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Bibliometric Patent Review of Minimally Invasive Spine Surgery. 微创脊柱手术的文献专利回顾。
IF 1.6 4区 医学 Q3 CLINICAL NEUROLOGY Pub Date : 2024-08-02 DOI: 10.1097/BSD.0000000000001661
Bashar Zaidat, Wasil Ahmed, Junho Song, Noor Maza, Nancy Shrestha, Rami Rajjoub, Suhas Etigunta, Jun S Kim, Samuel K Cho

Study design: This study analyzes patents associated with minimally invasive spine surgery (MISS) found on the Lens open online platform.

Objective: The goal of this research was to provide an overview of the most referenced patents in the field of MISS and to uncover patterns in the evolution and categorization of these patents.

Summary of background data: MISS has rapidly progressed, with a core focus on minimizing surgical damage, preserving the natural anatomy, and enabling swift recovery, all while achieving outcomes that rival traditional open surgery. While prior studies have primarily concentrated on MISS outcomes, the analysis of MISS patents has been limited.

Methods: To conduct this study, we used the Lens platform to search for patents that included the terms "minimally invasive" and "spine" in their titles, abstracts, or claims. We then categorized these patents and identified the top 100 with the most forward citations. We further classified these patents into 4 categories: Spinal Stabilization Systems, Joint Implants or Procedures, Screw Delivery System or Method, and Access and Surgical Pathway Formation.

Results: Five hundred two MISS patents were identified initially, and 276 were retained following a screening process. Among the top 100 patents, the majority had active legal status. The largest category within the top 100 patents was Access and Surgical Pathway Formation, closely followed by Spinal Stabilization Systems and Joint Implants or Procedures. The smallest category was Screw Delivery System or Method. Notably, the majority of the top 100 patents had priority years falling between 2000 and 2009, indicating a moderate positive correlation between patent rank and priority year.

Conclusions: Thus far, patents related to Access and Surgical Pathway Formation have laid the foundation for subsequent innovations in Spinal Stabilization Systems and Screw Technology. This study serves as a valuable resource for guiding future innovations in this rapidly evolving field.

研究设计:本研究分析了Lens开放在线平台上与微创脊柱手术(MISS)相关的专利:本研究的目的是概述微创脊柱手术领域被引用最多的专利,并揭示这些专利的演变和分类模式:MISS 技术发展迅速,其核心重点是最大限度地减少手术损伤、保留自然解剖结构和实现快速恢复,同时取得可与传统开腹手术相媲美的效果。虽然之前的研究主要集中在 MISS 的结果上,但对 MISS 专利的分析却很有限:为了开展这项研究,我们使用 Lens 平台搜索在标题、摘要或权利要求中包含 "微创 "和 "脊柱 "术语的专利。然后,我们对这些专利进行了分类,并确定了被引用次数最多的前 100 项专利。我们进一步将这些专利分为 4 类:脊柱稳定系统、关节植入物或程序、螺钉输送系统或方法以及通道和手术路径形成:初步确定了 5002 项 MISS 专利,经过筛选后保留了 276 项。在排名前 100 位的专利中,大多数都具有有效的法律地位。前 100 项专利中最大的类别是 "进入和手术路径形成",紧随其后的是 "脊柱稳定系统 "和 "关节植入物或程序"。最小的类别是螺钉输送系统或方法。值得注意的是,排名前 100 的专利中,大多数的优先权年限在 2000 年至 2009 年之间,这表明专利排名与优先权年限之间存在适度的正相关性:到目前为止,与入路和手术路径形成相关的专利为脊柱稳定系统和螺钉技术的后续创新奠定了基础。这项研究是指导这一快速发展领域未来创新的宝贵资源。
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引用次数: 0
First In Vivo Electromyographic Analysis of Mechanical Load Scenarios of the Cervicothoracic Junction During Daily Activities as a Basis for Future Postoperative Behavioral Instructions. 首次对日常活动中颈胸交界处的机械负荷情景进行体内肌电图分析,作为未来术后行为指导的基础。
IF 1.6 4区 医学 Q3 CLINICAL NEUROLOGY Pub Date : 2024-08-02 DOI: 10.1097/BSD.0000000000001655
Bennet Mathis Schröder, Heiko Koller, Emmanouil Liodakis, Stephan Sehmisch, Sonja Körner, Sebastian Decker

Study design: Clinical Research.

Objectives: Study participants were twenty- eigth healty volunteers.

Background: Soft tissue complications after posterior cervicothoracic fusion surgery occur frequently. Postoperative myofascial dehiscence (PMD) can cause disability and pain. So far, it is unknown whether patients can affect PMD development through behavioral adjustment. Consequently, this study aimed to analyze how much mechanical stress daily activities exert on the posterior muscles and fascia at the cervicothoracic junction.

Materials and methods: Surface electromyography was applied next to the upper thoracic spine at the trapezius muscle. All volunteers performed 22 different daily activities, such as tooth brushing, dressing, standing up, and different horizontal positions. During the exercises, the electromyographic activity was measured. For each volunteer, root mean square values were determined. All exercises were then repeated with the use of a clavicular bandage to unload the shoulder and cervicothoracic muscles. Afterwards, the rankings were statistically compared interindividually.

Results: Among the different tasks, significant differences in regard to the root mean square values were noted. For instance, horizontal positions caused significantly lower muscle activation compared with all other exercises (P≤ 0.001). Notably, no relevant electromyographic differences were detected between the tasks with and without a clavicular bandage.

Conclusions: This in vivo electromyographic analysis of cervicothoracic muscle activity during daily activities demonstrates that myofascial strain differs among various daily activities. Data indicate that potential postoperative mobilization protocols and behavioral instructions may have the potential to reduce the biomechanical load and consequently the risk of PMD and, therefore, may reduce the risk for surgical wound-related complications, disability, and need for revision surgery.

研究设计临床研究:背景:颈胸椎后路融合手术后经常出现软组织并发症:背景:颈胸椎后路融合手术后经常会出现软组织并发症。背景:颈胸椎后路融合术后软组织并发症经常发生,术后肌筋膜开裂(PMD)可导致残疾和疼痛。迄今为止,患者能否通过行为调整来影响肌筋膜开裂的发生尚不清楚。因此,本研究旨在分析日常活动对颈胸交界处后部肌肉和筋膜造成的机械压力:在上胸椎斜方肌旁应用表面肌电图。所有志愿者进行了 22 种不同的日常活动,如刷牙、穿衣、站立和不同的水平姿势。在运动过程中,对肌电活动进行了测量。每个志愿者的均方根值都已确定。然后,在使用锁骨绷带减轻肩部和颈胸肌肉负担的情况下重复所有练习。之后,对个人之间的排名进行统计比较:结果:在不同的任务中,均方根值存在明显差异。例如,与所有其他练习相比,水平姿势引起的肌肉激活明显较低(P≤ 0.001)。值得注意的是,有锁骨绷带和无锁骨绷带的任务之间没有发现相关的肌电图差异:这项对日常活动中颈胸肌活动的活体肌电图分析表明,肌筋膜劳损在不同的日常活动中存在差异。数据表明,潜在的术后活动方案和行为指导有可能减轻生物力学负荷,从而降低 PMD 的风险,进而降低手术伤口相关并发症、残疾和翻修手术需求的风险。
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引用次数: 0
Does Medicare Insurance Mitigate Racial/Ethnic Disparities in Access to Lumbar Spinal Surgery When Compared to Commercial Insurance? 与商业保险相比,医疗保险是否能减少腰椎手术治疗中的种族/族裔差异?
IF 1.6 4区 医学 Q3 CLINICAL NEUROLOGY Pub Date : 2024-08-01 Epub Date: 2024-02-19 DOI: 10.1097/BSD.0000000000001576
Michael M Herrera, Justin Tiao, Ashley Rosenberg, Nicole Zubizarreta, Jashvant Poeran, Saad B Chaudhary

Study design: Retrospective cohort study.

Objective: Compare disparities in lumbar surgical care utilization in Commercially insured versus Medicare patients.

Summary of background data: While disparities in spinal surgery have been previously described, less evidence exists on effective strategies to mitigate them. Theoretically, universal health care coverage under Medicare should improve health care access.

Materials and methods: Utilizing National Inpatient Sample data (2003-2018), we included inpatient lumbar discectomy or laminectomy/fusion cases in black, white, or Hispanic patients aged 18-74 years, with Commercial or Medicare insurance. A multivariable Poisson distribution model determined race/ethnicity subgroup-specific rate ratios (RRs) of patients undergoing lumbar surgery compared to their respective population distribution (using US Census data) based on race/ethnicity, region, gender, primary payor, and age (Commercially insured age subgroups: 18-39, 40-54, and 55-64 y; Medicare age subgroup: 65-74 y).

Results: Of the 2,310,956 lumbar spine procedures included, 88.9%, 6.1%, and 5.0% represented white, black, and Hispanic patients, respectively. Among Commercially insured patients, black and Hispanic (compared to white) patients had lower rates of surgical care utilization; however, these disparities decreased with increasing age: black (RR=0.37, 95% CI: 0.37-0.38) and Hispanic patients (RR=0.53, 95% CI: 0.52-0.54) aged 18-39 years versus black (RR=0.72, 95% CI: 0.71-0.73) and Hispanic patients (RR=0.64, 95% CI: 0.63-0.65) aged 55-64 years. Racial/ethnic disparities persisted in Medicare patients, especially when compared to the neighboring age subgroup that was Commercially insured: black (RR=0.61, 95% CI: 0.60-0.62) and Hispanic patients (RR=0.61, 95% CI: 0.60-0.61) under Medicare.

Conclusions: Disparities in surgical care utilization among black and Hispanic patients persist regardless of health care coverage, and an expansion of Medicare eligibility alone may not comprehensively address health care disparities.

Level of evidence: Level III.

研究设计回顾性队列研究:比较商业保险患者与医疗保险患者在腰椎手术治疗利用率方面的差异:虽然脊柱外科手术中的差异以前就有描述,但关于缓解这些差异的有效策略的证据较少。从理论上讲,医疗保险下的全民医保应能改善医疗服务的可及性:利用全国住院病人抽样数据(2003-2018 年),我们纳入了住院腰椎间盘切除术或椎板切除术/融合术病例,患者为黑人、白人或西班牙裔,年龄在 18-74 岁之间,有商业保险或医疗保险。多变量泊松分布模型根据种族/人种、地区、性别、主要付款人和年龄(商业保险年龄亚组:18-39 岁、40-54 岁和 55-64 岁;医疗保险年龄亚组:65-74 岁),确定接受腰椎手术患者的种族/人种亚组特异性比率(RRs)与各自的人口分布(使用美国人口普查数据):结果:在纳入的 2,310,956 例腰椎手术中,白人、黑人和西班牙裔患者分别占 88.9%、6.1% 和 5.0%。在参加商业保险的患者中,黑人和西语裔患者(与白人相比)的手术护理使用率较低;但是,随着年龄的增长,这些差异有所减小:18-39 岁的黑人(RR=0.37,95% CI:0.37-0.38)和西语裔患者(RR=0.53,95% CI:0.52-0.54)与55-64 岁的黑人(RR=0.72,95% CI:0.71-0.73)和西语裔患者(RR=0.64,95% CI:0.63-0.65)相比。医疗保险患者的种族/族裔差异依然存在,尤其是与商业保险的邻近年龄亚组相比:医疗保险下的黑人(RR=0.61,95% CI:0.60-0.62)和西班牙裔患者(RR=0.61,95% CI:0.60-0.61):结论:无论医疗保险的覆盖范围如何,黑人和西班牙裔患者在手术治疗利用率方面的差距依然存在,仅扩大医疗保险的覆盖范围可能无法全面解决医疗差距问题:证据等级:三级。
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引用次数: 0
A Retrospective Comparative Analysis on the Effect of Tranexamic Acid to Reduce Perioperative Blood Loss in Patients Undergoing Cervical Spine Surgery. 氨甲环酸减少颈椎手术患者围手术期失血量效果的回顾性对比分析
IF 1.6 4区 医学 Q3 CLINICAL NEUROLOGY Pub Date : 2024-08-01 Epub Date: 2024-02-20 DOI: 10.1097/BSD.0000000000001592
Adam J Money, Guillaume Dumont, Sean Sheppard, J Benjamin Jackson, Michael Spitnale, Yianni Bakaes, Chase Gauthier, Gregory Grabowski

Study design: Retrospective Cohort Study.

Objective: The purpose of this study is to assess the impact of intravenous TXA on blood loss outcomes in anterior, posterior, and combined approaches for elective cervical spine surgery.

Summary of background data: Tranexamic acid (TXA) has been shown to reduce blood loss in a variety of operations, such as lumbar spine surgery. However, limited studies have evaluated the efficacy of TXA in cervical spine surgery.

Methods: We performed a retrospective review of a single surgeon's elective cervical spine operations between September 2011 and March 2017. Patients were divided into 3 groups: anterior approach, posterior approach, or combined approach. Patients were then further subdivided into TXA versus control groups based on whether they received TXA treatment. We performed multiple linear regressions to assess the relationship between the use of TXA and other dependent variables (number of vertebral levels treated, need for a vertebral corpectomy) on total perioperative blood loss, intraoperative estimated blood loss, postoperative drain output, total operative time, postoperative change in hemoglobin, and occurrence of transfusion and/or postoperative deep venous thrombus (DVT).

Results: We found that the use of TXA statistically significantly reduced total perioperative blood loss ( P =0.04) and postoperative drain output ( P =0.004) in posterior surgical approach cervical spine surgery but did not statistically significantly impact any blood loss variables in anterior or combined surgical approaches to elective cervical spine surgery. The use of TXA was a significant predictor for a decrease in intraoperative ( P =0.02) and postoperative ( P <0.01) blood loss.

Conclusions: This study found that TXA statistically significantly decreased total blood loss and postoperative drain output when controlling for multiple confounding factors.

Level of evidence: Level III.

研究设计回顾性队列研究:本研究的目的是评估静脉注射氨甲环酸(TXA)对选择性颈椎手术前路、后路和联合入路失血结果的影响:氨甲环酸(TXA)已被证明可减少腰椎手术等多种手术的失血量。然而,评估氨甲环酸在颈椎手术中疗效的研究却很有限:我们对一名外科医生在 2011 年 9 月至 2017 年 3 月期间的择期颈椎手术进行了回顾性研究。患者被分为三组:前路、后路或联合路。然后根据是否接受 TXA 治疗将患者进一步细分为 TXA 组和对照组。我们进行了多元线性回归,以评估TXA的使用和其他因变量(治疗的椎体水平数、椎体切除术的需要)与围术期总失血量、术中估计失血量、术后引流量、总手术时间、术后血红蛋白变化以及输血和/或术后深静脉血栓(DVT)发生率之间的关系:我们发现,在后路手术入路的颈椎手术中,使用TXA可显著减少围术期总失血量(P=0.04)和术后引流管输出量(P=0.004),但在前路或联合手术入路的择期颈椎手术中,使用TXA对任何失血变量均无显著影响。使用 TXA 可显著预测术中(P=0.02)和术后(PConclusions)失血量的减少:本研究发现,在控制多种混杂因素的情况下,TXA可在统计学上显著降低总失血量和术后引流管输出量:证据等级:三级。
{"title":"A Retrospective Comparative Analysis on the Effect of Tranexamic Acid to Reduce Perioperative Blood Loss in Patients Undergoing Cervical Spine Surgery.","authors":"Adam J Money, Guillaume Dumont, Sean Sheppard, J Benjamin Jackson, Michael Spitnale, Yianni Bakaes, Chase Gauthier, Gregory Grabowski","doi":"10.1097/BSD.0000000000001592","DOIUrl":"10.1097/BSD.0000000000001592","url":null,"abstract":"<p><strong>Study design: </strong>Retrospective Cohort Study.</p><p><strong>Objective: </strong>The purpose of this study is to assess the impact of intravenous TXA on blood loss outcomes in anterior, posterior, and combined approaches for elective cervical spine surgery.</p><p><strong>Summary of background data: </strong>Tranexamic acid (TXA) has been shown to reduce blood loss in a variety of operations, such as lumbar spine surgery. However, limited studies have evaluated the efficacy of TXA in cervical spine surgery.</p><p><strong>Methods: </strong>We performed a retrospective review of a single surgeon's elective cervical spine operations between September 2011 and March 2017. Patients were divided into 3 groups: anterior approach, posterior approach, or combined approach. Patients were then further subdivided into TXA versus control groups based on whether they received TXA treatment. We performed multiple linear regressions to assess the relationship between the use of TXA and other dependent variables (number of vertebral levels treated, need for a vertebral corpectomy) on total perioperative blood loss, intraoperative estimated blood loss, postoperative drain output, total operative time, postoperative change in hemoglobin, and occurrence of transfusion and/or postoperative deep venous thrombus (DVT).</p><p><strong>Results: </strong>We found that the use of TXA statistically significantly reduced total perioperative blood loss ( P =0.04) and postoperative drain output ( P =0.004) in posterior surgical approach cervical spine surgery but did not statistically significantly impact any blood loss variables in anterior or combined surgical approaches to elective cervical spine surgery. The use of TXA was a significant predictor for a decrease in intraoperative ( P =0.02) and postoperative ( P <0.01) blood loss.</p><p><strong>Conclusions: </strong>This study found that TXA statistically significantly decreased total blood loss and postoperative drain output when controlling for multiple confounding factors.</p><p><strong>Level of evidence: </strong>Level III.</p>","PeriodicalId":10457,"journal":{"name":"Clinical Spine Surgery","volume":" ","pages":"E330-E334"},"PeriodicalIF":1.6,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139971164","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Elective Single-Level Primary Anterior Cervical Decompression and Fusion for Degenerative Spondylotic Cervical Myelopathy Is Associated With Decreased Resource Utilization Versus Posterior Cervical Decompression and Fusion. 与颈椎后路减压和融合术相比,选择性单层原发性颈椎前路减压和融合术治疗退行性脊柱颈椎病可减少资源使用。
IF 1.6 4区 医学 Q3 CLINICAL NEUROLOGY Pub Date : 2024-08-01 Epub Date: 2024-02-22 DOI: 10.1097/BSD.0000000000001594
Jerry Y Du, Karim Shafi, Collin W Blackburn, Jens R Chapman, Nicholas U Ahn, Randall E Marcus, Todd J Albert

Study design: Retrospective cohort study.

Objective: To compare elective single-level anterior cervical discectomy and fusion (ACDF) versus posterior cervical decompression and fusion (PCDF) for degenerative cervical myelopathy (DCM) in terms of (1) cost, (2) length of hospital stay, and (3) discharge destination in Medicare patients. A sub-analysis of potential cost drivers was also performed.

Background: In the era of value-based medicine, there is substantial interest in reducing the cost of care. Both ACDF and PCDF are used to treat DCM but carry different morbidity and risk profiles that can impact hospital resource utilization. However, this has not been assessed on a national level.

Methods: Patients undergoing single-level elective ACDF and PCDF surgery were identified using the 2019 Medicare Provider Analysis and Review (MedPAR) Limited Data Set (LDS) and Centers for Medicare and Medicaid Services (CMS) 2019 Impact File. Multivariate models of hospital cost of care, length of stay, and discharge destination were performed, controlling for confounders. A univariate sub-analysis of 9 revenue centers was performed.

Results: In all, 3942 patients met the inclusion criteria. The mean cost of elective single-level cervical fusion for myelopathy was $18,084±10,783, and the mean length of stay was 2.45±2.95 d. On multivariate analysis, ACDF was independently associated with decreased cost of $5,814 ( P <0.001), shorter length of stay by 1.1 days ( P <0.001), and decreased risk of nonhome discharge destination by 58% (adjusted odds ratio: 0.422, P <0.001).On sub-analysis of 9 revenue centers, medical/surgical supply ($10,497, 44%), operating room charges ($5401, 23%), and accommodations ($3999, 17%) were the largest drivers of charge differences.

Conclusions: Single-level elective primary ACDF for DCM was independently associated with decreased cost, decreased hospital length of stay, and a lower rate of nonhome discharge compared with PCDF. Medical and surgical supply, operating room, and accommodation differences between ACDF and PCDF are potential areas for intervention. Increased granularity in reimbursement structures is warranted to prevent the creation of disincentives to the treatment of patients with DCM with pathology that is better addressed with PCDF.

Level of evidence: Level-III Retrospective Cohort Study.

研究设计回顾性队列研究:比较选择性单水平颈椎前路椎间盘切除和融合术(ACDF)与颈椎后路减压和融合术(PCDF)治疗退行性颈椎脊髓病(DCM)在医疗保险患者(1)成本、(2)住院时间和(3)出院目的地方面的差异。此外,还对潜在的成本驱动因素进行了子分析:背景:在以价值为基础的医疗时代,降低医疗成本受到广泛关注。ACDF 和 PCDF 均用于治疗 DCM,但两者的发病率和风险情况不同,可能会影响医院资源的利用。然而,这一点尚未在全国范围内进行评估:使用 2019 年医疗保险提供者分析和审查(MedPAR)有限数据集(LDS)和美国医疗保险和医疗补助服务中心(CMS)2019 年影响文件,确定了接受单层次选择性 ACDF 和 PCDF 手术的患者。在控制混杂因素的基础上,建立了医院护理成本、住院时间和出院目的地的多变量模型。对 9 个收入中心进行了单变量子分析:共有 3942 名患者符合纳入标准。经多变量分析,ACDF与费用减少5814美元(PConclusions:与 PCDF 相比,DCM 的单级选择性初级 ACDF 与费用降低、住院时间缩短和非居家出院率降低密切相关。ACDF 和 PCDF 在医疗和手术供应、手术室和住宿方面的差异是潜在的干预领域。有必要提高报销结构的细化程度,以防止对治疗病理上更适合 PCDF 的 DCM 患者产生抑制作用:三级回顾性队列研究。
{"title":"Elective Single-Level Primary Anterior Cervical Decompression and Fusion for Degenerative Spondylotic Cervical Myelopathy Is Associated With Decreased Resource Utilization Versus Posterior Cervical Decompression and Fusion.","authors":"Jerry Y Du, Karim Shafi, Collin W Blackburn, Jens R Chapman, Nicholas U Ahn, Randall E Marcus, Todd J Albert","doi":"10.1097/BSD.0000000000001594","DOIUrl":"10.1097/BSD.0000000000001594","url":null,"abstract":"<p><strong>Study design: </strong>Retrospective cohort study.</p><p><strong>Objective: </strong>To compare elective single-level anterior cervical discectomy and fusion (ACDF) versus posterior cervical decompression and fusion (PCDF) for degenerative cervical myelopathy (DCM) in terms of (1) cost, (2) length of hospital stay, and (3) discharge destination in Medicare patients. A sub-analysis of potential cost drivers was also performed.</p><p><strong>Background: </strong>In the era of value-based medicine, there is substantial interest in reducing the cost of care. Both ACDF and PCDF are used to treat DCM but carry different morbidity and risk profiles that can impact hospital resource utilization. However, this has not been assessed on a national level.</p><p><strong>Methods: </strong>Patients undergoing single-level elective ACDF and PCDF surgery were identified using the 2019 Medicare Provider Analysis and Review (MedPAR) Limited Data Set (LDS) and Centers for Medicare and Medicaid Services (CMS) 2019 Impact File. Multivariate models of hospital cost of care, length of stay, and discharge destination were performed, controlling for confounders. A univariate sub-analysis of 9 revenue centers was performed.</p><p><strong>Results: </strong>In all, 3942 patients met the inclusion criteria. The mean cost of elective single-level cervical fusion for myelopathy was $18,084±10,783, and the mean length of stay was 2.45±2.95 d. On multivariate analysis, ACDF was independently associated with decreased cost of $5,814 ( P <0.001), shorter length of stay by 1.1 days ( P <0.001), and decreased risk of nonhome discharge destination by 58% (adjusted odds ratio: 0.422, P <0.001).On sub-analysis of 9 revenue centers, medical/surgical supply ($10,497, 44%), operating room charges ($5401, 23%), and accommodations ($3999, 17%) were the largest drivers of charge differences.</p><p><strong>Conclusions: </strong>Single-level elective primary ACDF for DCM was independently associated with decreased cost, decreased hospital length of stay, and a lower rate of nonhome discharge compared with PCDF. Medical and surgical supply, operating room, and accommodation differences between ACDF and PCDF are potential areas for intervention. Increased granularity in reimbursement structures is warranted to prevent the creation of disincentives to the treatment of patients with DCM with pathology that is better addressed with PCDF.</p><p><strong>Level of evidence: </strong>Level-III Retrospective Cohort Study.</p>","PeriodicalId":10457,"journal":{"name":"Clinical Spine Surgery","volume":" ","pages":"E317-E323"},"PeriodicalIF":1.6,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139971166","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Dural Closure Techniques and Cerebrospinal Fluid Leak Incidence After Resection of Primary Intradural Spinal Tumors: A Systematic Review. 硬膜封闭技术与原发性硬膜内脊柱肿瘤切除术后脑脊液漏的发生率:系统回顾
IF 1.6 4区 医学 Q3 CLINICAL NEUROLOGY Pub Date : 2024-08-01 Epub Date: 2023-07-24 DOI: 10.1097/BSD.0000000000001491
Arjun Syal, Francesca M Cozzi, Sima Vazquez, Eris Spirollari, Alexandria F Naftchi, Ankita Das, Christina Ng, OluwaToba Akinleye, Thomas Gagliardi, Jose F Dominguez, Arthur Wang, Merritt D Kinon

Study design: This is a systematic review of primary intradural spinal tumors (PIDSTs) and the frequency of postoperative cerebrospinal fluid (CSF) leaks.

Objective: This study aimed to compare CSF leak rates among techniques for dural watertight closure (WTC) after the resection of PIDSTs.

Summary of background data: Resection of PIDSTs may result in persistent CSF leak. This complication is associated with infection, wound dehiscence, increased length of stay, and morbidity. Dural closure techniques have been developed to decrease the CSF leak rate.

Methods: A PubMed search was performed in 2022 with these inclusion criteria: written in English, describe PIDST patients, specify the method of dural closure, report rates of CSF leak, and be published between 2015 and 2020. Articles were excluded if they had <5 patients. We used standardized toolkits to assess the risk of bias. We assessed patient baseline characteristics, tumor pathology, CSF leak rate, and dural closure techniques; analysis of variance and a 1-way Fisher exact test were used.

Results: A total of 4 studies (201 patients) satisfied the inclusion criteria. One study utilized artificial dura (AD) and fibrin glue to perform WTC and CSF diversion, with lumbar drainage as needed. The rate of CSF leak was different among the 4 studies ( P =0.017). The study using AD with dural closure adjunct (DCA) for WTC was associated with higher CSF leak rates than those using native dura (ND) with DCA. There was no difference in CSF leak rate between ND-WTC and AD-DCA, or with any of the ND-DCA studies.

Conclusions: After resection of PIDSTs, the use of autologous fat grafts with ND resulted in lower rates of CSF leak, while use of fibrin glue and AD resulted in the highest rates. These characteristics suggest that a component of hydrophobic scaffolding may be required for WTC. A limitation included articles with low levels of evidence. Continued investigation to understand mechanisms for WTC is warranted.

Level of evidence: Level 3.

研究设计:这是一篇关于原发性硬脊膜内肿瘤(PIDSTs)和术后脑脊液(CSF)漏频率的系统性综述:本研究旨在比较PIDSTs切除术后硬脑膜防水闭合(WTC)技术的脑脊液漏率:背景数据摘要:PIDSTs切除术可能会导致持续性CSF渗漏。这种并发症与感染、伤口开裂、住院时间延长和发病率有关。目前已开发出硬脑膜闭合技术来降低 CSF 渗漏率:在 2022 年进行了一次 PubMed 搜索,纳入标准如下:英文撰写、描述 PIDST 患者、明确硬膜封闭方法、报告 CSF 渗漏率、2015 年至 2020 年间发表。结果共有 4 项研究(201 名患者)符合纳入标准。其中一项研究使用人工硬脑膜(AD)和纤维蛋白胶进行 WTC 和 CSF 转移,并根据需要进行腰椎引流。4 项研究的 CSF 漏率不同(P =0.017)。使用 AD 和硬脑膜闭合辅助器(DCA)进行 WTC 的研究与使用原生硬脑膜(ND)和 DCA 的研究相比,CSF 漏出率更高。ND-WTC与AD-DCA或任何ND-DCA研究的CSF漏出率均无差异:结论:切除 PIDST 后,使用 ND 的自体脂肪移植导致 CSF 泄漏率较低,而使用纤维蛋白胶和 AD 的 CSF 泄漏率最高。这些特点表明,永利国际娱乐可能需要疏水支架的成分。局限性包括证据水平较低的文章。有必要继续调查以了解 WTC 的机制:证据等级:3 级。
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引用次数: 0
Survival in Patients With Spinal Metastatic Disease Treated Nonoperatively With Radiotherapy: Are the SORG-ML Algorithms Relevant? 非手术放疗脊柱转移性疾病患者的生存率:SORG-ML 算法是否相关?
IF 1.6 4区 医学 Q3 CLINICAL NEUROLOGY Pub Date : 2024-08-01 Epub Date: 2024-02-02 DOI: 10.1097/BSD.0000000000001575
Brian P Fenn, Aditya V Karhade, Olivier Q Groot, Austin K Collins, Tracy A Balboni, Kevin S Oh, Marco L Ferrone, Joseph H Schwab

Summary of background data: The SORG-ML algorithms for survival in spinal metastatic disease were developed in patients who underwent surgery and were externally validated for patients managed operatively.

Objective: To externally validate the SORG-ML algorithms for survival in spinal metastatic disease in patients managed nonoperatively with radiation.

Study design: Retrospective cohort.

Methods: The performance of the SORG-ML algorithms was assessed by discrimination [receiver operating curves and area under the receiver operating curve (AUC)], calibration (calibration plots), decision curve analysis, and overall performance (Brier score). The primary outcomes were 90-day and 1-year mortality.

Results: Overall, 2074 adult patients underwent radiation for spinal metastatic disease and 29% (n=521) and 59% (n=917) had 90-day and 1-year mortality, respectively. On complete case analysis (n=415), the AUC was 0.76 (95% CI: 0.71-0.80) and 0.78 (95% CI: 0.73-0.83) for 90-day and 1-year mortality with fair calibration and positive net benefit confirmed by the decision curve analysis. With multiple imputation (n=2074), the AUC was 0.85 (95% CI: 0.83-0.87) and 0.87 (95% CI: 0.85-0.89) for 90-day and 1-year mortality with fair calibration and positive net benefit confirmed by the decision curve analysis.

Conclusion: The SORG-ML algorithms for survival in spinal metastatic disease generalize well to patients managed nonoperatively with radiation.

背景数据摘要:SORG-ML脊柱转移性疾病生存率算法是针对接受手术治疗的患者制定的,并对接受手术治疗的患者进行了外部验证:研究设计:研究设计:回顾性队列:通过判别[接收器工作曲线和接收器工作曲线下面积(AUC)]、校准(校准图)、决策曲线分析和总体表现(Brier评分)评估SORG-ML算法的性能。主要结果是 90 天和 1 年死亡率:共有 2074 名成人患者因脊柱转移性疾病接受了放射治疗,90 天和 1 年死亡率分别为 29%(521 人)和 59%(917 人)。通过完整病例分析(n=415),90 天和 1 年死亡率的 AUC 分别为 0.76(95% CI:0.71-0.80)和 0.78(95% CI:0.73-0.83),校准结果尚可,决策曲线分析证实净获益为正。多重归因(n=2074)后,90天和1年死亡率的AUC分别为0.85(95% CI:0.83-0.87)和0.87(95% CI:0.85-0.89),校准结果尚可,决策曲线分析证实净效益为正:结论:SORG-ML 算法对脊柱转移性疾病患者的生存率具有很好的通用性,适用于接受放射治疗的非手术患者。
{"title":"Survival in Patients With Spinal Metastatic Disease Treated Nonoperatively With Radiotherapy: Are the SORG-ML Algorithms Relevant?","authors":"Brian P Fenn, Aditya V Karhade, Olivier Q Groot, Austin K Collins, Tracy A Balboni, Kevin S Oh, Marco L Ferrone, Joseph H Schwab","doi":"10.1097/BSD.0000000000001575","DOIUrl":"10.1097/BSD.0000000000001575","url":null,"abstract":"<p><strong>Summary of background data: </strong>The SORG-ML algorithms for survival in spinal metastatic disease were developed in patients who underwent surgery and were externally validated for patients managed operatively.</p><p><strong>Objective: </strong>To externally validate the SORG-ML algorithms for survival in spinal metastatic disease in patients managed nonoperatively with radiation.</p><p><strong>Study design: </strong>Retrospective cohort.</p><p><strong>Methods: </strong>The performance of the SORG-ML algorithms was assessed by discrimination [receiver operating curves and area under the receiver operating curve (AUC)], calibration (calibration plots), decision curve analysis, and overall performance (Brier score). The primary outcomes were 90-day and 1-year mortality.</p><p><strong>Results: </strong>Overall, 2074 adult patients underwent radiation for spinal metastatic disease and 29% (n=521) and 59% (n=917) had 90-day and 1-year mortality, respectively. On complete case analysis (n=415), the AUC was 0.76 (95% CI: 0.71-0.80) and 0.78 (95% CI: 0.73-0.83) for 90-day and 1-year mortality with fair calibration and positive net benefit confirmed by the decision curve analysis. With multiple imputation (n=2074), the AUC was 0.85 (95% CI: 0.83-0.87) and 0.87 (95% CI: 0.85-0.89) for 90-day and 1-year mortality with fair calibration and positive net benefit confirmed by the decision curve analysis.</p><p><strong>Conclusion: </strong>The SORG-ML algorithms for survival in spinal metastatic disease generalize well to patients managed nonoperatively with radiation.</p>","PeriodicalId":10457,"journal":{"name":"Clinical Spine Surgery","volume":" ","pages":"E290-E296"},"PeriodicalIF":1.6,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139697076","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Resource Utilization Following Anterior Versus Posterior Cervical Decompression and Fusion for Acute Central Cord Syndrome. 前路与后路颈椎减压融合术治疗急性中央型脊髓综合征后的资源利用情况。
IF 1.6 4区 医学 Q3 CLINICAL NEUROLOGY Pub Date : 2024-08-01 Epub Date: 2024-03-01 DOI: 10.1097/BSD.0000000000001598
Jerry Y Du, Karim Shafi, Collin W Blackburn, Jens R Chapman, Nicholas U Ahn, Randall E Marcus, Todd J Albert

Study design: Retrospective cohort study.

Objective: The purpose of this study is to compare the impact of anterior cervical decompression and fusion (ACDF) versus posterior cervical decompression and fusion (PCDF) for the treatment of acute traumatic central cord syndrome (CCS) on hospital episodes of care in terms of (1) cost, (2) length of hospital stay, and (3) discharge destination.

Summary of background data: Acute traumatic CCS is the most common form of spinal cord injury in the United States. CCS is commonly treated with surgical decompression and fusion. Hospital resource utilization based on surgical approach remains unclear.

Methods: Patients undergoing ACDF and PCDF for acute traumatic CCS were identified using the 2019 Medicare Provider Analysis and Review Limited Data Set and Centers for Medicare and Medicaid Services 2019 Impact File. Multivariate models for hospital cost of care, length of stay, and discharge destination were performed, controlling for confounders. Subanalysis of accommodation and revenue center cost drivers was performed.

Results: There were 1474 cases that met inclusion criteria: 673 ACDF (45.7%) and 801 PCDF (54.3%). ACDF was independently associated with a decreased cost of $9802 ( P <0.001) and a 59.2% decreased risk of discharge to nonhome destinations (adjusted odds ratio: 0.408, P <0.001). The difference in length of stay was not statistically significant. On subanalysis of cost drivers, ACDF was associated with decreased charges ($55,736, P <0.001) compared with PCDF, the largest drivers being the intensive care unit ($15,873, 28% of total charges, P <0.001) and medical/surgical supply charges ($19,651, 35% of total charges, P <0.001).

Conclusions: For treatment of acute traumatic CCS, ACDF was associated with almost $10,000 less expensive cost of care and a 60% decreased risk of discharge to nonhome destination compared with PCDF. The largest cost drivers appear to be ICU and medical/surgical-related. These findings may inform value-based decisions regarding the treatment of acute traumatic CCS. However, injury and patient clinical factors should always be prioritized in surgical decision-making, and increased granularity in reimbursement policies is needed to prevent financial disincentives in the treatment of patients with CCS better addressed with posterior approach-surgery.

研究设计回顾性队列研究:本研究的目的是比较颈椎前路减压融合术(ACDF)与颈椎后路减压融合术(PCDF)治疗急性外伤性中枢神经脊髓综合征(CCS)在以下方面对住院治疗的影响:(1)费用;(2)住院时间;(3)出院去向:急性外伤性中枢神经系统综合征是美国最常见的脊髓损伤形式。脊髓损伤通常采用手术减压和融合治疗。基于手术方法的医院资源利用情况仍不清楚:使用 2019 年医疗保险提供者分析和审查有限数据集以及美国医疗保险和医疗补助服务中心 2019 年影响文件,确定了接受 ACDF 和 PCDF 治疗急性外伤性 CCS 的患者。在控制混杂因素的情况下,建立了医院护理成本、住院时间和出院目的地的多变量模型。对住宿和收入中心成本驱动因素进行了子分析:符合纳入标准的病例有 1474 例:结果:共有 1474 例符合纳入标准:673 例 ACDF(45.7%)和 801 例 PCDF(54.3%)。ACDF 与成本降低 9802 美元(PConclusions:与 PCDF 相比,在治疗急性创伤性 CCS 时,ACDF 可降低近 1 万美元的护理成本,并将出院后去往非家庭目的地的风险降低 60%。最大的成本驱动因素似乎是重症监护室和医疗/手术相关。这些发现可以为治疗急性外伤性 CCS 的价值决策提供参考。但是,在手术决策中应始终优先考虑损伤和患者的临床因素,并且需要增加报销政策的细化程度,以防止在治疗CCS患者时出现经济抑制因素,因为后路手术能更好地治疗CCS。
{"title":"Resource Utilization Following Anterior Versus Posterior Cervical Decompression and Fusion for Acute Central Cord Syndrome.","authors":"Jerry Y Du, Karim Shafi, Collin W Blackburn, Jens R Chapman, Nicholas U Ahn, Randall E Marcus, Todd J Albert","doi":"10.1097/BSD.0000000000001598","DOIUrl":"10.1097/BSD.0000000000001598","url":null,"abstract":"<p><strong>Study design: </strong>Retrospective cohort study.</p><p><strong>Objective: </strong>The purpose of this study is to compare the impact of anterior cervical decompression and fusion (ACDF) versus posterior cervical decompression and fusion (PCDF) for the treatment of acute traumatic central cord syndrome (CCS) on hospital episodes of care in terms of (1) cost, (2) length of hospital stay, and (3) discharge destination.</p><p><strong>Summary of background data: </strong>Acute traumatic CCS is the most common form of spinal cord injury in the United States. CCS is commonly treated with surgical decompression and fusion. Hospital resource utilization based on surgical approach remains unclear.</p><p><strong>Methods: </strong>Patients undergoing ACDF and PCDF for acute traumatic CCS were identified using the 2019 Medicare Provider Analysis and Review Limited Data Set and Centers for Medicare and Medicaid Services 2019 Impact File. Multivariate models for hospital cost of care, length of stay, and discharge destination were performed, controlling for confounders. Subanalysis of accommodation and revenue center cost drivers was performed.</p><p><strong>Results: </strong>There were 1474 cases that met inclusion criteria: 673 ACDF (45.7%) and 801 PCDF (54.3%). ACDF was independently associated with a decreased cost of $9802 ( P <0.001) and a 59.2% decreased risk of discharge to nonhome destinations (adjusted odds ratio: 0.408, P <0.001). The difference in length of stay was not statistically significant. On subanalysis of cost drivers, ACDF was associated with decreased charges ($55,736, P <0.001) compared with PCDF, the largest drivers being the intensive care unit ($15,873, 28% of total charges, P <0.001) and medical/surgical supply charges ($19,651, 35% of total charges, P <0.001).</p><p><strong>Conclusions: </strong>For treatment of acute traumatic CCS, ACDF was associated with almost $10,000 less expensive cost of care and a 60% decreased risk of discharge to nonhome destination compared with PCDF. The largest cost drivers appear to be ICU and medical/surgical-related. These findings may inform value-based decisions regarding the treatment of acute traumatic CCS. However, injury and patient clinical factors should always be prioritized in surgical decision-making, and increased granularity in reimbursement policies is needed to prevent financial disincentives in the treatment of patients with CCS better addressed with posterior approach-surgery.</p>","PeriodicalId":10457,"journal":{"name":"Clinical Spine Surgery","volume":" ","pages":"E309-E316"},"PeriodicalIF":1.6,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140048963","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Trends in Indications and Contraindications for Cervical Disk Arthroplasty from 2009 to 2019. 2009 年至 2019 年颈椎间盘关节置换术的适应症和禁忌症趋势。
IF 1.6 4区 医学 Q3 CLINICAL NEUROLOGY Pub Date : 2024-08-01 Epub Date: 2024-03-01 DOI: 10.1097/BSD.0000000000001589
Karim Shafi, Jerry Y Du, Collin W Blackburn, Han Jo Kim, Sravisht Iyer, Sheeraz Qureshi, Randall E Marcus, Todd J Albert

Study design: Cross-sectional study.

Objective: Assess trends of indications and contraindications for the use of Cervical Disk Arthroplasty (CDA).

Summary of background data: As spine surgeons become more familiar with CDA, there have been expansions in indications.

Methods: The Medicare Provider Analysis and Review Limited Data Sets for 2009, 2014, and 2019 were utilized. Patients undergoing elective CDA were included. Diagnosis for index surgery and "contraindications" as defined by original CDA Investigative Device Exemption (IDE) criteria were assessed. Variables were identified by the International Classification of Diseases (ICD)-9 or ICD-10 diagnosis and procedural codes.

Results: A total of 1067 elective CDA patients were included. There were 230 patients in 2009, 300 patients in 2014, and 537 patients in 2019. The proportion of patients aged >65 increased from 35% to 51% ( P <0.001). Incidence of CDA for radiculopathy increased from 57% to 69% ( P <0.001), myelopathy increased from 23% to 78% ( P <0.001), and spondylosis without radiculopathy or myelopathy decreased from 19% to 3% ( P <0.001). There were increased incidences of ankylosing spondylitis (0.4% to 2.8%, P =0.007), long-term steroid use (1% to 2%, P =0.039), morbid obesity (2% to 6%, P =0.019), and osteoporosis (1% to 5%, P =0.014). The incidence of hybrid CDA and anterior cervical discectomy and fusion (ACDF) decreased from 28% to 23% ( P =0.007).

Conclusion: From 2009 to 2019, the number of CDA performed in older patients increased. An increase in the use of CDA for the treatment of myelopathy and radiculopathy and a decrease in the treatment of isolated cervical spondylosis was observed. The proportion of CDA performed in patients with original IDE trial "contraindications" increased. Further research into the efficacy of CDA for patients with contraindications is warranted.

研究设计横断面研究:评估颈椎间盘置换术(CDA)的适应症和禁忌症的使用趋势:随着脊柱外科医生对 CDA 越来越熟悉,适应症也在不断扩大:方法:利用 2009 年、2014 年和 2019 年的医疗保险提供者分析和审查有限数据集。纳入了接受择期 CDA 的患者。评估了指数手术的诊断和最初的 CDA 研究设备豁免 (IDE) 标准所定义的 "禁忌症"。变量通过国际疾病分类(ICD)-9 或 ICD-10 诊断和手术代码确定:结果:共纳入1067名择期CDA患者。2009年有230名患者,2014年有300名患者,2019年有537名患者。年龄大于 65 岁的患者比例从 35% 增加到 51%(PConclusion:从 2009 年到 2019 年,为老年患者实施 CDA 的数量有所增加。据观察,用于治疗脊髓病和根性颈椎病的 CDA 有所增加,而用于治疗孤立性颈椎病的 CDA 有所减少。对具有 IDE 试验原始 "禁忌症 "的患者实施 CDA 的比例有所增加。有必要进一步研究 CDA 对禁忌症患者的疗效。
{"title":"Trends in Indications and Contraindications for Cervical Disk Arthroplasty from 2009 to 2019.","authors":"Karim Shafi, Jerry Y Du, Collin W Blackburn, Han Jo Kim, Sravisht Iyer, Sheeraz Qureshi, Randall E Marcus, Todd J Albert","doi":"10.1097/BSD.0000000000001589","DOIUrl":"10.1097/BSD.0000000000001589","url":null,"abstract":"<p><strong>Study design: </strong>Cross-sectional study.</p><p><strong>Objective: </strong>Assess trends of indications and contraindications for the use of Cervical Disk Arthroplasty (CDA).</p><p><strong>Summary of background data: </strong>As spine surgeons become more familiar with CDA, there have been expansions in indications.</p><p><strong>Methods: </strong>The Medicare Provider Analysis and Review Limited Data Sets for 2009, 2014, and 2019 were utilized. Patients undergoing elective CDA were included. Diagnosis for index surgery and \"contraindications\" as defined by original CDA Investigative Device Exemption (IDE) criteria were assessed. Variables were identified by the International Classification of Diseases (ICD)-9 or ICD-10 diagnosis and procedural codes.</p><p><strong>Results: </strong>A total of 1067 elective CDA patients were included. There were 230 patients in 2009, 300 patients in 2014, and 537 patients in 2019. The proportion of patients aged >65 increased from 35% to 51% ( P <0.001). Incidence of CDA for radiculopathy increased from 57% to 69% ( P <0.001), myelopathy increased from 23% to 78% ( P <0.001), and spondylosis without radiculopathy or myelopathy decreased from 19% to 3% ( P <0.001). There were increased incidences of ankylosing spondylitis (0.4% to 2.8%, P =0.007), long-term steroid use (1% to 2%, P =0.039), morbid obesity (2% to 6%, P =0.019), and osteoporosis (1% to 5%, P =0.014). The incidence of hybrid CDA and anterior cervical discectomy and fusion (ACDF) decreased from 28% to 23% ( P =0.007).</p><p><strong>Conclusion: </strong>From 2009 to 2019, the number of CDA performed in older patients increased. An increase in the use of CDA for the treatment of myelopathy and radiculopathy and a decrease in the treatment of isolated cervical spondylosis was observed. The proportion of CDA performed in patients with original IDE trial \"contraindications\" increased. Further research into the efficacy of CDA for patients with contraindications is warranted.</p>","PeriodicalId":10457,"journal":{"name":"Clinical Spine Surgery","volume":" ","pages":"E283-E289"},"PeriodicalIF":1.6,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140048964","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Mechanistic and Preclinical Assessment of BioRestore Bioactive Glass as a Synthetic Bone Graft Extender and Substitute for Osteoinduction and Spine Fusion. BioRestore 生物活性玻璃作为骨诱导和脊柱融合的合成骨移植扩展剂和替代物的机制和临床前评估。
IF 1.6 4区 医学 Q3 CLINICAL NEUROLOGY Pub Date : 2024-08-01 Epub Date: 2024-03-22 DOI: 10.1097/BSD.0000000000001597
Elianna J Fred, Silvia Minardi, Alyssa M Goodwin, Tejas S Nandurkar, Mark A Plantz, Joseph G Lyons, Jonathan T Paul, James P Foley, Allison J Wintring, Andrew A Furman, Soyeon Jeong, Chawon Yun, Stuart R Stock, Wellington K Hsu, Erin L Hsu

Study design: Preclinical animal study.

Objective: Evaluate the osteoinductivity and bone regenerative capacity of BioRestore bioactive glass.

Summary of background data: BioRestore is a Food and Drug Administration (FDA)-approved bone void filler that has not yet been evaluated as a bone graft extender or substitute for spine fusion.

Methods: In vitro and in vivo methods were used to compare BioRestore with other biomaterials for the capacity to promote osteodifferentiation and spinal fusion. The materials evaluated (1) absorbable collagen sponge (ACS), (2) allograft, (3) BioRestore, (4) Human Demineralized Bone Matrix (DBM), and (5) MasterGraft. For in vitro studies, rat bone marrow-derived stem cells (BMSC) were cultured on the materials in either standard or osteogenic media (SM, OM), followed by quantification of osteogenic marker genes ( Runx2, Osx, Alpl, Bglap, Spp1 ) and alkaline phosphatase (ALP) activity. Sixty female Fischer rats underwent L4-5 posterolateral fusion (PLF) with placement of 1 of 5 implants: (1) ICBG from syngeneic rats; (2) ICBG+BioRestore; (3) BioRestore alone; (4) ICBG+Allograft; or (5) ICBG+MasterGraft. Spines were harvested 8 weeks postoperatively and evaluated for bone formation and fusion via radiography, blinded manual palpation, microCT, and histology.

Results: After culture for 1 week, BioRestore promoted similar expression levels of Runx2 and Osx to cells grown on DBM. At the 2-week timepoint, the relative ALP activity for BioRestore-OM was significantly higher ( P <0.001) than that of ACS-OM and DBM-OM ( P <0.01) and statistically equivalent to cells grown on allograft-OM. In vivo, radiographic and microCT evaluation showed some degree of bridging bone formation in all groups tested, with the exception of BioRestore alone, which did not produce successful fusions.

Conclusions: This study demonstrates the capacity of BioRestore to promote osteoinductivity in vitro. In vivo, BioRestore performed similarly to commercially available bone graft extender materials but was incapable of producing fusion as a bone graft substitute.

Level of evidence: Level V.

研究设计目的:评估 BioRestore 生物活性玻璃的骨诱导性和骨再生能力:评估 BioRestore 生物活性玻璃的骨诱导性和骨再生能力:BioRestore 是一种经美国食品和药物管理局 (FDA) 批准的骨空隙填充物,尚未作为脊柱融合术的骨移植扩展剂或替代物进行过评估:方法:采用体外和体内方法比较 BioRestore 与其他生物材料促进骨分化和脊柱融合的能力。评估的材料包括:(1) 可吸收胶原海绵 (ACS);(2) 同种异体移植;(3) BioRestore;(4) 人类脱矿物质骨基质 (DBM);(5) MasterGraft。在体外研究中,用标准或成骨培养基(SM、OM)在材料上培养大鼠骨髓干细胞(BMSC),然后对成骨标记基因(Runx2、Osx、Alpl、Bglap、Spp1)和碱性磷酸酶(ALP)活性进行定量分析。60 只雌性 Fischer 大鼠接受了 L4-5 后外侧融合术 (PLF),植入了 5 种植入物中的一种:(1) 来自同种异体大鼠的 ICBG;(2) ICBG+BioRestore;(3) BioRestore;(4) ICBG+Allograft;或 (5) ICBG+MasterGraft。术后 8 周取回脊柱,并通过射线照相、盲法人工触诊、显微 CT 和组织学评估骨形成和融合情况:培养 1 周后,BioRestore 促进的 Runx2 和 Osx 表达水平与在 DBM 上培养的细胞相似。在培养 2 周时,BioRestore-OM 的相对 ALP 活性明显更高(PConclusions:这项研究证明了 BioRestore 在体外促进骨诱导的能力。在体内,BioRestore 的表现与市售骨移植扩展材料相似,但无法作为骨移植替代物产生融合:证据等级:V 级。
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引用次数: 0
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Clinical Spine Surgery
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