Teyfik Demir

Design and biomechanical testing of pedicle screw for osteoporotic incidents

In this study, geometrical features of pedicle screws have been modified and their performances are compared. Performance analysis has been made in terms of pull-out strength and torsional strength. The parameters investigated are core diameter, holes drilled normal to screw axis, angle between sequential holes and distance between holes. Three different core diameter have been studied, which are 4 mm (normal core diameter), 5 mm (medium core diameter) and 5.5 mm (high core diameter). Distance between sequential holes has been arranged such that there is either one hole per pitch or one hole per two pitches. Angle between sequential holes is either 90° or 120°. According to the test results, the screw, with medium core diameter (5 mm) containing one hole per two pitches with 90° angle between sequential holes, has exhibited the optimum performance considering torsional strength and pull-out strength requirements. Its torsional strength is slightly higher than and, when Grade 40 polyurethane foam was used as bone simulating material, its pull-out strength is as good as, an undrilled normal core diameter screw, which is already being used in surgical operations. The fatigue performance of this best performed screw has also been found satisfactory according to the related standard. Its pull-out strength is also tested on a calf vertebra and a promising result has been obtained.

Postfusion pullout strength comparison of a novel pedicle screw with classical pedicle screws on synthetic foams.

Pullout is a very common failure mode on the use of pedicle screws. Numerous studies were completed to increase the pullout strength of pedicle screws especially for osteoporotic bones. In this study, a previously designed pedicle screw type was tested before and after fusion condition. Synthetic polyurethane foams were used in all tests. Three different grades of foams were used in tests to simulate severely osteoporotic, osteoporotic, and healthy bones. Test blocks were produced and characterized in our clinical biomechanics laboratory. Foaming of polyurethane was accepted as fusion process (bone in growth). Pedicle screw including radial holes (new design) was tested both before and after the fusion. It also exhibited remarkably higher pullout strength after fusion than before fusion and most of other alternatives stated in the literature. In total, 70% higher pullout strength was achieved with new design after fusion. On the other hand, new design did not dominate other alternatives when comparison was carried out on severely osteoporotic and healthy bones. To the knowledge of the authors, this is the first study investigating the postfusion properties on synthetic foams.

Biomechanical Performance of Various Cement-Augmented Cannulated Pedicle Screw Designs for Osteoporotic Bones

INTRODUCTION Early-stage pullout is a common problem for surgeons during the fixation of osteoporotic bones. Poor bone quality limits the use of pedicle screws for patients with osteoporosis. In this study, the researchers investigated the effects of hole and gap position and type on the pullout strength of cannulated screws. METHODS Seven different designs were tested, including a control group. All cannula diameters were 2 mm and holes were drilled with a diameter of 1.5 mm. Gaps were milled with a 2-mm-diameter tool with 2-mm displacement proximally. All holes and gaps were drilled or opened unilaterally and bilaterally. Grade 40 and 10 polyurethane foam was used to simulate healthy and osteoporotic bones, respectively. For pullout tests, insertion depth was 30 mm and 2-mm-diameter pilot holes were drilled into blocks before screws were inserted. The cross-head speed was 2 mm/min. For torsion tests, 1 side of the screw was fixed and other was twisted clockwise. RESULTS For torsion tests, the maximum torque value exhibited by the control group (non-cannulated) was 14.94 Nm. The highest torsional strength among tested cannulated screws was 13.54 Nm for Single side two holes including design (S2H) (p < .0001). The minimum torsional strength was 9.45 Nm with a breaking angle of 39° (p < .005). Comparing results for samples pulled out from grade 40 polyurethane foam, single side slot including design (SS) samples exhibited the highest pullout strength with a maximum force of 3,104 N. CONCLUSIONS The unilateral, sequential, 3-radial hole, drilled, cannulated screw was the optimal alternative when considering pullout and torsional strength as criteria.

Evaluation of the Effect of Fixation Angle between Polyaxial Pedicle Screw Head and Rod on the Failure of Screw-Rod Connection

Introduction. Polyaxial screws had been only tested according to the ASTM standards (when they were perpendicularly positioned to the rod). In this study, effects of the pedicle screws angled fixation to the rod on the mechanical properties of fixation were investigated. Materials and Method. 30 vertically fixed screws and 30 screws fixed with angle were used in the study. Screws were used in three different diameters which were 6.5 mm, 7.0 mm, and 7.5 mm, in equal numbers. Axial pull-out and flexion moment tests were performed. Test results compared with each other using appropriate statistical methods. Results. In pull-out test, vertically fixed screws, in 6.5 mm and 7.0 mm diameter, had significantly higher maximum load values than angled fixed screws with the same diameters (P < 0.01). Additionally, vertically fixed screws, in all diameters, had significantly greater stiffness according to corresponding size fixed with angle (P < 0.005). Conclusion. Fixing the pedicle screw to the rod with angle significantly decreased the pull-out stiffness in all diameters. Similarly, pedicle screw instrumentation fixed with angle decreased the minimum sagittal angle between the rod and the screw in all diameters for flexion moment test but the differences were not significant.

Pullout performance comparison of novel expandable pedicle screw with expandable poly-ether-ether-ketone shells and cement-augmented pedicle screws

Aim of this study is to assess the pullout performance of various pedicle screws in different test materials. Polyurethane foams (Grade 10 and Grade 40) produced in laboratory and bovine vertebrae were instrumented with normal, cannulated (cemented), novel expandable and normal (cemented) pedicle screws. Test samples were prepared according to the ASTM F543 standard testing protocols and surgical guidelines. To examine the screw placement and cement distribution, anteriosuperior and oblique radiographs were taken from each sample after insertion process was completed. Pullout tests were performed in an Instron 3369 testing device. Load versus displacement graphs were recorded and the ultimate pullout force was defined as the maximum load (pullout strength) sustained before failure of screw. Student’s t-test was performed on each group whether the differences between pullout strength of pedicle screws were significant or not. While normal pedicle screws have the lowest pullout strength in all test materials, normal pedicle screws cemented with polymethylmethacrylate exhibit significantly higher pullout performance than others. For all test materials, there is a significant improvement in pullout strength of normal screws by augmentation. While novel expandable pedicle screws with expandable poly-ether-ether-ketone shells exhibited lower pullout performance than normal screws cemented with polymethylmethacrylate, their pullout performances in all groups were higher than the ones of normal and cannulated pedicle screws. For all test materials, although cannulated pedicle screws exhibit higher pullout strength than normal pedicle screws, there are no significant differences between the two groups. The novel expandable pedicle screws with expandable poly-ether-ether-ketone shells may be used instead of normal and cannulated pedicle screws cemented with polymethylmethacrylate due to their good performances.

Pullout performance comparison of pedicle screws based on cement application and design parameters

Pedicle screws are the main fixation devices for certain surgeries. Pedicle screw loosening is a common problem especially for osteoporotic incidents. Cannulated screws with cement augmentation are widely used for that kind of cases. Dual lead dual cored pedicle screw has already given promising pullout values without augmentation. This study concentrates on the usage of dual lead dual core with cement augmentation as an alternative to cannulated and standard pedicle screws with cement augmentation. Five groups (dual lead dual core, normal pedicle screw and cannulated pedicle screw with augmentation, normal pedicle screw, dual lead dual cored pedicle screw) were designed for this study. Healthy bovine vertebrae and synthetic polyurethane foams (grade 20) were used as embedding test medium. Test samples were prepared in accordance with surgical guidelines and ASTM F543 standard testing protocols. Pullout tests were conducted with Instron 3300 testing frame. Load versus displacement values were recorded and maximum pullout loads were stated. The dual lead dual cored pedicle screw with poly-methyl methacrylate augmentation exhibited the highest pullout values, while dual lead dual cored pedicle screw demonstrated similar pullout strength as cannulated pedicle screw and normal pedicle screw with poly-methyl methacrylate augmentation. The dual lead dual cored pedicle screw with poly-methyl methacrylate augmentation can be used for osteoporotic and/or severe osteoporotic patients according to its promising results on animal cadaver and synthetic foams.

On the Surface Roughness of Al-4%Cu/B4C Metal Matrix Composites Machined by Milling Operation

In this study, the influence of cutting speed, feed rate and type of cutting tools on the surface roughness of the boron carbide particle reinforced aluminum composites in the milling operation was investigated. For this purpose, the composite samples were produced using powder metallurgy route. And then, the milling operations were carried out by using three different cutting tools at various feed rates (0.15, 0.20 and 0.25 mm/z) and cutting speeds (100, 130, 169 and 220 m/min). Experimental results showed that the surface roughness of the composites decreased significantly by increasing the cutting speed for all tools. Moreover, it was gradually increased for all tools when the feed rate was increased at the cutting speeds of 169 and 220 m/min.

Biomechanical properties of osteoporotic rat femurs after different hormonal treatments: genistein, estradiol, and estradiol/progesterone

Introduction: The purpose of the study is to compare the effects of genistein, estradiol, estradiol/progesterone combination on the bone mineral density and biomechanical properties of ovariectomized rats’ bone. Methods: 50 female adult Sprague-Dawley rats were divided into five groups. Bilaterally ovaeriectomy were performed in all groups except the sham-operated group. Groups were a sham-operated group and a control group (water was given), estradiol treated group (17-β estradiol 0.015 mg/kg per day), genistein treated group (genistein 10 mg/kg per day), and an estradiol/progesterone combination group (17-β estradiol 0.015 mg/kg plus drosperinone 0.028 mg/kg per day). The water or hormones were implemented in relevant groups for eight weeks by orogasthric catheter. The bone mineral density and biomechanical properties of the femur were analyzed. Results: Genistein, estradiol, and estradiol/progesterone groups increased bone mineral density significantly compared to the control group. In diaphysis and metaphysis bending test, all groups had higher peak load values than the control group. There were statistically significant differences between the estrogen/progesterone group and control group in diaphysis bending with regard to peak load. There were statistically significant differences between the estradiol and control groups in metaphysis bending with regard to peak load. In axial rotation test, all groups had higher peak torque values than the control groups. Conclusions: Genistein, estradiol and estrogen/progesterone combination improved the biomechanical properties of the ovariectomized rat bone. Genistein which has less side effects may be considered as an alternative in the treatment of postmenopausal osteoporosis.

Biomechanical comparison of unilateral semi-rigid and dynamic stabilization on ovine vertebrae.

Using the unilateral pedicle screw fixation was thought to decrease the stiffness of the fixed segments. Various prospective, randomized studies were performed to determine whether unilateral pedicle screw fixation provides the necessities of bilateral fixation in one- or two-segment lumbar spinal fusion. In this study, four different unilateral pedicle screw fixation systems were evaluated to determine which one best approximated an intact spine with respect to biomechanics and kinematics. The four groups included an intact group, a unilateral facetectomy group with no fixation, a unilateral semi-rigid pedicle screw fixation group with a poly-ether-ether-ketone rod, and a unilateral dynamic pedicle screw fixation group. The bone mineral densities of all specimens were measured and specimens were matched with groups randomly. Flexion, lateral bending, and axial rotation tests were performed to compare the groups. For the flexion, lateral bending, and axial rotation tests, the best biomechanical outcomes were in the control group. The unilateral facetectomy group had the poorest performance and was not stable enough, compared with the control group. The dynamic and semi-rigid groups showed performance closer to that of the control group. The biomechanical responses of these two groups were also in good agreement, showing no significant statistical differences. Based on these test results, it is concluded that the unilateral dynamic and semi-rigid pedicle screw fixations can be used to provide stability to the vertebrae.

A new alternative to expandable pedicle screws: Expandable poly-ether-ether-ketone shell

Screw pullout is a very common problem in the fixation of sacrum with pedicle screws. The principal cause of this problem is that the cyclic micro motions in the fixation of sacrum are higher than the other regions of the vertebrae that limit the osteo-integration between bone and screw. In addition to that, the bone quality is very poor at sacrum region. This study investigated a possible solution to the pullout problem without the expandable screws’ handicaps. Newly designed poly-ether-ether-ketone expandable shell and classical pedicle screws were biomechanically compared. Torsion test, pullout tests, fatigue tests, flexion/extension moment test, axial gripping capacity tests and torsional gripping capacity tests were conducted in accordance with ASTM F543, F1798 and F1717. Standard polyurethane foam and calf vertebrae were used as embedding medium for pullout tests. Classical pedicle screw pullout load on polyurethane foam was 564.8 N compared to the failure load for calf vertebrae’s 1264 N. Under the same test conditions, expandable poly-ether-ether-ketone shell system’s pullout loads from polyurethane foam and calf vertebrae were 1196.3 and 1890 N, respectively. The pullout values for expandable poly-ether-ether-ketone shell were 33% and 53% higher than classical pedicle screw on polyurethane foam and calf vertebrae, respectively. The expandable poly-ether-ether-ketone shell exhibited endurance on its 90% of yield load. Contrary to poly-ether-ether-ketone shell, classical pedicle screw exhibited endurance on 70% of its yield load. Expandable poly-ether-ether-ketone shell exhibited much higher pullout performance than classical pedicle screw. Fatigue performance of expandable poly-ether-ether-ketone shell is also higher than classical pedicle screw due to damping the micro motion capacity of the poly-ether-ether-ketone. Expandable poly-ether-ether-ketone shell is a safe alternative to all other expandable pedicle screw systems on mechanical perspective.