Implant augmentation: Adding bone cement to improve the treatment of osteoporotic distal femur fractures:A biomechanical study using human cadaver bones

The increasing problems in the field of osteoporotic fracture fixation results in specialized implants as well as new operation methods, for example, implant augmentation with bone cement. The aim of this study was to determine the biomechanical impact of augmentation in the treatment of osteoporotic distal femur fractures. Seven pairs of osteoporotic fresh frozen distal femora were randomly assigned to either an augmented or nonaugmented group. In both groups, an Orthopaedic Trauma Association 33 A3 fractures was fixed using the locking compression plate distal femur and cannulated and perforated screws. In the augmented group, additionally, 1 mL of polymethylmethacrylate cement was injected through the screw. Prior to mechanical testing, bone mineral density (BMD) and local bone strength were determined. Mechanical testing was performed by cyclic axial loading (100 N to 750 N + 0.05N/cycle) using a servo-hydraulic testing machine. As a result, the BMD as well as the axial stiffness did not significantly differ between the groups. The number of cycles to failure was significantly higher in the augmented group with the BMD as a significant covariate. In conclusion, cement augmentation can significantly improve implant anchorage in plating of osteoporotic distal femur fractures

Reinforcing the role of the conventional C-arm - a novel method for simplified distal interlocking

<p>Abstract</p> <p>Background</p> <p>The common practice for insertion of distal locking screws of intramedullary nails is a freehand technique under fluoroscopic control. The process is technically demanding, time-consuming and afflicted to considerable radiation exposure of the patient and the surgical personnel. A new concept is introduced utilizing information from within conventional radiographic images to help accurately guide the surgeon to place the interlocking bolt into the interlocking hole. The newly developed technique was compared to conventional freehand in an operating room (OR) like setting on human cadaveric lower legs in terms of operating time and radiation exposure.</p> <p>Methods</p> <p>The proposed concept (guided freehand), generally based on the freehand gold standard, additionally guides the surgeon by means of visible landmarks projected into the C-arm image. A computer program plans the correct drilling trajectory by processing the lens-shaped hole projections of the interlocking holes from a single image. Holes can be drilled by visually aligning the drill to the planned trajectory. Besides a conventional C-arm, no additional tracking or navigation equipment is required.</p> <p>Ten fresh frozen human below-knee specimens were instrumented with an Expert Tibial Nail (Synthes GmbH, Switzerland). The implants were distally locked by performing the newly proposed technique as well as the conventional freehand technique on each specimen. An orthopedic resident surgeon inserted four distal screws per procedure. Operating time, number of images and radiation time were recorded and statistically compared between interlocking techniques using non-parametric tests.</p> <p>Results</p> <p>A 58% reduction in number of taken images per screw was found for the guided freehand technique (7.4 ± 3.4) (mean ± SD) compared to the freehand technique (17.6 ± 10.3) (<it>p </it>< 0.001). Total radiation time (all 4 screws) was 55% lower for the guided freehand technique compared to conventional freehand (<it>p </it>= 0.001). Operating time per screw (from first shot to screw tightened) was on average 22% reduced by guided freehand (<it>p </it>= 0.018).</p> <p>Conclusions</p> <p>In an experimental setting, the newly developed guided freehand technique for distal interlocking has proven to markedly reduce radiation exposure when compared to the conventional freehand technique. The method utilizes established clinical workflows and does not require cost intensive add-on devices or extensive training. The underlying principle carries potential to assist implant positioning in numerous other applications within orthopedics and trauma from screw insertions to placement of plates, nails or prostheses.</p

In vitro temperature evaluation during cement augmentation of proximal humerus plate screw tips

BACKGROUND The treatment of proximal humerus fractures in patients with poor bone quality remains a challenge in trauma surgery. Augmentation with polymethylmethacrylate (PMMA) cement is a possible method to strengthen the implant anchorage in osteoporotic bone and to avoid loss of reduction and reduce the cut-out risk. The polymerisation of PMMA during cement setting leads, however, to an exothermic reaction and the development of supraphysiological temperatures may harm the bone and cartilage. This study addresses the issue of heat development during augmentation of subchondrally placed proximal humerus plate screws with PMMA and the possible risk of bone and cartilage necrosis and apoptosis. METHODS Seven fresh frozen humeri from geriatric female donors were instrumented with the proximal humerus interlocking system (PHILOS) plate and placed in a 37°C water bath. Thereafter, four proximal perforated screws were augmented with 0.5 ml PMMA each. During augmentation, the temperatures in the subchondral bone and on the articular surface were recorded with K-type thermocouples. The measured temperatures were compared to threshold values for necrosis and apoptosis of bone and cartilage reported in the literature. RESULTS The heat development was highest around the augmented tips of the perforated screws and diminished with growing distance from the cement cloud. The highest temperature recorded in the subchondral bone reached 43.5°C and the longest exposure time above 42°C was 86s. The highest temperature measured on the articular surface amounted to 38.6°C and the longest exposure time above 38°C was 5 min and 32s. CONCLUSION The study shows that augmentation of the proximal screws of the PHILOS plate with PMMA leads to a locally limited development of supraphysiological temperatures in the cement cloud and closely around it. The critical threshold values for necrosis and apoptosis of cartilage and subchondral bone reported in the literature, however, are not reached. In order to avoid cement extravasation, special care should be taken in detecting perforations or intra-articular cracks in the humeral head

Biphasic plating – In vivo study of a novel fixation concept to enhance mechanobiological fracture healing

Background: 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. This paper introduces the novel fixation concept and presents preclinical results from a large animal study. Methods: Twenty-four sheep underwent a mid-diaphyseal osteotomy stabilized with either the novel biphasic plate fixator or a control locking plate. Different fracture patterns regarding orientation and localization were investigated. Animals were free to fully bear weight during the post-operative period. After 12 weeks, the healing fractures were evaluated for bone formation using micro-computer tomography and strength and stiffness using biomechanical testing. Additionally, histological evaluation of soft tissue samples with respect to metal wear debris was performed. Results: No plate deformation or failures were observed under full weight bearing with the biphasic plate. Defects stabilized with the biphasic plate demonstrated robust callus formation compared to control group. 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. No histological signs of metal wear due to the biphasic feature could be found. Conclusions: The biphasic plate concept is aimed at improving the biomechanics of locked plating. The results of this large animal study demonstrate the feasibility and clinical potential of this novel stabilization concept.</p

Biphasic plating improves the mechanical performance of locked plating for distal femur fractures

Internal fixation by plate osteosynthesis is the gold standard treatment for distal femur fractures. Despite improvements that preserve the biological conditions for bone healing, there are concerns standard locked plating constructs may be overly stiff. Biphasic plating is a novel concept designed to provide suitable fracture motion and increased implant strength to support early full weight-bearing. This study aims to demonstrate that the Biphasic Plate can be incorporated into a pre-contoured distal femur plate while providing adequate flexibility and increased implant strength. The mechanical performance of the Biphasic Plate (BP) was investigated in comparison to a standard locking plate for the distal femur (LCP-DF). Constructs were formed by mounting the implants on a bone substitute. The construct stiffness and strength under axial loading and the magnitude of interfragmentary movement were determined using finite element analysis. The Biphasic Plate exhibited a bi-linear stiffness response; at low loads, the BP construct was 55% more compliant and at high loads 476% stiffer than the LCP-DF. The Biphasic Plate provided more consistent interfragmentary movement over a wider loading range. At partial weight-bearing loads, the Biphasic Plate produced larger interfragmentary movements (0.18 vs. 0.04 mm). However, at loads equivalent to full weight-bearing, the maximum movements were substantially smaller than the LCP-DF construct (1.5 vs. 3.5 mm). The increased flexibility at low loads was provided without sacrificing implant strength with peak stress in the Biphasic Plate 63% lower than the LCP-DF construct. The biphasic plating concept can be successfully incorporated into anatomically contoured distal femur plates while providing adequate flexibility and increasing implant strength.</p

Nonlinear quasi-static finite element simulations predict in vitro strength of human proximal femora assessed in a dynamic sideways fall setup

Osteoporotic proximal femur fractures are caused by low energy trauma, typically when falling on the hip from standing height. Finite element simulations, widely used to predict the fracture load of femora in fall, usually include neither mass-related inertial effects, nor the viscous part of bone's material behavior. The aim of this study was to elucidate if quasi-static non-linear homogenized finite element analyses can predict in vitro mechanical properties of proximal femora assessed in dynamic drop tower experiments. The case-specific numerical models of thirteen femora predicted the strength (R2=0.84, SEE=540 N, 16.2%), stiffness (R2=0.82, SEE=233 N/mm, 18.0%) and fracture energy (R2=0.72, SEE=3.85 J, 39.6%); and provided fair qualitative matches with the fracture patterns. The influence of material anisotropy was negligible for all predictions. These results suggest that quasi-static homogenized finite element analysis may be used to predict mechanical properties of proximal femora in the dynamic sideways fall situation

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 &lt; 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 &lt; 0.001. Augmented off-centre TFNA head elements had significantly higher failure load compared with non-augmented centrally placed implants, p &lt; 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