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Characterization of Spine Implant Device Recalls: A 21-Year Analysis. 脊柱植入器械召回的特征:21年分析。
IF 3.5 2区 医学 Q2 CLINICAL NEUROLOGY Pub Date : 2026-02-15 Epub Date: 2025-02-18 DOI: 10.1097/BRS.0000000000005304
Haseeb E Goheer, Mina Botros, Yasmine S Ghattas, Phillip T Yang, Rebecca M Irwin, Varun Puvanesarajah

Study design: Observational epidemiological study.

Objective: To identify and comprehensively assess reasons for recalls of spinal implant devices used in patients over the past 21 years.

Background: The number of spine implant devices on the market continues to rise. Although the Food and Drug Administration (FDA) regulates the safety of these devices, there is a paucity of literature on the reasons spine implant devices are recalled.

Materials and methods: The FDA device recall database was queried using the search term "spine" for recalls between 2003 and 2024. Data were collected regarding recall class, recall reason, FDA 510(k)/premarket approval decision date, product manufacturer, and device indication. The data were then reviewed to identify recalls for spine implant devices.

Results: A total of 386 spine implant devices were identified between January 2003 and December 2024. Among all recalls classified, 3.4% (n = 13) were class I, 88.1% (n = 340) were class II, and 8.5% (n = 33) were class III. The most common reasons for recall were "Device/Component Design" (52.8%) and "Packaging and Processing Control" (24.1%). The median number of devices recalled by manufacturers included in the study was 2, with the highest being 41 devices.

Conclusions: Overall, 76.9% of spine implant recalls reviewed were primarily due to issues with device design and processing control. Of recalls, 88.1% were classified with a class II FDA designation. This is the first study to present a retrospective regulatory analysis of FDA spine implant recalls and highlights the importance of premarket analysis and postmarketing surveillance to improve device safety.

Level of evidence: Level IV.

研究设计:观察性流行病学研究。目的:确定并综合评估过去21年来患者使用的脊柱植入装置召回的原因。背景资料摘要:市场上脊柱植入装置的数量持续上升。尽管美国食品和药物管理局(FDA)规定了这些器械的安全性,但关于脊柱植入物被召回的原因的文献很少。方法:使用检索词“spine”查询2003年至2024年FDA器械召回数据库中的召回信息。收集的数据包括召回类别、召回原因、FDA 510(k)/上市前批准决定日期、产品制造商和器械适应症。然后审查数据以确定脊柱植入装置的召回。结果:2003年1月至2024年12月共发现386个脊柱植入装置。在所有分类的召回中,3.4% (n=13)为ⅰ类召回,88.1% (n=340)为ⅱ类召回,8.5% (n=33)为ⅲ类召回。召回最常见的原因是“器械/组件设计”(52.8%)和“包装/加工控制”(24.1%)。研究中包括的制造商召回的设备中位数为2台,最高为41台。结论:总体而言,76.9%的脊柱植入物召回主要是由于器械设计和工艺控制问题。88.1%的召回被归类为FDA指定的II类。这是第一个对FDA脊柱植入物召回进行回顾性监管分析的研究,并强调了上市前分析和上市后监督对提高器械安全性的重要性。证据等级:4。
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引用次数: 0
P-15 Peptide Enhanced Bone Graft in Transforaminal Lumbar Interbody Fusion: A Randomized, Controlled, Investigational Device Exemption Study Demonstrating Improved Composite Clinical Success. 经椎间孔腰椎椎体间融合术中P-15肽增强骨移植物:一项随机、对照、不使用器械的研究性研究,证明了复合材料的临床成功。
IF 3.5 2区 医学 Q2 CLINICAL NEUROLOGY Pub Date : 2026-02-15 Epub Date: 2025-12-19 DOI: 10.1097/BRS.0000000000005579
James S Harrop, John E O'Toole, Michael P Steinmetz, Rick C Sasso, Christopher D Chaput, K Brandon Strenge, Greg Maislin, Jeffrey P Mullin, Thomas B Freeman, Anthony Guanciale, Howard Lantner, Michael E Janssen, David G Schwartz, John M Small, Wellington K Hsu, Paul M Arnold

Study design: Prospective, multicenter, single-blind, randomized, controlled pivotal study.

Objective: To evaluate whether P-15L (PearlMatrix P-15 Peptide Enhanced Bone Graft) is noninferior in effectiveness to local autograft when applied in single-level instrumented transforaminal lumbar interbody fusion (TLIF).

Summary of background data: P-15L, an FDA-designated Breakthrough Drug-Device, is a composite drug-device combination bone graft containing P-15, a 15-amino acid polypeptide, which enhances cell binding, proliferation, and differentiation, resulting in bone formation.

Materials and methods: Skeletally mature patients, aged 22 to 80 years, with degenerative disc disease (DDD) were randomized 1:1 to P-15L (investigational) or to the local autograft (control) during single-level TLIF with a polyetheretherketone (PEEK) cage and supplemental pedicle screw fixation. The primary outcome was composite clinical success (CCS) at 24 months, defined as: no index level secondary surgical procedures; achievement of fusion; ≥15-point improvement in Oswestry low back pain disability questionnaire (ODI) from baseline; no new or worsening persistent neurological deficit relative to baseline; and no device-related serious adverse events (SAEs).

Results: A total of 290 patients were enrolled at 33 sites: 141 (48.6%) received P-15L, and 149 (51.3%) received local autograft. P-15L was noninferior ( P <0.0001) and superior ( P =0.002) to autograft with respect to CCS, with 55.5% of the investigational group achieving composite clinical success compared with 37.5% of the control group. P-15L had a 25.8% higher fusion rate as compared with autograft for the CCS at 24 months (84.3% vs. 58.5%, respectively). Device-related SAE rates were similar in both groups.

Conclusion: P-15L was superior to local autograft in achieving clinical success at 24 months. Furthermore, P-15L produced a significantly higher fusion rate as compared with autograft. No meaningful clinical differences were found in the incidence of device-related SAEs. P-15L appears to be a safe and effective option for TLIF.

Level of evidence: Level I.

研究设计:前瞻性、多中心、单盲、随机、对照关键研究。目的:评价P-15L (PearlMatrix TM P-15 Peptide Enhanced Bone Graft)应用于单节段椎间孔腰椎椎体间融合术(TLIF)的疗效是否优于局部自体骨移植。背景资料摘要:P-15L是fda指定的突破性药物装置,是一种含有P-15的复合药物装置组合骨移植物,P-15是一种15个氨基酸的多肽,可增强细胞结合、增殖和分化,从而导致骨形成。方法:年龄22-80岁,伴有退行性椎间盘疾病(DDD)的骨骼成熟患者在单节段TLIF期间采用聚醚醚酮(PEEK)笼和辅助椎弓根螺钉固定,按1:1随机分为P-15L组(研究组)或局部自体移植物组(对照组)。主要终点是24个月时的综合临床成功(CCS),定义为:无二级外科手术;聚变的实现;Oswestry腰痛残疾问卷(ODI)较基线改善≥15分;与基线相比,无新的或恶化的持续性神经功能障碍;无器械相关严重不良事件(sae)。结果:33个地点290例患者入组:141例(48.6%)接受P-15L, 149例(51.3%)接受局部自体移植物。结论:P- 15l在24个月时取得临床成功的效果优于局部自体移植。此外,与自体移植物相比,P-15L产生了显著更高的融合率。在器械相关的SAEs发生率方面没有发现有意义的临床差异。P-15L似乎是TLIF安全有效的选择。证据等级:1;
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引用次数: 0
P-15 Peptide Enhanced Bone Graft Improves Time to Fusion in Transforaminal Lumbar Interbody Fusion: A Randomized, Controlled, Investigational Device Exemption Study. P-15肽增强骨移植物改善经椎间孔腰椎椎体间融合术的融合时间:一项随机、对照、试验性器械豁免研究。
IF 3.5 2区 医学 Q2 CLINICAL NEUROLOGY Pub Date : 2026-02-15 Epub Date: 2025-12-19 DOI: 10.1097/BRS.0000000000005580
James S Harrop, Michael P Steinmetz, John E O'Toole, Christopher D Chaput, Rick C Sasso, K Brandon Strenge, Greg Maislin, Jeffrey P Mullin, Thomas B Freeman, Anthony Guanciale, Howard Lantner, Michael E Janssen, David G Schwartz, John M Small, Wellington K Hsu, Paul M Arnold

Study design: Prospective, multicenter, single-blind, randomized, and controlled pivotal study.

Objective: Compare time-to-fusion in patients treated with P-15L (PearlMatrix TM P-15 peptide enhanced bone graft) versus local autograft over 24 months and evaluate changes in pain and quality of life at 24 months relative to baseline.

Summary of background data: P-15L, an FDA-designated breakthrough device, is a composite bone graft with P-15, a 15-amino acid polypeptide that promotes cellular adhesion, proliferation, and differentiation to support bone formation.

Methods: Patients (22-80 y) with degenerative disc disease were randomized to the investigational (P-15L) or control (local autograft) group during single-level transforaminal lumbar interbody fusion (TLIF) with a PEEK cage and supplemental pedicle screw fixation. Fusion assessments occurred at 6, 12, and 24 months. Time-to-fusion was tested for superiority as compared with the control using Kaplan-Meier survival analysis. Back and leg pain were measured using the Visual Analog Scale (VAS) and quality of life was assessed using the Short Form Survey (SF-12).

Results: The analysis included 290 patients from 33 sites; 141 (48.6%) received P-15L and 149 (51.3%) received local autograft. At randomization, at least one risk factor for pseudoarthrosis (obesity, nicotine use, or diabetes) was reported in 58.9% (83/141) of the investigational group and 60.4% (90/149) of the control group. More patients in the investigational group than the control group achieved fusion at 6 months (Kaplan-Meier fusion rates 57.6% vs. 26.9%, respectively), 12 months (68.8% vs. 41.5%, respectively), and 24 months (81.1% vs. 54.9%, respectively). P-15L was statistically superior to autograft for time-to-fusion (hazard ratio=1.87, 95% CI: 1.47-2.38; P  < 0.0001). There was marked improvement in VAS and SF-12 relative to baseline in both groups at 24 months.

Conclusion: P-15L promotes statistically superior earlier time-to-fusion than local autograft in instrumented TLIF. Both treatments resulted in clinically meaningful improvements in pain and quality of life at 24 months.

Level of evidence: Level I.

研究设计:前瞻性、多中心、单盲、随机、对照关键研究。目的:比较P-15L (PearlMatrix TM P-15肽增强骨移植物)和局部自体移植物治疗患者24个月内的融合时间,并评估24个月时相对于基线的疼痛和生活质量的变化。背景资料摘要:P-15L是fda指定的突破性设备,是一种含有P-15的复合骨移植物,P-15是一种15个氨基酸的多肽,可促进细胞粘附、增殖和分化,以支持骨形成。方法:22-80岁的退行性椎间盘疾病患者在单节段经椎间孔腰椎椎体间融合术(TLIF)中随机分为研究组(P-15L)和对照组(局部自体移植物),TLIF采用PEEK保持器和辅助椎弓根螺钉固定。融合评估分别在6、12和24个月进行。使用Kaplan-Meier生存分析测试融合时间与对照组相比的优势。使用视觉模拟量表(VAS)测量背部和腿部疼痛,使用SF-12短表格调查(SF-12)评估生活质量。结果:纳入33个部位290例患者;P-15L移植141例(48.6%),自体局部移植149例(51.3%)。在随机分组时,58.9%(83/141)的研究组和60.4%(90/149)的对照组报告了至少1个假关节的危险因素(肥胖、尼古丁使用或糖尿病)。在6个月(Kaplan-Meier融合率分别为57.6%和26.9%)、12个月(68.8%和41.5%)和24个月(81.1%和54.9%)时,研究组患者的融合率高于对照组。P- 15l在融合时间上优于自体移植物(风险比=1.87,95% CI: 1.47, 2.38; P)结论:P- 15l在有器械TLIF中促进早期融合时间优于局部自体移植物。两种治疗方法均在24个月时对疼痛和生活质量有临床意义的改善。证据等级:1;
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引用次数: 0
Does Advanced Age Negatively Impact Treatment Outcomes of Cervical Ossification of the Posterior Longitudinal Ligament? A Prospective Multicenter Study. 高龄是否会对颈椎后纵韧带骨化的治疗结果产生负面影响?一项前瞻性多中心研究。
IF 3.5 2区 医学 Q2 CLINICAL NEUROLOGY Pub Date : 2026-02-15 Epub Date: 2025-06-03 DOI: 10.1097/BRS.0000000000005415
Narihito Nagoshi, Satoru Egawa, Kenichiro Sakai, Kazuo Kusano, Shunji Tsutsui, Takashi Hirai, Yu Matsukura, Kanichiro Wada, Keiichi Katsumi, Masao Koda, Atsushi Kimura, Takeo Furuya, Satoshi Maki, Norihiro Nishida, Yukitaka Nagamoto, Yasushi Oshima, Kei Ando, Hiroaki Nakashima, Tsutomu Endo, Kanji Mori, Hideaki Nakajima, Kazuma Murata, Masayuki Miyagi, Takashi Kaito, Kei Yamada, Tomohiro Banno, Satoshi Kato, Tetsuro Ohba, Masahiko Takahata, Hiroshi Moridaira, Shunsuke Fujibayashi, Hiroyuki Katoh, Haruo Kanno, Kota Watanabe, Hiroshi Taneichi, Shiro Imagama, Yoshiharu Kawaguchi, Katsushi Takeshita, Masaya Nakamura, Morio Matsumoto, Masashi Yamazaki, Toshitaka Yoshii

Study design: A multicenter prospective cohort study.

Objective: To comprehensively evaluate the surgical impact, including patient-reported outcomes (PROs), in elderly patients with cervical ossification of the posterior longitudinal ligament (OPLL).

Background: With the rise of aging populations worldwide, understanding the impact of age on treatment outcomes for cervical OPLL has become increasingly important. Previous studies on degenerative cervical myelopathy have highlighted inconsistent outcomes for elderly patients, with limited focus on OPLL and PROs.

Materials and methods: This prospective, multi-institutional study included 402 cervical OPLL patients from 2014 to 2017, categorized into elderly (≥75 yr, n = 79) and nonelderly (<75 yr, n = 323) groups. Clinical outcomes were assessed preoperatively and 2 years postoperatively using cervical Japanese Orthopedic Association (JOA) scores, Visual Analog Scale (VAS) scores, and the JOA Cervical Myelopathy Evaluation Questionnaire (JOACMEQ). Multivariable regression analyses were conducted, adjusting for potential confounders, including demographic variables and imaging characteristics.

Results: Elderly patients had worse preoperative JOA scores (9.6 vs . 11.1, P < 0.01) and lower postoperative scores at 2 years (12.3 vs . 14.0, P < 0.01). However, the improvement in JOA scores was comparable (2.7 vs . 3.0, P = 0.48), with both exceeding the minimum clinically important difference (MCID). Complication rates and VAS score improvements were also comparable. JOACMEQ outcomes demonstrated significantly poorer upper extremity function in the elderly group following surgery ( P = 0.02), whereas no significant differences were observed between the two groups in other functional domains.

Conclusion: Despite worse baseline neurological function, elderly OPLL patients achieved similar degrees of postoperative neurological improvement as nonelderly patients. However, upper extremity function is unlikely to show significant improvement following surgery in elderly patients.

研究设计:多中心前瞻性队列研究。目的:综合评价老年后纵韧带颈椎骨化症(OPLL)手术治疗的影响,包括患者报告的预后(PROs)。背景资料摘要:随着世界范围内老龄化人口的增加,了解年龄对宫颈OPLL治疗结果的影响变得越来越重要。先前关于退行性颈椎病的研究强调了老年患者预后不一致,对OPLL和PROs的关注有限。方法:这项前瞻性、多机构研究纳入了2014年至2017年402例颈椎OPLL患者,分为老年人(≥75岁,n=79)和非老年人(结果:老年患者术前JOA评分较差(9.6比11.1,p)。结论:尽管老年OPLL患者的基线神经功能较差,但其术后神经功能改善程度与非老年患者相似。然而,老年患者手术后上肢功能不太可能有明显改善。
{"title":"Does Advanced Age Negatively Impact Treatment Outcomes of Cervical Ossification of the Posterior Longitudinal Ligament? A Prospective Multicenter Study.","authors":"Narihito Nagoshi, Satoru Egawa, Kenichiro Sakai, Kazuo Kusano, Shunji Tsutsui, Takashi Hirai, Yu Matsukura, Kanichiro Wada, Keiichi Katsumi, Masao Koda, Atsushi Kimura, Takeo Furuya, Satoshi Maki, Norihiro Nishida, Yukitaka Nagamoto, Yasushi Oshima, Kei Ando, Hiroaki Nakashima, Tsutomu Endo, Kanji Mori, Hideaki Nakajima, Kazuma Murata, Masayuki Miyagi, Takashi Kaito, Kei Yamada, Tomohiro Banno, Satoshi Kato, Tetsuro Ohba, Masahiko Takahata, Hiroshi Moridaira, Shunsuke Fujibayashi, Hiroyuki Katoh, Haruo Kanno, Kota Watanabe, Hiroshi Taneichi, Shiro Imagama, Yoshiharu Kawaguchi, Katsushi Takeshita, Masaya Nakamura, Morio Matsumoto, Masashi Yamazaki, Toshitaka Yoshii","doi":"10.1097/BRS.0000000000005415","DOIUrl":"10.1097/BRS.0000000000005415","url":null,"abstract":"<p><strong>Study design: </strong>A multicenter prospective cohort study.</p><p><strong>Objective: </strong>To comprehensively evaluate the surgical impact, including patient-reported outcomes (PROs), in elderly patients with cervical ossification of the posterior longitudinal ligament (OPLL).</p><p><strong>Background: </strong>With the rise of aging populations worldwide, understanding the impact of age on treatment outcomes for cervical OPLL has become increasingly important. Previous studies on degenerative cervical myelopathy have highlighted inconsistent outcomes for elderly patients, with limited focus on OPLL and PROs.</p><p><strong>Materials and methods: </strong>This prospective, multi-institutional study included 402 cervical OPLL patients from 2014 to 2017, categorized into elderly (≥75 yr, n = 79) and nonelderly (<75 yr, n = 323) groups. Clinical outcomes were assessed preoperatively and 2 years postoperatively using cervical Japanese Orthopedic Association (JOA) scores, Visual Analog Scale (VAS) scores, and the JOA Cervical Myelopathy Evaluation Questionnaire (JOACMEQ). Multivariable regression analyses were conducted, adjusting for potential confounders, including demographic variables and imaging characteristics.</p><p><strong>Results: </strong>Elderly patients had worse preoperative JOA scores (9.6 vs . 11.1, P < 0.01) and lower postoperative scores at 2 years (12.3 vs . 14.0, P < 0.01). However, the improvement in JOA scores was comparable (2.7 vs . 3.0, P = 0.48), with both exceeding the minimum clinically important difference (MCID). Complication rates and VAS score improvements were also comparable. JOACMEQ outcomes demonstrated significantly poorer upper extremity function in the elderly group following surgery ( P = 0.02), whereas no significant differences were observed between the two groups in other functional domains.</p><p><strong>Conclusion: </strong>Despite worse baseline neurological function, elderly OPLL patients achieved similar degrees of postoperative neurological improvement as nonelderly patients. However, upper extremity function is unlikely to show significant improvement following surgery in elderly patients.</p>","PeriodicalId":22193,"journal":{"name":"Spine","volume":" ","pages":"294-301"},"PeriodicalIF":3.5,"publicationDate":"2026-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144209581","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Impact of Short-Term Perioperative Steroid Administration on Outcomes of One-Level and Two-Level Transforaminal Lumbar Interbody Fusion. 围手术期短期类固醇治疗对1节段和2节段经椎间孔腰椎椎间融合术疗效的影响。
IF 3.5 2区 医学 Q2 CLINICAL NEUROLOGY Pub Date : 2026-02-15 Epub Date: 2025-03-03 DOI: 10.1097/BRS.0000000000005321
Mitsuhiro Nishizawa, Steven D Glassman, Mladen Djurasovic, Charles H Crawford, Jeffrey L Gum, John R Dimar, R Kirk Owens, Leah Y Carreon

Study design: Retrospective observational cohort.

Objective: To assess the impact of short-term perioperative use of systemic steroids on the surgical outcomes of one-level to two-level transforaminal lumbar fusion (TLIF), with a primary focus on complications.

Summary of background data: Steroids are commonly used in the perioperative period, including as a standard anesthesia practice and control for postoperative pain. However, the impact of perioperative use of systemic steroids on the surgical outcomes of lumbar fusion surgery remains unclear.

Methods: We retrospectively reviewed 560 patients who underwent one-level or two-level TLIF. Complications rates within one year postoperatively were compared between the patients who received perioperative steroids and those who did not. In addition, the total cumulative steroid dose as prednisolone equivalents was compared between patients with and without complications.

Results: Three hundred eighty patients (68%) received steroids perioperatively, with a mean prednisolone equivalent dose of 110±341.3 mg. Intraoperative steroids were administered to 359 patients (64%), with a mean dose of 46.6±13.8 mg, whereas 45 patients (8%) received steroids postoperatively, with a mean dose of 558.1±863.5 mg. There were no significant differences in any complication rates between patients who received steroids perioperatively, postoperatively, or intraoperatively and those who did not, respectively. Patients who experienced complications had lower total cumulative steroid dose compared with those without any complications, and the differences reached to significant in infections (39.9±53.2 vs. 77.6±297.0 mg, P =0.015); minor complications (37.2±51.5 vs. 79.9±304.2 mg, P =0.005); and nonunion (49.8±78.1 vs. 89.1±336.5 mg, P =0.046).

Conclusion: This study found that short-term perioperative use of systemic steroids was not associated with increased complications, and perioperative administration of steroids may have potential protective effects.

研究设计:回顾性观察队列。目的:评估围手术期短期使用全身性类固醇对一至二节段经椎间孔腰椎融合术(TLIF)手术结果的影响,主要关注并发症。背景资料总结:类固醇通常用于围手术期,包括作为标准麻醉和术后疼痛控制。然而,围手术期使用全身性类固醇对腰椎融合术手术结果的影响尚不清楚。方法:我们回顾性分析了560例接受一级或二级TLIF的患者。比较围手术期接受类固醇治疗和未接受类固醇治疗的患者术后一年内的并发症发生率。此外,作为强的松龙当量的总累积类固醇剂量在有和没有并发症的患者之间进行了比较。结果:380例患者(68%)围手术期接受类固醇治疗,平均强的松龙等效剂量为110±341.3 mg。术中使用类固醇药物359例(64%),平均剂量为46.6±13.8 mg;术后使用类固醇药物45例(8%),平均剂量为558.1±863.5 mg。在围手术期、术后和术中分别接受类固醇治疗的患者和未接受类固醇治疗的患者之间,并发症发生率无显著差异。与无并发症的患者相比,出现并发症的患者类固醇总累积剂量较低,感染方面差异达到显著性(39.9±53.2 mg vs. 77.6±297.0 mg, P=0.015);轻微并发症(37.2±51.5 mg vs 79.9±304.2 mg, P=0.005);骨不连(49.8±78.1 mg vs. 89.1±336.5 mg, P=0.046)。结论:本研究发现围手术期短期使用全身类固醇与并发症增加无关,围手术期使用类固醇可能具有潜在的保护作用。
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引用次数: 0
Historical Staffing and Performance of US Role II and III Surgical Facilities: Implications for Spine Casualty Care in Future Large-Scale Combat Operations. 美国角色II和III外科设施的历史人员配备和性能:对未来大规模作战行动中脊柱损伤护理的影响。
IF 3.5 2区 医学 Q2 CLINICAL NEUROLOGY Pub Date : 2026-02-15 Epub Date: 2025-11-26 DOI: 10.1097/BRS.0000000000005578
Kaitlyn E Holly, Aaron W Gu, Roman J Schoenfeld, Tracey P Koehlmoos, Andrew J Schoenfeld

Study design: Scoping review for historical perspective.

Objective: We sought to provide a comprehensive review of the number of physicians and support staff assigned to Role II and Role III facilities, and performance over the course of the 20th and 21st centuries. We sought to use the historical experience to lay the groundwork for reform efforts in anticipation of large-scale combat.

Summary of background data: The conflicts in Iraq and Afghanistan were characterized by air superiority for US forces, asymmetric engagements, and irregular combat operations. Large-scale combat operations (LSCO) that are anticipated in the future will differ in both scale and tactics-with anticipated higher numbers of severely injured personnel and spine trauma.

Materials and methods: We performed a scoping review of the available literature on Role II and Role III facilities in the US Military Health System from 1900 to the present. Compiled data included the types of Role II and III units (or military medical units that filled similar roles) in the time period 1900 to present, their assigned personnel, and performance in combat operations.

Results: The current composition and use of Role II and III surgical facilities primarily reflect the nature of combat experience in Iraq and Afghanistan. The lack of air superiority, increased reliance on ground transportation, and the volume of high-acuity combat casualties, including those with spine trauma, are anticipated to be major challenges to Role II and III facilities in the context of future LSCO. The "Golden Hour" principle that was successfully implemented during the Iraq and Afghanistan conflicts will be difficult to adhere to without adjusting the composition and capabilities of Role II and III units. Increased flexibility, interoperability, and mobility, with a reliance on larger cadres of surgical and intensive care specialists with greater familiarity with military techniques, spine trauma care, and operational medicine, are anticipated to be necessary.

Conclusions: We anticipate less of a "one-size fits all" capability for military medical units in the future and the need for robust medical units as close to the front lines as possible, with an emphasis on prolonged casualty care, including the management of complex spine trauma.

研究设计:历史视角的范围回顾。目的:我们试图对20世纪和21世纪分配到角色II和角色III设施的医生和支持人员的数量及其表现进行全面回顾。我们试图利用历史经验为预期大规模战斗的改革努力奠定基础。背景资料摘要:伊拉克和阿富汗冲突的特点是美军的空中优势、不对称交战和不规则作战行动。预计未来的大规模作战行动(LSCO)将在规模和战术上有所不同,预计会有更多的严重受伤人员和脊柱创伤。方法:我们对1900年至今美国军事卫生系统中角色II和角色III设施的现有文献进行了范围审查。汇编的数据包括1900年至今第二类和第三类单位(或发挥类似作用的军事医疗单位)的类型、其分配的人员和战斗行动中的表现。结果:目前II和III角色手术设施的组成和使用主要反映了伊拉克和阿富汗战斗经验的性质。在未来LSCO的背景下,缺乏空中优势、日益依赖地面运输和高敏锐度战斗伤亡(包括脊柱创伤)的数量预计将成为第二和第三角色设施面临的主要挑战。如果不调整第二、第三角色部队的组成和能力,在伊拉克和阿富汗冲突中成功实施的“黄金时间”原则将难以坚持。预计有必要增加灵活性、互操作性和机动性,依靠更熟悉军事技术、脊柱创伤护理和手术医学的大批外科和重症监护专家。结论:我们预计未来军事医疗单位的“一刀切”能力将会减少,需要强大的医疗单位尽可能靠近前线,重点是长期伤员护理,包括复杂脊柱创伤的管理。
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引用次数: 0
Complications in Minimally Invasive Spine Surgery (2013-2024): Lumbar Spine-Tubular Minimally Invasive Techniques: A Proportional Meta-Analysis. 微创脊柱手术并发症(2013-2024):腰椎管微创技术:比例荟萃分析。
IF 3.5 2区 医学 Q2 CLINICAL NEUROLOGY Pub Date : 2026-02-15 Epub Date: 2025-10-29 DOI: 10.1097/BRS.0000000000005550
Chibuikem A Ikwuegbuenyi, Sean Inzerillo, Eesha Gurav, Noah Willett, Mousa Hamad, Alan Hernández-Hernández, Ibrahim Hussain, Galal Elsayed, Osama Kashlan, Roger Härtl

Study design: Systematic review and proportional meta-analysis.

Objective: To quantify overall and specific complication rates associated with tubular minimally invasive spine surgery (MISS) for lumbar pathologies over the past decade.

Summary of background data: Tubular MISS is widely used for lumbar pathologies due to its reduced tissue disruption and faster recovery compared with open surgery. However, reported complication rates vary, and pooled estimates for specific complications remain limited.

Materials and methods: A systematic search of PubMed, Medline, Embase, and the Cochrane Library (January 2013-March 2024) was conducted following PRISMA guidelines. Studies were included if they involved 10 adult patients undergoing tubular lumbar MISS and provided extractable complication data. A random-effects model was used to pool complication rates, and study quality was assessed using the Cochrane Risk of Bias Tool and Newcastle-Ottawa Scale. All analyses were done using R studio.

Results: Seventy-five studies involving ∼12,600 patients were included in the analysis. The complication rate was 10% (95% CI: 8%-14%, I2=93%). Specific complication rates were: dural tears 4% (95% CI: 3%-5%, I2=69%) in 56 studies (6651 patients); nerve injuries 1% (95% CI: 1%-3%, I2=70%) in 41 studies (5278 patients); postoperative hematoma 1% (95% CI: 1%-2%, I2=31%) in 19 studies (2454 patients); surgical site infections 1% (95% CI: 0%-1%, I2=27%) in 46 studies (10,439 patients); revision surgeries 2% (95% CI: 2%-3%, I2=77%) in 43 studies (8948 patients); and disc reherniation 3% (95% CI: 1%-7%, I2=84%) in 14 studies (1928 patients).

Conclusion: This meta-analysis provides a comprehensive overview of complication rates in tubular lumbar MISS, revealing generally low rates but significant heterogeneity across studies. These findings offer valuable insights for patient counseling and surgical planning, though individual patient factors and surgeon experience should be considered.

研究设计:系统评价和比例荟萃分析。目的:量化在过去十年中与腰椎病变的管状微创脊柱手术(MISS)相关的总体和特定并发症发生率。背景资料总结:与开放手术相比,管状MISS术因其较少的组织破坏和更快的恢复而被广泛用于腰椎病变。然而,报道的并发症发生率各不相同,对特定并发症的综合估计仍然有限。材料和方法:系统检索PubMed, Medline, Embase和Cochrane图书馆(2013年1月- 2024年3月),遵循PRISMA指南。如果涉及10名接受管状腰椎MISS的成年患者并提供可提取的并发症数据,则纳入研究。采用随机效应模型汇总并发症发生率,并采用Cochrane偏倚风险工具和Newcastle-Ottawa量表评估研究质量。所有的分析都是使用R studio完成的。结果:分析纳入了75项研究,涉及约12,600名患者。并发症发生率为10% (95% CI: 8% ~ 14%, I2=93%)。具体并发症发生率为:56项研究(6651例患者)中硬脑膜撕裂4% (95% CI: 3%-5%, I2=69%);41项研究(5278例)中神经损伤1% (95% CI: 1%-3%, I2=70%);19项研究(2454例患者)中术后血肿1% (95% CI: 1%-2%, I2=31%);46项研究(10,439例患者)中手术部位感染1% (95% CI: 0%-1%, I2=27%);43项研究(8948例患者)中翻修手术占2% (95% CI: 2%-3%, I2=77%);在14项研究(1928例)中,椎间盘再突出3% (95% CI: 1%-7%, I2=84%)。结论:本荟萃分析提供了管状腰椎MISS并发症发生率的全面概述,揭示了总体较低的发生率,但各研究之间存在显著的异质性。这些发现为患者咨询和手术计划提供了有价值的见解,尽管个体患者因素和外科医生的经验应该考虑在内。
{"title":"Complications in Minimally Invasive Spine Surgery (2013-2024): Lumbar Spine-Tubular Minimally Invasive Techniques: A Proportional Meta-Analysis.","authors":"Chibuikem A Ikwuegbuenyi, Sean Inzerillo, Eesha Gurav, Noah Willett, Mousa Hamad, Alan Hernández-Hernández, Ibrahim Hussain, Galal Elsayed, Osama Kashlan, Roger Härtl","doi":"10.1097/BRS.0000000000005550","DOIUrl":"https://doi.org/10.1097/BRS.0000000000005550","url":null,"abstract":"<p><strong>Study design: </strong>Systematic review and proportional meta-analysis.</p><p><strong>Objective: </strong>To quantify overall and specific complication rates associated with tubular minimally invasive spine surgery (MISS) for lumbar pathologies over the past decade.</p><p><strong>Summary of background data: </strong>Tubular MISS is widely used for lumbar pathologies due to its reduced tissue disruption and faster recovery compared with open surgery. However, reported complication rates vary, and pooled estimates for specific complications remain limited.</p><p><strong>Materials and methods: </strong>A systematic search of PubMed, Medline, Embase, and the Cochrane Library (January 2013-March 2024) was conducted following PRISMA guidelines. Studies were included if they involved 10 adult patients undergoing tubular lumbar MISS and provided extractable complication data. A random-effects model was used to pool complication rates, and study quality was assessed using the Cochrane Risk of Bias Tool and Newcastle-Ottawa Scale. All analyses were done using R studio.</p><p><strong>Results: </strong>Seventy-five studies involving ∼12,600 patients were included in the analysis. The complication rate was 10% (95% CI: 8%-14%, I2=93%). Specific complication rates were: dural tears 4% (95% CI: 3%-5%, I2=69%) in 56 studies (6651 patients); nerve injuries 1% (95% CI: 1%-3%, I2=70%) in 41 studies (5278 patients); postoperative hematoma 1% (95% CI: 1%-2%, I2=31%) in 19 studies (2454 patients); surgical site infections 1% (95% CI: 0%-1%, I2=27%) in 46 studies (10,439 patients); revision surgeries 2% (95% CI: 2%-3%, I2=77%) in 43 studies (8948 patients); and disc reherniation 3% (95% CI: 1%-7%, I2=84%) in 14 studies (1928 patients).</p><p><strong>Conclusion: </strong>This meta-analysis provides a comprehensive overview of complication rates in tubular lumbar MISS, revealing generally low rates but significant heterogeneity across studies. These findings offer valuable insights for patient counseling and surgical planning, though individual patient factors and surgeon experience should be considered.</p>","PeriodicalId":22193,"journal":{"name":"Spine","volume":"51 4","pages":"E78-E96"},"PeriodicalIF":3.5,"publicationDate":"2026-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146087347","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Automated Detection of Cervical Spinal Cord Compression on MRI Using YOLO11 Deep Learning Architecture: A Two-Center External Validation Study. 使用YOLO11深度学习架构在MRI上自动检测颈脊髓压迫:一项双中心外部验证研究。
IF 3.5 2区 医学 Q2 CLINICAL NEUROLOGY Pub Date : 2026-02-03 DOI: 10.1097/BRS.0000000000005639
Qian Du, Weijun Kong, Yonghu Chang, Zhijun Xin, Xinxin Shao, Libo Feng, Jiaxiang Zhou, Yuancheng Zhang, Xinjuan Li, Guangru Cao, Rao Fu, Qingde Wa, Zhiyu Zhou

Study design: Retrospective two-center external validation study conducted at two medical centers, collecting cervical spine MRI data from patients suspected of degenerative cervical myelopathy (DCM) between March 2022 and August 2024, forming a consecutive series with external validation.

Objective: To develop and validate a deep learning model utilizing YOLO11 architecture for automated detection of cervical spinal cord compression on MRI and evaluate its performance against expert annotations.

Summary of background data: DCM represents the leading cause of non-traumatic spinal cord injury in adults. While MRI facilitates early detection and provides the foundation for timely intervention, image interpretation remains subjective and dependent on physician experience, resulting in diagnostic variability and challenges in clinical consistency.

Methods: A YOLO11-based deep learning model was implemented with binary classification scheme (Normal vs. Compression). Five physicians annotated 1,431 sagittal T2-weighted cervical MRI images from 735 patients using standardized protocols, achieving excellent inter-observer agreement. Dataset comprised training/validation sets (577 patients, 1,141 images), internal test set (64 patients, 115 images), and external test set (94 patients, 175 images). Five-fold cross-validation assessed model robustness. Standardized preprocessing incorporating contrast enhancement, noise reduction, and normalization was applied. Gradient-weighted Class Activation Mapping enhanced model interpretability.

Results: Five-fold cross-validation yielded consistent performance with mAP50 ranging from 0.917 to 0.970, precision from 0.897 to 0.923, and recall from 0.922 to 0.946. External testing demonstrated statistically superior agreement with expert annotations (mAP50=0.944, 95% CI: 0.934-0.953) compared to mid-level physician annotations (mAP50=0.912, 95% CI: 0.908-0.919), with the difference being statistically significant (95% CI of difference: 0.015-0.043, P < 0.05).

Conclusion: The YOLO11-based model demonstrated stable two-center performance with close alignment to expert-level clinical standards. The rapid inference, high sensitivity, and integrated visualization system address key challenges related to efficiency and interpretability in clinical AI applications for cervical spinal cord compression assessment.

研究设计:在两家医疗中心进行回顾性双中心外部验证研究,收集2022年3月至2024年8月间疑似退行性颈椎病(DCM)患者的颈椎MRI数据,形成连续的外部验证系列。目的:开发并验证利用YOLO11架构的深度学习模型在MRI上自动检测颈脊髓压迫,并根据专家注释评估其性能。背景资料摘要:DCM是成人非创伤性脊髓损伤的主要原因。虽然MRI有助于早期发现并为及时干预提供基础,但图像解释仍然是主观的,依赖于医生的经验,导致诊断的可变性和临床一致性的挑战。方法:基于yolo11的深度学习模型采用二元分类方案(Normal vs. Compression)实现。5位医生使用标准化方案对735名患者的1431张矢状t2加权颈椎MRI图像进行了注释,获得了出色的观察者间一致性。数据集包括训练/验证集(577名患者,1141张图像),内部测试集(64名患者,115张图像)和外部测试集(94名患者,175张图像)。五重交叉验证评估了模型的稳健性。采用了标准化的预处理,包括对比度增强、降噪和归一化。梯度加权类激活映射增强了模型的可解释性。结果:5重交叉验证结果一致,mAP50在0.917 ~ 0.970之间,精密度在0.897 ~ 0.923之间,召回率在0.922 ~ 0.946之间。外部检验表明,与中级医师注释(mAP50=0.912, 95% CI: 0.908-0.919)相比,专家注释(mAP50=0.944, 95% CI: 0.934-0.953)的一致性在统计学上优于中级医师注释(mAP50=0.912, 95% CI: 0.908-0.919),差异具有统计学意义(95% CI: 0.015-0.043, P < 0.05)。结论:基于yolo11的模型具有稳定的双中心性能,接近专家水平的临床标准。快速推理、高灵敏度和集成可视化系统解决了与临床人工智能应用于颈椎脊髓压迫评估的效率和可解释性相关的关键挑战。
{"title":"Automated Detection of Cervical Spinal Cord Compression on MRI Using YOLO11 Deep Learning Architecture: A Two-Center External Validation Study.","authors":"Qian Du, Weijun Kong, Yonghu Chang, Zhijun Xin, Xinxin Shao, Libo Feng, Jiaxiang Zhou, Yuancheng Zhang, Xinjuan Li, Guangru Cao, Rao Fu, Qingde Wa, Zhiyu Zhou","doi":"10.1097/BRS.0000000000005639","DOIUrl":"https://doi.org/10.1097/BRS.0000000000005639","url":null,"abstract":"<p><strong>Study design: </strong>Retrospective two-center external validation study conducted at two medical centers, collecting cervical spine MRI data from patients suspected of degenerative cervical myelopathy (DCM) between March 2022 and August 2024, forming a consecutive series with external validation.</p><p><strong>Objective: </strong>To develop and validate a deep learning model utilizing YOLO11 architecture for automated detection of cervical spinal cord compression on MRI and evaluate its performance against expert annotations.</p><p><strong>Summary of background data: </strong>DCM represents the leading cause of non-traumatic spinal cord injury in adults. While MRI facilitates early detection and provides the foundation for timely intervention, image interpretation remains subjective and dependent on physician experience, resulting in diagnostic variability and challenges in clinical consistency.</p><p><strong>Methods: </strong>A YOLO11-based deep learning model was implemented with binary classification scheme (Normal vs. Compression). Five physicians annotated 1,431 sagittal T2-weighted cervical MRI images from 735 patients using standardized protocols, achieving excellent inter-observer agreement. Dataset comprised training/validation sets (577 patients, 1,141 images), internal test set (64 patients, 115 images), and external test set (94 patients, 175 images). Five-fold cross-validation assessed model robustness. Standardized preprocessing incorporating contrast enhancement, noise reduction, and normalization was applied. Gradient-weighted Class Activation Mapping enhanced model interpretability.</p><p><strong>Results: </strong>Five-fold cross-validation yielded consistent performance with mAP50 ranging from 0.917 to 0.970, precision from 0.897 to 0.923, and recall from 0.922 to 0.946. External testing demonstrated statistically superior agreement with expert annotations (mAP50=0.944, 95% CI: 0.934-0.953) compared to mid-level physician annotations (mAP50=0.912, 95% CI: 0.908-0.919), with the difference being statistically significant (95% CI of difference: 0.015-0.043, P < 0.05).</p><p><strong>Conclusion: </strong>The YOLO11-based model demonstrated stable two-center performance with close alignment to expert-level clinical standards. The rapid inference, high sensitivity, and integrated visualization system address key challenges related to efficiency and interpretability in clinical AI applications for cervical spinal cord compression assessment.</p>","PeriodicalId":22193,"journal":{"name":"Spine","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2026-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146114359","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Long-Term Persistence of Sagittal Imbalance Following Single-Level Lumbar Fusion. 单节段腰椎融合术后矢状位不平衡的长期持续。
IF 3.5 2区 医学 Q2 CLINICAL NEUROLOGY Pub Date : 2026-02-02 DOI: 10.1097/BRS.0000000000005644
Mitchell Ng, Joydeep Baidya, Joshua Mathew, Jonathan Dalton, Teeto Ezeonu, Gregorio Baek, Yulia Lee, William Green, Sebastian Fras, Jeremy C Heard, Rajkishen Narayanan, Yunsoo A Lee, Tariq Z Issa, Benjamin Miller, William Purtill, Samantha Kolowrat, John J Mangan, Barrett I Woods, Zachary Wilt, Jose A Canseco, Mark F Kurd, Ian David Kaye, Alan S Hilibrand, Alexander R Vaccaro, Christopher K Kepler, Gregory D Schroeder

Study design: Retrospective Cohort Study.

Objective: To assess long-term changes in spinopelvic alignment following single-level lumbar fusion.

Summary of background data: Restoration of sagittal balance is known to influence outcomes in adult deformity surgery, but its relevance after short-segment fusion for degenerative disease remains uncertain. The durability of spinopelvic parameters after single-level fusion is not well defined.

Methods: Adult patients who underwent primary single-level fusion between L4-S1 (2010-2019) were retrospectively identified. Standing lateral radiographs were analyzed at baseline, immediately postoperatively, and at 6 months, 1 year, and 2-3 years. Parameters included lumbar lordosis (LL), segmental lordosis (SL), disc height (DH), sacral slope (SS), pelvic tilt (PT), pelvic incidence (PI), and PI-LL mismatch. Sagittal imbalance was defined as PT >20° or PI-LL >10°. Data were analyzed with t-tests or Mann-Whitney U tests as appropriate, and stepwise regression modeling identified predictors of imbalance.

Results: A total of 413 patients (mean age 62 y, 53% female) met inclusion criteria. SL decreased progressively, with a greater decline at 2-3 years than at 6 months (-1.48° versus -0.64°, P=0.028). Changes in LL, DH, SS, and PT were minimal across follow-up intervals. The proportion of patients with PI-LL mismatch >10° declined from 40.9% immediately postoperatively to 31.0% at 2-3 years (P <0.001). Similarly, PT >20° decreased from 67.6% to 56.9% (P <0.001). Despite these modest improvements, over half of patients remained imbalanced at final follow-up. Regression analysis showed that older age and greater number of decompressed levels were associated with persistent imbalance.

Conclusions: After single-level lumbar fusion, sagittal parameters stabilize by 6 months, with slight compensatory improvement thereafter. Most patients, however, continue to demonstrate imbalance, and the clinical significance of correcting spinopelvic parameters in focal degenerative disease remains uncertain.

研究设计:回顾性队列研究。目的:评估单节段腰椎融合术后脊柱骨盆对线的长期变化。背景资料总结:矢状面平衡的恢复已知会影响成人畸形手术的结果,但其与退行性疾病短节段融合的相关性仍不确定。单节段融合后椎盂参数的耐久性还没有很好的定义。方法:回顾性分析2010-2019年接受L4-S1间一期单节段融合术的成年患者。分析基线、术后立即、6个月、1年和2-3年的站立侧位x线片。参数包括腰椎前凸(LL)、节段性前凸(SL)、椎间盘高度(DH)、骶骨斜度(SS)、骨盆倾斜(PT)、骨盆发生率(PI)和PI-LL不匹配。矢状面失衡定义为PT >20°或PI-LL >10°。采用t检验或Mann-Whitney U检验对数据进行分析,逐步回归模型确定不平衡的预测因子。结果:共有413例患者(平均年龄62岁,女性53%)符合纳入标准。SL逐渐下降,2-3年下降幅度大于6个月(-1.48°vs -0.64°,P=0.028)。在随访期间,LL、DH、SS和PT的变化最小。PI-LL失配bbb10°的患者比例从术后立即的40.9%下降到2-3年的31.0% (p20°从67.6%下降到56.9%)。结论:单节段腰椎融合术后,矢状面参数稳定6个月,此后代偿性略有改善。然而,大多数患者仍然表现出不平衡,纠正局灶性退行性疾病的脊柱参数的临床意义仍不确定。
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引用次数: 0
Benefits of Pre-Operative Embolization in Surgery for Hypervascular Spinal Tumors: A Meta-Analysis. 术前栓塞治疗脊柱高血管肿瘤的益处:荟萃分析。
IF 3.5 2区 医学 Q2 CLINICAL NEUROLOGY Pub Date : 2026-02-02 DOI: 10.1097/BRS.0000000000005635
Mohammad Daher, Tarek Nahle, Sami Abi Farraj, Ethan J Cottrill, Amer Sebaaly, Peter G Passias, Alan H Daniels, William C Eward

Study design: Meta-Analysis.

Objective: The purpose of this meta-analysis is to appraise the evidence comparing surgical outcomes with and without preoperative embolization.

Background: Hypervascular tumors present a surgical challenge, due to their substantial intraoperative blood loss. Although preoperative embolization is often employed to mitigate intraoperative bleeding, its consistent advantage has not been conclusively demonstrated across existing studies.

Methods: Following the PRISMA guidelines, PubMed, Cochrane, and Google Scholar were accessed and explored until May 2025. Articles were included if they reported comparative studies evaluating perioperative outcomes of preoperative embolization (E) versus no embolization (NE) in the surgical treatment of hypervascular spinal tumors. A sub-analysis was performed based on whether studies reported no statistically significant difference in surgical invasiveness between the two groups.

Results: Fifteen studies met the inclusion criteria, including 225 patients in group NE and 340 in group E. When all studies were analyzed collectively, no significant differences were observed between the NE group and E group for any of the outcomes. However, in the subgroup of studies that reported no statistically significant differences in surgical invasiveness, there was no significant difference in blood loss (P=0.75) between the NE group and E group. In contrast, in the other subgroup of studies, the NE group showed greater blood loss (mean difference=283.08 mL; 95% CI: 2.21-563.95, P=0.05,).

Conclusion: Pre-operative embolization was not associated with consistent benefits in surgical outcomes for hypervascular spinal tumors. While some studies reported reduced blood loss with embolization, these findings were limited to analyses lacking control for specific surgical characteristics. This suggests that the perceived advantages may reflect confounding factors rather than the true effect of embolization. However, surgical equipoise remains and the decision to embolize should be individualized based on surgical and patient-related factors.

Level of evidence: III.

研究设计:荟萃分析。目的:本荟萃分析的目的是评估比较术前栓塞和未术前栓塞手术结果的证据。背景:高血管肿瘤由于术中大量失血,对外科手术提出了挑战。虽然术前栓塞通常用于减轻术中出血,但其一贯的优势尚未在现有研究中得到结论性证明。方法:按照PRISMA指南,检索PubMed、Cochrane和谷歌Scholar,直到2025年5月。评价术前栓塞(E)与不栓塞(NE)手术治疗高血管性脊柱肿瘤围手术期疗效的比较研究纳入。根据研究是否报告两组间手术侵入性无统计学差异进行亚分析。结果:15项研究符合纳入标准,其中NE组225例,E组340例。将所有研究进行综合分析时,NE组和E组在任何结果上均无显著差异。然而,在手术侵入性无统计学差异的研究亚组中,NE组与E组的失血量无统计学差异(P=0.75)。相比之下,在其他亚组研究中,NE组出血量更大(平均差异为283.08 mL; 95% CI: 2.21-563.95, P=0.05,)。结论:术前栓塞与高血管性脊柱肿瘤的手术结果不一致。虽然一些研究报道栓塞术减少了失血量,但这些发现仅限于缺乏对特定手术特征控制的分析。这表明,感知到的优势可能反映了混杂因素,而不是栓塞的真实效果。然而,手术平衡仍然存在,栓塞的决定应根据手术和患者相关因素进行个体化。证据水平:III。
{"title":"Benefits of Pre-Operative Embolization in Surgery for Hypervascular Spinal Tumors: A Meta-Analysis.","authors":"Mohammad Daher, Tarek Nahle, Sami Abi Farraj, Ethan J Cottrill, Amer Sebaaly, Peter G Passias, Alan H Daniels, William C Eward","doi":"10.1097/BRS.0000000000005635","DOIUrl":"https://doi.org/10.1097/BRS.0000000000005635","url":null,"abstract":"<p><strong>Study design: </strong>Meta-Analysis.</p><p><strong>Objective: </strong>The purpose of this meta-analysis is to appraise the evidence comparing surgical outcomes with and without preoperative embolization.</p><p><strong>Background: </strong>Hypervascular tumors present a surgical challenge, due to their substantial intraoperative blood loss. Although preoperative embolization is often employed to mitigate intraoperative bleeding, its consistent advantage has not been conclusively demonstrated across existing studies.</p><p><strong>Methods: </strong>Following the PRISMA guidelines, PubMed, Cochrane, and Google Scholar were accessed and explored until May 2025. Articles were included if they reported comparative studies evaluating perioperative outcomes of preoperative embolization (E) versus no embolization (NE) in the surgical treatment of hypervascular spinal tumors. A sub-analysis was performed based on whether studies reported no statistically significant difference in surgical invasiveness between the two groups.</p><p><strong>Results: </strong>Fifteen studies met the inclusion criteria, including 225 patients in group NE and 340 in group E. When all studies were analyzed collectively, no significant differences were observed between the NE group and E group for any of the outcomes. However, in the subgroup of studies that reported no statistically significant differences in surgical invasiveness, there was no significant difference in blood loss (P=0.75) between the NE group and E group. In contrast, in the other subgroup of studies, the NE group showed greater blood loss (mean difference=283.08 mL; 95% CI: 2.21-563.95, P=0.05,).</p><p><strong>Conclusion: </strong>Pre-operative embolization was not associated with consistent benefits in surgical outcomes for hypervascular spinal tumors. While some studies reported reduced blood loss with embolization, these findings were limited to analyses lacking control for specific surgical characteristics. This suggests that the perceived advantages may reflect confounding factors rather than the true effect of embolization. However, surgical equipoise remains and the decision to embolize should be individualized based on surgical and patient-related factors.</p><p><strong>Level of evidence: </strong>III.</p>","PeriodicalId":22193,"journal":{"name":"Spine","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2026-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146106876","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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