Digitally enhanced hands-on surgical training (DEHST) enhances the performance during freehand nail distal interlocking.

PURPOSE: Freehand distal interlocking of intramedullary nails remains a challenging task. Recently, a new training device for digitally enhanced hands-on surgical training (DEHST) was introduced, potentially improving surgical skills needed for distal interlocking. AIM: To evaluate whether training with DEHST enhances the performance of novices (first-year residents without surgical experience in freehand distal nail interlocking). METHODS: Twenty novices were randomly assigned to two groups and performed distal interlocking of a tibia nail in mock operation under operation-room-like conditions. Participants in Group 1 were trained with DEHST (five distal interlocking attempts, 1 h of training), while those in Group 2 did not receive training. Time, number of X-rays shots, hole roundness in the X-rays projection and hit rates were compared between the groups. RESULTS: Time to complete the task [414.7 s (range 290-615)] and X-rays exposure [17.8 µGcm2 (range 9.8-26.4)] were significantly lower in Group 1 compared to Group 2 [623.4 s (range 339-1215), p = 0.041 and 32.6 µGcm2 (range 16.1-55.3), p = 0.003]. Hole projections were significantly rounder in Group 1 [95.0% (range 91.1-98.0) vs. 80.8% (range 70.1-88.9), p < 0.001]. In Group 1, 90% of the participants achieved successful completion of the task in contrast to a 60% success rate in Group 2. This difference was not statistically significant (p = 0.121). CONCLUSIONS: In a mock-operational setting, training with DEHST significantly enhanced the performance of novices without surgical experience in distal interlocking of intramedullary nails and hence carries potential to improve safety and efficacy of this important and demanding surgical task to steepen the learning curve without endangering patients. LEVEL OF EVIDENCE: II.

In Vitro Testing and Clinical Handling of a Novel Implant Positioning Technology for Proximal Humeral Plating.

BACKGROUND AND OBJECTIVES: Fractures of the proximal humerus are common, particularly in elderly populations. Anatomical locking plates target stabilization with a multitude of screws spanning into the humeral head. Sound implant placement and screw length determination are key for a successful clinical outcome but are difficult to obtain from planar X-rays. A novel implant positioning technology for proximal humerus plating (Xin1) outputs screw lengths suggestions and plate position based on hole projections in conventional X-ray images. This study investigated the performance of a prototype Xin1 system in a postmortem (in vitro) experiment as well as in a clinical handling test. MATERIALS AND METHODS: For in vitro testing, twelve shoulders from six anatomical specimens were randomized into two groups to compare the Xin1 technique to the conventional operation in terms of surgical precision, procedure time and X-ray exposure. For the clinical trial, 11 patients undergoing plating of the proximal humerus were included. The aim was to investigate clinical handling of the Xin1 marker clip and to retrospectively evaluate the system performance in a real-life fracture situation. Image pairs before and after insertion of the proximal screws were retrospectively processed to investigate the influence of potential bone fragment shifts on the system output. RESULTS: In the postmortem experiment, the use of the system significantly improved the surgical precision (52% error reduction), procedure time (38% shorter) and radiation exposure (64% less X-rays). Clinical handling demonstrated seamless embedding of the marker clip into existing clinical workflows without adverse events reported. Retrospective X-ray analysis on six eligible patients revealed differences in the calculated screw lengths of ≤2 mm before and after screw insertion for five patients. In one patient, the screw lengths differed up to 8 mm, which might indicate displacement of the head fragment. CONCLUSIONS: Results suggest a strong potential of the Xin1 assistance technology to enhance the surgical procedure and patient outcomes in the rising incidence of osteoporotic humeral fractures. Robust performance in a real-life fracture situation was observed. In-depth validation of the system is, however, needed before placing it into clinical practice.

Statistical Morphology and Fragment Mapping of Complex Proximal Humeral Fractures.

Background and Objectives: Proximal humerus fractures (PHFs) are common in the elderly, but the treatment results are often poor. A clear understanding of fracture morphology and distribution of cortical bone loss is important for improved surgical decision making, operative considerations, and new implant designs. The aim of this study was to develop a 3D segmentation fracture mapping technique to create a statistical description of the spatial pattern and cortical bone loss of complex PHFs. Materials and Methods: Fifty clinical computed tomography (CT) scans of complex PHFs and their contralateral intact shoulders were collected. In-house software was developed for semi-automated segmentation and fracture line detection and was combined with manual fracture reduction to the contralateral template in a commercial software. A statistical mean model of these cases was built and used to describe probability maps of the fracture lines and cortical fragments. Results: The fracture lines predominantly passed through the surgical neck and between the tuberosities and tendon insertions. The superior aspects of the tuberosities were constant fragments where comminution was less likely. Some fracture lines passed through the bicipital sulcus, but predominantly at its edges and curving around the tuberosities proximally and distally. Conclusions: A comprehensive and systematic approach was developed for processing clinical CT images of complex fractures into fracture morphology and fragment probability maps and applied on PHFs. This information creates an important basis for better understanding of fracture morphology that could be utilized in future studies for surgical training and implant design.

Validity of a Novel Digitally Enhanced Skills Training Station for Freehand Distal Interlocking.

Background and Objectives: Freehand distal interlocking of intramedullary nails is technically demanding and prone to handling issues. It requires precise placement of a screw through the nail under fluoroscopy guidance and can result in a time consuming and radiation expensive procedure. Dedicated training could help overcome these problems. The aim of this study was to assess construct and face validity of new Digitally Enhanced Hands-On Surgical Training (DEHST) concept and device for training of distal interlocking of intramedullary nails. Materials and Methods: Twenty-nine novices and twenty-four expert surgeons performed interlocking on a DEHST device. Construct validity was evaluated by comparing captured performance metrics-number of X-rays, nail hole roundness, drill tip position and drill hole accuracy-between experts and novices. Face validity was evaluated with a questionnaire concerning training potential and quality of simulated reality using a 7-point Likert scale. Results: Face validity: mean realism of the training device was rated 6.3 (range 4-7). Training potential and need for distal interlocking training were both rated with a mean of 6.5 (range 5-7), with no significant differences between experts and novices, p ≥ 0.234. All participants (100%) stated that the device is useful for procedural training of distal nail interlocking, 96% wanted to have it at their institution and 98% would recommend it to colleagues. Construct validity: total number of X-rays was significantly higher for novices (20.9 ± 6.4 versus 15.5 ± 5.3, p = 0.003). Success rate (ratio of hit and miss attempts) was significantly higher for experts (novices hit: n = 15; 55.6%; experts hit: n = 19; 83%, p = 0.040). Conclusion: The evaluated training device for distal interlocking of intramedullary nails yielded high scores in terms of training capability and realism. Furthermore, construct validity was proven by reliably discriminating between experts and novices. Participants indicate high further training potential as the device may be easily adapted to other surgical tasks.

Continuous Implant Load Monitoring to Assess Bone Healing Status-Evidence from Animal Testing.

Background and Objectives: Fracture healing is currently assessed through qualitative evaluation of radiographic images, which is highly subjective in nature. Radiographs can only provide snapshots in time, which are limited due to logistics and radiation exposure. We recently proposed assessing the bone healing status through continuous monitoring of the implant load, utilizing an implanted sensor system, the Fracture Monitor. The device telemetrically transmits statistically derived implant parameters via the patient's mobile phone to assist physicians in diagnostics and treatment decision-making. This preclinical study aims to systematically investigate the device safety and performance in an animal setting. Materials and Methods: Mid-shaft tibial osteotomies of different sizes (0.6-30 mm) were created in eleven Swiss mountain sheep. The bones were stabilized with either a conventional Titanium or stainless-steel locking plate equipped with a Fracture Monitor. Data were continuously collected over the device's lifetime. Conventional radiographs and clinical CT scans were taken longitudinally over the study period. The radiographs were systematically scored and CTs were evaluated for normalized bone volume in the defect. The animals were euthanized after 9 months. The sensor output was correlated with the radiologic parameters. Tissue samples from the device location were histologically examined. Results: The sensors functioned autonomously for 6.5-8.4 months until energy depletion. No macroscopic or microscopic adverse effects from device implantation were observed. The relative implant loads at 4 and 8 weeks post-operation correlated significantly with the radiographic scores and with the normalized bone volume metric. Conclusions: Continuous implant load monitoring appears as a relevant approach to support and objectify fracture healing assessments and carries a strong potential to enable patient-tailored rehabilitation in the future.

Continuous Rod Load Monitoring to Assess Spinal Fusion Status-Pilot In Vivo Data in Sheep.

Background and Objectives: Spinal fusion is an effective and widely accepted intervention. However, complications such as non-unions and hardware failures are frequently observed. Radiologic imaging and physical examination are still the gold standards in the assessment of spinal fusion, despite multiple limitations including radiation exposure and subjective image interpretation. Furthermore, current diagnostic methods only allow fusion assessment at certain time points and require the patient's presence at the hospital or medical practice. A recently introduced implantable sensor system for continuous and wireless implant load monitoring in trauma applications carries the potential to overcome these drawbacks, but transferability of the principle to the spine has not been demonstrated yet. Materials and Methods: The existing trauma sensor was modified for attachment to a standard pedicle-screw-rod system. Two lumbar segments (L2 to L4) of one Swiss white alpine sheep were asymmetrically instrumented. After facetectomy, three sensors were attached to the rods between each screw pair and activated for measurement. The sheep was euthanized 16 weeks postoperatively. After radiological assessment the spine was explanted and loaded in flexion-extension to determine the range of motion of the spinal segments. Sensor data were compared with mechanical test results and radiologic findings. Results: The sensors measured physiological rod loading autonomously over the observation period and delivered the data daily to bonded smartphones. At euthanasia the relative rod load dropped to 67% of the respective maximum value for the L23 segment and to 30% for the L34 segment. In agreement, the total range of motion of both operated segments was lower compared to an intact reference segment (L23: 0.57°; L34: 0.49°; intact L45: 4.17°). Radiologic assessment revealed fusion mass in the facet joint gaps and bilateral bridging bone around the joints at both operated segments. Conclusions: Observations of this single-case study confirm the basic ability of continuous rod load measurement to resolve the spinal fusion process as indicated by a declining rod load with progressing bone fusion. A strong clinical potential of such technology is eminent, but further data must be collected for final proof of principle.

Cortical parameters predict bone strength at the tibial diaphysis, but are underestimated by HR-pQCT and µCT compared to histomorphometry.

Cortical bone and its microstructure are crucial for bone strength, especially at the long bone diaphysis. However, it is still not well-defined how imaging procedures can be used as predictive tools for mechanical bone properties. This study evaluated the capability of several high-resolution imaging techniques to capture cortical bone morphology and assessed the correlation with the bone's mechanical properties. The microstructural properties (cortical thickness [Ct.Th], porosity [Ct.Po], area [Ct.Ar]) of 11 female tibial diaphysis (40-90 years) were evaluated by dual-energy X-ray absorptiometry (DXA), high-resolution peripheral-quantitative-computed-tomography (HR-pQCT), micro-CT (µCT) and histomorphometry. Stiffness and maximal torque to failure were determined by mechanical testing. T-Scores determined by DXA ranged from 0.6 to -5.6 and a lower T-Score was associated with a decrease in Ct.Th (p ≤ 0.001) while the Ct.Po (p ≤ 0.007) increased, and this relationship was independent of the imaging method. With decreasing T-Score, histology showed an increase in Ct.Po from the endosteal to the periosteal side (p = 0.001) and an exponential increase in the ratio of osteons at rest to those after remodelling. However, compared to histomorphometry, HR-pQCT and µCT underestimated Ct.Po and Ct.Th. A lower T-Score was also associated with significantly reduced stiffness (p = 0.031) and maximal torque (p = 0.006). Improving the accuracy of Ct.Po and Ct.Th did not improve prediction of the mechanical properties, which was most closely related to geometry (Ct.Ar). The ex-vivo evaluation of mechanical properties correlated with all imaging modalities, with Ct.Th and Ct.Po highly correlated with the T-Score of the tibial diaphysis. Cortical microstructural changes were underestimated with the lower resolution of HR-pQCT and µCT compared to the histological 'gold standard'. The increased accuracy did not result in an improved prediction for local bone strength in this study, which however might be related to the limited number of specimens and thus needs to be evaluated in a larger collective.

Impact of Bone Cement Augmentation on the Fixation Strength of TFNA Blades and Screws.

Background and Objectives: Hip fractures constitute the most debilitating complication of osteoporosis with steadily increasing incidences in the aging population. Their intramedullary nailing can be challenging because of poor anchorage in the osteoporotic femoral head. Cement augmentation of Proximal Femoral Nail Antirotation (PFNA) blades demonstrated promising results by enhancing cut-out resistance in proximal femoral fractures. The aim of this study was to assess the impact of augmentation on the fixation strength of TFN-ADVANCEDTM Proximal Femoral Nailing System (TFNA) blades and screws within the femoral head and compare its effect when they are implanted in centre or anteroposterior off-centre position. Materials and Methods: Eight groups were formed out of 96 polyurethane low-density foam specimens simulating isolated femoral heads with poor bone quality. The specimens in each group were implanted with either non-augmented or cement-augmented TFNA blades or screws in centre or anteroposterior off-centre positions, 7 mm anterior or posterior. Mechanical testing was performed under progressively increasing cyclic loading until failure, in setup simulating an unstable pertrochanteric fracture with a lack of posteromedial support and load sharing at the fracture gap. Varus-valgus and head rotation angles were monitored. A varus collapse of 5° or 10° head rotation was defined as a clinically relevant failure. Results: Failure load (N) for specimens with augmented TFNA head elements (screw/blade centre: 3799 ± 326/3228 ± 478; screw/blade off-centre: 2680 ± 182/2591 ± 244) was significantly higher compared with respective non-augmented specimens (screw/blade centre: 1593 ± 120/1489 ± 41; screw/blade off-centre: 515 ± 73/1018 ± 48), p < 0.001. For both non-augmented and augmented specimens failure load in the centre position was significantly higher compared with the respective off-centre positions, regardless of the head element type, p < 0.001. Augmented off-centre TFNA head elements had significantly higher failure load compared with non-augmented centrally placed implants, p < 0.001. Conclusions: Cement augmentation clearly enhances the fixation stability of TFNA blades and screws. Non-augmented blades outperformed screws in the anteroposterior off-centre position. Positioning of TFNA blades in the femoral head is more forgiving than TFNA screws in terms of failure load.

Programable Active Fixator System for Systematic In Vivo Investigation of Bone Healing Processes.

This manuscript introduces a programable active bone fixator system that enables systematic investigation of bone healing processes in a sheep animal model. In contrast to previous systems, this solution combines the ability to precisely control the mechanical conditions acting within a fracture with continuous monitoring of the healing progression and autonomous operation of the system throughout the experiment. The active fixator system was implemented on a double osteotomy model that shields the experimental fracture from the influence of the animal's functional loading. A force sensor was integrated into the fixator to continuously measure stiffness of the repair tissue as an indicator for healing progression. A dedicated control unit was developed that allows programing of different loading protocols which are later executed autonomously by the active fixator. To verify the feasibility of the system, it was implanted in two sheep with different loading protocols, mimicking immediate and delayed weight-bearing, respectively. The implanted devices operated according to the programmed protocols and delivered seamless data over the whole course of the experiment. The in vivo trial confirmed the feasibility of the system. Hence, it can be applied in further preclinical studies to better understand the influence of mechanical conditions on fracture healing.

Screw configuration in proximal humerus plating has a significant impact on fixation failure risk predicted by finite element models.

BACKGROUND: Proximal humeral fractures occur frequently, with fixed angle locking plates often being used for their treatment. No current quantitative evidence for the effect of different screw configurations exists, and the large number of variations makes biomechanical testing prohibitive. Therefore, we used an established and validated finite element osteosynthesis test kit to quantify the effect of variations in screw configuration on predicted failure risk of PHILOS plate fixation for unstable proximal humerus fractures. METHODS: Twenty-six low-density humerus models were osteotomized to create malreduced unstable 3-part fractures that were virtually fixed with PHILOS plates. Twelve screw configurations were simulated: 6 using 2 screw rows, 4 using 3 rows, and 1 with either 8 or 9 screws. Three physiological loading cases were modeled and an established finite element analysis methodology was used. The average peri-screw bone strain, previously demonstrated to predict fatigue cutout failure, was used to compare the different configurations. RESULTS: Significant differences in peri-screw strains, and thus predicted failure risk, were seen with different combinations. The 9-screw configuration demonstrated the lowest peri-screw strains. Fewer screw constructs showed lower strains when placed further apart. The calcar screws (row E) significantly (P < .001) reduced fixation failure risk. CONCLUSION: Screw configurations significantly impact predicted cutout failure risk for locking plate fixations of unstable proximal humerus fractures in low-density bone. Although requiring clinical corroboration, the result of this study suggests that additional screws reduce peri-screw strains, the distance between them should be maximized whenever possible and the calcar screws should be used.

The influence of screw length on predicted cut-out failures for proximal humeral fracture fixations predicted by finite element simulations.

BACKGROUND: The aim of this study was to identify the effect of screw length on predictions of fixation failure in three-part proximal humeral fractures using a finite element-based osteosynthesis modelling toolkit. METHODS: A mal-reduced unstable three-part AO/OTA 11-B3.2 fracture with medial comminution was simulated in forty-two digitally processed proximal humeri covering a spectrum of bone densities and fixed with the PHILOS plate using three distal and six proximal locking screws. Four test groups were generated based on the screw tip to joint surface distance (TJD), with all proximal screws being shortened from 4 mm TJD to be 8, 12 or 16 mm TJD. Average bone strains around the screw tips, correlating with biomechanical cyclic cut-out-type failure, were evaluated in three physiological loading protocols representing simple shoulder motions. Six further groups were tested, where five of the proximal screws were inserted to 4 mm TJD and the sixth screw to 8 mm TJD. RESULTS: Exponential increases in the predicted risk of fixation failure were seen with increased tip-to-joint distances (p < 0.001). When one of the proximal screws was placed 8 mm from the joint, with the remaining five at 4 mm distance, significant increases (p < 0.001) were registered in the strains around the screw tips in all except the two superior screws. This effect was maximal around the calcar screws (p < 0.001) and for lower density samples (p < 0.001). CONCLUSIONS: These results suggest that longer screws provide reduced risk of cut-out failure, i.e. distalisation and/or varisation of the head fragment, and thus may decrease failure rates in proximal humeral fractures treated with angular stable plates. These findings require clinical corroboration and further studies to investigate the risk of screw perforation.

A cadaveric biomechanical study comparing the ease of femoral nail insertion: 1.0- vs 1.5-m bow designs.

INTRODUCTION: Anatomic fit of intramedullary nails was suggested by previous studies to improve significantly when the nail radius of curvature (ROC) is closer to the average femoral anatomy. However, no attempt has been made to investigate the impact of different ROC designs on the nail insertion process. Therefore, this biomechanical study quantitatively compared the ease of insertion between femoral intramedullary nails with a 1.0-m and a 1.5-m bow radius. MATERIALS AND METHODS: Long TFN-ADVANCED™ (TFNA, 1.0 m ROC) and Proximal Femoral Nail Antirotation nails (PFNA, 1.5 m ROC) were implanted pairwise into seven paired cadaver femora. All bones were reamed 1.5 mm larger than the nail diameter. Using a material testing machine, intramedullary nailing was then performed stepwise with 20-mm steps and a 10-mm/s insertion rate, and force was measured. The nail deformation caused by the insertion was assessed through 3D computer models built from pre- and post-nailing CT scans. The ease of insertion between TFNA and PFNA nails was quantified in terms of insertion force, insertion energy and nail deformation. RESULTS: There was no significant difference in the peak force generated during nailing between TFNA and PFNA nails (P = 0.731). However, the force measured at the end of insertion (P = 0.002) was significantly smaller in TFNA nails compared to PFNA nails. After implantation, TFNA nails showed significantly smaller deformation when compared to PFNA nails (P = 0.005, both ends aligned). Furthermore, less energy was required to insert TFNA nails; however, the difference was not significant (P = 0.25). CONCLUSIONS: Compared to PFNA nails, a significant decrease in insertion force and nail deformation was found at the end of insertion for TFNA nails. Results suggest that TFNA having a 1.0-m ROC is easier to insert for the set of femora used in this study compared to PFNA with a 1.5-m ROC.

Bone Mass Distribution of the Distal Tibia in Normal, Osteopenic, and Osteoporotic Conditions: An Ex Vivo Assessment Using HR-pQCT, DXA, and Computational Modelling.

Osteoporosis leads to bone loss and structural deterioration, which increase the risk of fractures. The aim of this study was to characterize the three-dimensional (3D) bone mass distributions of the distal tibia in normal, osteopenic, and osteoporotic conditions. High-resolution peripheral quantitative computed tomography (HR-pQCT) of the 33 % of the distal tibia and local dual-energy X-ray absorptiometry were applied to 53 intact, fresh-frozen tibiae. The HR-pQCTs were graded to assign local T-scores and merged into three equally sized average normal, osteopenic, and osteoporotic surface models. Volumetric bone mineral density (vBMD) was determined using categorized T-scores, volumetric visualization, and virtual bore probes at the dia-, meta-, and epiphyseal sites (T-DIA, T-META, and T-EPI). We observed a distinct 3D bone mass distribution that was gradually uninfluenced by T-score categories. T-DIA was characterized by the lowest bone mass located in the medullary cavity and a wide homogenous cortex containing the maximum vBMD. The T-META showed decreased cortical thickness and maximal vBMD. At the T-EPI, the relatively low vBMD of the mostly trabecular bone was similar to the maximal cortical vBMD in this sub-region. Four trabecular regions of low bone mass were identified in the recesses. The bone content gradually decreased at all sites, whereas the pattern of bone mass distribution remained essentially unchanged, with the exception of disproportionate losses at T-DIA, T-META, and T-EPI that consistently showed increased endocortical, intracortical, and trabecular bone loss. Extra information can be obtained from the specific pattern of bone mass distribution, potential disproportionate bone losses, and method used.

Analysis of sacro-iliac joint screw fixation: does quality of reduction and screw orientation influence joint stability? A biomechanical study.

INTRODUCTION: Treatment of posterior pelvic ring injuries is frequently associated with pain or/and high mortality rates. Percutaneous sacro-iliac (SI) screw fixation has proved to be one of the methods of choice, providing minimal operative time, blood loss and wound-related morbidity. However, fixation failures due to secondary fracture dislocation or screw backing out have been reported. There is a little knowledge regarding the impact of varying screw orientation and quality of reduction on the fixation strength. PURPOSE: The purpose of the present study was biomechanical investigation of joint stability after SI screw fixation and its dependence on quality of reduction and screw orientation. METHODS: Thirty-two artificial hemi-pelvices were assigned to four study groups and simulated SI dislocations were fixed with two SI screws in oblique or transverse screw orientation and anatomical or non-anatomical reduction in group A (oblique/anatomical), B (transverse/anatomical), C (oblique/non-anatomical) and D (transverse/non-anatomical). Mechanical testing was performed under progressively increasing cyclic axial loading until fixation failure. SI joint movements were captured via optical motion tracking. Fixation performance was statistically evaluated at a level of significance p = 0.05. RESULTS: The highest cycles to failure were observed in group A (14038 ± 1057), followed by B (13909 ± 1217), D (6936 ± 1654) and C (6706 ± 1295). Groups A and B revealed significantly longer endurance than C and D (p ≤ 0.01). CONCLUSIONS: Different screw orientations in the presented model do not influence substantially SI joint stability. However, anatomical reduction is not only mandatory to restore a malalignment, but also to increase the SI screw fixation strength and prevent fixation failures.

A biomechanical comparison of fixed angle locking compression plate osteosynthesis and cement augmented screw osteosynthesis in the management of intra articular calcaneal fractures.

PURPOSE: The purpose of this study was to investigate whether cement-augmented screw osteosynthesis results in stability comparable to conventional fixed-angle locking plate osteosynthesis using cadaveric bones to model a Sanders type 2B fracture. METHODS: Seven pairs of fresh frozen human calcanei and the corresponding tali were used. The specimens were assigned pairwise to two study groups in a randomised manner. In order to determine the initial quasi-static stiffness of the bone-implant construct, testing commenced with quasi-static compression ramp loading; subsequently, sinusoidal cyclic compression loading at 2 Hz was performed until construct failure occurred. Initial dynamic stiffness (cycle 1), range of motion (ROM), cycles to failure and load to failure were determined from the machine data during the cyclic test. In addition, at 250-cycle intervals, Böhler's angle and the critical angle of Gissane were determined on mediolateral X-rays shot with a triggered C-arm; 5° angle flattening was arbitrarily defined as a failure criterion. RESULTS: Bone mineral density was normally distributed without significant differences between the groups. The augmented screw osteosynthesis resulted in higher stiffness values compared to the fixed-angle locking plate osteosynthesis. The fracture fragment motion in the locking plate group was significantly higher compared to the group with augmented screw osteosynthesis. CONCLUSIONS: The results of this study indicate that in our selected test set-up augmented screw osteosynthesis was significantly superior to the conventional fixed-angle locking plate osteosynthesis with respect to primary stability and ROM during cyclic testing.

Severity of Complications after Locking Plate Osteosynthesis in Distal Femur Fractures.

Background: Locked plating for distal femur fractures is widely recommended and used. We systematically reviewed clinical studies assessing the benefits and harms of fracture fixation with locked plates in AO/OTA Type 32 and 33 femur fractures. Methods: A comprehensive literature search of PubMed, Embase, Cinahl, Web of Science, and the Cochrane Database was performed. The studies included randomized and non-randomized clinical trials, observational studies, and case series involving patients with distal femur fractures. Studies of other fracture patterns, studies conducted on children, pathological fractures, cadaveric studies, animal models, and those with non-clinical study designs were excluded. Results: 53 studies with 1788 patients were found to satisfy the inclusion and exclusion criteria. The most common harms were nonunion (14.8%), malunion (13%), fixation failure (5.3%), infection (3.7%), and symptomatic implant (3.1%). Time to full weight-bearing ranged from 5 to 24 weeks, averaging 12.3 weeks. The average duration of follow-up was 18.18 months, ranging from 0.5 to 108 months. Surgical time ranged between 40 and 540 min, with an average of 141 min. The length of stay in days was 12.7, ranging from 1 to 61. The average plate length was ten holes, ranging from 5 to 20 holes. Conclusion: This review aimed to systematically synthesize the available evidence on the risk associated with locked plating osteosynthesis in distal femur fractures. Nonunion is the most common harm and is the primary cause of reoperation. The overall combined risk of a major and critical complication (i.e., requiring reoperation) is approximately 20%.

Decreasing implant load indicates spinal fusion when measured continuously.

Reliable and timely assessment of bone union between vertebrae is considered a key challenge after spinal fusion surgery. Recently, a novel sensor concept demonstrated the ability to objectively assess posterolateral fusion based on continuous implant load monitoring. The aim of this study was to investigate systematically the concept in a mono-segmental fusion model using an updated sensor setup. Three sheep underwent bilateral facetectomy at level L2-L3 and L4-L5. The segments were stabilized using two unconnected pedicle-screw-rod constructs per level. Sensing devices were attached to the rods between each pedicle screw pair and the loads were continuously monitored over 16 weeks. After euthanasia, the spines were biomechanically tested for their range of motion and high-resolution CT scans were performed to confirm the fusion success. After an initial increase in implant load until reaching a maximum (100 %) at approximately week 4, eleven out of twelve sensors measured a constant decrease in implant load to 52 ± 9 % at euthanasia. One sensor measurement was compromised by newly forming bone growing against the sensor clamp. Bridging bone at each facet and minor remnant segmental motion (<0.7°) confirmed the fusion of all motion segments. Data obtained by continuous measurement of implant loading of spinal screw-rod constructs enables objective monitoring of spinal fusion progression. The sensor concept provides valuable real-time information, offering quantifiable data as an alternative to traditional imaging techniques. However, the design of the current sensor concept needs to be matured, tailored to, and validated for the human spine.

Experimental and virtual testing of bone-implant systems equipped with the AO Fracture Monitor with regard to interfragmentary movement.

Introduction: The management of fractured bones is a key domain within orthopedic trauma surgery, with the prevention of delayed healing and non-unions forming a core challenge. This study evaluates the efficacy of the AO Fracture Monitor in conjunction with biomechanical simulations to better understand the local mechanics of fracture gaps, which is crucial for comprehending mechanotransduction, a key factor in bone healing. Through a series of experiments and corresponding simulations, the study tests four hypotheses to determine the relationship between physical measurements and the predictive power of biomechanical models. Methods: Employing the AO Fracture Monitor and Digital Image Correlation techniques, the study demonstrates a significant correlation between the surface strain of implants and interfragmentary movements. This provides a foundation for utilizing one-dimensional AO Fracture Monitor measurements to predict three-dimensional fracture behavior, thereby linking mechanical loading with fracture gap dynamics. Moreover, the research establishes that finite element simulations of bone-implant systems can be effectively validated using experimental data, underpinning the accuracy of simulations in replicating physical behaviors. Results and Discussion: The findings endorse the combined use of monitoring technologies and simulations to infer the local mechanical conditions at the fracture site, offering a potential leap in personalized therapy for bone healing. Clinically, this approach can enhance treatment outcomes by refining the assessment precision in trauma trials, fostering the early detection of healing disturbances, and guiding improvements in future implant design. Ultimately, this study paves the way for more sophisticated patient monitoring and tailored interventions, promising to elevate the standard of care in orthopedic trauma surgery.

Fatigue performance of angle-stable tibial nail interlocking screws.

PURPOSE: Tibial nail interlocking screw failure often occurs during delayed fracture consolidation or at early weight bearing of nailed unstable fractures, in general when high implant stress could not be reduced by other means. Is there a biomechanical improvement in long-term performance of angle stable locking screws compared to conventional locking screws for distal locking of intramedullary tibial nails? METHODS: Surrogate bones of human tibiae were cut in the distal third and distal locking of the 10 mm intramedullary tibial nail was performed with either two angle stable locking screws or two conventional locking screws in the mediolateral plane. Six specimens per group were mechanically tested under quasi-static and cyclic axial loading with constantly increasing force. RESULTS: Angle stable locking screw constructs exhibited significantly higher stiffness values (7,809 N/mm ± 647, mean ± SD) than conventional locking screw constructs (6,614 N/mm ± 859, p = 0.025). Angle stable locking screw constructs provided a longer fatigue life, expressed in a significantly higher number of cycles to failure (187,200 ± 18,100) compared to conventional locking screw constructs (128,700 ± 7,000, p = 0.004). CONCLUSION: Fatigue performance of locking screws can be ameliorated by the use of angle stable locking screws, being especially important if the nail acts as load carrier and an improved stability during fracture healing is needed.

Biomechanical performance of different cable and wire cerclage configurations.

PURPOSE: Cerclage technology is regaining interest due to the increasing number of periprosthetic fractures. Different wiring techniques have been formerly proposed and have hibernated over years. Hereby, they are compared to current cerclage technology. METHODS: Seven groups (n = 6) of different cable cerclage (Ø1.7 mm, crimp closure) configurations (one single cerclage looped once around the shells, one single cerclage looped twice, two cerclages each looped once) and solid wire cerclages (Ø1.5 mm, twist closure) (same configurations as cable cerclages, and two braided wires, twisted around each other looped once) fixed two cortical half shells of human femoral shaft mounted on a testing jig. Sinusoidal cyclic loading with constantly increasing force (0.1 N/cycle) was applied starting at 50 N peak load. Cerclage pretension (P), load leading to onset of plastic deformation (D) and load at total failure (T) were identified. Statistical differences between the groups were detected by univariate ANOVA. RESULTS: Double looped cables (P442N ± 129; D1334N ± 319; T2734N ± 330) performed significantly better (p < 0.05) than single looped cables (P292N ± 56; D646N ± 108; T1622N ± 171) and were comparable to two single cables (P392N ± 154; D1191N ± 334; T2675N ± 361). Double looped wires (P335N ± 49; D752N ± 119; T1359N ± 80) were significantly better (p < 0.05) than single looped wires (P181N ± 16; D343N ± 33; T606N ± 109) and performed similarly to single looped cables. Braided wires (P119N ± 26; D225N ± 55; T919N ± 197) exhibited early loss of pretension and plastic deformation. CONCLUSION: Double looped cerclages provided a better fixation stability compared to a single looped cerclage. Double looped wires were comparable to a single looped cable. The use of braided wires could not be recommended mechanically.