后凸成形骨水泥强化技术对骶骨钉固定强度的生物力学影响

目的评价后凸成形骨水泥(Polymethylmethacrylate,PMMA)强化技术对骨质疏松情况下骶骨钉固定强度的生物力学影响,为骶骨钉松动选择坚强的补救技术提供依据。方法11具新鲜骶骨标本用于实验,并采用DEXA评价标本骨密度。在同一骶骨标本上,依次建立非PMMA强化和PMMA强化骶骨钉的固定模型如下,A组:单皮质椎弓根钉;B组:双皮质椎弓根钉;C组:传统PMMA强化单皮质椎弓根钉;D组:后凸成形PMMA强化椎弓根钉;E组:后凸成形PMMA强化侧翼钉。在MTS试验机上对五种骶骨钉依次进行轴向拔出测试,记录最大拔出力并比较。结果11具标本的平均骨密度为0.71±0.08g/cm2。A组的螺钉拔出力(508N)显著低于其他4种固定组(P0.05)。B组的螺钉拔出力(685N)与E组(702N)无显著差异(P0.05),但是,两者的拔出力均显著低于C和D组(P0.05)。重要的是,D组(986N)的拔出力显著高于C组(846N)。结论在骨质疏松患者的骶骨固定中,双皮质骶骨椎弓根钉较单皮质具有显著的力学优势。骶骨椎弓根钉一旦发生松动,传统的和后凸成形PMMA强化技术均可成为补救手段,并且后凸成形PMMA强化骶骨椎弓根钉可获得最坚强的锚定。     

Enhancement of pedicle screw fixation through washers

This study examined the effect of washer usage on initial pedicle screw fixation and on the salvage of replaced pedicle screws, and the effect of minor adjustments of pedicle screws on insertional torque. Titanium, nontapered pedicle screws (6.5-mm in diameter and 35-mm in length) from one manufacturer and custom-made 5-mm washers were used in the fixation of porcine lumbar spines. Insertional torque was measured with an electronic torque screwdriver and failure strength was determined by straight pullout of the screws using an MTS machine. Initial insertional torque values were significantly greater in pedicle screws placed with washers compared with screws placed without washers. When the screw placed without a washer was salvaged with the addition of a washer, a significant increase in insertional torque resulted. Pullout testing failed to show a significant difference between the screws that were placed with washers and the screws that were placed without washers. In the second part of the experiment, there was a significant decrease in insertional torque after backing out the screw as little as 90 degrees. This current study showed that (1) washers significantly increase the insertional torque of pedicle screws; (2) screws placed without a washer can be salvaged and replaced with a washer, which results in significantly increased insertional torque; and (3) backing out a pedicle screw 90 degrees significantly decreases its insertional torque. Washers can be used with pedicle screws to enhance the initial stability of the screw constructs, and to maximize insertional torque when screws need to be replaced, revised, or adjusted (backed out).     

不同椎弓根螺钉固定及骨水泥强化方法在骨质疏松骶骨上锚定强度的比较

目的:通过比较不同椎弓根螺钉固定及骨水泥强化方法在骨质疏松骶骨上的锚定强度,探讨骶骨椎弓根螺钉松动后的理想补救技术.方法:应用11具成人新鲜骶骨标本,经骨密度测试确认为骨质疏松后,在同一骶骨标本上,依次建立5种骶骨螺钉固定模型,A组,单皮质椎弓根螺钉固定(左侧):B组,双皮质椎弓根螺钉固定(右侧);C组,PMMA钉道强化后单皮质椎弓根螺钉固定(建立于A组螺钉拔出后);D组,PMMA钉道强化后侧翼钉固定(右侧);E组,后凸成形技术支持下的PMMA强化后侧翼钉固定(左侧).应用MTS材料测试机进行轴向拔出测试,记录各种骶骨螺钉固定技术的最大拔出力并进行比较.结果:11具标本的骨密度为0.55～0.79g,cm~2,平均0.71±0.08g/cm~2.A～E组最大拔出力分别为508±128N、685±126N、846±230N、543±121N和702±144N.A组与D组间无显著性差异(P>0.05),且均显著低于B、C和E组(P<0.05);B组与E组间无显著性差异(P>0.05),但两组的拔出力均显著低于C组(P<0.05).结论:在骨质疏松患者的骶骨固定中,双皮质骶骨椎弓根钉较单皮质具有更高的锚定强度.骶骨椎弓根钉一旦发生松动,PMMA钉道强化和后凸成形技术支持下的PMMA强化后的侧翼钉固定均可成为理想的补救手段.     

Biomechanical evaluation of an expansive pedicle screw in calf vertebrae

incetheintroductionofthetranspedicularscrewsystembyBoucher ,1theapplicationofthissysteminthetreatmentofdegenerativedisordersandunstablefractures ,tumorsofthespinehasbecomeverypopularinthelasttwodecades.2 Looseningandfailureofthescrewsareamongthemostcommoncomplicationsreported ,especiallyforosteoporosis .3Thesefailuresoftenleadtonon union ,sagittalcollapseoftheconstructandpainfulkyphosis .Revisionisoftennecessary .Increasingthediameterand/orlengthofthepediclescrewseemstobethebestsolution .Howe…     

Augmentation of a loosened sacral pedicle screw with percutaneous polymethylmethacrylate injection

STUDY DESIGN: Case report describing augmentation of a loosened sacral screw with percutaneous injection of polymethylmethacrylate. OBJECTIVE: To highlight the advantages of percutaneous injection of polymethylmethacrylate in treatment of loosened pedicle screws. SETTING: Turkey. SUMMARY OF BACKGROUND DATA: Lumbosacral instrumentation with pedicle screws is a commonly used procedure for correcting deformity and stabilizing the spine until bony fusion occurs. Loosening of the screws is a complication of this procedure and is seen more frequently in multilevel instrumentation, particularly in those instrumentations using sacral screws. METHOD: We present the case of a woman who had had L3-L4-L5-S1 instrumentation with pedicle screws who developed severe low back pain radiating to the left hip 2 months after the operation. Radiologic and clinical examination revealed that the left pedicle screw of the sacrum had loosened, and revision surgery was planned. The left sacral screw was augmented with percutaneous injection of polymethylmethacrylate. RESULTS: The patient was free of pain after the operation. CONCLUSIONS: We suggest that percutaneous polymethylmethacrylate injection around a loosened screw may be an alternative to major open revision surgery in cases of sacral screw failure in multisegmental instrumentation.     

聚甲基丙烯酸甲酯强化对骨质疏松椎弓根螺钉固定的生物力学作用

目的探讨聚甲基丙烯酸甲酯 (polymethylmethacrylate,PMMA)骨水泥强化椎弓根螺钉的方法和评价 PMMA强化骨质疏松椎弓根螺钉后的生物力学性质。方法 6具新鲜老年女性胸腰段骨质疏松脊柱标本 (T10～ L5),使用双能 X线骨密度吸收仪测试每个椎体的骨密度,随机取 16个椎体 (32侧椎弓根 ),一侧椎弓根拧入 CCD螺钉,测量最大旋入力偶矩后拔出螺钉作为正常对照组,用 PMMA骨水泥强化椎弓根螺钉作为修复固定组,行螺钉拔出试验;另一侧经导孔直接强化椎弓根螺钉后拔出作为强化固定组,记录三组螺钉的最大轴向拔出力。结果椎体平均骨密度为 (0.445± 0.019)g/cm2;螺钉最大旋入力偶矩为（ 0.525± 0.104） Nm;正常对照组螺钉最大轴向拔出力为 (271.5± 57.3)N;修复固定组为 (765.9± 130.7)N;强化固定组为 (845.7± 105.0)N。 PMMA骨水泥强化或修复骨质疏松椎弓根螺钉后最大抗压力明显高于强化前,差异有非常显著性意义 (P< 0.01)。结论 PMMA骨水泥强化骨质疏松椎弓根螺钉能显著增加螺钉在椎体内的稳固性。     

Biomechanical evaluation of a double-threaded pedicle screw in elderly vertebrae

We sought to test the hypothesis that a pedicle screw that has two parallel threads of different heights throughout the full length of the screw could increase both bone purchase and pull-out strength compared with a standard single-threaded screw of similar dimensions. A single-threaded pedicle screw and a double-threaded pedicle screw were respectively placed into the paired pedicles of 21 vertebral bodies. The screws were then pulled out of the pedicles, and output parameters were measured. Although insertional torque was, on average, 14.5% higher (p = 0.039) for the single-threaded screw, maximum pull-out strength (p = 0.12), energy-to-failure (p = 0.39), and stiffness (p = 0.54) were not statistically different for the two screw types. It is concluded that a second, smaller inner thread on a double-threaded pedicle screw does not translate into either increased bone purchase or higher pull-out strengths.     

Feasibility of using tapping torque during lumbar pedicle screw insertion to predict screw fixation strength

BackgroundRigid pedicle screw fixation is mandatory for achieving successful spinal fusion; however, there is no reliable method predicting screw fixation before screw insertion. The purpose of the present study was to investigate the efficacy of measurement of tapping torque to predict pedicle screw fixation.MethodsFirst, different densities of polyurethane foam were used to measure tapping torque. The insertional torque during pedicle screw insertion and axial pullout strength were measured and compared between under-tapped and same-tapped groups. Next, for in vivo study, the tapping and insertional torque of lumbar pedicle screws using the cortical bone trajectory technique were measured intraoperatively in 45 consecutive patients. Then, correlations between tapping torque, the bone mineral density of the femoral neck and lumbar vertebrae, and insertional torque were investigated.ResultsEx vivo tapping torque significantly correlated with the insertional torque and pullout strength regardless of tapping sizes (r = 0.98, p < 0.001). The mean in vivo tapping and insertional torque were 1.48 ± 0.73 and 2.48 ± 1.25 Nm, respectively (p < 0.001). Insertional torque significantly correlated with tapping torque and two BMD parameters, and the correlation coefficient of tapping torque (r = 0.83, p < 0.001) was higher than those of femoral neck BMD (r = 0.59, p < 0.001) and lumbar BMD (r = 0.39, p < 0.001).ConclusionsTapping torque is a reliable predictor of pedicle screw fixation and allows surgeons to improve the integrity of the bone-screw interface by making modification prior to actual screw insertion.     

Biomechanical evaluation of an expansive pedicle screw in calf vertebrae

The main objective of the present study is to evaluate biomechanically a newly designed expansive pedicle screw (EPS) using fresh pedicles from calf lumber vertebrae in comparison with conventional pedicle screws, (CDH) CD Horizon, Universal Spine System pedicle screw (USS) and Tenor (Sofamor Denek). Pull-out and turning-back tests were performed on these pedicle screws to compare their holding strength. Additionally, revision tests were undertaken to evaluate the mechanical properties of EPS as a rescue revision screw. A fatigue simulation test using a perpendicular load up to 1,500,000 cycles was also carried out. The results showed that the turning back torque (Tmax) and pull-out force (Fmax) of EPS screws were significantly greater than those of USS, Tenor and CDH screws (6.5×40 mm). In revision tests, the Fmax of both types of EPS screws (6.5×40 mm; 7.0×40 mm) were significantly greater than that of CDH, USS, and Tenor screws (P<0.05). Furthermore, no screws were broken or bent at the end of fatigue tests. The findings from the current study suggest that expansive pedicle screws can significantly improve the bone purchase and the pull-out strength compared to USS, Tenor and CDH screws of similar dimensions before and after a failure simulation.     

钉道强化提高椎弓根螺钉固定强度的生物力学研究

目的 评价椎弓根钉道局部强化技术及其结合膨胀式椎弓根螺钉提高椎弓根螺钉固定强度的效果.方法 通过自行设计及加工的钉道局部强化装置,向钉道周壁点状注入CaSO4骨水泥以强化椎弓根钉道.5具新鲜冻存人体脊柱标本,每具随机选取4个腰椎共20个腰椎标本,采用随机区组设计方法分为10个区组.设计四种固定方法:A组(普通椎弓根螺钉)、B组(普通椎弓根螺钉+钉道局部强化)、C组(膨胀式椎弓根螺钉+钉道局部强化)、D组(普通椎弓根螺钉+钉道内灌注CaSO4骨水泥),随机应用在每个区组的2个椎体共4个椎弓根钉道.分别测试每个椎弓根螺钉的最大轴向拔出力及能量吸收值.从剩余腰椎标本中任意取两个腰椎,应用钉道局部强化技术后利用Micro-CT观察钉道周壁微观结构变化.结果 C、D两组的最大轴向拔出力均值及能量吸收值均值高于A组(P＜0.01)及B组(P＜0.05),B组最大轴向拔出力均值及能量吸收值均值高于A组(P＜0.01),C、D两组之间的差异无统计学意义(P＞0.05).结论 钉道局部强化技术可显著提高椎弓根螺钉的固定强度,结合使用膨胀式椎弓根螺钉可进一步提高螺钉的固定强度.     

geneX骨水泥强化骨质疏松椎体椎弓根钉的生物力学研究

目的评估骨质疏松情况下geneX骨水泥强化椎弓根钉的固定强度。方法应用微量注射泵对30个新鲜小牛腰椎标本注射稀盐酸建立骨质疏松椎体模型。60个椎弓根分为四组:geneX骨水泥组,硫酸钙骨水泥(CSC)组,聚甲基丙烯酸甲酯骨水泥(PMMA)组,对照组。随机选择一侧注射2.5 ml骨水泥,然后置入螺钉;另一侧行正常螺钉固定对照,应用材料试验机进行轴向拔出力测试,记录各组的轴向最大拔出力和能量吸收值并进行比较。结果 geneX组与CSC组两组拔出力及能量吸收值比较,差异无统计学意义(P>0.05),两组均显著低于PMMA组(P<0.05),两组均显著高于对照组(P<0.05)。结论 geneX骨水泥强化椎弓根钉可显著提高椎弓根固定强度,geneX骨水泥可用作椎弓根强化螺钉的填充材料。     

Triangulated pedicle screw construct technique and pull-out strength of conical and cylindrical screws

To compare the mechanical effectiveness of a new conical screw design with a conventional cylindrical screw design, the screw insertion time, torque, and pull-out strength of single-pedicle screw and triangulated-pedicle screw constructs of each type of screw were compared in human cadaveric vertebral bodies. The time required to insert the conical screws was less than that required for cylindrical screws. Regression analysis revealed a positive correlation between insertion torque and pull-out strength of single and triangulated constructs of each type of screw. The conical screw had a greater increase than the cylindrical screw in the pull-out strength of triangulated pedicle screw constructs. Application of the new conical screw design was significantly faster, and the new screw had better mechanical fixation to the vertebral body than did the conventional cylindrical screw tested.     

In vitro biomechanical study of pedicle screw pull-out strength based on different screw path preparation techniques

Background:

Poor screw-to-bone fixation is a clinical problem that can lead to screw loosening. Under-tapping (UT) the pedicle screw has been evaluated biomechanically in the past. The objective of the study was to determine if pedicle preparation with a sequential tapping technique will alter the screw-to-bone fixation strength using a stress relaxation testing loading protocol.

Materials and Methods:

Three thoracolumbar calf spines were instrumented with pedicle screws that were either probed, UT, standard-tapped (ST), or sequential tapped to prepare the pedicle screw track and a stress relaxation protocol was used to determine pull-out strength. The maximum torque required for pedicle screw insertion and pull-out strength was reported. A one-way ANOVA and Tukeys post-hoc test were used to determine statistical significance.

Results:

The pedicle screw insertion torques for the probed, UT, ST and sequentially tapped (SQT) techniques were 5.09 (±1.08) Nm, 5.39 (±1.61) Nm, 2.93 (±0.43) Nm, and 3.54 (±0.67) Nm, respectively. There is a significant difference between probed compared to ST (P ≤ 0.05), as well as UT compared to both ST and SQT (P ≤ 0.05). The pull-out strength for pedicle screws for the probed, UT, ST and SQT techniques was 2443 (±782) N, 2353(±918) N, 2474 (±521) N, and 2146 (±582) N, respectively, with no significant difference (P ≥ 0.05) between techniques.

Conclusions:

The ST technique resulted in the highest pull-out strength while the SQT technique resulted in the lowest. However, there was no significant difference in the pull-out strength for the various preparation techniques and there was no correlation between insertion torque and pull-out strength. This suggests that other factors such as bone density may have a greater influence on pull-out strength.     

椎弓根螺钉骨水泥强化固定治疗腰椎退行性变的临床效果

目的 探讨椎弓根螺钉骨水泥强化固定治疗腰椎退行性变的临床效果.方法 对56例腰椎退行性变患者行椎弓根螺钉骨水泥强化固定、椎间植骨融合,术前测量拟固定椎体的骨密度,术中测量螺钉的最大旋入力偶矩后取出螺钉,钉道注入聚甲基丙烯酸甲酯（PMMA）3ml再次置入螺钉并测量螺钉的最大旋入力偶矩,椎体固定后减压并行椎体间植骨融合.结果 患者均获随访,时间6~24（14.4±3.6）个月,均未发生内固定物松动、断钉及断棒等并发症.影像学评估：骨水泥分布于钉道周围松质骨中无明显椎体外渗.末次随访时按改良Macnab标准评价临床疗效：优27例,良22例,可7例;椎弓根螺钉的最大旋入力偶矩经术中骨水泥强化固定后由（0.61±0.23）N·m增至（1.35±0.32） N·m,差异有统计学意义（P〈0.05）.结论椎弓根螺钉骨水泥强化固定治疗腰椎退行性变可以明显增强螺钉的稳定性.     

强化骨质疏松椎弓根螺钉治疗老年腰椎疾患

目的评价骨水泥强化骨质疏松椎弓根螺钉治疗老年腰椎疾患的临床疗效。方法对22例老年腰椎疾病患者行骨水泥强化椎弓根螺钉、椎间植骨融合。术前测量待植入螺钉之椎体的骨密度;术中测量螺钉的最大旋入力偶矩;用3ml骨水泥强化椎弓根螺钉,测量螺钉的最大旋入力偶矩;减压后行椎间植骨融合术。结果患者均未发生手术并发症,睽腿痛治愈、好转20例,2例症状无明显改善。强化椎弓根螺钉后,螺钉的最大旋入力偶矩由（0．591±0．213）Nm增至（1．332±0．377）Nm．差异有显著性（P〈0．01）。影像学表现为骨水泥分布于钉道周围松质骨中,未出现椎体外渗漏。结论骨水泥强化骨质疏松椎弓根螺钉治疗老年腰椎疾患能明显增强螺钉的稳定性。     

Insertional torque of the lumbar pedicle screw during surgery

The purposes of this study were to determine if the intraoperative insertional torque of pedicle screws correlates with the degree of osteoporosis and if insertional torque can be used as a predictor of screw loosening and clinical results in elderly patients. Pedicle screw fixation was performed in 25 patients. Their mean age at the time of surgery was 72.2 years (range 65–79 years). The mean follow-up period was 2.8 years (range 1.0–4.8 years). The insertional torque of the pedicle screws was measured using a Kannon-type torque wrench with a special connector. In the present study, 136 screws were evaluated. The mean insertional torque was 12.2 ± 5.0kgf·cm. A negative relation was found between insertional torque and the grade of osteoporosis. Roentgenograms showed the radiolucency of 18 screws in eight patients. Radiolucency appeared as early as 6 months postoperatively. However, there was no significant relation between insertional torque and the presence of screw loosening. Furthermore, there was no significant difference in the clinical results between patients with low insertional torque and those with high insertional torque. This study demonstrated that intraoperative insertional torque is not an objective predictor of screw loosening or clinical results.     

The effect of pedicle screw redirection after lateral wall breach—a biomechanical study using human lumbar vertebrae

Background contextCurrently, pedicle screw segmental fixation of the spine is considered a standard of care for a number of conditions. Most surgeons employ a free-hand technique using various intraoperative modalities to improve pedicle screw accuracy. Despite continued improvements in technique, pedicle breach remains a frequent occurrence. Once a breach is detected intraoperatively, the most common corrective maneuver is to medially redirect the pedicle screw into the pedicle. To our knowledge, the biomechanical impact of medially redirecting a pedicle screw after a lateral pedicle breach has not been examined.PurposeTo compare the fixation strength of perfectly placed pedicle screws to the fixation strength of pedicle screws that were correctly placed after having been redirected (RD) following a lateral pedicle breach.Study design/settingA biomechanical study using human lumbar vertebrae.MethodsTen fresh human lumbar vertebrae were isolated from five donors. Each vertebra was instrumented with a monoaxial pedicle screw into each pedicle using two different techniques. On one side, a perfect center-center (CC) screw path was created using direct visualization and fluoroscopy. A 6.0-mm-diameter cannulated tap and a pedicle probe were used to develop the pedicle for the 7.0-mm-diameter by 45-mm-long cannulated pedicle screw, which was placed using a digital torque driver. On the contralateral side, an intentional lateral pedicle wall breach was created at the pedicle-vertebral body junction using a guide wire, a 6.0-mm-diameter cannulated tap, and a pedicle probe. This path was then redirected into a CC position, developed, and instrumented with a 7.0-mm-diameter by 45-mm-long cannulated pedicle screw: the RD screw. For each pedicle screw, we assessed four outcome measures: maximal torque, seating torque, screw loosening, and post-loosening axial pullout. Screw loosening and axial pullout were assessed using an MTS machine.ResultsThe biomechanical cost of a lateral pedicle breach and the requirement to redirect the pedicle screw are as follows: an overall drop of 28% (p<.002) in maximal insertion torque and 25% (p<.049) in seating torque, a drop of 25% (p<.040) in resistance to screw loosening, and a drop in axial pullout force of 11% (p<.047).ConclusionsCompared with a CC lumbar pedicle screw, an RD lumbar pedicle screw placed after a lateral wall breach is significantly weaker in terms of maximal insertional torque, seating torque, screw loosening force, and axial pullout strength. These significant decreases in biomechanical properties are clearly important when RD pedicle screws are placed at the cephalad or caudal end of a long construct. In this situation, augmentation of the RD screw is an option.     

Biomechanical study of pedicle screw fixation in severely osteoporotic bone.

BACKGROUND CONTEXT: Obtaining adequate purchase with standard pedicle screw techniques remains a challenge in poor quality bone. The development of alternate insertion techniques and screw designs was prompted by recognition of potential fixation complications. An expandable pedicle screw design has been shown to significantly improve fixation compared to a conventional screw in poor quality bone. PURPOSE: The purpose of this study was to determine if polymethylmethacrylate (PMMA) bone cement augmentation of an expandable pedicle screw can further improve fixation strength compared to the expandable screw alone in severely osteoporotic bone. A technique for cement insertion into the pedicle by means of the cannulated central portion of the expandable screw is also described. STUDY DESIGN: The axial pullout strength, stiffness and energy absorbed of cemented and noncemented expandable pedicle screws was determined in cadaveric vertebrae. METHODS: Twenty-one fresh unembalmed vertebrae from the thoracolumbar spine were used. Radiographs and bone mineral density measurements (BMD) were used to characterize bone quality. Paired cemented and noncemented pedicle screw axial pullout strength was determined through mechanical testing. Mechanical pullout strength, stiffness and energy to failure was correlated with BMD. RESULTS: Overall, there was a 250% increase in mean pullout strength with the cemented expandable screw compared with a noncemented expandable screw including a greater than twofold increase in pullout strength in the most severely osteoporotic bone. The mean stiffness and energy absorbed to failure was also significantly increased. A cemented conventional screw achieved a pullout strength similar to the noncemented expandable screw. CONCLUSIONS: PMMA cement augmentation of the expandable pedicle screw may be a viable clinical option for achieving fixation in severely osteoporotic bone.     

Pedicle screw fixation strength: pullout versus insertional torque.

BACKGROUND CONTEXT: Researchers studying early pedicle screw designs have suggested that pullout strength and insertional torque are correlated. For surgeons using pedicle screws, insertional torque is widely believed to be a good predictor of pullout strength and initial stability of the screw and construct. How appropriate is this assumption when applied to new screw and thread designs? PURPOSE: This study investigated the correlation between insertional torque and pullout strength of three different pedicle screw designs, with different insertional torque characteristics. We hypothesized that a significant increase in insertional torque would indicate a commensurate increase in pullout strength. STUDY DESIGN: Biomechanical analysis of instrumented vertebral specimens. METHODS: Calf lumbar vertebra were prepared and instrumented with one of three pedicle screws. Pilot hole preparation was standardized and coaxial orientation was confirmed by direct inspection. Screws did not penetrate the pedicle cortex or abut or penetrate the anterior vertebral cortex. Any specimen with pedicle wall breach was discarded. The pedicles were instrumented with one of three screws: 1) 7.5 x 40 mm conical, asymmetric progressive thread (Xia; Stryker Spine, Allendale, NJ), 2) 7.5 x 40 mm conical with traditional V-shaped thread (Osteonics, Stryker Spine, Allendale, NJ)) or 3) 6.5 x 40 mm cylindrical with V thread (Osteonics, cylindrical). Paired testing allowed individual screws to be directly compared with a contralateral "control." Insertional torque and peak torque values were recorded for each rotation up to full insertion. Pullout testing was conducted at a rate of 1 mm/minute. Load-displacement data were recorded at 20 Hz. Stiffness was considered the slope of the most linear part of the curve before the yield point. RESULTS: Peak loads for 7.5 conical Xia screws measured 1,783+/-589.1 N compared with 1,943.0+/-625.8 N for 7.5 conical Osteonics screws and 1,641.0+/-356.7 N for 6.5 cylindrical Osteonics screws. The peak insertional torque values were 6.7+/-1.9 Nm (158% greater than control), 4.5+/-1.1 Nm (73% greater than control) and 2.6+/-0.7 Nm, respectively. Insertional torques for Xia screws were significantly greater than conical (p=.001) and cylindrical Osteonics screws (p<.0001), and insertional torques for Osteonics conical screws were significantly greater than those of cylindrical screws (p<.0001). Although pullout loads for the conical Osteonics screws were consistently higher than either the Xia or Osteonics cylindrical screws, the differences were not significant (p>.05). There was no significant correlation between pullout strength and insertional torque (p>.05). CONCLUSIONS: This unexpected result is best explained by the progressively narrowing flutes of the Xia screw, which compact the trabeculae into a smaller volume as the screw nears full insertion. The trapezoidal threads also increase contact with the cortical surface area and compress trabeculae toward the cortex, thus creating greater friction and higher torque values. This increase in torque did not translate into a commensurate increase in pullout strength, where trabeculae fail in shear.     

Comparative biomechanical analysis of an improved novel pedicle screw with sheath and bone cement

STUDY DESIGN: A human cadaveric biomechanical study of fixation strength of an improved novel pedicle screw (NPS) with cement and a conventional screw. OBJECTIVE: To clarify whether the NPS has adequate fixation strength without leakage in vertebrae with low bone quality. SUMMARY OF BACKGROUND DATA: The fixation strength of pedicle screws decreases in frail spines of elderly osteoporotic patients. Augmentation of screw fixation with bone cement must be balanced against increased difficulty of screw removal and risk of cement leakage. We developed the NPS consisting of an internal screw and an outer sheath to mitigate the disadvantages of cement augmentation. METHODS: The T12 and L1 vertebrae obtained from 18 formalin preserved cadavers (11 males and 7 females; mean age, 82.7 y) were used. The mean bone mineral density was 0.39 +/- 0.14 g/cm2. The NPS was inserted into one pedicle of each vertebra and the control screw, a Compact CD2 screw, was inserted into the contralateral pedicle. Both screws were 6mm in diameter and 40 mm in length. Pull-out tests were performed at a crosshead speed of 10 mm/min. Cyclic loading tests were performed with a maximum 250 N load at 2 Hz until 30,000 cycles. RESULTS: Cement leakage did not occur in any of the specimens tested. The mean maximum force at pull-out was 760 +/- 344 N for the NPS and 346 +/- 172N for the control screw (P < 0.01). Loosening of 50% of the screws was observed after 17,000 cycles of the NPS and after 30 cycles of the control screw. The hazard ratio of loosening was 19.6 (95% confidence interval 19.3-19.9) (P < 0.001). CONCLUSIONS: The NPS showed a significantly higher mechanical strength than the control screw in both pull-out tests and cyclic loading tests. The NPS showed more than adequate strength without cement leakage.