risk.

Preoperative planning of osteotomies creating an unstable 3-part fracture and fixation with a locking plate was performed based on CT scans of eight pairs of low-density proximal humerus samples from elderly female donors (85.2±5.4 years). 3D-printed subject-specific guides were used to osteotomise and instrument the samples according to the pre-OP plan. Instrumentation accuracies in terms of screw lengths and orientations were evaluated by comparing post-OP CT scans with the pre-OP plan. The fixation constructs were biomechanically tested until cyclic cut-out failure [2]. Failure risks of the planned and the post-OP configurations were predicted using a validated sample-specific finite element (FE) simulation approach [2] and correlated with the experimental outcomes.

Small deviations were found for the instrumented screw trajectories compared to the planned configuration in the proximal-distal (0.3±1.3º) and anterior-posterior directions (-1.7±1.8º), and for screw tip to joint distances (-0.3±1.1 mm). Significantly higher failure risk was predicted for the post-OP compared to the planned configurations (p<0.01) via FE. When incorporating the instrumentation inaccuracies, the biomechanical results could be predicted well with FE (R²=0.70).

Despite the high instrumentation accuracy achieved using sophisticated subject-specific 3D-printed guides, even minor deviations from the pre-OP plan significantly increased the FE-predicted risk of failure. This underlines the importance of intraoperative guiding technology [3] in tandem with careful pre-OP planning to assist surgeons to achieve optimal outcomes.

Acknowledgements

This study was performed with the assistance of the AO Foundation via the AOTRAUMA Network.

Freehand distal interlocking of intramedullary nails is technical demanding and prone to handling issues. It requires the surgeon to precisely place a screw through the nail under x-ray. If not performed accurately it can be a time consuming and radiation expensive procedure. The aims of this study were to assess construct and face validity of a new training device for distal interlocking of intramedullary nails.

53 participants (29 novices and 24 experts) were included. Construct validity was evaluated by comparing simulator metrics (number of x-rays, nail hole roundness, drill tip position and accuracy of the drilled hole) between experts and novices. Face validity was evaluated by means of a questionnaire concerning training potential and quality of simulated reality using a 7-point Likert scale (range 1-7).

Mean realism of the training device was rated 6.3 (range 4-7) and mean training potential as well as need for distal interlocking training was rated 6.5 (range 5-7) with no significant differences between experts and novices, p≥0.236. All participants stated that the simulator is useful for procedural training of distal nail interlocking, 96% would like to have it at their institution and 98% would recommend it to their colleagues. Total number of x-rays were significantly higher for novices (20.9±6.4 vs. 15.5±5.3), p=0.003. Successful task completion (hit the virtual nail hole with the drill) was significantly higher in experts (p=0.04; novices hit: n=12; 44,4%; experts hit: n=19; 83%).

The evaluated training device for distal interlocking of intramedullary nails yielded high scores in terms of training capability and realism. Furthermore, construct validity was established as it reliably discriminates between experts and novices. Participants see a high further training potential as the system may be easily adapted to other surgical task requiring screw or pin position with the help of x-rays.

Introduction and Objective

It is widely accepted that interfragmentary strain stimulus promotes callus formation during secondary bone healing. However, the impact of the temporal variation of mechanical stimulation on fracture healing is still not well understood. Moreover, the minimum strain value that initiates callus formation is unknown. The goal of this study was to develop an active fixation system that allows for in vivo testing of varying temporal distribution of mechanical stimulation and that enables detection of the strain limit that initiates callus formation.

The course of secondary fracture healing typically consists of four major phases including inflammation, soft and hard callus formation, and bone remodeling. Callus formation is promoted by mechanical stimulation, yet little is known about the healing tissue response to strain stimuli over shorter timeframes on hourly and daily basis. The aim of this study was to explore the hourly, daily and weekly variations in bone healing progression and to analyze the short-term response of the repair tissue to well-controlled mechanical stimulation.

A system for continuous monitoring of fracture healing was designed for implantation in sheep tibia. The experimental model was adapted from Tufekci et al. 2018 and consisted of 3 mm transverse osteotomy and 30 mm bone defect resulting in an intermediate mobile bone fragment in the tibial shaft. Whereas the distal and proximal parts of the tibia were fixed with external fixator, the mobile fragment was connected to the proximal part via a second, active fixator. A linear actuator embedded in the active fixator moved the mobile fragment axially, thus stimulating mechanically the tissue in the osteotomy gap via well-controlled displacement being independent from the sheep's functional weightbearing. A load sensor was integrated in the active fixation to measure the force acting in the osteotomy gap. During each stimulation cycle the displacement and force magnitudes were recorded to determine in vivo fracture stiffness. Following approval of the local ethics committee, experiments were conducted on four skeletally mature sheep. Starting from the first day after surgery, the daily stimulation protocols consisted of 1000 loading events equally distributed over 12 hours from 9:00 to 21:00 resulting in a single loading event every 44 seconds. No stimulation was performed overnight.

One animal had to be excluded due to inconsistencies in the load sensor data. The onset of tissue stiffening was detected around the eleventh day post-op. However, on a daily basis, the stiffness was not steadily increasing, but instead, an abrupt drop was observed in the beginning of the daily stimulations. Following this initial drop, the stiffness increased until the last stimulation cycle of the day.

The continuous measurements enabled resolving the tissue response to strain stimuli over hours and days. The presented data contributes to the understanding of the influence of patient activity on daily variations in tissue stiffness and can serve to optimize rehabilitation protocols post fractures.

Fracture fixation has advanced significantly with the introduction of locked plating and minimally invasive surgical techniques. However, healing complications occur in up to 10% of cases, of which a significant portion may be attributed to unfavorable mechanical conditions at the fracture. Moreover, state-of-the-art plates are prone to failure from excessive loading or fatigue. A novel biphasic plating concept has been developed to create reliable mechanical conditions for timely bone healing and simultaneously improve implant strength. The goal of this study was to test the feasibility and investigate the robustness of fracture healing with a biphasic plate in a large animal experiment. Twenty-four sheep underwent a 2mm mid-diaphyseal tibia osteotomy stabilized with either the novel biphasic plate or a control locking plate.

Different fracture patterns in terms of defect location and orientation were investigated. Animals were free to fully bear weight during the post-operative period. After 12 weeks, the healing fractures were evaluated for callus formation using micro-computer tomography and strength and stiffness using biomechanical testing. No plate deformation or failures were observed under full weight bearing with the biphasic plate. Osteotomies stabilized with the biphasic plate demonstrated robust callus formation. Torsion tests after plate removal revealed no statistical difference in peak torsion to failure and stiffness for the different fracture patterns stabilized with the biphasic plate. However, the biphasic plate group specimens were 45% stronger (p=0.002) and 48% stiffer (p=0.007) than the controls.

The results of this large animal study demonstrate the clinical potential of this novel stabilization concept.

To date, the fixation of proximal humeral fractures with angular stable locking plates is still insufficient with mechanical failure rates of 18% to 35%. The PHILOS plate (DePuy Synthes, Switzerland) is one of the most used implants. However, this plate has not been demonstrated to be optimal; the closely symmetric plate design and the largely heterogeneous bone mineral density (BMD) distribution of the humeral head suggest that the primary implant stability may be improved by optimizing the screw orientations. Finite element (FE) analysis allows testing of various implant configurations repeatedly to find the optimal design. The aim of this study was to evaluate whether computational optimization of the orientation of the PHILOS plate locking screws using a validated FE methodology can improve the predicted primary implant stability.

The FE models of nineteen low-density (humeral head BMD range: 73.5 – 139.5 mg/cm3) left proximal humeri of 10 male and 9 female elderly donors (mean ± SD age: 83 ± 8.8 years) were created from high-resolution peripheral computer tomography images (XtremeCT, Scanco Medical, Switzerland), using a previously developed and validated computational osteosynthesis framework. To simulate an unstable mal-reduced 3-part fracture (AO/OTA 11-B3.2), the samples were virtually osteotomized and fixed with the PHILOS plate, using six proximal screws (rows A, B and E) according to the surgical guide. Three physiological loading modes with forces taken from musculoskeletal models (AnyBody, AnyBody Technology A/S, Denmark) were applied. The FE analyses were performed with Abaqus/Standard (Simulia, USA). The average principal compressive strain was evaluated in cylindrical bone regions around the screw tips; since this parameter was shown to be correlated with the experimental number of cycles to screw cut-out failure (R2 = 0.90). In a parametric analysis, the orientation of each of the six proximal screws was varied by steps of 5 in a 5×5 grid, while keeping the screw head positions constant. Unfeasible configurations were discarded. 5280 simulations were performed by repeating the procedure for each sample and loading case. The best screw configuration was defined as the one achieving the largest overall reduction in peri-screw bone strain in comparison with the PHILOS plate.

With the final optimized configuration, the angle of each screw could be improved, exhibiting significantly smaller average bone strain around the screw tips (range of reduction: 0.4% – 38.3%, mean ± SD: 18.49% ± 9.56%).

The used simulation approach may help to improve the fixation of complex proximal humerus fractures, especially for the target populations of patients at high risk of failure.

Aims

Fixation of osteoporotic proximal humerus fractures remains challenging even with state-of-the-art locking plates. Despite the demonstrated biomechanical benefit of screw tip augmentation with bone cement, the clinical findings have remained unclear, potentially as the optimal augmentation combinations are unknown. The aim of this study was to systematically evaluate the biomechanical benefits of the augmentation options in a humeral locking plate using finite element analysis (FEA).

Proximal humeral fractures occur frequently, with fixed angle locking plates often being used for their treatment. However, the failure rate of this fixation is high, ranging between 10 and 35%. Numerous variables are thought to affect the performance of the fixation used, including the length and configuration of screws used and the plate position. However, there is currently limited quantitative evidence to support concepts for optimal fixation. The variations in surgical techniques and human anatomy make biomechanical testing prohibitive for such investigations. Therefore, a finite element osteosynthesis test kit has been developed and validated - SystemFix. The aim of this study was to quantify the effect of variations in screw length, configuration and plate position on predicted failure risk of PHILOS plate fixation for unstable proximal humerus fractures using the test kit.

Twenty-six low-density humerus models were selected and osteotomized to create a malreduced unstable three-part fracture AO/OTA 11-B3.2 with medial comminution which was virtually fixed with the PHILOS plate. In turn, four different screw lengths, twelve different screw configurations and five plate positions were simulated. Each time, three physiological loading cases were modelled, with an established finite element analysis methodology utilized to evaluate average peri-screw bone strain, this measure has been previously demonstrated to predict experimental fatigue fixation failure.

All three core variables lead to significant differences in peri-screw strain magnitudes, i.e. predicted failure risk. With screw length, shortening of 4 mm in all screw lengths (the distance of the screw tips to the joint surface increasing from 4 mm to 8 mm) significantly (p < 0 .001) increased the risk of failure. In the lowest density bone, every additional screw reduced failure risk compared to the four-screw construct, whereas in more dense bone, once the sixth screw was inserted, no further significant benefit was seen (p=0.40). Screw configurations not including calcar screws, also demonstrated significant (p < 0 .001) increased risk of failure. Finally, more proximal plate positioning, compared to the suggested operative technique, was associated with reduced the predicted failure risk, especially in constructs using calcar screws, and distal positioning increased failure risk.

Optimal fixation constructs were found when placing screws 4 mm from the joint surface, in configurations including calcar screws, in plates located more proximally, as these factors were associated with the greatest reduction in predicted fixation failure in 3-part unstable proximal humeral fractures. These results may help to provide practical recommendations on the implant usage for improved primary implant stability and may lead to better healing outcomes for osteoporotic proximal fracture patients. Whilst prospective clinical confirmation is required, using this validated computational tool kit enables the discovery of findings otherwise hidden by the variation and prohibitive costs of appropriately powered biomechanical studies using human samples.

Background

Osteoporotic fracture fixation in the proximal humerus remains a critical challenge. While the biomechanical benefits of screw augmentation with bone cement are established, minimising the cement volume may help control any risk of extravasation and reduce surgical procedure time. Previous experimental studies suggest that it may be sufficient to only augment the screws at the sites of the lowest bone quality. However, adequately testing this hypothesis in vitro is not feasible.

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.

The high risk and the associated high mortality of secondary, contralateral hip fractures [1,2] could justify internal, invasive prophylactic reinforcement of the osteoporotic proximal femur to avoid these injuries in case of a low energy fall. Previous studies have demonstrated high potential of augmentation approaches [3,4,5], but to date there has no ideal solution been found. The development of optimized reinforcement strategies can be aided with validated computer simulation tools that can be used to evaluate new ideas.

A validated non-linear finite element (FE) simulation tool was used here to predict the yield and fracture load of twelve osteoporotic or osteopenic proximal femora in sideways fall based on high resolution CT images. Various augmentation strategies using bone cement or novel metal implants were developed, optimized and virtually performed on the bone models. The relative strengthening compared to the non-augmented state was evaluated using case-specific FE analyses.

Strengthening effect of the cement-based augmentation was linearly proportional to cement volume and was significantly affected by cement location. With the clinically acceptable 12.6 ± 1.2 ml volume and optimized location of the cement cloud, compared to the non-augmented state, 71 ± 26% (42 – 134%) and 217 ± 166% (83 – 509%) increase in yield force and energy was reached, respectively. These were significantly higher than previously published experimental results using the “central” cement location [5], which could be well predicted by our FE models. The optimized metal implant could provide even higher strengthening effect: 140 ± 39% (76 – 194%) increase in yield force and +357 ± 177% (132 – 691%) increase in yield energy. However, for metal implants, a higher risk of subcapital fractures was indicated. For both cement and metal, the originally weaker bones were strengthened exponentially more compared to the stronger ones.

The ideal solution for prophylactic augmentation should provide an appropriate balance between the requirements of being clinically feasible, ethically acceptable and mechanically sufficient. Even with the optimized location, the cement-based approach may not provide enough strengthening effect and adequate reproducibility of the identified optimal cement cloud position may not be achieved clinically. While the metal implant based strategy appears to be able to deliver the required strengthening effect, the ethical acceptance of this more invasive option is questionable. Further development is therefore required to identify the ideal, clinically relevant augmentation strategy. This may involve new cement materials, less invasive metal implants, or a combination of both. The FE simulation approach presented here could help to screen the potential ideas and highlight promising candidates for experimental evaluation.

End caps are intended to prevent nail migration (push-out) in elastic stable intramedullary nailing. The aim of this study was to investigate the force at failure with and without end caps, and whether different insertion angles of nails and end caps would alter that force at failure.

Simulated oblique fractures of the diaphysis were created in 15 artificial paediatric femurs. Titanium Elastic Nails with end caps were inserted at angles of 45°, 55° and 65° in five specimens for each angle to create three study groups. Biomechanical testing was performed with axial compression until failure. An identical fracture was created in four small adult cadaveric femurs harvested from two donors (both female, aged 81 and 85 years, height 149 cm and 156 cm, respectively). All femurs were tested without and subsequently with end caps inserted at 45°.

In the artificial femurs, maximum force was not significantly different between the three groups (p = 0.613). Push-out force was significantly higher in the cadaveric specimens with the use of end caps by an up to sixfold load increase (830 N, standard deviation (SD) 280 vs 150 N, SD 120, respectively; p = 0.007).

These results indicate that the nail and end cap insertion angle can be varied within 20° without altering construct stability and that the risk of elastic stable intramedullary nailing push–out can be effectively reduced by the use of end caps.

Cite this article: Bone Joint J 2015;97-B:558–63.

Summary

Time-lapsed CT offers new opportunities to predict the risk of cement leakage and to evaluate the mechanical effects on a vertebral body by monitoring each incremental injection step in an in-vitro vertebroplasty procedure.

The common practice for insertion of distal locking screws of intramedullary (IM) nails is a freehand technique under fluoroscopic control. The process is technically demanding, time-consuming and afflicted to considerable radiation exposure to patient and surgical personnel. A new technique is introduced which guides the surgeon by landmarks on the X-ray projection.

18 fresh frozen human below-knee specimens (incl. soft tissue) were used. Each specimen was instrumented with an Expert Tibial Nail (Synthes GmbH, Switzerland) and was mounted on an OR-table. Two distal interlocking techniques were performed in random order using a Siemens ARCADIS C-arm system (Siemens AG, Munich, Germany). The newly developed guided technique, guides the surgeon by visible landmarks projected onto the fluoroscopy image. A computer program plans the drilling trajectory by 2D-3D conversion and provides said guiding landmarks for drilling in real-time. No additional tracking or navigation equipment is needed.

All four distal screws (2 mediolateral, 2 anteroposterior) were placed in each procedure. Operating time, number of taken X-rays and radiation time were recorded per procedure and for each single screw.

8 procedures were performed with the freehand technique and 10 with the guided technique. A 58% reduction in number of fluoroscopy shots per screw was found for the guided technique (7.4±3.4 vs. 17.6±10.3; p < 0.001). Total radiation time was 55% lower for the guided technique (17.1 ± 3.7s vs. 37.9 ± 9.1s) (p = 0.001). Operating time was shorter by 22% in the guided technique (3.2±1.2 min vs. 4.1±2.1 min p = 0.018).

In an experimental setting, the newly developed guided freehand technique has proven to markedly reduce radiation exposure when compared to the conventional freehand technique. The method enhances established clinical workflows and does not require cost intensive add-on devices or extensive training.

A newly developed simple navigated technique has proven to markedly reduce radiation exposure and time for distal locking of intramedullary nails.

We investigated the static and cyclical strength of parallel and angulated locking plate screws using rigid polyurethane foam (0.32 g/cm³) and bovine cancellous bone blocks. Custom-made stainless steel plates with two conically threaded screw holes with different angulations (parallel, 10° and 20° divergent) and 5 mm self-tapping locking screws underwent pull-out and cyclical pull and bending tests. The bovine cancellous blocks were only subjected to static pull-out testing. We also performed finite element analysis for the static pull-out test of the parallel and 20° configurations. In both the foam model and the bovine cancellous bone we found the significantly highest pull-out force for the parallel constructs. In the finite element analysis there was a 47% more damage in the 20° divergent constructs than in the parallel configuration. Under cyclical loading, the mean number of cycles to failure was significantly higher for the parallel group, followed by the 10° and 20° divergent configurations.

In our laboratory setting we clearly showed the biomechanical disadvantage of a diverging locking screw angle under static and cyclical loading.