Biomechanical validation of novel polyurethane-resin synthetic osteoporotic femoral bones in axial compression, four-point bending and torsion.

In addition to human donor bones, bone models made of synthetic materials are the gold standard substitutes for biomechanical testing of osteosyntheses. However, commercially available artificial bone models are not able to adequately reproduce the mechanical properties of human bone, especially not human osteoporotic bone. To overcome this issue, new types of polyurethane-based synthetic osteoporotic bone models have been developed. Its base materials for the cancellous bone portion and for the cortical portion have already been morphologically and mechanically validated against human bone. Thus, the aim of this study was to combine the two validated base materials for the two bone components to produce femur models with real human geometry, one with a hollow intramedullary canal and one with an intramedullary canal filled with synthetic cancellous bone, and mechanically validate them in comparison to fresh frozen human bone. These custom-made synthetic bone models were fabricated from a computer-tomography data set in a 2-step casting process to achieve not only the real geometry but also realistic cortical thicknesses of the femur. The synthetic bones were tested for axial compression, four-point bending in two planes, and torsion and validated against human osteoporotic bone. The results showed that the mechanical properties of the polyurethane-based synthetic bone models with hollow intramedullary canals are in the range of those of the human osteoporotic femur. Both, the femur models with the hollow and spongy-bone-filled intramedullary canal, showed no substantial differences in bending stiffness and axial compression stiffness compared to human osteoporotic bone. Torsional stiffnesses were slightly higher but within the range of human osteoporotic femurs. Concluding, this study shows that the innovative polyurethane-based femur models are comparable to human bones in terms of bending, axial compression, and torsional stiffness.

Impact of lateral cortical notching on biomechanical performance in cephalomedullary nailing for unstable pertrochanteric fractures.

PURPOSE: In pertrochanteric femur fractures the risk for fracture healing complications increases with the complexity of the fracture. In addition to dynamization along the lag screw, successful fracture healing may also be facilitated by further dynamization along the shaft axis. The aim of this study was to investigate the mechanical stability of additional axial notch dynamization compared to the standard treatment in an unstable pertrochanteric femur fracture treated with cephalomedullary nailing. METHODS: In 14 human cadaver femora, an unstable pertrochanteric fracture was stabilized with a cephalomedullary nail. Additional axial notch dynamization was enabled in half of the samples and compared against the standard treatment (n = 7). Interfragmentary motion, axial construct stiffness and load to failure were investigated in a stepwise increasing cyclic load protocol. RESULTS: Mean load to failure (1414 ± 234 N vs. 1428 ± 149 N, p = 0.89) and mean cycles to failure (197,129 ± 45,087 vs. 191,708 ± 30,490, p = 0.81) were equivalent for axial notch dynamization and standard treatment, respectively. Initial construct stiffness was comparable for both groups (axial notch dynamization 684 [593-775] N/mm, standard treatment 618 [497-740] N/mm, p = 0.44). In six out of seven specimens the additional axial dynamization facilitated interfragmentary compression, while maintaining its mechanical stability. After initial settling of the constructs, there were no statistically significant differences between the groups for either subsidence or rotation of the femoral head fragment (p ≤ 0.30). CONCLUSION: Axial notch dynamization provided equivalent mechanical stability compared to standard treatment in an unstable pertrochanteric fracture. Whether the interfragmentary compression generated by axial notch dynamization will promote fracture healing through improved fracture reduction needs to be evaluated clinically.

Open the pores - Polydimethylsiloxane influences the porous structure of cancellous bone surrogates for biomechanical testing of osteosyntheses.

Synthetic materials used for valid and reliable implant testing and design should reflect the mechanical and morphometric properties of human bone. Such bone models are already available on the market, but they do not reflect the population variability of human bone, nor are they open-celled porous as human bone is. Biomechanical studies aimed at cementing the fracture or an implant cannot be conducted with them. The aim of this study was to investigate the influence of a cell stabilizer on polyurethane-based cancellous synthetic bone in terms of morphology, compressive mechanics, and opening of the cancellous bone structure for bone cement application. Mechanical properties of cylindrical specimens of the bone surrogates were determined by static compression tests to failure. Furthermore, a morphometric analysis was performed using microcomputed tomography. To prove the open-cell nature of the bone surrogates, an attempt was made to apply bone cement. Effects on the mechanical properties of the polyurethane-based bone surrogates were observed by the addition of polydimethylsiloxane. All mechanical parameters like Young's modulus, ultimate stress and yield stress increased statistically significantly with increasing amounts of cell stabilizer (all p > 0.001), except for yield stress. The analysis of morphometric parameters showed a decrease in trabecular thickness, spacing and connectivity density, which was accompanied by an increase in trabecular number and an increase in pore size. The open-cell nature was proven by the application and distribution of bone cement in specimens with stabilizer, which was visualized by X-ray. In conclusion, the results show that by adding a cell stabilizer, polyurethane-based cancellous bone substrates can be produced that have an open-cell structure similar to human bone. This makes these bone surrogates suitable for biomechanical testing of osteosyntheses and for osteosynthesis cementation issues.

Risk of Interprosthetic Femur Fracture Is Associated with Implant Spacing-A Biomechanical Study.

BACKGROUND: Ipsilateral revision surgeries of total hip or knee arthroplasties due to periprosthetic fractures or implant loosening are becoming more frequent in aging populations. Implants in revision arthroplasty usually require long anchoring stems. Depending on the residual distance between two adjacent knee and hip implants, we assume that the risk of interprosthetic fractures increases with a reduction in the interprosthetic distance. The aim of the current study was to investigate the maximum strain within the femoral shaft between two ipsilateral implants tips. METHODS: A simplified physical model consisting of synthetic bone tubes and metallic implant cylinders was constructed and the surface strains were measured using digital image correlation. The strain distribution on the femoral shaft was analyzed in 3-point- and 4-point-bending scenarios. The physical model was transferred to a finite element model to parametrically investigate the effects of the interprosthetic distance and the cortical thickness on maximum strain. Strain patterns for all parametric combinations were compared to the reference strain pattern of the bone without implants. RESULTS: The presence of an implant reduced principal strain values but resulted in distinct strain peaks at the locations of the implant tips. A reduced interprosthetic distance and thinner cortices resulted in strain peaks of up to 180% compared to the reference. At low cortical thicknesses, the strain peaks increased exponentially with a decrease in the interprosthetic distance. An increasing cortical thickness reduced the peak strains at the implant tips. CONCLUSIONS: A minimum interprosthetic distance of 10 mm seems to be crucial to avoid the accumulation of strain peaks caused by ipsilateral implant tips. Interprosthetic fracture management is more important in patients with reduced bone quality.

Cerclage Wiring Improves Biomechanical Stability in Distal Tibia Spiral Fractures Treated by Intramedullary Nailing.

BACKGROUND: Partial weight-bearing after operatively treated fractures has been the standard of care over the past decades. Recent studies report on better rehabilitation and faster return to daily life in case of immediate weight-bearing as tolerated. To allow early weight-bearing, osteosynthesis needs to provide sufficient mechanical stability. The purpose of this study was to investigate the stabilizing benefits of additive cerclage wiring in combination with intramedullary nailing of distal tibia fractures. METHODS: In 14 synthetic tibiae, a reproducible distal spiral fracture was treated by intramedullary nailing. In half of the samples, the fracture was further stabilized by additional cerclage wiring. Under clinically relevant partial and full weight-bearing loads the samples were biomechanically tested and axial construct stiffness as well as interfragmentary movements were assessed. Subsequently, a 5 mm fracture gap was created to simulate insufficient reduction, and tests were repeated. RESULTS: Intramedullary nails offer already high axial stability. Thus, axial construct stiffness cannot be significantly enhanced by an additive cerclage (2858 ± 958 N/mm NailOnly vs. 3727 ± 793 N/mm Nail + Cable; p = 0.089). Under full weight-bearing loads, additive cerclage wiring in well-reduced fractures significantly reduced shear (p = 0.002) and torsional movements (p = 0.013) and showed similar low movements as under partial weight-bearing (shear 0.3 mm, p = 0.073; torsion 1.1°, p = 0.085). In contrast, additional cerclage had no stabilizing effect in large fracture gaps. CONCLUSIONS: In well-reduced spiral fractures of the distal tibia, the construct stability of intramedullary nailing can be further increased by additional cerclage wiring. From a biomechanical point of view, augmentation of the primary implant reduced shear movement sufficiently to allow immediate weight-bearing as tolerated. Especially, elderly patients would benefit from early post-operative mobilization, which allows for accelerated rehabilitation and a faster return to daily activities.

Smart Artificial Soft Tissue - Application to a Hybrid Simulator for Training of Laryngeal Pacemaker Implantation.

Surgical simulators are safe and evolving educational tools for developing surgical skills. In particular, virtual and hybrid simulators are preferred due to their detailedness, customization and evaluation capabilities. To accelerate the revolution of a novel class of hybrid simulators, a Smart Artificial Soft Tissue is presented here, that determines the relative position of conductive surgical instruments in artificial soft tissue by inverse resistance mappings without the need for a fixed reference point. This is particularly beneficial for highly deformable structures when specific target regions need to be reached or avoided. The carbon-black-silicone composite used can be shaped almost arbitrarily and its elasticity can be tuned by modifying the silicone base material. Thus, objective positional feedback for haptically correct artificial soft tissue can be ensured. This is demonstrated by the development of a laryngeal phantom to simulate the implantation of laryngeal pacemaker electrodes. Apart from the position-detecting larynx phantom, the simulator uses a tablet computer for the virtual representation of the vocal folds' movements, in accordance with the electrical stimulation by the inserted electrodes. The possibility of displaying additional information about target regions and anatomy is intended to optimize the learning progress and illustrates the extensibility of hybrid surgical simulators.

Single or Double Plating for Acromial Type III Fractures: Biomechanical Comparison of Load to Failure and Fragment Motion.

BACKGROUND: Acromial Levy III fractures after inverse shoulder arthroplasty occur in up to 7% of patients. To date, it is not clear how these fractures should be treated as clinical outcomes remain unsatisfactory. The aim of this study was to evaluate the biomechanical performance of three different plating methods of type III acromion fractures. METHODS: Levy III fractures in synthetic scapulae were fixed with three different methods. Angular stable locking plates were placed on the spina scapula to bridge the fracture either dorsally, caudally, or on both aspects by double plating. In a biomechanical experiment, the pull of the deltoid muscle at 40° abduction of the arm was simulated by cyclic loading with increasing load levels until failure. Failure load, cycles to failure, and fragment motions were evaluated. RESULTS: The results showed that double plating (350 ± 63 N) withstood the highest loads until failure, followed by dorsal (292 ± 20 N) and caudal (217 ± 49 N) plating. Similarly, double plating showed significantly smaller fragment movement than the other two groups. CONCLUSIONS: Double plating appeared to provide the largest biomechanical stability in type III acromion fracture under arm abduction. Caudal plating in contract resulted in insufficient fracture stability and early failure and can thus not be recommended from a biomechanical point of view.

Biomechanical comparison of acetabular fracture fixation with stand-alone THA or in combination with plating.

PURPOSE: A common surgical treatment in anterior column acetabular fractures with preexisting osteoarthritis is THA, which is commonly combined with plate osteosynthesis. Implantation of a solitary revision cup cranially fixed to the os ilium is less common. The purpose of this study was to compare the stabilization of anterior column acetabular fractures fixed with a cranial socket revision cup with flange and iliac peg or with a suprapectineal plate osteosynthesis combined with an additional revision cup. METHODS: In 20 human hemipelves, an anterior column fracture was stabilized by either a cranial socket revision cup with integrated flange (CF = Cup with Flange) or by a suprapectineal plate combined with a revision cup (CP = Cup and Plate). Each specimen was loaded under a stepwise increasing dynamic load protocol. Initial construct stiffness, interfragmentary movements along the fracture line, as well as femoral head movement in relation to the acetabulum were analyzed. RESULTS: Both groups showed comparable initial construct stiffness (CP: 3180 ± 1162 N/mm and CF: 3754 ± 668 N/mm; p = 0.158). At an applied load of 1400 N, interfragmentary movements at the acetabular (p = 0.139) and the supraacetabular region (p = 0.051) revealed comparable displacement for both groups and remained below 1 mm. Femoral head movement in relation to the acetabulum also remained below 1 mm for both test groups (p = 0.260). CONCLUSION: From a biomechanical point of view, both surgical approaches showed comparable fracture reduction in terms of initial construct stiffness and interfragmentary movement. The potential benefit of the less-invasive cranial socket revision cup has to be further investigated in clinical studies.

Three internal fixation methods for Danis-Weber-B distal fibular fractures: A biomechanical comparison in an osteoporotic fibula model.

A common agreement for the surgical treatment of osteoporotic ankle fractures has not been defined yet although locking plates are preferred for fractures with poor bone quality. This study aims to evaluate the mechanical stability of locked and conventional plates on osteoporotic Danis-Weber-B-fibula fracture models. Fractured custom-made osteoporotic fibulae were treated with neutralization plate plus lag screw, locking plate plus lag screw, or a standalone locking plate. Load until failure was applied mimicking single-leg stance. Stiffness, failureload, and interfragmentary movements were investigated. Stiffness, failureload and axial fragment movement showed no significant differences among groups. Shear movements and fragment rotation around the shaft of the neutralization plate were on average twice as high as those of the locking plates. Although no superiority was shown for overall mechanical performance, the locking plate groups exhibited higher shear and rotational stability than the neutralization plate.

Graft position at the femoral condyle affects knee mobility after posterior cruciate ligament replacement.

BACKGROUND: In some cases posterior cruciate ligament (PCL) tears require surgical reconstruction. As the femoral footprint of the ligament is quite large, an ideal graft fixation position on the medial notch wall has not yet been identified. The aim of this study was to compare three different graft fixation positions within the anatomical footprint of the PCL and test it for posterior tibial translation at different knee flexion angles. METHODS: In six human knee specimens a drawer test was simulated on a material testing machine by applying load on the tibia. At three different knee flexion angles (0°, 45°, 90°) knee mobility was examined with respect to tibial posterior translation and stiffness for the following conditions: intact ligaments, detached PCL, three different graft fixation positions on the femoral condyle. RESULTS: Replacement of the PCL within its femoral footprint restored knee stability in terms of tibial posterior translation. Low graft position showed comparable drawer displacements to the intact condition for all knee flexion angles (p > 0.344). A higher graft position excessively reduced the posterior translation (p < 0.047) and resulted in a restricted knee mobility and a stiffer joint. CONCLUSIONS: Graft fixation positions on the femoral condyle play a crucial role in post-operative knee mobility and joint functionality after PCL replacement. Even though all graft fixation positions were placed within the femoral footprint of a native PCL, only the lower position on the medial notch wall showed comparable posterior tibial translation to an intact PCL.

A minimally invasive cerclage of the tibia in a modified Goetze technique: operative technique and first clinical results.

INTRODUCTION: In spiral fractures of the tibia, the stability of an osteosynthesis may be significantly increased by additive cerclages and, according to biomechanical studies, be brought into a state that allows immediate full weight bearing. As early as 1933, Goetze described a minimally invasive technique for classic steel cerclages. This technique was modified, so that it can be used for modern cable cerclages in a soft part saving way. METHOD: After closed reduction, an 8 Fr redon drain is first inserted in a minimally invasive manner, strictly along the bone and placed around the tibia via 1 cm incisions on the anterolateral and dorsomedial tibial edges using a curette and a tissue protection sleeve. Via this drain, a 1.7 mm cable cerclage can be inserted. The fracture is then anatomically reduced while simultaneously tightening the cerclage. Subsequently, a nail or a minimally invasive plate osteosynthesis is executed using the standard technique. Using the hospital documentation system, data of patients that were treated with additional cerclages for tibial fractures between 01/01/2014 and 06/30/2020 were subjected to a retrospective analysis for postoperative complications (wound-healing problems, infections and neurovascular injury). Inclusion criteria were: operatively treated tibial fractures, at least one minimally invasive additive cerclage, and age of 18 years or older. Exclusion criteria were: periprosthetic or pathological fractures and the primary need of reconstructive plastic surgery. SPSS was used for statistical analysis. RESULTS: 96 tibial shaft spiral fractures were treated with a total of 113 additive cerclages. The foregoing resulted in 10 (10.4%) postoperative wound infections, 7 of which did not involve the cerclage. One lesion of the profundal peroneal nerve was detected, which largely declined after cerclage removal. In 3 cases, local irritation from the cerclage occurred and required removal of material. CONCLUSION: In the described technique, cerclages may be inserted additively at the tibia in a minimally invasive manner and with a few complications, thus significantly increasing the stability of an osteosynthesis. How this ultimately affects fracture healing is the subject of an ongoing study.

Supplemental cerclage wiring in angle stable plate fixation of distal tibial spiral fractures enables immediate post-operative full weight-bearing: a biomechanical analysis.

PURPOSE: Distal tibial fractures generally require post-operative weight-bearing restrictions. Especially geriatric patients are unable to follow these recommendations. To increase post-operative implant stability and enable early weight-bearing, augmentation of the primary osteosynthesis by cerclage is desirable. The purpose of this study was to identify the stabilizing effects of a supplemental cable cerclage following plate fixation of distal tibial spiral fractures compared to solitary plate osteosynthesis. METHODS: In eight synthetic tibiae, a reproducible spiral fracture (AO/OTA 42-A1.1c) was stabilized by angle stable plate fixation. Each specimen was statically loaded under combined axial and torsional loads to simulate partial (200 N, 2 Nm) and full (750 N, 7 Nm) weight-bearing. Tests were repeated with supplemental cable cerclage looped around the fracture zone. In a subsequent stepwise increased dynamic load scenario, construct stiffness and interfragmentary movements were analyzed. RESULTS: With supplemental cable cerclage, construct stiffness almost tripled compared to solitary plate osteosynthesis (2882 ± 739 N/mm vs. 983 ± 355 N/mm; p < 0.001). Under full weight-bearing static loads, a supplemental cerclage revealed reduced axial (- 55%; p = 0.001) and shear movement (- 83%; p < 0.001), and also lowered shear movement (- 42%; p = 0.001) compared to a solitary plate under partial weight-bearing. Under dynamic loads supplemental cerclage significantly reduced axial (p = 0.005) as well as shear movements (p < 0.001). CONCLUSION: Supplemental cable cerclage significantly increases fixation stiffness and reduces shear movement in distal tibial spiral fractures. This stabilizing effect enables from a biomechanical point of view immediate mobilization without any weight-bearing restrictions, which may improve the quality of care of orthopedic patients and may trigger a change towards early weight-bearing regimes, especially geriatric patients would benefit from.

Biomechanical comparison of different cerclage types in addition to an angle stable plate osteosynthesis of distal tibial fractures.

BACKGROUND: Different stand-alone cerclage configurations and their optimal twisting techniques have been investigated over the years. This study tests for the stabilizing effect of different supplemental cerclage materials in combination with locked plating of distal tibia fractures. METHODS: Locking plate fixation of a distal tibial spiral fracture was tested as stand-alone and with supplemental cerclage materials (one cable, two cables, wire, fiber tape). Construct stiffness and fracture gap movements were investigated under quasi-static and dynamic loads and compared to the stand-alone locking plate. RESULTS: With each of the tested cerclages, stiffness was significantly higher than for a solitary plate osteosynthesis. Most reduction in fracture gap movement was achieved by cable cerclages, followed by double-looped wire and double-looped fiber tape cerclages. Under dynamic loading an additional cable cerclage reduces excessive gap movement. CONCLUSION: Compared to solitary plate osteosynthesis all supplemental cerclage materials were generally superior with reduced fracture gap movements whereas cable cerclages showing the greatest stabilizing effect.

Custom-made polyurethane-based synthetic bones mimic screw cut-through of intramedullary nails in human long bones.

Intramedullary nails are considered the gold standard for the treatment of tibial shaft fractures. Thereby, the screw-bone interface is considered the weakest link. For biomechanical evaluation of osteosyntheses synthetic bones are often used to overcome the disadvantages of human specimens. However, commercially available synthetic bones cannot adequately mimic the local mechanical properties of human bone. Thus, the aim of this study was to develop and evaluate novel cortical bone surrogate materials that mimic human tibial shafts in the screw-loosening mechanisms of intramedullary nails. Bone surrogates, based on two different polyurethanes, were developed and shaped as simple tubes with varying cortical thicknesses to simulate the diaphyseal cortex of human tibiae. Fresh frozen human tibiae and commercially available synthetic bones with similar cortical thickness were used as references. All specimens were treated with a nail dummy and bicortical locking screws to simulate treatment of a distal tibia shaft fracture. The nail-bone construct was loaded in a combined axial-torsional-sinusoidal loading protocol to simulate the physiological load during human gait. The loads to failure as well as the number of load cycles were evaluated. Furthermore, the cut-through length of the screws was analysed by additional micro computed -tomography images of the tested specimens. The failure load of custom made synthetic bone tubes with 6 mm cortical thickness (3242 ± 136 N) was in accordance with the failure load of human samples (3300 ± 307 N, p = 0.418) with a similar cortical thickness of 4.9 ± 1.4 mm. Commercially available synthetic bones with similar cortical thickness of 4.5 ± 0.7 mm were significantly stronger (4575 ± 795 N, p = 0.008). Oval-shaped migration patterns were "cut" into the cortices by the screws due to the cyclical loading. The cut-through length of the self-developed synthetic bones with 6 mm cortices (0.8 ± 0.6 mm, p = 0.516) matched the cut-through of the human tibiae (0.7 ± 0.6 mm). The cut-through of commercially available epoxy-based synthetic bones deviated from the human reference (0.2 ± 0.1 mm, p < 0.001). The results of this study indicate that the novel bone surrogates realistically mimic the failure and screw migration behaviour in human tibiae. Thus, they offer a new possibility to serve as substrate for biomechanical testing. The use of commercially available surrogates is discouraged for biomechanical testing as there is a risk of drawing incorrect conclusions.

[Impairment of the blood supply by cerclages: myth or reality? : An overview of the experimental study situation]. / Beeinträchtigung der Blutversorgung durch Cerclagen: Mythos oder Realität? : Ein Überblick über die experimentelle Studienlage.

INTRODUCTION: The use of a cerclage for osteosynthesis is a controversially discussed topic. They are said to damage the periosteal blood circulation and therefore impair bony healing. This article examines the available evidence on whether cerclages actually lead to a relevant reduction in periosteal perfusion. METHODS: A systematic review of the literature was performed in the PubMed library, searching for experimental studies concerning the influence of cerclages on periosteal blood supply. RESULTS: No experimental study exists which used a fracture model to investigate the influence of cerclages on the periosteal blood supply of fractured bones. A total of seven experimental studies could be identified. Of these studies two used human cadaver femora, which showed no relevant impairment of the blood supply. The other five investigations were animal experiments carried out on live animals. In rabbit femora the blood perfusion was shown by scintigraphy to be postoperatively decreased by 45-56% . In contrast, three other studies using dog femora and one using equine radii showed no relevant impairment of the periosteal blood supply. One study used an osteotomy model, the others used intact bones. CONCLUSION: Only one study using a rabbit model could demonstrate a relevant reduction of the periosteal blood supply by cerclages. In four other investigations on animal models over longer postoperative time periods the blood perfusion of the bones showed no impairment. In two series of experiments on human cadaveric femora no negative effects were also found. At least in the mid-term and long-term run the fear that cerclages could impair the blood supply of intact bone or postosteotomy cannot be confirmed by experimental studies. There is no experimental study using a fractured bone model.

Biomechanics of Osteoporotic Fracture Fixation.

PURPOSE OF REVIEW: Fractures of osteoporotic bone in elderly individuals need special attention. This manuscript reviews the current strategies to provide sufficient fracture fixation stability with a particular focus on fractures that frequently occur in elderly individuals with osteoporosis and require full load-bearing capacity, i.e., pelvis, hip, ankle, and peri-implant fractures. RECENT FINDINGS: Elderly individuals benefit immensely from immediate mobilization after fracture and thus require stable fracture fixation that allows immediate post-operative weight-bearing. However, osteoporotic bone has decreased holding capacity for metallic implants and is thus associated with a considerable fracture fixation failure rate both short term and long term. Modern implant technologies with dedicated modifications provide sufficient mechanical stability to allow immediate weight-bearing for elderly individuals. Depending on fracture location and fracture severity, various options are available to reinforce or augment standard fracture fixation systems. Correct application of the basic principles of fracture fixation and the use of modern implant technologies enables mechanically stable fracture fixation that allows early weight-bearing and results in timely fracture healing even in patients with osteoporosis.

Opening-wedge osteotomies of the distal femur: minor advantages for a biplanar compared to a uniplanar technique.

PURPOSE: Valgus malalignment of the distal femur may be treated with corrective osteotomy. The purpose of this study was to compare the primary stability of a lateral opening-wedge osteotomy (LOWO) using a uniplanar compared to a biplanar technique. A study was carried out to test both surgeries, with both an intact medial cortex and with a deliberate attached cut of the medial cortex simulating a fracture. The primary hypothesis was that the biplanar technique provides higher axial and torsional stiffness. It was further hypothesized that the mechanical superiority of the biplanar technique would not be affected in the case of breakage of the far medial cortex. METHODS: A LOWO was performed in ten synthetic femora (#3406 left large Femur, 4th Generation, Sawbones, Malmö, Sweden) using a lateral angle stable locking plate (NCB© Distal Femur Plate, Zimmer Biomet, Warsaw, USA). A uniplanar osteotomy was performed in five femora, and a biplanar osteotomy was performed in five femora. The femora were tested for axial and torsional loads using a servo-hydraulic testing machine (Instron 8874, Instron Structural Testing GmbH, High Wycombe, UK). RESULTS: Axial stiffness decreased significantly (p = 0.001) in both groups (20% in the uniplanar group and 28 % in the biplanar group) by cutting the medial cortex. The type of osteotomy had no significant effect. A slightly lower but not statistically significant axial stiffness was seen in the biplanar group both for intact and broken medial cortices. Internal torsional stiffness dropped by more than 30% for the uniplanar group and almost 24% for the biplanar group when the cortex was cut (p < 0.001). No significant change concerning internal torsional stiffness was found between the two groups. External torsional stiffness decreased by 32% for the uniplanar group and 4% for the biplanar group after the cortical cut (p = 0.029). No significant change concerning external torsional stiffness was found between the groups, but the biplanar group showed a tendency towards higher values of external torsional stiffness. CONCLUSIONS: The axial and torsional stiffness of the implant-bone construct were not significantly affected by the type of osteotomy performed. Biplanar osteotomy tended to increase external torsional stiffness. In cases of fracture of the medial cortex, biplanar osteotomy significantly reduced the external rotation at the osteotomy and showed a significantly increased external torsional stiffness.

Characterization of polyurethane-based synthetic vertebrae for spinal cement augmentation training.

Vertebral augmentation techniques are used to stabilize impacted vertebrae. To minimize intraoperative risks, a solid education of surgeons is desirable. Thus, to improve education of surgeons as well as patient safety, the development of a high-fidelity simulator for the surgical training of cement augmentation techniques was initiated. The integrated synthetic vertebrae should be able to provide realistic haptics during all procedural steps. Synthetic vertebrae were developed, tested and validated with reference to human vertebrae. As a further reference, commercially available vertebrae surrogates for orthopedic testing were investigated. To validate the new synthetic vertebrae, characteristic mechanical parameters for tool insertion, balloon dilation pressure and volume were analyzed. Fluoroscopy images were taken to evaluate the bone cement distribution. Based on the measurement results, one type of synthetic vertebrae was able to reflect the characteristic parameters in comparison to human vertebrae. The different tool insertion forces (19.7 ± 4.1, 13.1 ± 0.9 N, 1.5 ± 0.2 N) of the human reference were reflected by one bone surrogate (11.9 ± 9.8, 24.3 ± 3.9 N, 2.4 ± 1.0 N, respectively). The balloon dilation pressure (13.0 ± 2.4 bar), volume (2.3 ± 1.5 ml) of the synthetic vertebrae were in good accordance with the human reference (10.7 ± 3.4 bar, 3.1 ± 1.1 ml). Cement application forces were also in good accordance whereas the cement distribution couldn't be reproduced accurately. Synthetic vertebrae were developed that delivered authentic haptics during transpedicular instrument insertion, balloon tamp dilation and bone cement application. The validated vertebra model will be used within a hybrid simulator for minimally invasive spine surgery to educate and train surgeons.

Locking design affects the jamming of screws in locking plates.

The seizing of locking screws is a frequently encountered clinical problem during implant removal of locking compression plates (LCP) after completion of fracture healing. The aim of this study was to investigate the effect of two different locking mechanisms on the seizing of locking screws. Specifically, the removal torques before and after cyclic dynamic loading were assessed for screws inserted at the manufacturer-recommended torque or at an increased insertion torque. The seizing of 3.5-mm angular stable screws was assessed as a function of insertion torque for two different locking mechanisms (Thread & Conus and Thread Only). Locking screws (n=10 for each configuration) were inserted either according to the manufacturer-recommended torque or at an increased torque of 150% to simulate an over-insertion of the screw. Half of the screws were removed directly after insertion and the remaining half was removed after a dynamic load protocol of 100,000 cycles. The removal torques of locking screws exceeded the insertion torques for all tested conditions confirming the adequacy of the test setup in mimicking screw seizing in locked plating. Screw seizing was more pronounced for Thread Only design (+37%) compared to Thread & Conus design (+14%; P<0.0001). Cyclic loading of the locking construct consistently resulted in an increased seizing of the locking screws (P<0.0001). Clinical observations from patients treated with the Thread & Conus locking design confirm the biomechanical findings of reduction in seizing effect by using a Thread & Conus design. In conclusion, both over-tightening and cyclic loading are potential causes for screw seizing in locking plate implants. Both effects were found to be less pronounced in the Thread & Conus design as compared to the traditional Thread Only design.

Effect of cage design, supplemental posterior instrumentation and approach on primary stability of a lumbar interbody fusion - A biomechanical in vitro study.

BACKGROUND: There are various techniques and approaches for lumbar interbody fusion differing in access, cage type and type of supplemental posterior instrumentation. While a transforaminal access usually includes a hemifacetectomy, the facet joint can be preserved with a more lateral extraforaminal access. The supplemental posterior instrumentation required for both fusion techniques is still debated. The purpose of the present study was to compare primary stability of the two accesses for two different cage types with none, unilateral and bilateral supplemental posterior instrumentation. METHODS: Six monosegmental lumbar functional spinal units (FSUs) were included in each of the two groups, and subjected to a flexibility test. As cages, a newly designed cage was compared to a standard cage in the following states: (a) native, (b) stand-alone cage, (c) bilateral internal fixator, (d) unilateral internal fixator, (e) unilateral facetectomy+bilateral internal fixator, (f) unilateral facetectomy+unilateral internal fixator and (g) unilateral facetectomy with stand-alone cage. For comparison the range of motion was normalized to the native state and the effects of the facetectomy, cage type, and supplemental instrumentation was compared. FINDINGS: Within the subject comparison showed a significantly higher flexibility for the unilateral facetectomy in all motion directions (p<0.001). In between subject comparison showed a significant effect of cage type on flexibility in flexion/extension (p=0.002) and lateral bending (p=0.028) but not in axial rotation (p=0.322). The type of supplemental posterior fixation had a significant effect on the flexibility in all motion directions (stand-alone>unilateral fixator>bilateral fixator). INTERPRETATION: Cage design and approach type are affecting the primary stability of lumbar interbody fusion procedures while the type of posterior instrumentation is the most influencing factor.