Pub Date : 2025-12-13DOI: 10.1016/j.spinee.2025.12.002
Matthew Smuck, Dylan Lukes, Byron Schneider, David J Kennedy, Allen S Chen, Zachary L McCormick
<p><strong>Background context: </strong>When chronic low back pain (cLBP) persists after conservative management, there are limited treatment options. Increasingly, researchers and clinicians are defining distinct phenotypes within the cLBP population to develop and provide more targeted and effective interventions. One such phenotype involves people with mechanical low back pain and impaired motor control, identified by physical exam or MRI evidence of multifidus dysfunction. An implantable neurostimulation device that delivers an electrical stimulation to the L2 medial branch has been recently FDA-approved, with initially encouraging preliminary results. The pivotal trial demonstrated statistically-significant benefits over sham treatment in all secondary outcomes but not the primary outcome at the 120-day primary endpoint. However, recently published 1- and 5-year studies have shown better outcomes compared to optimal medical management.</p><p><strong>Purpose: </strong>It was our purpose to expand the comparison of clinical outcomes between this neurostimulation treatment and sham by re-evaluating the data from the aforementioned pivotal trial using common clinically-relevant thresholds of treatment success that were not included in the pivotal trial's uncommon composite definition of treatment success or in its analysis of secondary outcomes for Oswestry Disability Index (ODI) and EQ-5D that compared mean improvements instead of categorical responder rates.</p><p><strong>Study design/setting: </strong>Posthoc reanalysis of previously published data from a prospective, randomized, double-blind, multicenter sham-controlled clinical trial.</p><p><strong>Patient sample: </strong>From 26 centers, 204 participants age 46.53±9.38 years (range 22-71) and 53.9% (110/204) female were recruited with mechanical cLBP despite physical therapy and medical management, and a positive prone instability test on physical exam.</p><p><strong>Outcome measures: </strong>Participants completed several patient-reported outcomes at baseline and at the primary endpoint of 120 days following activation of the implanted stimulator or sham, including: visual analog scale, ODI, EQ-5D, and subject global impression of change.</p><p><strong>Methods: </strong>Using a complete-case analysis, we compared differences between the neurostimulation treatment group and the sham-control group. Demographics are expressed using descriptive statistics. Patient-reported outcomes are compared between groups with a categorical analysis, setting responder thresholds at commonly used benchmarks and established minimum clinically important change (MCIC) thresholds. Statistical significance is determined by a two-sided p-value from Fisher's exact test with significance set at p<.05. Potential conflicts of interest directly related to this manuscript include research funding to support MS (level e) and DL (level b). The sponsor funded the original sham-controlled trial and funded this reanalysi
背景背景:当慢性腰痛(cLBP)在保守治疗后持续存在时,治疗选择有限。越来越多的研究人员和临床医生在cLBP人群中定义不同的表型,以开发和提供更有针对性和有效的干预措施。其中一种表型包括机械性腰痛和运动控制受损的人,通过身体检查或多裂肌功能障碍的MRI证据确定。最近fda批准了一种植入式神经刺激装置,该装置可向L2内侧分支提供电刺激,初步结果令人鼓舞。关键试验显示,在120天的主要终点,在所有次要结局中,与假药治疗相比,统计学上有显著的益处,但在主要结局中没有。然而,最近发表的1年和5年研究表明,与最佳医疗管理相比,结果更好。目的:我们的目的是通过重新评估上述关键试验的数据,扩大神经刺激治疗和假手术之间的临床结果的比较,使用常见的临床相关治疗成功阈值,这些阈值未包括在关键试验不常见的治疗成功复合定义中,也未包括在ODI和EQ-5D的次要结局分析中,比较的是平均改善而不是分类反应率。研究设计/设置:对一项前瞻性、随机、双盲、多中心假对照临床试验先前发表的数据进行事后再分析。患者样本:来自26个中心的204名参与者,年龄46.53±9.38岁(22-71岁),53.9%(110/204)为女性,尽管进行了物理治疗和医疗管理,但仍患有机械性cLBP,体检中倾向不稳定试验呈阳性。结果测量:在植入刺激器或假体激活后120天的基线和主要终点,参与者完成了几个患者报告的结果,包括:VAS、ODI、EQ-5D和受试者总体变化印象(SGIC)。方法:采用全病例分析方法,比较神经刺激治疗组与假对照组的差异。人口统计数据是用描述性统计来表示的。通过分类分析比较两组患者报告的结果,在常用基准上设置应答者阈值,并建立最小临床重要变化(MCIC)阈值。统计显著性由Fisher精确检验的双侧p值确定,显著性集为结果:3名患者(2名活跃患者,1名假手术患者)失去随访,留下201名参与者进行完整病例分析。从基线到120天的主要终点,在ODI的MCIC阈值上观察到支持积极治疗的统计学显著差异:≥15点改善(59% vs 40.6%, p=0.0111)和≥30%改善(65.0% vs 47.5%, p=0.0156);EQ-5D的MCIC:改善≥0.15 (57.0% vs 36.0%, p=0.0045);SGIC为“更好”或更高(54.0% vs 33.7%; p=0.0045)。疼痛结果是混合的;尽管平均变化倾向于积极治疗(-3.3±2.7 vs -2.4±2.9;p=0.0209),但两组的分类有效率无显著差异(MCIC≥2点VAS改善和≥50%改善)。结论:将双侧L2内侧分支恢复性神经刺激与假手术在120天的主要终点进行比较,采用常见的临床相关治疗成功阈值,这项由赞助商资助的假手术对照关键试验的再分析显示,在残疾、生活质量和患者满意度方面的治疗具有统计学意义和临床意义,而疼痛的变化则有不同的结果。
{"title":"Re-evaluation of categorial outcomes using common clinically relevant improvement thresholds following bilateral L2 medial branch restorative neurostimulation versus sham.","authors":"Matthew Smuck, Dylan Lukes, Byron Schneider, David J Kennedy, Allen S Chen, Zachary L McCormick","doi":"10.1016/j.spinee.2025.12.002","DOIUrl":"10.1016/j.spinee.2025.12.002","url":null,"abstract":"<p><strong>Background context: </strong>When chronic low back pain (cLBP) persists after conservative management, there are limited treatment options. Increasingly, researchers and clinicians are defining distinct phenotypes within the cLBP population to develop and provide more targeted and effective interventions. One such phenotype involves people with mechanical low back pain and impaired motor control, identified by physical exam or MRI evidence of multifidus dysfunction. An implantable neurostimulation device that delivers an electrical stimulation to the L2 medial branch has been recently FDA-approved, with initially encouraging preliminary results. The pivotal trial demonstrated statistically-significant benefits over sham treatment in all secondary outcomes but not the primary outcome at the 120-day primary endpoint. However, recently published 1- and 5-year studies have shown better outcomes compared to optimal medical management.</p><p><strong>Purpose: </strong>It was our purpose to expand the comparison of clinical outcomes between this neurostimulation treatment and sham by re-evaluating the data from the aforementioned pivotal trial using common clinically-relevant thresholds of treatment success that were not included in the pivotal trial's uncommon composite definition of treatment success or in its analysis of secondary outcomes for Oswestry Disability Index (ODI) and EQ-5D that compared mean improvements instead of categorical responder rates.</p><p><strong>Study design/setting: </strong>Posthoc reanalysis of previously published data from a prospective, randomized, double-blind, multicenter sham-controlled clinical trial.</p><p><strong>Patient sample: </strong>From 26 centers, 204 participants age 46.53±9.38 years (range 22-71) and 53.9% (110/204) female were recruited with mechanical cLBP despite physical therapy and medical management, and a positive prone instability test on physical exam.</p><p><strong>Outcome measures: </strong>Participants completed several patient-reported outcomes at baseline and at the primary endpoint of 120 days following activation of the implanted stimulator or sham, including: visual analog scale, ODI, EQ-5D, and subject global impression of change.</p><p><strong>Methods: </strong>Using a complete-case analysis, we compared differences between the neurostimulation treatment group and the sham-control group. Demographics are expressed using descriptive statistics. Patient-reported outcomes are compared between groups with a categorical analysis, setting responder thresholds at commonly used benchmarks and established minimum clinically important change (MCIC) thresholds. Statistical significance is determined by a two-sided p-value from Fisher's exact test with significance set at p<.05. Potential conflicts of interest directly related to this manuscript include research funding to support MS (level e) and DL (level b). The sponsor funded the original sham-controlled trial and funded this reanalysi","PeriodicalId":49484,"journal":{"name":"Spine Journal","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2025-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145764481","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-13DOI: 10.1016/j.spinee.2025.12.008
Muhammad Talal Ibrahim, James Caid Kirven, Diego Martinez Castaneda, Phillip Glivar, Venkat Kavuri, Varun Kumar Singh, Elizabeth Yu
<p><strong>Background context: </strong>Morbid obesity is a known risk factor for worse outcomes after spinal fusion. Preoperative weight loss (WL) is routinely advocated for obese spinal fusion candidates based on the assumption that postoperative risk in patients with lower body mass index (BMI), after recent WL, is equivalent to that in weight-stable patients. However, this assumption has not been directly tested in the literature.</p><p><strong>Purpose: </strong>To compare obese patients who lost ≥5% of body weight within 2 years prior to undergoing cervical or lumbar fusion with obese patients who maintained a stable weight prior to surgery.</p><p><strong>Design: </strong>Retrospective cohort study with propensity score matching.</p><p><strong>Patient sample: </strong>Epic Cosmos was used to identify obese patients (BMI 30-50 kg/m<sup>2</sup>) undergoing cervical or lumbar fusion between 2017 and 2023. Patients were divided into two cohorts: (1) WL: patients with 5% to 30% body WL within 2 years preoperatively, (2) no WL (NoWL): controls with stable weight. Patients with pathological WL were excluded.</p><p><strong>Outcome measures: </strong>At 90 days, length of stay, healthcare utilization (HCU), severe adverse events (SAEs), and minor adverse events (MAEs) were assessed. At the 2-year follow-up, surgical failure (SF) was assessed.</p><p><strong>Methods: </strong>Cohorts were matched on demographics, preweight-loss BMI, comorbidities, diagnoses, and operative factors using propensity score matching. Analyses for cervical and lumbar fusions were run independently. Multivariable linear or logistic regression was used to determine the odds ratio of outcomes, adjusting for age, sex, race, preweight-loss BMI, comorbidities, diagnoses, and operative factors. Sensitivity analysis was conducted by excluding myelopathic patients and additionally adjusting the regression models for BMI at surgery.</p><p><strong>Results: </strong>After matching, the cervical fusion groups consisted of 10,201 patients per cohort, with a mean age of 59.4 years, 52.6% females, and 75.3% white patients. The WL cohort had higher rates of HCU (11.5% vs. 8.8%), SAEs (10.7% vs. 9.0%), MAEs (14.0% vs. 10.9%), and SF (11.6% vs. 9.7%). The lumbar fusion groups consisted of 10,755 patients per cohort, with a mean age of 62.4 years, 56.1% female, and 77.7% white patients. The WL cohort also had higher rates of HCU (12.2% vs. 11.6%), SAEs (11.0% vs. 10.0%), MAEs (24.9% vs. 22.8%), and SF (13.8% vs. 12.9%). In multivariable regression analysis, the cervical fusion WL cohort had higher odds of HCU (adjusted odds ratio [aOR]: 1.28, p<.001), MAEs (aOR: 1.26, p<.001), and SF (aOR: 1.20, p<.001), as well as increased length of stay (adjusted beta-coefficient [aβ]: 0.53, p<.001) compared to cervical fusion NoWL cohort. Statistical significance was no longer observed after removing myelopathic patients. In the lumbar fusion cohorts, there were no statistical differences in the outcomes in
背景:病态肥胖是脊柱融合术后不良预后的已知危险因素。术前减重通常被提倡用于肥胖脊柱融合术候选者,这是基于一个假设,即体重指数(BMI)较低的患者在近期减重后的术后风险与体重稳定的患者相当。然而,这一假设尚未在文献中得到直接检验。目的:比较颈椎或腰椎融合术前两年内体重减轻≥5%的肥胖患者与术前体重保持稳定的肥胖患者。设计:倾向评分匹配的回顾性队列研究。患者样本:EPIC COSMOS用于识别2017年至2023年间接受颈椎或腰椎融合术的肥胖患者(BMI 30-50 kg/m2)。患者分为两组:(a)体重减轻(WL):术前两年内体重减轻5-30%的患者;(b)体重未减轻(NoWL):体重稳定的对照组。排除病理性体重减轻的患者。结果测量:在90天时,评估住院时间(LOS)、医疗保健利用率(HCU)、严重不良事件(SAEs)和轻微不良事件(MAEs)。在两年的随访中,评估手术失败(SF)。方法:采用倾向评分匹配,根据人口统计学、减肥前BMI、合并症、诊断和手术因素对队列进行匹配。对颈椎和腰椎融合进行独立分析。采用多变量线性或逻辑回归来确定结果的优势比,调整年龄、性别、种族、减肥前BMI、合并症、诊断和手术因素。通过排除脊髓病患者并调整手术时BMI的回归模型进行敏感性分析。结果:匹配后,颈椎融合组每队列10,201例患者,平均年龄59.4岁,女性占52.6%,白人占75.3%。WL组的HCU发生率(11.5%比8.8%)、SAEs发生率(10.7%比9.0%)、MAEs发生率(14.0%比10.9%)和手术失败发生率(11.6%比9.7%)较高。腰椎融合术组每组10,755例患者,平均年龄为62.4岁,56.1%为女性,77.7%为白人。WL组的HCU(12.2%比11.6%)、SAEs(11.0%比10.0%)、MAEs(24.9%比22.8%)和手术失败(13.8%比12.9%)的发生率也更高。在多变量回归分析中,颈椎融合术WL队列与颈椎融合术NoWL队列相比,HCU(校正优势比(aOR): 1.28, p < 0.001)、MAEs (aOR: 1.26, p < 0.001)和手术失败(aOR: 1.20, p < 0.001)的几率更高,LOS(校正β系数(aβ): 0.53, p < 0.001)也更高。在切除脊髓病患者后,不再观察到统计学意义。在腰椎融合队列中,WL和NoWL队列的所有测量结果均无统计学差异。结论:在肥胖患者中,通过近期减肥来降低BMI并不能获得与体重稳定的较低BMI相同的益处,并且可能增加脊柱融合术后一些并发症的发生率。肌肉量的减少和营养的缺乏也许可以解释为什么在减肥后立即从低BMI中得不到好处。在获得更多数据之前,这些患者的康复前和营养优化可能是合理的。
{"title":"Preoperative weight loss is not beneficial in obese patients undergoing cervical or lumbar fusion-a national cohort study of 57,961 patients.","authors":"Muhammad Talal Ibrahim, James Caid Kirven, Diego Martinez Castaneda, Phillip Glivar, Venkat Kavuri, Varun Kumar Singh, Elizabeth Yu","doi":"10.1016/j.spinee.2025.12.008","DOIUrl":"10.1016/j.spinee.2025.12.008","url":null,"abstract":"<p><strong>Background context: </strong>Morbid obesity is a known risk factor for worse outcomes after spinal fusion. Preoperative weight loss (WL) is routinely advocated for obese spinal fusion candidates based on the assumption that postoperative risk in patients with lower body mass index (BMI), after recent WL, is equivalent to that in weight-stable patients. However, this assumption has not been directly tested in the literature.</p><p><strong>Purpose: </strong>To compare obese patients who lost ≥5% of body weight within 2 years prior to undergoing cervical or lumbar fusion with obese patients who maintained a stable weight prior to surgery.</p><p><strong>Design: </strong>Retrospective cohort study with propensity score matching.</p><p><strong>Patient sample: </strong>Epic Cosmos was used to identify obese patients (BMI 30-50 kg/m<sup>2</sup>) undergoing cervical or lumbar fusion between 2017 and 2023. Patients were divided into two cohorts: (1) WL: patients with 5% to 30% body WL within 2 years preoperatively, (2) no WL (NoWL): controls with stable weight. Patients with pathological WL were excluded.</p><p><strong>Outcome measures: </strong>At 90 days, length of stay, healthcare utilization (HCU), severe adverse events (SAEs), and minor adverse events (MAEs) were assessed. At the 2-year follow-up, surgical failure (SF) was assessed.</p><p><strong>Methods: </strong>Cohorts were matched on demographics, preweight-loss BMI, comorbidities, diagnoses, and operative factors using propensity score matching. Analyses for cervical and lumbar fusions were run independently. Multivariable linear or logistic regression was used to determine the odds ratio of outcomes, adjusting for age, sex, race, preweight-loss BMI, comorbidities, diagnoses, and operative factors. Sensitivity analysis was conducted by excluding myelopathic patients and additionally adjusting the regression models for BMI at surgery.</p><p><strong>Results: </strong>After matching, the cervical fusion groups consisted of 10,201 patients per cohort, with a mean age of 59.4 years, 52.6% females, and 75.3% white patients. The WL cohort had higher rates of HCU (11.5% vs. 8.8%), SAEs (10.7% vs. 9.0%), MAEs (14.0% vs. 10.9%), and SF (11.6% vs. 9.7%). The lumbar fusion groups consisted of 10,755 patients per cohort, with a mean age of 62.4 years, 56.1% female, and 77.7% white patients. The WL cohort also had higher rates of HCU (12.2% vs. 11.6%), SAEs (11.0% vs. 10.0%), MAEs (24.9% vs. 22.8%), and SF (13.8% vs. 12.9%). In multivariable regression analysis, the cervical fusion WL cohort had higher odds of HCU (adjusted odds ratio [aOR]: 1.28, p<.001), MAEs (aOR: 1.26, p<.001), and SF (aOR: 1.20, p<.001), as well as increased length of stay (adjusted beta-coefficient [aβ]: 0.53, p<.001) compared to cervical fusion NoWL cohort. Statistical significance was no longer observed after removing myelopathic patients. In the lumbar fusion cohorts, there were no statistical differences in the outcomes in","PeriodicalId":49484,"journal":{"name":"Spine Journal","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2025-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145764506","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-13DOI: 10.1016/j.spinee.2025.12.003
Venkateswaran Ganesh, Douglas C Fredericks, Mitchell C Coleman, Emily B Petersen, Youssef W Naguib, Jordon D Turner, Jaison Marks, James A Martin, Aliasger K Salem, Tae-Hong Lim, Dongrim Seol
Background: Evidence that oxidative stress contributes to the progression of post-traumatic intervertebral disc degeneration suggests targeting oxidant metabolism in disc cells as a strategy to mitigate degeneration in injured discs. We previously identified amobarbital, a drug that suppresses mitochondrial activity in a cell culture model with the chemical induction of oxidative stress, as a promising candidate for this purpose.
Purpose: The objective of this study was to investigate the preventive effects of amobarbital on the progression of disc degeneration using a rabbit disc herniation model.
Study design/setting: The effects of amobarbital on the prevention of disc degeneration were evaluated in both ex vivo and in vivo herniated discs.
Methods: Spine motion segments or animals were randomly assigned for intact control, vehicle control (hydrogel only), and amobarbital. Disc herniation was initiated by puncturing the annulus fibrosus with a needle, and amobarbital was delivered to the nucleus pulposus (NP) in a Pluronic F-127/hyaluronic acid hydrogel. A modified histological classification was applied to evaluate for degenerative cellular and matrix changes in both the annulus fibrosus and NP. Additionally, immunohistochemical staining for apoptosis and oxidative stress response, and radiography for disc height index were examined in the ex vivo and in vivo models, respectively.
Results: Amobarbital injection allowed uniform distribution in the whole NP and showed sustained release for 3 to 4 days. In an organ culture model, amobarbital treatment after a discal injury prohibited morphologic changes of notochordal cells, structural changes of extracellular matrix, endplate chondrocyte migration, and cell apoptosis compared with the vehicle control. Similarly, the preventive effects of amobarbital on disc degeneration were confirmed in an animal study, especially at 2 weeks, with maintained disc height.
Conclusions: In summary, amobarbital injection loaded in F127/hyaluronic acid hydrogel reduced cellular and structural degenerative changes against herniated discal injuries. Therefore, amobarbital has great potential for treating degenerative disc degeneration.
Clinical significance: Amobarbital encapsulated in hydrogel in this model allowed for effective local delivery into the NP and sustained release of amobarbital, which is promising for potential clinical application. Delivering amobarbital in NP cells may be a therapeutic option to retard intervertebral disc degeneration.
{"title":"Targeting oxidative stress with amobarbital to prevent intervertebral disc degeneration: part II. Rabbit disc herniation model.","authors":"Venkateswaran Ganesh, Douglas C Fredericks, Mitchell C Coleman, Emily B Petersen, Youssef W Naguib, Jordon D Turner, Jaison Marks, James A Martin, Aliasger K Salem, Tae-Hong Lim, Dongrim Seol","doi":"10.1016/j.spinee.2025.12.003","DOIUrl":"10.1016/j.spinee.2025.12.003","url":null,"abstract":"<p><strong>Background: </strong>Evidence that oxidative stress contributes to the progression of post-traumatic intervertebral disc degeneration suggests targeting oxidant metabolism in disc cells as a strategy to mitigate degeneration in injured discs. We previously identified amobarbital, a drug that suppresses mitochondrial activity in a cell culture model with the chemical induction of oxidative stress, as a promising candidate for this purpose.</p><p><strong>Purpose: </strong>The objective of this study was to investigate the preventive effects of amobarbital on the progression of disc degeneration using a rabbit disc herniation model.</p><p><strong>Study design/setting: </strong>The effects of amobarbital on the prevention of disc degeneration were evaluated in both ex vivo and in vivo herniated discs.</p><p><strong>Methods: </strong>Spine motion segments or animals were randomly assigned for intact control, vehicle control (hydrogel only), and amobarbital. Disc herniation was initiated by puncturing the annulus fibrosus with a needle, and amobarbital was delivered to the nucleus pulposus (NP) in a Pluronic F-127/hyaluronic acid hydrogel. A modified histological classification was applied to evaluate for degenerative cellular and matrix changes in both the annulus fibrosus and NP. Additionally, immunohistochemical staining for apoptosis and oxidative stress response, and radiography for disc height index were examined in the ex vivo and in vivo models, respectively.</p><p><strong>Results: </strong>Amobarbital injection allowed uniform distribution in the whole NP and showed sustained release for 3 to 4 days. In an organ culture model, amobarbital treatment after a discal injury prohibited morphologic changes of notochordal cells, structural changes of extracellular matrix, endplate chondrocyte migration, and cell apoptosis compared with the vehicle control. Similarly, the preventive effects of amobarbital on disc degeneration were confirmed in an animal study, especially at 2 weeks, with maintained disc height.</p><p><strong>Conclusions: </strong>In summary, amobarbital injection loaded in F127/hyaluronic acid hydrogel reduced cellular and structural degenerative changes against herniated discal injuries. Therefore, amobarbital has great potential for treating degenerative disc degeneration.</p><p><strong>Clinical significance: </strong>Amobarbital encapsulated in hydrogel in this model allowed for effective local delivery into the NP and sustained release of amobarbital, which is promising for potential clinical application. Delivering amobarbital in NP cells may be a therapeutic option to retard intervertebral disc degeneration.</p>","PeriodicalId":49484,"journal":{"name":"Spine Journal","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2025-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145764473","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
<p><strong>Background context: </strong>Diffuse idiopathic skeletal hyperostosis (DISH) is a disorder characterized by the calcification and ossification of ligaments and soft tissues, especially ossification of the anterior longitudinal ligament, resulting in the formation of "bridging" osteophytes extending over multiple contiguous segments. The precise etiology of DISH remains unclear; however, metabolic disorders such as diabetes mellitus and hyperlipidemia may be associated with its development. Insulin resistance (IR), a critical component of metabolic syndrome, not only contributes to the dysregulation of blood glucose homeostasis but also influences bone metabolism disorders.</p><p><strong>Purpose: </strong>Considering the association between DISH and metabolic disturbances, we aimed to investigate the relationship between IR and DISH.</p><p><strong>Study design: </strong>Cross-sectional, observational study.</p><p><strong>Patient sample: </strong>This study was conducted using data from the XXX. After screening, a total of 522 patients (206 males, 316 females) were included in the study cohort (mean age: 62.04±10.68 years).</p><p><strong>Outcome measures: </strong>The primary outcome measure was the prevalence of DISH, which was diagnosed using the modified Resnick's criteria based on prior studies. The secondary outcome measure was IR, which was quantified using the Homeostatic Model Assessment of IR (HOMA-IR), with the 75th percentile (1.52) used as the cut-off value.</p><p><strong>Methods: </strong>Logistic regression and receiver operating curve analyses were performed between HOMA-IR and the visceral fat area to verify whether the 75th percentile of HOMA-IR could be used as a cut-off for defining IR. Subsequently, χ² tests and logistic regression analyses were conducted to evaluate the association between HOMA-IR and DISH. Covariates included waist circumference, blood pressure, lipid profiles, fasting glucose levels adjusted for International Diabetes Federation metabolic syndrome criteria, and age. The robustness of the study findings was assessed using log-transformed HOMA-IR and internal validation.</p><p><strong>Results: </strong>Of the 522 participants, 40 were diagnosed with DISH. Higher HOMA-IR (≥1.52, 75th percentile) strongly correlated with higher visceral fat area and significantly higher prevalence of DISH (15.1% vs. 5.1%; p<.001). IR was significantly associated with DISH (odds ratio: 3.17; p=.000478). In adjusted models, the HOMA-IR effect was attenuated, whereas systolic blood pressure and waist circumference remained robustly associated. No significant relationship was found between the HOMA-IR and early-phase DISH.</p><p><strong>Conclusions: </strong>In this sample, higher HOMA-IR was associated with DISH; however, the association attenuated after adjustment for metabolic syndrome components, suggesting that IR is consistent with shared pathways with central obesity and blood pressure rather than demonstrating an i
背景背景:弥漫性特发性骨骼肥厚症(DISH)是一种以韧带和软组织钙化和骨化为特征的疾病,尤其是前纵韧带骨化,导致“桥接”骨赘的形成,延伸到多个连续的节段。DISH的确切病因尚不清楚;然而,代谢紊乱如糖尿病和高脂血症可能与其发展有关。胰岛素抵抗是代谢综合征的重要组成部分,不仅会导致血糖稳态失调,还会影响骨代谢紊乱。目的:考虑到DISH与代谢紊乱之间的关系,我们旨在探讨胰岛素抵抗与DISH的关系。研究设计:横断面观察性研究。患者样本:本研究使用的数据来自XXX。经筛选,共纳入522例患者(男性206例,女性316例),平均年龄:62.04±10.68岁。结果测量:主要结果测量是DISH的患病率,根据先前的研究使用修改的Resnick标准进行诊断。次要结局指标是胰岛素抵抗,使用胰岛素抵抗稳态模型评估(HOMA-IR)进行量化,以第75百分位(1.52)作为截止值。方法:对HOMA-IR和内脏脂肪面积(VFA)进行Logistic回归和受试者工作曲线分析,验证HOMA-IR的第75百分位是否可以作为定义胰岛素抵抗的截止值。随后进行χ 2检验和logistic回归分析,评价HOMA-IR与DISH的相关性。协变量包括腰围、血压、血脂、根据国际糖尿病联合会代谢综合征标准调整的空腹血糖水平和年龄。研究结果的稳健性评估使用对数转换HOMA-IR和内部验证。结果:在522名参与者中,40名被诊断为DISH。较高的HOMA-IR(≥1.52,第75百分位)与较高的VFA和显著较高的DISH患病率密切相关(15.1% vs. 5.1%)。结论:在本样本中,较高的HOMA-IR与DISH相关,然而,在调整代谢综合征成分后,这种关联减弱,这表明胰岛素抵抗与中心性肥胖和血压有共同的途径,而不是胰岛素抵抗的独立影响。
{"title":"Exploring the association between insulin resistance and diffuse idiopathic skeletal hyperostosis: a cross-sectional observational study.","authors":"Yu Li, Kairo Wada, Kanichiro Wada, Takaaki Nakano, Gentaro Kumagai, Sho Kaneko, Kazushige Koyama, Sunao Tanaka, Yasuyuki Ishibashi","doi":"10.1016/j.spinee.2025.12.007","DOIUrl":"10.1016/j.spinee.2025.12.007","url":null,"abstract":"<p><strong>Background context: </strong>Diffuse idiopathic skeletal hyperostosis (DISH) is a disorder characterized by the calcification and ossification of ligaments and soft tissues, especially ossification of the anterior longitudinal ligament, resulting in the formation of \"bridging\" osteophytes extending over multiple contiguous segments. The precise etiology of DISH remains unclear; however, metabolic disorders such as diabetes mellitus and hyperlipidemia may be associated with its development. Insulin resistance (IR), a critical component of metabolic syndrome, not only contributes to the dysregulation of blood glucose homeostasis but also influences bone metabolism disorders.</p><p><strong>Purpose: </strong>Considering the association between DISH and metabolic disturbances, we aimed to investigate the relationship between IR and DISH.</p><p><strong>Study design: </strong>Cross-sectional, observational study.</p><p><strong>Patient sample: </strong>This study was conducted using data from the XXX. After screening, a total of 522 patients (206 males, 316 females) were included in the study cohort (mean age: 62.04±10.68 years).</p><p><strong>Outcome measures: </strong>The primary outcome measure was the prevalence of DISH, which was diagnosed using the modified Resnick's criteria based on prior studies. The secondary outcome measure was IR, which was quantified using the Homeostatic Model Assessment of IR (HOMA-IR), with the 75th percentile (1.52) used as the cut-off value.</p><p><strong>Methods: </strong>Logistic regression and receiver operating curve analyses were performed between HOMA-IR and the visceral fat area to verify whether the 75th percentile of HOMA-IR could be used as a cut-off for defining IR. Subsequently, χ² tests and logistic regression analyses were conducted to evaluate the association between HOMA-IR and DISH. Covariates included waist circumference, blood pressure, lipid profiles, fasting glucose levels adjusted for International Diabetes Federation metabolic syndrome criteria, and age. The robustness of the study findings was assessed using log-transformed HOMA-IR and internal validation.</p><p><strong>Results: </strong>Of the 522 participants, 40 were diagnosed with DISH. Higher HOMA-IR (≥1.52, 75th percentile) strongly correlated with higher visceral fat area and significantly higher prevalence of DISH (15.1% vs. 5.1%; p<.001). IR was significantly associated with DISH (odds ratio: 3.17; p=.000478). In adjusted models, the HOMA-IR effect was attenuated, whereas systolic blood pressure and waist circumference remained robustly associated. No significant relationship was found between the HOMA-IR and early-phase DISH.</p><p><strong>Conclusions: </strong>In this sample, higher HOMA-IR was associated with DISH; however, the association attenuated after adjustment for metabolic syndrome components, suggesting that IR is consistent with shared pathways with central obesity and blood pressure rather than demonstrating an i","PeriodicalId":49484,"journal":{"name":"Spine Journal","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2025-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145764460","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-12DOI: 10.1016/j.spinee.2025.12.009
Charla R Fischer
{"title":"What is endoscopic spine surgery? an introduction to a special issue.","authors":"Charla R Fischer","doi":"10.1016/j.spinee.2025.12.009","DOIUrl":"10.1016/j.spinee.2025.12.009","url":null,"abstract":"","PeriodicalId":49484,"journal":{"name":"Spine Journal","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2025-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145758270","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-09DOI: 10.1016/j.spinee.2025.09.001
Zhen Liu MD , Ziyang Tang PhD , Jie Li PhD , Zongshan Hu MD , Xiaodong Qin MD , Benlong Shi MD , Saihu Mao MD , Yong Qiu MD , Zezhang Zhu MD
{"title":"Response to letter to the Editor regarding “Tri-cortical pedicle screw fixation in the most cranial instrumented segment to prevent proximal junctional kyphosis”","authors":"Zhen Liu MD , Ziyang Tang PhD , Jie Li PhD , Zongshan Hu MD , Xiaodong Qin MD , Benlong Shi MD , Saihu Mao MD , Yong Qiu MD , Zezhang Zhu MD","doi":"10.1016/j.spinee.2025.09.001","DOIUrl":"10.1016/j.spinee.2025.09.001","url":null,"abstract":"","PeriodicalId":49484,"journal":{"name":"Spine Journal","volume":"26 1","pages":"Pages 217-218"},"PeriodicalIF":4.7,"publicationDate":"2025-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145705731","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-09DOI: 10.1016/j.spinee.2025.08.339
Joshua Mathew BS, Mitchell Ng MD, Jonathan Dalton MD, Yasmine Eichbaum BS, Yulia Lee BS, Alexander R. Vaccaro MD, PhD, MBA
{"title":"Letter to the Editor regarding “Tri-cortical pedicle screw fixation in the most cranial instrumented segment to prevent proximal junctional kyphosis” by Liu et al","authors":"Joshua Mathew BS, Mitchell Ng MD, Jonathan Dalton MD, Yasmine Eichbaum BS, Yulia Lee BS, Alexander R. Vaccaro MD, PhD, MBA","doi":"10.1016/j.spinee.2025.08.339","DOIUrl":"10.1016/j.spinee.2025.08.339","url":null,"abstract":"","PeriodicalId":49484,"journal":{"name":"Spine Journal","volume":"26 1","pages":"Pages 215-216"},"PeriodicalIF":4.7,"publicationDate":"2025-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145705617","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-22DOI: 10.1016/j.spinee.2025.10.034
Nádia F. Simões de Souza MD , Anne E.H. Broekema MD, PhD , Remko Soer PhD , Katalin Tamási PhD , Antoinette D.I. van Asselt PhD , Michiel F. Reneman PhD , J. Marc C. van Dijk MD, PhD , Jos M.A. Kuijlen MD, PhD , FACET Investigator group
{"title":"Corrigendum to “Integrating a randomized controlled trial with a parallel observational cohort study in cervical spine surgery insights from the foraminotomy ACDF cost-effectiveness trial (FACET)” [Spine J 25 (2025) 2014–2025]","authors":"Nádia F. Simões de Souza MD , Anne E.H. Broekema MD, PhD , Remko Soer PhD , Katalin Tamási PhD , Antoinette D.I. van Asselt PhD , Michiel F. Reneman PhD , J. Marc C. van Dijk MD, PhD , Jos M.A. Kuijlen MD, PhD , FACET Investigator group","doi":"10.1016/j.spinee.2025.10.034","DOIUrl":"10.1016/j.spinee.2025.10.034","url":null,"abstract":"","PeriodicalId":49484,"journal":{"name":"Spine Journal","volume":"26 2","pages":"Pages 434-435"},"PeriodicalIF":4.7,"publicationDate":"2025-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145589932","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-14DOI: 10.1016/j.spinee.2025.11.001
Julien Francisco Zaldivar-Jolissaint, Nathan Evaniew, Nicolas Dea, W Bradley Jacobs, Jérome Paquet, Jefferson R Wilson, Hamilton Hall, Supriya Singh, Michael H Weber, Andrew Nataraj, Najmedden Attabib, David W Cadotte, Y Raja Rampersaud, Philippe Phan, Sean D Christie, Charles G Fisher, Christopher Small, Alex Soroceanu, Christopher S Bailey, Kenneth Thomas, Neil Manson, Greg McIntosh, Zhi Wang, Jay Toor, R Andrew Glennie, Raphaële Charest-Morin
<p><strong>Background context: </strong>While abundant literature supports the clinical benefits of surgery for degenerative cervical myelopathy (DCM), limited evidence exists regarding the extent to which patients' preoperative expectations are met postoperatively.</p><p><strong>Purpose: </strong>This study primarily aimed to report the fulfillment of preoperative expectations 12 months postsurgery. Secondary objectives included identifying predictors of expectation fulfillment and overall patient satisfaction following surgical intervention for DCM.</p><p><strong>Study design/setting: </strong>We conducted a multicenter analysis of spine surgery patients enrolled in the Canadian Spine Outcomes and Research Network (CSORN)-DCM prospective cohort.</p><p><strong>Patient sample: </strong>Patients who underwent surgical treatment for DCM between April 2015 and September 2022 were included.</p><p><strong>Outcome measures: </strong>Patients completed a preoperative 11-domain expectation questionnaire, quantifying their expected clinical changes in each domain. At 12 months postoperatively, patients reported the extent to which their preoperative expectations were met in each domain, as well as their overall satisfaction with surgical outcomes.</p><p><strong>Methods: </strong>Multivariable logistic regression models were employed to identify and validate variables associated with expectation fulfillment and satisfaction.</p><p><strong>Results: </strong>Among the 490 patients included, 49.2% had all their expectations met and 3.7% had none of their expectations met. The expectations that were most frequently met were prevention of neurological decline (87.5%) and maintaining of independence (86.7%). There were 83% of patients who were satisfied at 12 months. Multivariable logistic regression identified preoperative variables (not smoking, not using pain medication presurgery, having lower levels of depressive symptoms (PHQ-8)), surgical variables (anterior and posterior nonfusion approaches), the absence of peri‑operative adverse events and improvement in pain and Health-Related Quality of life scores at 12 months (NRS neck-pain, SF12 PCS and SF-12 MCS scores) as predictors of expectation fulfillment. Improvement in the mJOA score was not a predictor of expectation fulfillment. Having preoperative expectations met was a strong predictor of being satisfied with the surgery (p<.01).</p><p><strong>Conclusions: </strong>The majority of patients undergoing surgery for degenerative cervical myelopathy (DCM) reported satisfaction with their outcomes, with nearly half experiencing complete fulfillment of their preoperative expectations. Importantly, we identified 9 independent predictors of expectation fulfillment, which in turn emerged as a strong determinant of overall patient satisfaction. These findings highlight the critical role of personalized preoperative counseling in optimizing surgical outcomes. By aligning patients' expectations with realistic goals
{"title":"Fulfillment of patient expectations after surgery for degenerative cervical myelopathy. A retrospective analysis of prospectively collected data from the multicenter Canadian Surgical Spine Registry (CSORN).","authors":"Julien Francisco Zaldivar-Jolissaint, Nathan Evaniew, Nicolas Dea, W Bradley Jacobs, Jérome Paquet, Jefferson R Wilson, Hamilton Hall, Supriya Singh, Michael H Weber, Andrew Nataraj, Najmedden Attabib, David W Cadotte, Y Raja Rampersaud, Philippe Phan, Sean D Christie, Charles G Fisher, Christopher Small, Alex Soroceanu, Christopher S Bailey, Kenneth Thomas, Neil Manson, Greg McIntosh, Zhi Wang, Jay Toor, R Andrew Glennie, Raphaële Charest-Morin","doi":"10.1016/j.spinee.2025.11.001","DOIUrl":"10.1016/j.spinee.2025.11.001","url":null,"abstract":"<p><strong>Background context: </strong>While abundant literature supports the clinical benefits of surgery for degenerative cervical myelopathy (DCM), limited evidence exists regarding the extent to which patients' preoperative expectations are met postoperatively.</p><p><strong>Purpose: </strong>This study primarily aimed to report the fulfillment of preoperative expectations 12 months postsurgery. Secondary objectives included identifying predictors of expectation fulfillment and overall patient satisfaction following surgical intervention for DCM.</p><p><strong>Study design/setting: </strong>We conducted a multicenter analysis of spine surgery patients enrolled in the Canadian Spine Outcomes and Research Network (CSORN)-DCM prospective cohort.</p><p><strong>Patient sample: </strong>Patients who underwent surgical treatment for DCM between April 2015 and September 2022 were included.</p><p><strong>Outcome measures: </strong>Patients completed a preoperative 11-domain expectation questionnaire, quantifying their expected clinical changes in each domain. At 12 months postoperatively, patients reported the extent to which their preoperative expectations were met in each domain, as well as their overall satisfaction with surgical outcomes.</p><p><strong>Methods: </strong>Multivariable logistic regression models were employed to identify and validate variables associated with expectation fulfillment and satisfaction.</p><p><strong>Results: </strong>Among the 490 patients included, 49.2% had all their expectations met and 3.7% had none of their expectations met. The expectations that were most frequently met were prevention of neurological decline (87.5%) and maintaining of independence (86.7%). There were 83% of patients who were satisfied at 12 months. Multivariable logistic regression identified preoperative variables (not smoking, not using pain medication presurgery, having lower levels of depressive symptoms (PHQ-8)), surgical variables (anterior and posterior nonfusion approaches), the absence of peri‑operative adverse events and improvement in pain and Health-Related Quality of life scores at 12 months (NRS neck-pain, SF12 PCS and SF-12 MCS scores) as predictors of expectation fulfillment. Improvement in the mJOA score was not a predictor of expectation fulfillment. Having preoperative expectations met was a strong predictor of being satisfied with the surgery (p<.01).</p><p><strong>Conclusions: </strong>The majority of patients undergoing surgery for degenerative cervical myelopathy (DCM) reported satisfaction with their outcomes, with nearly half experiencing complete fulfillment of their preoperative expectations. Importantly, we identified 9 independent predictors of expectation fulfillment, which in turn emerged as a strong determinant of overall patient satisfaction. These findings highlight the critical role of personalized preoperative counseling in optimizing surgical outcomes. By aligning patients' expectations with realistic goals","PeriodicalId":49484,"journal":{"name":"Spine Journal","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2025-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145534925","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}