Pub Date : 2009-03-01eCollection Date: 2009-01-01DOI: 10.1016/SASJ-2009-Comment1
Donna D Ohnmeiss
{"title":"Overview of the Role of Statistic Analysis in the Design of Spine-related Studies.","authors":"Donna D Ohnmeiss","doi":"10.1016/SASJ-2009-Comment1","DOIUrl":"https://doi.org/10.1016/SASJ-2009-Comment1","url":null,"abstract":"","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"3 1","pages":"26-9"},"PeriodicalIF":0.0,"publicationDate":"2009-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f9/de/SAS-3-2009-Comment1.PMC4365590.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33154943","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2009-03-01DOI: 10.1016/S1935-9810(09)70004-0
Donna D. Ohnmeiss Dr.Med
{"title":"Overview of the Role of Statistic Analysis in the Design of Spine-related Studies","authors":"Donna D. Ohnmeiss Dr.Med","doi":"10.1016/S1935-9810(09)70004-0","DOIUrl":"https://doi.org/10.1016/S1935-9810(09)70004-0","url":null,"abstract":"","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"3 1","pages":"Pages 26-29"},"PeriodicalIF":0.0,"publicationDate":"2009-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S1935-9810(09)70004-0","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"137242616","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2009-03-01eCollection Date: 2009-01-01DOI: 10.1016/SASJ-2008-0019-RR
Fred H Geisler, Paul C McAfee, Robert J Banco, Scott L Blumenthal, Richard D Guyer, Richard T Holt, Mohamed E Majd
Background: Candidates for spinal arthrodesis or arthroplasty often present with a history of prior surgery such as laminectomy, laminotomy or discectomy. In this study, lumbar arthroplasty patients with prior surgery, and in particular patients with prior discectomy, were evaluated for their clinical outcomes at the 5-year time point.
Methods: Randomized patients from the 5-year CHARITÉ investigational device exemption (IDE) study were divided as follows: 1) fusion prior surgery (excluding prior decompression with fusion) group (FSG); 2) fusion prior discectomy group (FDG); 3) fusion no prior surgery group (FNG); 4) arthroplasty prior surgery group (ASG); 5) arthroplasty prior discectomy group (ADG); and 6) arthroplasty no prior surgery group (ANG). The 5-year clinical outcomes included visual analog scale (VAS), Oswestry Disability Index 2.0 (ODI), patient satisfaction, and work status.
Results: In the arthroplasty group, all subgroups had statistically significant VAS improvements from baseline (VAS change from baseline: ASG = -36.6 ± 29.6, P < 0.0001; ADG = -40.2 ± 30.9, P = 0.0002; ANG = -36.5 ± 34.6, P < 0.0001). There was no statistical difference between subgroups (P = 0.5587). In the fusion group, VAS changes from baseline were statistically significant for the FNG and FSG subgroups, but not for the FDG patients (FNG = -46.3 ± 28.8, P < 0.0001; FSG = -24.2 ± 36.4, P = 0.0444; FDG = -26.7 ± 38.7, P = 0.2188). A trend of decreased VAS improvements was observed for FSG versus FNG (P = 0.0703) subgroups. Similar findings and trends were observed in ODI scores (Changes in ODI from baseline: ASG = -20.4 ± 23.8, P < 0.0001; ANG = -26.6±21.1, P < 0.0001; ADG= -17.6 ± 28.6, P = 0.0116; FSG = -14.5 ± 21.2, P = 0.0303; FNG= -32.5 ± 22.6, P < 0.0001; FDG = -10.7 ± 9.4, P = 0.0938). The greatest improvement in work status from preoperative to postoperative was seen in the ADG subgroup (28% increase in part- and full-time employment), while the FDG subgroup showed the greatest reduction in work status (17% decrease).
Conclusions: Arthroplasty patients with prior surgery or prior discectomy had similar clinical outcomes as arthroplasty patients without prior surgery, while fusion patients with prior surgery or prior discectomy showed trends of lowered clinical outcomes compared to fusion patients without prior surgery or discectomy.
{"title":"Prospective, Randomized, Multicenter FDA IDE Study of CHARITÉ Artificial Disc versus Lumbar Fusion: Effect at 5-year Follow-up of Prior Surgery and Prior Discectomy on Clinical Outcomes Following Lumbar Arthroplasty.","authors":"Fred H Geisler, Paul C McAfee, Robert J Banco, Scott L Blumenthal, Richard D Guyer, Richard T Holt, Mohamed E Majd","doi":"10.1016/SASJ-2008-0019-RR","DOIUrl":"https://doi.org/10.1016/SASJ-2008-0019-RR","url":null,"abstract":"<p><strong>Background: </strong>Candidates for spinal arthrodesis or arthroplasty often present with a history of prior surgery such as laminectomy, laminotomy or discectomy. In this study, lumbar arthroplasty patients with prior surgery, and in particular patients with prior discectomy, were evaluated for their clinical outcomes at the 5-year time point.</p><p><strong>Methods: </strong>Randomized patients from the 5-year CHARITÉ investigational device exemption (IDE) study were divided as follows: 1) fusion prior surgery (excluding prior decompression with fusion) group (FSG); 2) fusion prior discectomy group (FDG); 3) fusion no prior surgery group (FNG); 4) arthroplasty prior surgery group (ASG); 5) arthroplasty prior discectomy group (ADG); and 6) arthroplasty no prior surgery group (ANG). The 5-year clinical outcomes included visual analog scale (VAS), Oswestry Disability Index 2.0 (ODI), patient satisfaction, and work status.</p><p><strong>Results: </strong>In the arthroplasty group, all subgroups had statistically significant VAS improvements from baseline (VAS change from baseline: ASG = -36.6 ± 29.6, P < 0.0001; ADG = -40.2 ± 30.9, P = 0.0002; ANG = -36.5 ± 34.6, P < 0.0001). There was no statistical difference between subgroups (P = 0.5587). In the fusion group, VAS changes from baseline were statistically significant for the FNG and FSG subgroups, but not for the FDG patients (FNG = -46.3 ± 28.8, P < 0.0001; FSG = -24.2 ± 36.4, P = 0.0444; FDG = -26.7 ± 38.7, P = 0.2188). A trend of decreased VAS improvements was observed for FSG versus FNG (P = 0.0703) subgroups. Similar findings and trends were observed in ODI scores (Changes in ODI from baseline: ASG = -20.4 ± 23.8, P < 0.0001; ANG = -26.6±21.1, P < 0.0001; ADG= -17.6 ± 28.6, P = 0.0116; FSG = -14.5 ± 21.2, P = 0.0303; FNG= -32.5 ± 22.6, P < 0.0001; FDG = -10.7 ± 9.4, P = 0.0938). The greatest improvement in work status from preoperative to postoperative was seen in the ADG subgroup (28% increase in part- and full-time employment), while the FDG subgroup showed the greatest reduction in work status (17% decrease).</p><p><strong>Conclusions: </strong>Arthroplasty patients with prior surgery or prior discectomy had similar clinical outcomes as arthroplasty patients without prior surgery, while fusion patients with prior surgery or prior discectomy showed trends of lowered clinical outcomes compared to fusion patients without prior surgery or discectomy.</p>","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"3 1","pages":"17-25"},"PeriodicalIF":0.0,"publicationDate":"2009-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/98/c9/SAS-3-2008-0019-RR.PMC4365588.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33154942","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The incidence of osteochondroma is rare and only 2% of such tumors are found in the spine area. When they are found in the vertebral column, less than 1% of all osteochondromas and few tumors occur in the thoracic vertebrae. An osteochondroma arising from the transverse process of the vertebra is even rarer, especially following from the thoracic transverse process. Here we report a giant solitary osteochondroma arising from the thoracic transverse process of T8 vertebra and involving the corresponding transverse process and rib.
A 28-year-old man presented with a progressive thoracic node, and neuroradiological evaluation of the spine showed a giant mass lesion involving the transverse process of T8 vertebra and concomitant corresponding facet joint and rib on the left side. At surgery, a firm and cartilaginous tumor originating from the transverse process was radically excised and surgical curettage of the lesion was performed.
It is concluded that accurate and prompt diagnosis requires a high index of suspicion followed by surgical treatment to prevent severe morbidity in cases of primary spinal column tumors. The histological examination of this patient revealed the lesion was osteochondroma.
The best choice of treatment for spinal osteochondromas is surgical excision or curettage and spinal stabilization, if necessary.
{"title":"Osteochondroma Arising from the Thoracic Transverse Process","authors":"Ding Wenyuan MD , Li Baojun MD , Shen Yong PhD, MD , Zhang Wei PhD, MD , Zhang Yingze MD","doi":"10.1016/S1935-9810(09)70002-7","DOIUrl":"https://doi.org/10.1016/S1935-9810(09)70002-7","url":null,"abstract":"<div><p>The incidence of osteochondroma is rare and only 2% of such tumors are found in the spine area. When they are found in the vertebral column, less than 1% of all osteochondromas and few tumors occur in the thoracic vertebrae. An osteochondroma arising from the transverse process of the vertebra is even rarer, especially following from the thoracic transverse process. Here we report a giant solitary osteochondroma arising from the thoracic transverse process of T8 vertebra and involving the corresponding transverse process and rib.</p><p>A 28-year-old man presented with a progressive thoracic node, and neuroradiological evaluation of the spine showed a giant mass lesion involving the transverse process of T8 vertebra and concomitant corresponding facet joint and rib on the left side. At surgery, a firm and cartilaginous tumor originating from the transverse process was radically excised and surgical curettage of the lesion was performed.</p><p>It is concluded that accurate and prompt diagnosis requires a high index of suspicion followed by surgical treatment to prevent severe morbidity in cases of primary spinal column tumors. The histological examination of this patient revealed the lesion was osteochondroma.</p><p>The best choice of treatment for spinal osteochondromas is surgical excision or curettage and spinal stabilization, if necessary.</p></div>","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"3 1","pages":"Pages 12-16"},"PeriodicalIF":0.0,"publicationDate":"2009-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S1935-9810(09)70002-7","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"137355398","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The increasing complexity of articulating spinal implants prohibits the use of serum-supplemented simulator fluid testing because multicomponent interfaces retain residual protein and preclude gravimetric measurement. Our original hypothesis was that simulator testing of a posterior dynamic stabilization implant that has metal-on-metal articulating bearings will not produce dramatically different wear debris when tested using pure saline versus testing in saline supplemented with 20% serum.
Methods
This hypothesis was tested using simulator testing of 12 dynamic stabilization spinal implants, 6 in 100% saline and 6 in 20%-serum saline. Gravimetric and particle analysis were performed after every million cycles up to 10 million cycles, with flexion of 11.3/extension of 5.6° coupled with axial rotation of ± 4°.
Results
The mean gravimetric weight loss was approximately 200 mg over 10 million cycles for the implants tested in 100% saline, while the mean weight loss for those tested in 20%-serum saline was below the method detection limits (< 10 mg over 10 million cycles). For the 100%-saline and 20%-serum simulator fluids, the average particle size over the course of 0 to 10 million cycles remained relatively constant at 0.2 μm-dia (saline) and 3.2 μm-dia (20%-serum saline). Testing in 100% saline generated > 1000-fold more particles, compared to testing in 20% serum-supplemented saline. Energy-dispersive X-ray (EDAX) analyses of particles demonstrated that the 100% saline debris was composed of Co-Cr-P-O (Cr-Co metal oxides), and for the 20%-serum saline debris only bulk metal Co-Cr was detected.
Conclusion
Our initial hypothesis was not supported. There were significant differences in gravimetric wear, average size, and type of wear debris that were mechanistically attributable to the type of simulator fluid used. The over-protective effect of serum proteins appears to underscore the importance of using both saline and serum when establishing upper and lower bounds of predictive implant debris generation modeling, where saline represents a worst-case scenario and as little as 20% serum masks all weight loss completely in highly modular articulating implants.
Clinical Relevance
Clinical Relevance = 5 (Oxford Centre for Evidence-based Medicine Levels of Evidence). Study findings are limited to a greater understanding of the science associated with predictive wear testing of articulating spinal implants.
背景:关节式脊柱植入物日益复杂,禁止使用血清补充模拟器液体测试,因为多组分界面保留了残留的蛋白质,并且妨碍了重量测量。我们最初的假设是,当使用纯生理盐水和添加20%血清的生理盐水进行测试时,具有金属对金属关节轴承的后路动态稳定植入物的模拟器测试不会产生明显不同的磨损碎片。方法对12例动态稳定脊柱植入物进行模拟试验,其中6例置入100%生理盐水,6例置入20%血清盐水。每100万次循环至1000万次循环后进行重量和颗粒分析,屈曲11.3°/延伸5.6°,轴向旋转±4°。结果在100%生理盐水中测试的植入物在1000万周期内的平均重量损失约为200 mg,而在20%血清盐水中测试的植入物的平均重量损失低于方法的检测限(<每1000万次10毫克)。对于100%生理盐水和20%血清模拟液,在0到1000万次循环过程中,平均粒径保持相对恒定,分别为0.2 μm-dia(生理盐水)和3.2 μm-dia(20%生理盐水)。100%生理盐水测试;与在20%血清补充盐水中测试相比,颗粒多1000倍。粒子的能量色散x射线(EDAX)分析表明,100%的生理盐水碎片由Co-Cr- p - o (Cr-Co金属氧化物)组成,而20%的血清生理盐水碎片仅检测到大块金属Co-Cr。结论我们最初的假设不成立。在重量磨损、平均尺寸和磨损碎屑类型方面存在显著差异,这在机械上可归因于所使用的模拟器流体的类型。血清蛋白的过度保护作用似乎强调了在建立预测植入物碎片生成模型的上界和下界时同时使用生理盐水和血清的重要性,其中生理盐水代表最坏情况,而在高度模块化关节植入物中,只有20%的血清完全掩盖了所有体重减轻。临床相关性:临床相关性= 5(牛津循证医学证据水平中心)。研究结果仅限于对关节脊柱植入物预测磨损测试相关科学的更深入理解。
{"title":"In Vitro Assessment of Serum-Saline Ratios for Fluid Simulator Testing of Highly Modular Spinal Implants With Articulating Surfaces","authors":"Nadim Hallab PhD , Ashutosh Khandha , George Malcolmson , J.P. Timm","doi":"10.1016/S1935-9810(08)70036-7","DOIUrl":"https://doi.org/10.1016/S1935-9810(08)70036-7","url":null,"abstract":"<div><h3>Background</h3><p>The increasing complexity of articulating spinal implants prohibits the use of serum-supplemented simulator fluid testing because multicomponent interfaces retain residual protein and preclude gravimetric measurement. Our original hypothesis was that simulator testing of a posterior dynamic stabilization implant that has metal-on-metal articulating bearings will not produce dramatically different wear debris when tested using pure saline versus testing in saline supplemented with 20% serum.</p></div><div><h3>Methods</h3><p>This hypothesis was tested using simulator testing of 12 dynamic stabilization spinal implants, 6 in 100% saline and 6 in 20%-serum saline. Gravimetric and particle analysis were performed after every million cycles up to 10 million cycles, with flexion of 11.3/extension of 5.6° coupled with axial rotation of ± 4°.</p></div><div><h3>Results</h3><p>The mean gravimetric weight loss was approximately 200<!--> <!-->mg over 10 million cycles for the implants tested in 100% saline, while the mean weight loss for those tested in 20%-serum saline was below the method detection limits (<<!--> <!-->10<!--> <!-->mg over 10 million cycles). For the 100%-saline and 20%-serum simulator fluids, the average particle size over the course of 0 to 10<!--> <!-->million cycles remained relatively constant at 0.2<!--> <!-->μm-dia (saline) and 3.2<!--> <!-->μm-dia (20%-serum saline). Testing in 100% saline generated ><!--> <!-->1000-fold more particles, compared to testing in 20% serum-supplemented saline. Energy-dispersive X-ray (EDAX) analyses of particles demonstrated that the 100% saline debris was composed of Co-Cr-P-O (Cr-Co metal oxides), and for the 20%-serum saline debris only bulk metal Co-Cr was detected.</p></div><div><h3>Conclusion</h3><p>Our initial hypothesis was not supported. There were significant differences in gravimetric wear, average size, and type of wear debris that were mechanistically attributable to the type of simulator fluid used. The over-protective effect of serum proteins appears to underscore the importance of using both saline and serum when establishing upper and lower bounds of predictive implant debris generation modeling, where saline represents a worst-case scenario and as little as 20% serum masks all weight loss completely in highly modular articulating implants.</p></div><div><h3>Clinical Relevance</h3><p>Clinical Relevance<!--> <!-->=<!--> <!-->5 (Oxford Centre for Evidence-based Medicine Levels of Evidence). Study findings are limited to a greater understanding of the science associated with predictive wear testing of articulating spinal implants.</p></div>","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"2 4","pages":"Pages 171-183"},"PeriodicalIF":0.0,"publicationDate":"2008-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S1935-9810(08)70036-7","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"137007612","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2008-12-01eCollection Date: 2008-01-01DOI: 10.1016/SASJ-2008-0020-RR
Joshua D Auerbach, Surena Namdari, Andrew H Milby, Andrew P White, Sudheer C Reddy, Baron S Lonner, Richard A Balderston
Background: Range of motion (ROM) has been shown to influence clinical outcomes of total disc replacement (TDR). While the parallax effect in image acquisition has been shown in the literature to influence the accuracy of a variety of measurements, this concept has not been investigated in the assessment of ROM analysis following TDR. We performed an evaluation of the influence of radiograph beam angle on "by hand" and on "gold standard" flexionextension ROM measurements in lumbar total disc replacement. The purpose of this study is to determine (1) the influence of X-ray beam angle on index level angle (ILA) measurements in lumbar TDR using the keel method, and (2) whether the out-of-plane radiographic beam effects cause a difference between true and calculated range of motion.
Methods: Eight blinded orthopaedic surgeons used the keel method to calculate ROM measurements from radiographs of a flexible Sawbones model (Pacific Research Laboratories, Inc., Vashon, Washington) implanted with a ProDisc-L device (Synthes Spine, West Chester, Pennsylvania). Radiographs were obtained at beam angles of 0°, 5°, 10°, and 15° in the sagittal plane from the device center. Calculations were compared to measurements obtained by a validated digitized software method (Quantitative Motion Analysis, QMA, Medical Metrics, Inc., Houston, Texas). Inter- and intraobserver precision and accuracy were determined.
Results: Compared with QMA, the radiographic keel method had an average error of 3.7°. No significant effect of variation in beam angle on interobserver precision (N = 16, P = .92) or accuracy (N = 16, P = 0.86) or intraobserver precision (N = 8, P = .09) or accuracy (N = 8, P = 0.07) of ROM measurements was identified. Repeat testing with QMA also revealed no effect of parallax and resulted in nearly identical ROM measurements.
Conclusions: Accuracy and precision of the keel method to determine ROM from index level angle measurements after TDR was not affected by increases in X-ray beam angles up to 15° from the device center.
Clinical relevance: Our study demonstrates that range of motion measurements are not influenced by parallax effect when using the keel method to determine index level angle measurements in lumbar total disc replacement.
背景:运动范围(ROM)已被证明会影响全椎间盘置换术(TDR)的临床效果。虽然文献显示图像采集中的视差效应会影响各种测量的准确性,但在评估 TDR 术后的 ROM 分析时,尚未对这一概念进行研究。我们对腰椎间盘全置换术中放射线束角度对 "徒手 "和 "金标准 "屈伸ROM测量的影响进行了评估。本研究的目的是确定:(1) X 射线束角度对使用龙骨法进行腰椎间盘置换术的指数水平角 (ILA) 测量的影响;(2) 平面外射线束效应是否会导致真实运动范围与计算运动范围之间的差异:方法:八位双盲矫形外科医生使用龙骨法,通过植入 ProDisc-L 装置(Synthes Spine,West Chester,Pennsylvania)的柔性锯骨模型(Pacific Research Laboratories,Inc.)从装置中心出发,在矢状面上分别以 0°、5°、10° 和 15° 的角度拍摄射线照片。计算结果与经过验证的数字化软件方法(定量运动分析,QMA,Medical Metrics, Inc.)结果:结果:与 QMA 相比,放射学龙骨法的平均误差为 3.7°。光束角度的变化对 ROM 测量的观察者间精度(N = 16,P = .92)或准确度(N = 16,P = 0.86)或观察者内精度(N = 8,P = .09)或准确度(N = 8,P = 0.07)均无明显影响。使用 QMA 重复测试也未发现视差的影响,ROM 测量结果几乎相同:结论:龙骨法根据 TDR 后的指数水平角测量值确定 ROM 的准确性和精确性不受 X 射线光束角度增加的影响,最多达设备中心 15°:我们的研究表明,在腰椎间盘全置换术中使用龙骨法确定指数水平角度测量值时,运动范围测量值不会受到视差效应的影响。
{"title":"The parallax effect in the evaluation of range of motion in lumbar total disc replacement.","authors":"Joshua D Auerbach, Surena Namdari, Andrew H Milby, Andrew P White, Sudheer C Reddy, Baron S Lonner, Richard A Balderston","doi":"10.1016/SASJ-2008-0020-RR","DOIUrl":"10.1016/SASJ-2008-0020-RR","url":null,"abstract":"<p><strong>Background: </strong>Range of motion (ROM) has been shown to influence clinical outcomes of total disc replacement (TDR). While the parallax effect in image acquisition has been shown in the literature to influence the accuracy of a variety of measurements, this concept has not been investigated in the assessment of ROM analysis following TDR. We performed an evaluation of the influence of radiograph beam angle on \"by hand\" and on \"gold standard\" flexionextension ROM measurements in lumbar total disc replacement. The purpose of this study is to determine (1) the influence of X-ray beam angle on index level angle (ILA) measurements in lumbar TDR using the keel method, and (2) whether the out-of-plane radiographic beam effects cause a difference between true and calculated range of motion.</p><p><strong>Methods: </strong>Eight blinded orthopaedic surgeons used the keel method to calculate ROM measurements from radiographs of a flexible Sawbones model (Pacific Research Laboratories, Inc., Vashon, Washington) implanted with a ProDisc-L device (Synthes Spine, West Chester, Pennsylvania). Radiographs were obtained at beam angles of 0°, 5°, 10°, and 15° in the sagittal plane from the device center. Calculations were compared to measurements obtained by a validated digitized software method (Quantitative Motion Analysis, QMA, Medical Metrics, Inc., Houston, Texas). Inter- and intraobserver precision and accuracy were determined.</p><p><strong>Results: </strong>Compared with QMA, the radiographic keel method had an average error of 3.7°. No significant effect of variation in beam angle on interobserver precision (N = 16, P = .92) or accuracy (N = 16, P = 0.86) or intraobserver precision (N = 8, P = .09) or accuracy (N = 8, P = 0.07) of ROM measurements was identified. Repeat testing with QMA also revealed no effect of parallax and resulted in nearly identical ROM measurements.</p><p><strong>Conclusions: </strong>Accuracy and precision of the keel method to determine ROM from index level angle measurements after TDR was not affected by increases in X-ray beam angles up to 15° from the device center.</p><p><strong>Clinical relevance: </strong>Our study demonstrates that range of motion measurements are not influenced by parallax effect when using the keel method to determine index level angle measurements in lumbar total disc replacement.</p>","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"2 4","pages":"184-8"},"PeriodicalIF":0.0,"publicationDate":"2008-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/8f/3c/SAS-2-2008-0020-RR.PMC4365660.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33036419","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2008-12-01DOI: 10.1016/S1935-9810(08)70035-5
Cédric Y. Barrey MD , Ravi K. Ponnappan MD , Jason Song MD , Alexander R. Vaccaro MD, PhD, FACS
Study Design
This study is a systematic review of published biomechanical studies involving pedicle screw-based posterior dynamic stabilization devices (PDS) with a special focus on kinematics and load transmission through the functional spine unit (FSU).
Methods
A literature search was performed via the PubMed online database from 1990 to 2008 using the following key words: “biomechanics,” “lumbar dynamic stabilization,” “Graf system,” “Dynesys,” and “posterior dynamic implant.” Citations were limited to papers describing biomechanics of pedicle screw-based PDS devices currently available for clinical use. Studies describing clinical experience, radiology, and in vivo testing were excluded from the review. Parameters measured included kinematics of the FSU (range of motion (ROM), neutral zone (NZ), and location of the center of rotation) and load transmission through the disk, facets, and instrumentation.
Results
A total of 27 publications were found that concerned the biomechanical evaluation of lumbar pedicle screw-based dynamic stabilization instrumentation. Nine in vitro experimental studies and 4 finite element analyses satisfied the inclusion criteria. The Dynesys implant was the most investigated pedicle screw-based PDS system. In vitro cadaveric studies mainly focused on kinematics comparing ROM of intact versus instrumented spines whereas finite element analyses allowed analysis of load transmission at the instrumented and adjacent levels.
Conclusion
Biomechanical studies demonstrate that pedicle screw-based PDS devices limit intervertebral motion while unloading the intervertebral disk. The implant design and the surgical technique have a significant impact on the biomechanical behavior of the instrumented spinal segment. The posterior placement of such devices results in non-physiologic intervertebral kinematics with a posterior shift of the axis of rotation. Biomechanical studies suggest that the difference at the adjacent level between investigated dynamic devices and rigid stabilization systems may not be as high as reported. Finally, additional investigations of semirigid devices are needed to further evaluate their biomechanical properties compared to soft stabilization PDS systems.
{"title":"Biomechanical Evaluation of Pedicle Screw-Based Dynamic Stabilization Devices for the Lumbar Spine: A Systematic Review","authors":"Cédric Y. Barrey MD , Ravi K. Ponnappan MD , Jason Song MD , Alexander R. Vaccaro MD, PhD, FACS","doi":"10.1016/S1935-9810(08)70035-5","DOIUrl":"https://doi.org/10.1016/S1935-9810(08)70035-5","url":null,"abstract":"<div><h3>Study Design</h3><p>This study is a systematic review of published biomechanical studies involving pedicle screw-based posterior dynamic stabilization devices (PDS) with a special focus on kinematics and load transmission through the functional spine unit (FSU).</p></div><div><h3>Methods</h3><p>A literature search was performed via the PubMed online database from 1990 to 2008 using the following key words: “biomechanics,” “lumbar dynamic stabilization,” “Graf system,” “Dynesys,” and “posterior dynamic implant.” Citations were limited to papers describing biomechanics of pedicle screw-based PDS devices currently available for clinical use. Studies describing clinical experience, radiology, and in vivo testing were excluded from the review. Parameters measured included kinematics of the FSU (range of motion (ROM), neutral zone (NZ), and location of the center of rotation) and load transmission through the disk, facets, and instrumentation.</p></div><div><h3>Results</h3><p>A total of 27 publications were found that concerned the biomechanical evaluation of lumbar pedicle screw-based dynamic stabilization instrumentation. Nine in vitro experimental studies and 4 finite element analyses satisfied the inclusion criteria. The Dynesys implant was the most investigated pedicle screw-based PDS system. In vitro cadaveric studies mainly focused on kinematics comparing ROM of intact versus instrumented spines whereas finite element analyses allowed analysis of load transmission at the instrumented and adjacent levels.</p></div><div><h3>Conclusion</h3><p>Biomechanical studies demonstrate that pedicle screw-based PDS devices limit intervertebral motion while unloading the intervertebral disk. The implant design and the surgical technique have a significant impact on the biomechanical behavior of the instrumented spinal segment. The posterior placement of such devices results in non-physiologic intervertebral kinematics with a posterior shift of the axis of rotation. Biomechanical studies suggest that the difference at the adjacent level between investigated dynamic devices and rigid stabilization systems may not be as high as reported. Finally, additional investigations of semirigid devices are needed to further evaluate their biomechanical properties compared to soft stabilization PDS systems.</p></div>","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"2 4","pages":"Pages 159-170"},"PeriodicalIF":0.0,"publicationDate":"2008-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S1935-9810(08)70035-5","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"137007611","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2008-12-01DOI: 10.1016/S1935-9810(08)70037-9
Joshua D. Auerbach MD , Surena Namdari MD , Andrew H. Milby BA , Andrew P. White MD , Sudheer C. Reddy MD , Baron S. Lonner MD , Richard A. Balderston MD
Background
Range of motion (ROM) has been shown to influence clinical outcomes of total disc replacement (TDR). While the parallax effect in image acquisition has been shown in the literature to influence the accuracy of a variety of measurements, this concept has not been investigated in the assessment of ROM analysis following TDR.
We performed an evaluation of the influence of radiograph beam angle on “by hand” and on “gold standard” flexion-extension ROM measurements in lumbar total disc replacement. The purpose of this study is to determine (1) the influence of X-ray beam angle on index level angle (ILA) measurements in lumbar TDR using the keel method, and (2) whether the out-of-plane radiographic beam effects cause a difference between true and calculated range of motion.
Methods
Eight blinded orthopaedic surgeons used the keel method to calculate ROM measurements from radiographs of a flexible Sawbones model (Pacific Research Laboratories, Inc., Vashon, Washington) implanted with a ProDisc-L device (Synthes Spine, West Chester, Pennsylvania). Radiographs were obtained at beam angles of 0°, 5°, 10°, and 15° in the sagittal plane from the device center. Calculations were compared to measurements obtained by a validated digitized software method (Quantitative Motion Analysis, QMA, Medical Metrics, Inc., Houston, Texas). Inter- and intraobserver precision and accuracy were determined.
Results
Compared with QMA, the radiographic keel method had an average error of 3.7°. No significant effect of variation in beam angle on interobserver precision (N = 16, P = .92) or accuracy (N = 16, P = 0.86) or intraobserver precision (N = 8, P = .09) or accuracy (N = 8, P = 0.07) of ROM measurements was identified. Repeat testing with QMA also revealed no effect of parallax and resulted in nearly identical ROM measurements.
Conclusions
Accuracy and precision of the keel method to determine ROM from index level angle measurements after TDR was not affected by increases in X-ray beam angles up to 15̊ from the device center.
Clinical Relevance
Our study demonstrates that range of motion measurements are not influenced by parallax effect when using the keel method to determine index level angle measurements in lumbar total disc replacement.
活动范围(ROM)已被证明影响全椎间盘置换术(TDR)的临床结果。虽然文献显示图像采集中的视差效应会影响各种测量的准确性,但这一概念尚未在TDR后ROM分析的评估中进行研究。我们评估了在腰椎全椎间盘置换术中x线片束角对“手工”和“金标准”屈伸ROM测量的影响。本研究的目的是确定(1)使用龙骨法测量腰椎TDR时x射线束角对指数水平角(ILA)测量的影响,以及(2)平面外射线束效应是否会导致真实运动范围与计算的运动范围之间的差异。方法8名盲法骨科医生使用龙骨法从植入ProDisc-L装置(Synthes Spine, West Chester, Pennsylvania)的柔性Sawbones模型(Pacific Research Laboratories, Inc., Vashon, Washington)的x线片上计算ROM测量值。在矢状面距离装置中心0°、5°、10°和15°的光束角度拍摄x线片。将计算结果与经过验证的数字化软件方法(Quantitative Motion Analysis, QMA, Medical Metrics, Inc, Houston, Texas)获得的测量结果进行比较。测定了观察者间和观察者内的精度和准确度。结果与QMA相比,x线龙骨法的平均误差为3.7°。波束角度的变化对ROM测量的观察者间精度(N = 16, P = 0.92)、准确度(N = 16, P = 0.86)、观察者内精度(N = 8, P = 0.09)和准确度(N = 8, P = 0.07)均无显著影响。用QMA重复测试也显示没有视差的影响,并导致几乎相同的ROM测量。结论龙骨法在TDR后通过指数水平角测量ROM的准确度和精密度不受x射线束角度从装置中心增加15°的影响。临床相关性我们的研究表明,在腰椎全椎间盘置换术中使用龙骨法测定指数水平角时,运动范围测量不受视差效应的影响。
{"title":"The Parallax Effect in the Evaluation of Range of Motion in Lumbar Total Disc Replacement","authors":"Joshua D. Auerbach MD , Surena Namdari MD , Andrew H. Milby BA , Andrew P. White MD , Sudheer C. Reddy MD , Baron S. Lonner MD , Richard A. Balderston MD","doi":"10.1016/S1935-9810(08)70037-9","DOIUrl":"https://doi.org/10.1016/S1935-9810(08)70037-9","url":null,"abstract":"<div><h3>Background</h3><p>Range of motion (ROM) has been shown to influence clinical outcomes of total disc replacement (TDR). While the parallax effect in image acquisition has been shown in the literature to influence the accuracy of a variety of measurements, this concept has not been investigated in the assessment of ROM analysis following TDR.</p><p>We performed an evaluation of the influence of radiograph beam angle on “by hand” and on “gold standard” flexion-extension ROM measurements in lumbar total disc replacement. The purpose of this study is to determine (1) the influence of X-ray beam angle on index level angle (ILA) measurements in lumbar TDR using the keel method, and (2) whether the out-of-plane radiographic beam effects cause a difference between true and calculated range of motion.</p></div><div><h3>Methods</h3><p>Eight blinded orthopaedic surgeons used the keel method to calculate ROM measurements from radiographs of a flexible Sawbones model (Pacific Research Laboratories, Inc., Vashon, Washington) implanted with a ProDisc-L device (Synthes Spine, West Chester, Pennsylvania). Radiographs were obtained at beam angles of 0°, 5°, 10°, and 15° in the sagittal plane from the device center. Calculations were compared to measurements obtained by a validated digitized software method (Quantitative Motion Analysis, QMA, Medical Metrics, Inc., Houston, Texas). Inter- and intraobserver precision and accuracy were determined.</p></div><div><h3>Results</h3><p>Compared with QMA, the radiographic keel method had an average error of 3.7°. No significant effect of variation in beam angle on interobserver precision (N<!--> <!-->=<!--> <!-->16, <em>P</em> <!-->=<!--> <!-->.92) or accuracy (N<!--> <!-->=<!--> <!-->16, <em>P</em> <!-->=<!--> <!-->0.86) or intraobserver precision (N<!--> <!-->=<!--> <!-->8, <em>P</em> <!-->=<!--> <!-->.09) or accuracy (N<!--> <!-->=<!--> <!-->8, <em>P</em> <!-->=<!--> <!-->0.07) of ROM measurements was identified. Repeat testing with QMA also revealed no effect of parallax and resulted in nearly identical ROM measurements.</p></div><div><h3>Conclusions</h3><p>Accuracy and precision of the keel method to determine ROM from index level angle measurements after TDR was not affected by increases in X-ray beam angles up to 15̊ from the device center.</p></div><div><h3>Clinical Relevance</h3><p>Our study demonstrates that range of motion measurements are not influenced by parallax effect when using the keel method to determine index level angle measurements in lumbar total disc replacement.</p></div>","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"2 4","pages":"Pages 184-188"},"PeriodicalIF":0.0,"publicationDate":"2008-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S1935-9810(08)70037-9","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91758034","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2008-12-01DOI: 10.1016/S1935-9810(08)70038-0
Alexander D. Choo , Gilad Regev MD , Steven R. Garfin MD , Choll W. Kim MD, PhD
Background
Computer-assisted spinal navigation allows for real time localization of surgical instruments in multiple views. Its use decreases radiation exposure and clears the surgical field of the C-arm fluoroscope. Despite these advantages, spinal navigation has yet to gain general acceptance among spine surgeons. The purpose of this study is to survey spine surgeons about their opinions on the strengths and weaknesses of spinal navigation.
Methods
Spine surgeons from the membership of the Spine Arthroplasty Society (SAS) and the Society for Minimally Invasive Spine Surgery (SMISS) were surveyed regarding their current use of spinal navigation and their perceptions of the strengths and weaknesses of spinal navigation (N = 147). Responses were analyzed using 2-sided chi-square tests.
Results
Most spine surgeons (63.4%) have only superficial experience with spinal navigation, and 76.2% of surgeons rarely use spinal navigation in their cases. Spine surgeons have the most experience with virtual fluoroscopy spinal navigation systems (35.9%). Surgeons considered longer operating times (63.5%), increased cost (48.3%), lack of necessity (40.7%), unreliable navigation accuracy (37.9%), and too many intraoperative glitches (35.2%) to be the major weaknesses of spinal navigation.
Surgeons considered decreased radiation exposure to the surgeon (76.1%), increased screw placement accuracy (65.7%), decreased radiation exposure to the patient (41.8%), and keeping the C-arm away from the operating field (29.1%) to be the greatest advantages of spinal navigation. Among the types of procedures surgeons believe are most likely to benefit from spinal navigation are minimally invasive instrumentation and fusion (72.5%) and complex open deformity (55.6%).
Conclusion
Most spine surgeons have only superficial experience in spinal navigation. The most commonly selected weaknesses of spinal navigation are increased operative time, cost, and lack of necessity. Increased fluoroscopy and MIS use in the future may shift focus from weaknesses to the strengths of spinal navigation, including decreased radiation exposure and elimination of the C-arm from the operative field.
{"title":"Surgeons’ Perceptions of Spinal Navigation: Analysis of Key Factors Affecting the Lack of Adoption of Spinal Navigation Technology","authors":"Alexander D. Choo , Gilad Regev MD , Steven R. Garfin MD , Choll W. Kim MD, PhD","doi":"10.1016/S1935-9810(08)70038-0","DOIUrl":"https://doi.org/10.1016/S1935-9810(08)70038-0","url":null,"abstract":"<div><h3>Background</h3><p>Computer-assisted spinal navigation allows for real time localization of surgical instruments in multiple views. Its use decreases radiation exposure and clears the surgical field of the C-arm fluoroscope. Despite these advantages, spinal navigation has yet to gain general acceptance among spine surgeons. The purpose of this study is to survey spine surgeons about their opinions on the strengths and weaknesses of spinal navigation.</p></div><div><h3>Methods</h3><p>Spine surgeons from the membership of the Spine Arthroplasty Society (SAS) and the Society for Minimally Invasive Spine Surgery (SMISS) were surveyed regarding their current use of spinal navigation and their perceptions of the strengths and weaknesses of spinal navigation (N<!--> <!-->=<!--> <!-->147). Responses were analyzed using 2-sided chi-square tests.</p></div><div><h3>Results</h3><p>Most spine surgeons (63.4%) have only superficial experience with spinal navigation, and 76.2% of surgeons rarely use spinal navigation in their cases. Spine surgeons have the most experience with virtual fluoroscopy spinal navigation systems (35.9%). Surgeons considered longer operating times (63.5%), increased cost (48.3%), lack of necessity (40.7%), unreliable navigation accuracy (37.9%), and too many intraoperative glitches (35.2%) to be the major weaknesses of spinal navigation.</p><p>Surgeons considered decreased radiation exposure to the surgeon (76.1%), increased screw placement accuracy (65.7%), decreased radiation exposure to the patient (41.8%), and keeping the C-arm away from the operating field (29.1%) to be the greatest advantages of spinal navigation. Among the types of procedures surgeons believe are most likely to benefit from spinal navigation are minimally invasive instrumentation and fusion (72.5%) and complex open deformity (55.6%).</p></div><div><h3>Conclusion</h3><p>Most spine surgeons have only superficial experience in spinal navigation. The most commonly selected weaknesses of spinal navigation are increased operative time, cost, and lack of necessity. Increased fluoroscopy and MIS use in the future may shift focus from weaknesses to the strengths of spinal navigation, including decreased radiation exposure and elimination of the C-arm from the operative field.</p></div>","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"2 4","pages":"Pages 189-194"},"PeriodicalIF":0.0,"publicationDate":"2008-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S1935-9810(08)70038-0","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91773878","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}