Influence of the screw augmentation technique and a diameter increase on pedicle screw fixation in the osteoporotic spine: pullout versus fatigue testing.

PURPOSE: For posterior spinal stabilization, loosening of pedicle screws at the bone-screw interface is a clinical complication, especially in the osteoporotic population. Axial pullout testing is the standard pre-clinical testing method for new screw designs although it has questioned clinical relevance. The aim of this study was to determine the fixation strength of three current osteoporotic fixation techniques and to investigate whether or not pullout testing results can directly relate to those of the more physiologic fatigue testing. METHODS: Thirty-nine osteoporotic, human lumbar vertebrae were instrumented with pedicle screws according to four treatment groups: (1) screw only (control), (2) prefilled augmentation, (3) screw injected augmentation, and (4) unaugmented screws with an increased diameter. Toggle testing was first performed on one pedicle, using a cranial-caudal sinusoidal, cyclic (1.0 Hz) fatigue loading applied at the screw head. The initial compressive forces ranged from 25 to 75 N. Peak force increased stepwise by 25 N every 250 cycles until a 5.4-mm screw head displacement. The contralateral screw then underwent pure axial pullout (5 mm/min). RESULTS: When compared to the control group, screw injected augmentation increased fatigue force (27 %, p = 0.045) while prefilled augmentation reduced fatigue force (-7 %, p = 0.73). Both augmentation techniques increased pullout force compared to the control (ps < 0.04). Increasing the screw diameter by 1 mm increased pullout force (24 %, p = 0.19), fatigue force (5 %, p = 0.73), and induced the least stiffness loss (-29 %) from control. CONCLUSIONS: For the osteoporotic spine, screw injected augmentation showed the best biomechanical stability. Although pullout testing was more sensitive, the differences observed were not reflected in the more physiological fatigue testing, thus casting further doubt on the clinical relevance of pullout testing.

Biomechanical advantage of C1 pedicle screws over C1 lateral mass screws: a cadaveric study.

PURPOSE: The established technique for posterior C1 screw placement is via the lateral mass. Use of C1 monocortical pedicle screws is an emerging technique which utilizes the bone of the posterior arch while avoiding the paravertebral venous plexus and the C2 nerve root. This study compared the relative biomechanical fixation strengths of C1 pedicle screws with C1 lateral mass screws. METHODS: Nine human C1 vertebrae were instrumented with one lateral mass screw and one pedicle screw. The specimens were subjected to sinusoidal, cyclic (0.5 Hz) fatigue loading. Peak compressive and tensile forces started from ±25 N and constantly increased by 0.05 N every cycle. Testing was stopped at 5 mm displacement. Cycles to failure, displacement, and initial and end stiffness were measured. Finally, CT scans were taken and the removal torque measured. RESULTS: The pedicle screw technique consistently and significantly outperformed the lateral mass technique in cycles to failure (1,083 ± 166 vs. 689 ± 240 cycles), initial stiffness (24.6 ± 3.9 vs. 19.9 ± 3.2 N/mm), end stiffness (16.6 ± 2.7 vs. 11.6 ± 3.6 N/mm) and removal torque (0.70 ± 0.78 vs. 0.13 ± 0.09 N m). Only 33 % of pedicle screws were loose after testing compared to 100 % of lateral mass screws. CONCLUSIONS: C1 pedicle screws were able to withstand higher toggle forces than lateral mass screws while maintaining a higher stiffness throughout and after testing. From a biomechanical point of view, the clinical use of pedicle screws in C1 is a promising alternative to lateral mass screws.

Does the cement stiffness affect fatigue fracture strength of vertebrae after cement augmentation in osteoporotic patients?

PURPOSE: Normal progression of osteoporosis or the rigid reinforcement of the fractured vertebral body with polymethyl methacrylate (PMMA) cement is being discussed as a cause for adjacent-level fractures after vertebroplasty. The purpose of this study was to investigate whether augmentation with low stiffness cement can decrease the risk of adjacent-level fractures in low-quality bone. METHODS: Eighteen female osteoporotic lumbar specimens (L1-L5) were harvested and divided into three groups according to bone mineral density: (I) native; (II) PMMA; (III) modified PMMA (lower stiffness). For the PMMA and modified PMMA groups, a compression fracture was first mechanically induced in L3, and then the fracture received vertebroplasty treatment. The cement stiffness reduction of the modified PMMA group was achieved via an addition of 8 mL of serum to the typical PMMA base. All specimens were exposed to cyclic loading (4 Hz) and a stepwise increasing applied peak force. Cement stiffness was tested according to ISO 5833. RESULTS: A 51% decrease in cement stiffness was achieved in the modified PMMA group (954 ± 141 vs. 1,937 ± 478 MPa, p < 0.001). Fatigue fracture force (the force level during cyclic loading at which the deformation experienced a sudden increase; FFF) was significantly affected by bone quality (r (2) = 0.39, p = 0.006) and by the initial fracture force (the force necessary to create the initial fracture in L3 prior to augmentation; r (2) = 0.82, p < 0.001). Using initial fracture force as a covariate, the FFF of the modified PMMA group (1,764 ± 49 N) was significantly higher than in the PMMA group (1,544 ± 55 N; p = 0.03). CONCLUSIONS: A possible method to reduce adjacent-level fractures after vertebroplasty in patients with reduced bone quality could be the use of a lower modulus cement. Therefore, mixing cement with biocompatible fluids could prove useful to tailor cement properties in the operating theater.

Biomechanical evaluation of location and mode of failure in three screw fixations for a comminuted transforaminal sacral fracture model.

BACKGROUND: Pelvic ring-comminuted transforaminal sacral fracture injuries are rotationally and vertically unstable and have a high rate of failure. OBJECTIVE: Our study purpose was to use three-dimensional (3D) optical tracking to detect onset location of bone-implant interface failure and measure the distances and angles between screws and line of applied force for correlation to strength of pelvic fracture fixation techniques. METHODS: 3D relative motion across sacral-rami fractures and screws relative to bone was measured with an optical tracking system. Synthetic pelves were used. Comminuted transforaminal sacral-rami fractures were modelled. Each pelvis was stabilised by either (1) two iliosacral screws in S1, (2) one transsacral screw in S1 and one iliosacral screw in S1 and (3) one trans-alar screw in S1 and one iliosacral screw in S1; groups 4-6 consisted of fixation groups with addition of anterior inferior iliac pelvic external fixator. Eighteen-instrumented pelvic models with right ilium fixed simulate single-leg stance. Load was applied to centre of S1 superior endplate. Five cycles of torque was initially applied, sequentially increased until permanent deformation occurred. Five cycles of axial load compression was next applied, sequentially increased until permanent deformation occurred, followed by axial loading to catastrophic failure. A Student t test was used to determine significance (p < 0.05). RESULTS: The model, protocol and 3D optical system have the ability to locate how sub-catastrophic failures initiate. Our results indicate failure of all screw-based constructs is due to localised bone failure (screw pull-in push-out at the ipsilateral ilium-screw interface, not in sacrum); thus, no difference was observed when not supplemented with external fixation. CONCLUSION: Inclusion of external fixation improved resistance only to torsional loading. TRANSLATIONAL POTENTIAL OF THIS ARTICLE: Patients with comminuted transforaminal sacral-ipsilateral rami fractures benefit from this fixation.

Biomechanical Effects of a Dynamic Topping off Instrumentation in a Long Rigid Pedicle Screw Construct.

STUDY DESIGN: Biomechanical ex vivo study. OBJECTIVE: To determine if topping off instrumentation can reduce the hypermobility in the adjacent segments when compared with the classic rigid spinal instrumentation. SUMMARY OF THE BACKGROUND DATA: Long rigid instrumentation might increase the mechanical load in the adjacent segments, the resulting hypermobility, and the risk for adjacent segment disease. Topping off instrumentation intends to reduce the hypermobility at the adjacent level by more evenly distributing segmental motion and, thereby, potentially mitigating adjacent level disease. MATERIALS AND METHODS: Eight human spines (Th12-L5) were divided into 2 groups. In the rigid group, a 3-segment metal rod instrumentation (L2-L5) was performed. The hybrid group included a 2-segment metal rod instrumentation (L3-L5) with a dynamic topping off instrumentation (L2-L3). Each specimen was tested consecutively in 3 different configurations: native (N=8), 2-segment rod instrumentation (L3-L5, N=8), 3-segment instrumentation (rigid: N=4, hybrid: N=4). For each configuration the range of motion (ROM) of the whole spine and each level was measured by a motion capture system during 5 cycles of extension-flexion (angle controlled to ±5 degrees, 0.1 Hz frequency, no preload). RESULTS: In comparison with the intact spine, both the rigid 3-segment instrumentation and the hybrid instrumentation significantly reduced the ROM in the instrumented segments (L2-L5) while increasing the movement in the adjacent segment L1-L2 (P=0.002, η=0.82) and in Th12-L1 (P<0.001, η=0.90). There were no ROM differences between the rigid and hybrid instrumentation in all segments. CONCLUSIONS: Introducing the dynamic topping off did not impart any significant difference in the segmental motion when compared with the rigid instrumentation. Therefore, the current biomechanical study could not show a benefit of using this specific topping off instrumentation to solve the problem of adjacent segment disease.