Pub Date : 2009-06-01DOI: 10.1016/S1935-9810(09)70008-8
Thomas J. Errico MD , Jonathan R. Kamerlink MD , Martin Quirno MD , Jacques Samani MD , Robert J. Chomiak MS
Background
The purpose of this study was to determine the indications for implantation of the coflex device (Paradigm Spine, LLC, New York, New York), assess long-term complications, and evaluate the long-term clinical outcomes of patients.
Methods
A total of 127 patients underwent placement of a coflex implant for various indications by one orthopaedic spine surgeon. The mean follow-up was 6.3 years. The original indications for implantation were determined based upon the data provided in the case report forms. Preoperatively and postoperatively, patients were asked to grade their low-back and leg pain using the visual analog scale (VAS) and the pain severity scale: no pain (0), mild pain (1), moderate pain (2), or severe pain (3). Patients were queried about their satisfaction with the surgical procedure. Follow-up radiographs were taken to determine any device-related issues.
Results
The most prevalent diagnoses for implantation were spinal stenosis (19.7%) and spinal stenosis with lumbar disc herniation (35.4%). The mean severity of low-back pain was decreased by 33% (from moderate to mild) at the 2-year follow-up (P < .001) and at the 5-year follow-up (from moderate to mild, P < .001). The mean severity of leg pain was decreased by 66% (from severe to mild) at the 2-year follow-up (P < .001) and at the 5-year follow-up (from severe to mild, P < .001). At the mean follow-up period of 6.3 years, a patient satisfaction query demonstrated that 7% were unsatisfied, 46% were satisfied, and 46% were very satisfied with their clinical outcome. Based on the follow-up radiographs, 92 of patients had no device-related issues and 8% had device-related issues.
Conclusion
The data provided have demonstrated that the coflex implant provides pain relief for patients with low-back pain and leg pain. The most common indications for implantation were spinal stenosis and spinal stenosis with lumbar disc herniation. There were very few device-related complications.
Clinical Significance
Using coflex is a safe and viable option in the selection of instrumentation for spinal stabilization.
本研究的目的是确定coflex装置植入的适应症(Paradigm Spine, LLC, New York, New York),评估长期并发症,并评估患者的长期临床结果。方法对127例不同适应症的患者,由一名脊柱外科医生行椎体内固定。平均随访时间为6.3年。最初的植入适应症是根据病例报告表格中提供的数据确定的。术前和术后,患者被要求使用视觉模拟量表(VAS)和疼痛严重程度量表对腰背痛和腿部疼痛进行分级:无疼痛(0)、轻度疼痛(1)、中度疼痛(2)或重度疼痛(3)。询问患者对手术过程的满意度。随访x线片以确定任何与器械相关的问题。结果植入术中最常见的诊断为椎管狭窄(19.7%)和椎管狭窄合并腰椎间盘突出(35.4%)。在2年随访中,腰痛的平均严重程度降低了33%(从中度到轻度)(P <.001)和5年随访(从中度到轻度,P <措施)。在2年随访中,腿部疼痛的平均严重程度降低了66%(从严重到轻度)(P <.001)和5年随访(从严重到轻度,P <措施)。在平均6.3年的随访期间,患者满意度查询显示,7%的患者不满意,46%的患者满意,46%的患者非常满意他们的临床结果。根据随访x线片,92例患者无器械相关问题,8%有器械相关问题。结论所提供的数据表明,coflex植入物可以缓解腰痛和腿痛患者的疼痛。最常见的适应症是椎管狭窄和椎管狭窄合并腰椎间盘突出。很少有器械相关的并发症。临床意义使用coflex是一种安全可行的脊柱固定工具选择。
{"title":"Survivorship of coflex Interlaminar-Interspinous Implant","authors":"Thomas J. Errico MD , Jonathan R. Kamerlink MD , Martin Quirno MD , Jacques Samani MD , Robert J. Chomiak MS","doi":"10.1016/S1935-9810(09)70008-8","DOIUrl":"https://doi.org/10.1016/S1935-9810(09)70008-8","url":null,"abstract":"<div><h3>Background</h3><p>The purpose of this study was to determine the indications for implantation of the coflex device (Paradigm Spine, LLC, New York, New York), assess long-term complications, and evaluate the long-term clinical outcomes of patients.</p></div><div><h3>Methods</h3><p>A total of 127 patients underwent placement of a coflex implant for various indications by one orthopaedic spine surgeon. The mean follow-up was 6.3 years. The original indications for implantation were determined based upon the data provided in the case report forms. Preoperatively and postoperatively, patients were asked to grade their low-back and leg pain using the visual analog scale (VAS) and the pain severity scale: no pain (0), mild pain (1), moderate pain (2), or severe pain (3). Patients were queried about their satisfaction with the surgical procedure. Follow-up radiographs were taken to determine any device-related issues.</p></div><div><h3>Results</h3><p>The most prevalent diagnoses for implantation were spinal stenosis (19.7%) and spinal stenosis with lumbar disc herniation (35.4%). The mean severity of low-back pain was decreased by 33% (from moderate to mild) at the 2-year follow-up (<em>P<!--> </em><<!--> <!-->.001) and at the 5-year follow-up (from moderate to mild, <em>P<!--> </em><<!--> <!-->.001). The mean severity of leg pain was decreased by 66% (from severe to mild) at the 2-year follow-up (<em>P<!--> </em><<!--> <!-->.001) and at the 5-year follow-up (from severe to mild, <em>P<!--> </em><<!--> <!-->.001). At the mean follow-up period of 6.3 years, a patient satisfaction query demonstrated that 7% were unsatisfied, 46% were satisfied, and 46% were very satisfied with their clinical outcome. Based on the follow-up radiographs, 92 of patients had no device-related issues and 8% had device-related issues.</p></div><div><h3>Conclusion</h3><p>The data provided have demonstrated that the coflex implant provides pain relief for patients with low-back pain and leg pain. The most common indications for implantation were spinal stenosis and spinal stenosis with lumbar disc herniation. There were very few device-related complications.</p></div><div><h3>Clinical Significance</h3><p>Using coflex is a safe and viable option in the selection of instrumentation for spinal stabilization.</p></div>","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"3 2","pages":"Pages 59-67"},"PeriodicalIF":0.0,"publicationDate":"2009-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S1935-9810(09)70008-8","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"137345080","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 : 2009-06-01eCollection Date: 2009-01-01DOI: 10.1016/SASJ-2009-0006-NT
Fred Mo, James Yue, Jianghui Zhang, Kreg Howk, Allister Williams
Background: Adhesion formation after spine surgery is a result of normal wound healing that may place patients at increased risk for complications during revision surgery. Preventing adhesions could reduce the risk of complications during revision surgery, and possibly reduce the need for revision procedures. This study evaluates the ability of DuraSeal Xact Adhesion Barrier System (DSX) (Covidien, Mansfield, Massachusetts) and Oxiplex/SP gel (OX) (FzioMed, San Luis Obispo, California) to affect the extent and severity of postoperative perivascular adhesion development in an anterior spinal surgical rabbit model.
Methods: We determined the extent and severity of postoperative adhesion development 34 days after surgery in 12 male New Zealand White rabbits randomly assigned to intraoperative treatment with either DSX or OX, or to an untreated control group. Adhesion severity and extent were scored on scale from 0 (none) to 3 (severe).
Results: The extent and severity of adhesions in the DSX group were significantly less than in the untreated control group. The DSX group mean extent score was 1.3 ± 0.5 (vs 2.5, P = .01) and the mean severity score was 1.25 ± 0.5 (vs 2.8, P = .005). The extent and severity of adhesions in the OX group were not significantly different from the control group.
Conclusion: In this study, we found DSX to be the most effective compound in preventing adhesion formation after anterior spine surgery.
Clinical relevance: Extrapolating these results in rabbits to humans, less scarring between the major blood vessels could decrease the rate of complications in revision spine procedures.
背景:脊柱手术后粘连的形成是伤口正常愈合的结果,这可能使患者在翻修手术中出现并发症的风险增加。预防粘连可以减少翻修手术中并发症的风险,并可能减少翻修手术的需要。本研究评估DuraSeal Xact粘连屏障系统(DSX) (Covidien, Mansfield, Massachusetts)和oxplex /SP凝胶(OX) (FzioMed, San Luis Obispo, California)在兔脊柱前路手术模型中影响术后血管周围粘连发展的程度和严重程度的能力。方法:我们测定了术后34天粘连发展的程度和严重程度,12只雄性新西兰大白兔被随机分配到术中使用DSX或OX的组,或未治疗的对照组。粘附严重程度和程度评分从0(无)到3(严重)。结果:DSX组粘连程度和严重程度均明显小于未治疗对照组。DSX组平均程度评分为1.3±0.5 (vs 2.5, P = 0.01),平均严重程度评分为1.25±0.5 (vs 2.8, P = 0.005)。OX组的粘连程度和严重程度与对照组无显著差异。结论:在本研究中,我们发现DSX是预防脊柱前路手术后粘连形成最有效的化合物。临床意义:将这些结果从兔子身上推断到人类身上,减少主要血管之间的疤痕可以降低脊柱翻修手术的并发症发生率。
{"title":"Evaluation of Perivascular Adhesion Formation in New Zealand White Rabbits Using Oxiplex and DuraSeal Xact Adhesion Barrier System.","authors":"Fred Mo, James Yue, Jianghui Zhang, Kreg Howk, Allister Williams","doi":"10.1016/SASJ-2009-0006-NT","DOIUrl":"https://doi.org/10.1016/SASJ-2009-0006-NT","url":null,"abstract":"<p><strong>Background: </strong>Adhesion formation after spine surgery is a result of normal wound healing that may place patients at increased risk for complications during revision surgery. Preventing adhesions could reduce the risk of complications during revision surgery, and possibly reduce the need for revision procedures. This study evaluates the ability of DuraSeal Xact Adhesion Barrier System (DSX) (Covidien, Mansfield, Massachusetts) and Oxiplex/SP gel (OX) (FzioMed, San Luis Obispo, California) to affect the extent and severity of postoperative perivascular adhesion development in an anterior spinal surgical rabbit model.</p><p><strong>Methods: </strong>We determined the extent and severity of postoperative adhesion development 34 days after surgery in 12 male New Zealand White rabbits randomly assigned to intraoperative treatment with either DSX or OX, or to an untreated control group. Adhesion severity and extent were scored on scale from 0 (none) to 3 (severe).</p><p><strong>Results: </strong>The extent and severity of adhesions in the DSX group were significantly less than in the untreated control group. The DSX group mean extent score was 1.3 ± 0.5 (vs 2.5, P = .01) and the mean severity score was 1.25 ± 0.5 (vs 2.8, P = .005). The extent and severity of adhesions in the OX group were not significantly different from the control group.</p><p><strong>Conclusion: </strong>In this study, we found DSX to be the most effective compound in preventing adhesion formation after anterior spine surgery.</p><p><strong>Clinical relevance: </strong>Extrapolating these results in rabbits to humans, less scarring between the major blood vessels could decrease the rate of complications in revision spine procedures.</p>","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"3 2","pages":"68-76"},"PeriodicalIF":0.0,"publicationDate":"2009-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/4e/40/SAS-3-2009-0006-NT.PMC4365594.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33154947","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 : 2009-06-01eCollection Date: 2009-01-01DOI: 10.1016/SASJ-2009-0005-NT
Aliza A Allon, Richard A Schneider, Jeffrey C Lotz
Background: Our goal is to optimize stem cell-based tissue engineering strategies in the context of the intervertebral disc environment. We explored the benefits of co-culturing nucleus pulposus cells (NPC) and adult mesenchymal stem cells (MSC) using a novel spherical bilaminar pellet culture system where one cell type is enclosed in a sphere of the other cell type. Our 3D system provides a structure that exploits embryonic processes such as tissue induction and condensation. We observed a unique phenomenon: the budding of co-culture pellets and the formation of satellite pellets that separate from the main pellet.
Methods: MSC and NPC co-culture pellets were formed with three different structural organizations. The first had random organization. The other two had bilaminar organization with either MSC inside and NPC outside or NPC inside and MSC outside.
Results: By 14 days, all co-culture pellets exhibited budding and spontaneously generated satellite pellets. The satellite pellets were composed of both cell types and, surprisingly, all had the same bilaminar organization with MSC on the inside and NPC on the outside. This organization was independent of the structure of the main pellet that the satellites stemmed from.
Conclusion: The main pellets generated satellite pellets that spontaneously organized into a bilaminar structure. This implies that structural organization occurs naturally in this cell culture system and may be inherently favorable for cell-based tissue engineering strategies. The occurrence of budding and the organization of satellite pellets may have important implications for the use of co-culture pellets in cell-based therapies for disc regeneration.
Clinical relevance: From a therapeutic point of view, the generation of satellite pellets may be a beneficial feature that would serve to spread donor cells throughout the host matrix and restore normal matrix composition in a sustainable way, ultimately renewing tissue function.
{"title":"Co-culture of Adult Mesenchymal Stem Cells and Nucleus Pulposus Cells in Bilaminar Pellets for Intervertebral Disc Regeneration.","authors":"Aliza A Allon, Richard A Schneider, Jeffrey C Lotz","doi":"10.1016/SASJ-2009-0005-NT","DOIUrl":"https://doi.org/10.1016/SASJ-2009-0005-NT","url":null,"abstract":"<p><strong>Background: </strong>Our goal is to optimize stem cell-based tissue engineering strategies in the context of the intervertebral disc environment. We explored the benefits of co-culturing nucleus pulposus cells (NPC) and adult mesenchymal stem cells (MSC) using a novel spherical bilaminar pellet culture system where one cell type is enclosed in a sphere of the other cell type. Our 3D system provides a structure that exploits embryonic processes such as tissue induction and condensation. We observed a unique phenomenon: the budding of co-culture pellets and the formation of satellite pellets that separate from the main pellet.</p><p><strong>Methods: </strong>MSC and NPC co-culture pellets were formed with three different structural organizations. The first had random organization. The other two had bilaminar organization with either MSC inside and NPC outside or NPC inside and MSC outside.</p><p><strong>Results: </strong>By 14 days, all co-culture pellets exhibited budding and spontaneously generated satellite pellets. The satellite pellets were composed of both cell types and, surprisingly, all had the same bilaminar organization with MSC on the inside and NPC on the outside. This organization was independent of the structure of the main pellet that the satellites stemmed from.</p><p><strong>Conclusion: </strong>The main pellets generated satellite pellets that spontaneously organized into a bilaminar structure. This implies that structural organization occurs naturally in this cell culture system and may be inherently favorable for cell-based tissue engineering strategies. The occurrence of budding and the organization of satellite pellets may have important implications for the use of co-culture pellets in cell-based therapies for disc regeneration.</p><p><strong>Clinical relevance: </strong>From a therapeutic point of view, the generation of satellite pellets may be a beneficial feature that would serve to spread donor cells throughout the host matrix and restore normal matrix composition in a sustainable way, ultimately renewing tissue function.</p>","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"3 2","pages":"41-9"},"PeriodicalIF":0.0,"publicationDate":"2009-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/bc/b2/SAS-3-2009-0005-NT.PMC4365592.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33154944","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 : 2009-06-01DOI: 10.1016/S1935-9810(09)70009-X
Fred Mo MD , James Yue MD , Jianghui Zhang MD , Kreg Howk MS , Allister Williams MD
Background
Adhesion formation after spine surgery is a result of normal wound healing that may place patients at increased risk for complications during revision surgery. Preventing adhesions could reduce the risk of complications during revision surgery, and possibly reduce the need for revision procedures. This study evaluates the ability of DuraSeal Xact Adhesion Barrier System (DSX) (Covidien, Mansfield, Massachusetts) and Oxiplex/SP gel (OX) (FzioMed, San Luis Obispo, California) to affect the extent and severity of postoperative perivascular adhesion development in an anterior spinal surgical rabbit model.
Methods
We determined the extent and severity of postoperative adhesion development 34 days after surgery in 12 male New Zealand White rabbits randomly assigned to intraoperative treatment with either DSX or OX, or to an untreated control group. Adhesion severity and extent were scored on scale from 0 (none) to 3 (severe).
Results
The extent and severity of adhesions in the DSX group were significantly less than in the untreated control group. The DSX group mean extent score was 1.3 ± 0.5 (vs 2.5, P = .01) and the mean severity score was 1.25 ± 0.5 (vs 2.8, P = .005). The extent and severity of adhesions in the OX group were not significantly different from the control group.
Conclusion
In this study, we found DSX to be the most effective compound in preventing adhesion formation after anterior spine surgery.
Clinical Relevance
Extrapolating these results in rabbits to humans, less scarring between the major blood vessels could decrease the rate of complications in revision spine procedures.
脊柱手术后粘连的形成是伤口正常愈合的结果,这可能使患者在翻修手术中出现并发症的风险增加。预防粘连可以减少翻修手术中并发症的风险,并可能减少翻修手术的需要。本研究评估DuraSeal Xact粘连屏障系统(DSX) (Covidien, Mansfield, Massachusetts)和oxplex /SP凝胶(OX) (FzioMed, San Luis Obispo, California)在兔脊柱前路手术模型中影响术后血管周围粘连发展的程度和严重程度的能力。方法对12只雄性新西兰大白兔进行术后34天粘连程度和严重程度的测定,这些雄性新西兰大白兔被随机分为术中给予DSX或OX治疗组和未给予治疗的对照组。粘附严重程度和程度评分从0(无)到3(严重)。结果DSX组的粘连程度和严重程度均明显小于未治疗对照组。DSX组平均程度评分为1.3±0.5 (vs 2.5, P = 0.01),平均严重程度评分为1.25±0.5 (vs 2.8, P = 0.005)。OX组的粘连程度和严重程度与对照组无显著差异。结论在本研究中,我们发现DSX是预防脊柱前路手术后粘连形成最有效的化合物。临床相关性将这些结果从兔子到人类进行推断,减少主要血管之间的疤痕可以降低脊柱翻修手术的并发症发生率。
{"title":"Evaluation of Perivascular Adhesion Formation in New Zealand White Rabbits Using Oxiplex and DuraSeal Xact Adhesion Barrier System","authors":"Fred Mo MD , James Yue MD , Jianghui Zhang MD , Kreg Howk MS , Allister Williams MD","doi":"10.1016/S1935-9810(09)70009-X","DOIUrl":"https://doi.org/10.1016/S1935-9810(09)70009-X","url":null,"abstract":"<div><h3>Background</h3><p>Adhesion formation after spine surgery is a result of normal wound healing that may place patients at increased risk for complications during revision surgery. Preventing adhesions could reduce the risk of complications during revision surgery, and possibly reduce the need for revision procedures. This study evaluates the ability of DuraSeal Xact Adhesion Barrier System (DSX) (Covidien, Mansfield, Massachusetts) and Oxiplex/SP gel (OX) (FzioMed, San Luis Obispo, California) to affect the extent and severity of postoperative perivascular adhesion development in an anterior spinal surgical rabbit model.</p></div><div><h3>Methods</h3><p>We determined the extent and severity of postoperative adhesion development 34 days after surgery in 12 male New Zealand White rabbits randomly assigned to intraoperative treatment with either DSX or OX, or to an untreated control group. Adhesion severity and extent were scored on scale from 0 (none) to 3 (severe).</p></div><div><h3>Results</h3><p>The extent and severity of adhesions in the DSX group were significantly less than in the untreated control group. The DSX group mean extent score was 1.3<!--> <!-->±<!--> <!-->0.5 (vs 2.5, P<!--> <!-->=<!--> <!-->.01) and the mean severity score was 1.25<!--> <!-->±<!--> <!-->0.5 (vs 2.8, P<!--> <!-->=<!--> <!-->.005). The extent and severity of adhesions in the OX group were not significantly different from the control group.</p></div><div><h3>Conclusion</h3><p>In this study, we found DSX to be the most effective compound in preventing adhesion formation after anterior spine surgery.</p></div><div><h3>Clinical Relevance</h3><p>Extrapolating these results in rabbits to humans, less scarring between the major blood vessels could decrease the rate of complications in revision spine procedures.</p></div>","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"3 2","pages":"Pages 68-76"},"PeriodicalIF":0.0,"publicationDate":"2009-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S1935-9810(09)70009-X","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"137345082","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-2008-0022-RR
Paul C McAfee, Bryan W Cunningham, P Justin Tortolani, Ira L Fedder, John C Sefter, Charles Davis
Background: This prospective study analyzes the perioperative outcomes and long-term fusion success of 100 consecutive lumbar degenerative cases. The cases were managed using a non-threaded locking screw system, in conjunction with polyetheretherketone (PEEK) cages, for posterior lumbar interbody fusion (PLIF) procedures. These 100 cases were compared to another prospective study treating patients with the same inclusion and exclusion criteria using conventional plate-based pedicle screw spinal instrumentation augmented with carbon fiber interbody cages.
Methods: A total of 167 operative levels were treated in 100 patients (51 single-level, 39 two-level and 10 three-level cases). Eleven cases were revisions and 67 patients received interbody fusion cages. Patients had an average of 22.8 ± 4.0 months followup.
Results: There was one instrumentation failure but no significant subsidence at the interbody fusion level. The disc space height was restored as part of the surgical procedure at the interbody cage levels: from 7.5 ± 2.3 mm preoperative to 9.0 ± 2.1 mm postoperative. There were 2 cases of pseudarthrosis (2 / 100 = 2%). The average operative time for 1-level cases was 111 ± 25 minutes; for 2-level cases it was 132.4 ± 21.8 minutes; and for 3-level cases it was 162.6 ± 33 minutes. Blood loss averaged 800 ± 473 cc for 1-level cases, 1055 ± 408 cc for 2 levels, and 1155 ± 714 cc for 3 levels. The length of stay was similar between the 3 groups (4.4 ± 1.2 days for single-level cases, 4.7 ± 1.1 for 2 levels, and 5.0 ± 1.1 for 3 levels; P > .05). There were 3 incidental durotomies, and 4 other patients developed infections postoperatively that required reoperation.
Conclusion: The disc and foraminal heights can be restored and maintained with a unilateral cage and pedicle screw construct. Unilateral transforaminal lumbar interbody fusion using a PEEK cage combined with a non-threaded locking pedicle screw and rod system results in similar fusion rates to those achieved using the bilateral Brantigan interbody fusion cage or a single BAK Vista implant. When compared to the bilateral Brantigan cages, decreased operative time (P < .001), decreased blood loss (P < .001) and reduced incidence of dural tears (P < .001) are advantages of using a non-threaded locking screw system and single PEEK interbody cage for lumbar degenerative conditions without compromising subsequent fusion rates.
{"title":"100 consecutive cases of degenerative lumbar conditions using a non-threaded locking screw system with a 90-degree locking cap.","authors":"Paul C McAfee, Bryan W Cunningham, P Justin Tortolani, Ira L Fedder, John C Sefter, Charles Davis","doi":"10.1016/SASJ-2008-0022-RR","DOIUrl":"https://doi.org/10.1016/SASJ-2008-0022-RR","url":null,"abstract":"<p><strong>Background: </strong>This prospective study analyzes the perioperative outcomes and long-term fusion success of 100 consecutive lumbar degenerative cases. The cases were managed using a non-threaded locking screw system, in conjunction with polyetheretherketone (PEEK) cages, for posterior lumbar interbody fusion (PLIF) procedures. These 100 cases were compared to another prospective study treating patients with the same inclusion and exclusion criteria using conventional plate-based pedicle screw spinal instrumentation augmented with carbon fiber interbody cages.</p><p><strong>Methods: </strong>A total of 167 operative levels were treated in 100 patients (51 single-level, 39 two-level and 10 three-level cases). Eleven cases were revisions and 67 patients received interbody fusion cages. Patients had an average of 22.8 ± 4.0 months followup.</p><p><strong>Results: </strong>There was one instrumentation failure but no significant subsidence at the interbody fusion level. The disc space height was restored as part of the surgical procedure at the interbody cage levels: from 7.5 ± 2.3 mm preoperative to 9.0 ± 2.1 mm postoperative. There were 2 cases of pseudarthrosis (2 / 100 = 2%). The average operative time for 1-level cases was 111 ± 25 minutes; for 2-level cases it was 132.4 ± 21.8 minutes; and for 3-level cases it was 162.6 ± 33 minutes. Blood loss averaged 800 ± 473 cc for 1-level cases, 1055 ± 408 cc for 2 levels, and 1155 ± 714 cc for 3 levels. The length of stay was similar between the 3 groups (4.4 ± 1.2 days for single-level cases, 4.7 ± 1.1 for 2 levels, and 5.0 ± 1.1 for 3 levels; P > .05). There were 3 incidental durotomies, and 4 other patients developed infections postoperatively that required reoperation.</p><p><strong>Conclusion: </strong>The disc and foraminal heights can be restored and maintained with a unilateral cage and pedicle screw construct. Unilateral transforaminal lumbar interbody fusion using a PEEK cage combined with a non-threaded locking pedicle screw and rod system results in similar fusion rates to those achieved using the bilateral Brantigan interbody fusion cage or a single BAK Vista implant. When compared to the bilateral Brantigan cages, decreased operative time (P < .001), decreased blood loss (P < .001) and reduced incidence of dural tears (P < .001) are advantages of using a non-threaded locking screw system and single PEEK interbody cage for lumbar degenerative conditions without compromising subsequent fusion rates.</p>","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"3 1","pages":"1-11"},"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/bb/de/SAS-3-2008-0022-RR.PMC4365587.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33154940","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)70003-9
Fred H. Geisler MD PhD , Paul C. McAfee MD , Robert J. Banco MD , Scott L. Blumenthal MD , Richard D. Guyer MD , Richard T. Holt MD , Mohamed E. Majd MD
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 clini
{"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 MD PhD , Paul C. McAfee MD , Robert J. Banco MD , Scott L. Blumenthal MD , Richard D. Guyer MD , Richard T. Holt MD , Mohamed E. Majd MD","doi":"10.1016/S1935-9810(09)70003-9","DOIUrl":"https://doi.org/10.1016/S1935-9810(09)70003-9","url":null,"abstract":"<div><h3>Background</h3><p>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></div><div><h3>Methods</h3><p>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></div><div><h3>Results</h3><p>In the arthroplasty group, all subgroups had statistically significant VAS improvements from baseline (VAS change from baseline: ASG<!--> <!-->=<!--> <!-->-36.6<!--> <!-->±<!--> <!-->29.6, <em>P</em> <!--><<!--> <!-->0.0001; ADG<!--> <!-->=<!--> <!-->-40.2<!--> <!-->±<!--> <!-->30.9, <em>P</em> <!-->=<!--> <!-->0.0002; ANG<!--> <!-->=<!--> <!-->-36.5<!--> <!-->±<!--> <!-->34.6, <em>P</em> <!--><<!--> <!-->0.0001). There was no statistical difference between subgroups (<em>P</em> <!-->=<!--> <!-->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, <em>P</em> <!--><<!--> <!-->0.0001; FSG<!--> <!-->=<!--> <!-->-24.2<!--> <!-->±<!--> <!-->36.4, <em>P</em> <!-->=<!--> <!-->0.0444; FDG<!--> <!-->=<!--> <!-->-26.7<!--> <!-->±<!--> <!-->38.7, <em>P</em> <!-->=<!--> <!-->0.2188). A trend of decreased VAS improvements was observed for FSG versus FNG (<em>P</em> <!-->=<!--> <!-->0.0703) subgroups. Similar findings and trends were observed in ODI scores (Changes in ODI from baseline: ASG<!--> <!-->=<!--> <!-->-20.4<!--> <!-->±<!--> <!-->23.8, <em>P</em> <!--><<!--> <!-->0.0001; ANG<!--> <!-->=<!--> <!-->-26.6±21.1, <em>P</em> <!--><<!--> <!-->0.0001; ADG= -17.6<!--> <!-->±<!--> <!-->28.6, <em>P</em> <!-->=<!--> <!-->0.0116; FSG<!--> <!-->=<!--> <!-->-14.5<!--> <!-->±<!--> <!-->21.2, <em>P</em> <!-->=<!--> <!-->0.0303; FNG= -32.5<!--> <!-->±<!--> <!-->22.6, <em>P</em> <!--><<!--> <!-->0.0001; FDG<!--> <!-->=<!--> <!-->-10.7<!--> <!-->±<!--> <!-->9.4, <em>P</em> <!-->=<!--> <!-->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></div><div><h3>Conclusions</h3><p>Arthroplasty patients with prior surgery or prior discectomy had similar clini","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"3 1","pages":"Pages 17-25"},"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)70003-9","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"137355399","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-2008-0026-CR
Ding Wenyuan, Li Baojun, Shen Yong, Zhang Wei, Zhang Yingze
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, Li Baojun, Shen Yong, Zhang Wei, Zhang Yingze","doi":"10.1016/SASJ-2008-0026-CR","DOIUrl":"https://doi.org/10.1016/SASJ-2008-0026-CR","url":null,"abstract":"<p><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. 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. </p>","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"3 1","pages":"12-6"},"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/d0/b7/SAS-3-2008-0026-CR.PMC4365589.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33154941","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)70001-5
Paul C. McAfee MD , Bryan W. Cunningham MSc , P. Justin Tortolani MD , Ira L. Fedder MD , John C. Sefter DO , Charles Davis MD
Background
This prospective study analyzes the perioperative outcomes and long-term fusion success of 100 consecutive lumbar degenerative cases. The cases were managed using a non-threaded locking screw system, in conjunction with polyetheretherketone (PEEK) cages, for posterior lumbar interbody fusion (PLIF) procedures. These 100 cases were compared to another prospective study treating patients with the same inclusion and exclusion criteria using conventional plate-based pedicle screw spinal instrumentation augmented with carbon fiber interbody cages.
Methods
A total of 167 operative levels were treated in 100 patients (51 single-level, 39 two-level and 10 three-level cases). Eleven cases were revisions and 67 patients received interbody fusion cages. Patients had an average of 22.8 ± 4.0 months follow-up. Results: There was one instrumentation failure but no significant subsidence at the interbody fusion level. The disc space height was restored as part of the surgical procedure at the interbody cage levels: from 7.5 ± 2.3 mm preoperative to 9.0 ± 2.1 mm postoperative. There were 2 cases of pseudarthrosis (2 / 100 = 2%). The average operative time for 1-level cases was 111 ± 25 minutes; for 2-level cases it was 132.4 ± 21.8 minutes; and for 3-level cases it was 162.6 ± 33 minutes. Blood loss averaged 800 ± 473 cc for 1-level cases, 1055 ± 408 cc for 2 levels, and 1155 ± 714 cc for 3 levels. The length of stay was similar between the 3 groups (4.4 ± 1.2 days for single-level cases, 4.7 ± 1.1 for 2 levels, and 5.0 ± 1.1 for 3 levels; P > .05). There were 3 incidental durotomies, and 4 other patients developed infections postoperatively that required reoperation.
Conclusion
The disc and foraminal heights can be restored and maintained with a unilateral cage and pedicle screw construct. Unilateral transforaminal lumbar interbody fusion using a PEEK cage combined with a non-threaded locking pedicle screw and rod system results in similar fusion rates to those achieved using the bilateral Brantigan interbody fusion cage or a single BAK Vista implant. When compared to the bilateral Brantigan cages, decreased operative time (P < .001), decreased blood loss (P < .001) and reduced incidence of dural tears (P < .001) are advantages of using a non-threaded locking screw system and single PEEK interbody cage for lumbar degenerative conditions without compromising subsequent fusion rates.
{"title":"100 Consecutive Cases of Degenerative Lumbar Conditions Using a Non-Threaded Locking Screw System With a 90-Degree Locking Cap","authors":"Paul C. McAfee MD , Bryan W. Cunningham MSc , P. Justin Tortolani MD , Ira L. Fedder MD , John C. Sefter DO , Charles Davis MD","doi":"10.1016/S1935-9810(09)70001-5","DOIUrl":"https://doi.org/10.1016/S1935-9810(09)70001-5","url":null,"abstract":"<div><h3>Background</h3><p>This prospective study analyzes the perioperative outcomes and long-term fusion success of 100 consecutive lumbar degenerative cases. The cases were managed using a non-threaded locking screw system, in conjunction with polyetheretherketone (PEEK) cages, for posterior lumbar interbody fusion (PLIF) procedures. These 100 cases were compared to another prospective study treating patients with the same inclusion and exclusion criteria using conventional plate-based pedicle screw spinal instrumentation augmented with carbon fiber interbody cages.</p></div><div><h3>Methods</h3><p>A total of 167 operative levels were treated in 100 patients (51 single-level, 39 two-level and 10 three-level cases). Eleven cases were revisions and 67 patients received interbody fusion cages. Patients had an average of 22.8<!--> <!-->±<!--> <!-->4.0 months follow-up. Results: There was one instrumentation failure but no significant subsidence at the interbody fusion level. The disc space height was restored as part of the surgical procedure at the interbody cage levels: from 7.5<!--> <!-->±<!--> <!-->2.3<!--> <!-->mm preoperative to 9.0<!--> <!-->±<!--> <!-->2.1<!--> <!-->mm postoperative. There were 2 cases of pseudarthrosis (2 / 100<!--> <!-->=<!--> <!-->2%). The average operative time for 1-level cases was 111<!--> <!-->±<!--> <!-->25<!--> <!-->minutes; for 2-level cases it was 132.4<!--> <!-->±<!--> <!-->21.8<!--> <!-->minutes; and for 3-level cases it was 162.6<!--> <!-->±<!--> <!-->33<!--> <!-->minutes. Blood loss averaged 800<!--> <!-->±<!--> <!-->473<!--> <!-->cc for 1-level cases, 1055<!--> <!-->±<!--> <!-->408<!--> <!-->cc for 2 levels, and 1155<!--> <!-->±<!--> <!-->714<!--> <!-->cc for 3 levels. The length of stay was similar between the 3 groups (4.4<!--> <!-->±<!--> <!-->1.2 days for single-level cases, 4.7<!--> <!-->±<!--> <!-->1.1 for 2 levels, and 5.0<!--> <!-->±<!--> <!-->1.1 for 3 levels; <em>P</em> <!-->><!--> <!-->.05). There were 3 incidental durotomies, and 4 other patients developed infections postoperatively that required reoperation.</p></div><div><h3>Conclusion</h3><p>The disc and foraminal heights can be restored and maintained with a unilateral cage and pedicle screw construct. Unilateral transforaminal lumbar interbody fusion using a PEEK cage combined with a non-threaded locking pedicle screw and rod system results in similar fusion rates to those achieved using the bilateral Brantigan interbody fusion cage or a single BAK Vista implant. When compared to the bilateral Brantigan cages, decreased operative time (<em>P</em> <!--><<!--> <!-->.001), decreased blood loss (<em>P</em> <!--><<!--> <!-->.001) and reduced incidence of dural tears (<em>P</em> <!--><<!--> <!-->.001) are advantages of using a non-threaded locking screw system and single PEEK interbody cage for lumbar degenerative conditions without compromising subsequent fusion rates.</p></div>","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"3 1","pages":"Pages 1-11"},"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)70001-5","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"92091870","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 : 2009-03-01DOI: 10.1016/S1935-9810(09)70005-2
Henrik Weber MD
Two hundred eighty patients with herniated lumbar discs, verified by radiculography, were divided into three groups. One group, which mainly will be dealt with in this paper, consisted of 126 patients with uncertain indication for surgical treatment, who had their therapy decided by randomization which permitted comparison between the results of surgical and conservative treatment. Another group comprising 67 patients had symptoms and signs that beyond doubt, required surgical therapy. The third group of 87 patients was treated conservatively because there was no indication for operative intervention. Follow-up examinations in the first group were performed after one, four, and ten years.
The controlled trial showed a statistically significant better result in the surgically treated group at the one-year follow-up examination. After four years the operated patients still showed better results, but the difference was no longer statistically significant. Only minor changes took place during the last six years of observation.
{"title":"Lumbar Disc Herniation: A Controlled, Prospective Study with Ten Years of Observation","authors":"Henrik Weber MD","doi":"10.1016/S1935-9810(09)70005-2","DOIUrl":"https://doi.org/10.1016/S1935-9810(09)70005-2","url":null,"abstract":"<div><p>Two hundred eighty patients with herniated lumbar discs, verified by radiculography, were divided into three groups. One group, which mainly will be dealt with in this paper, consisted of 126 patients with uncertain indication for surgical treatment, who had their therapy decided by randomization which permitted comparison between the results of surgical and conservative treatment. Another group comprising 67 patients had symptoms and signs that beyond doubt, required surgical therapy. The third group of 87 patients was treated conservatively because there was no indication for operative intervention. Follow-up examinations in the first group were performed after one, four, and ten years.</p><p>The controlled trial showed a statistically significant better result in the surgically treated group at the one-year follow-up examination. After four years the operated patients still showed better results, but the difference was no longer statistically significant. Only minor changes took place during the last six years of observation.</p></div>","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"3 1","pages":"Pages 30-40"},"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)70005-2","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"92013092","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}