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Prehabilitation Reimagined as Policy: A Multidimensional Framework to Reduce Pain, Opioid Use, and Surgical Risk. 重新设想的康复政策:多维框架,以减少疼痛,阿片类药物的使用,和手术风险。
IF 1.7 Q2 SURGERY Pub Date : 2025-12-11 DOI: 10.14444/8807
Kai-Uwe Lewandrowski, Morgan P Lorio, Igor Elman, Kenneth Blum, Albert Pinhasov, Panayotis K Thanos, Sergio Luis Schmidt, Rossano Kepler Alvim Fiorelli

Background: Traditional surgical prehabilitation emphasizes biomechanical conditioning. In a pain landscape shaped by opioid exposure, trauma histories, and psychosocial distress, this reductionist approach is insufficient.

Objective: To propose a multidimensional, whole-person framework for perioperative readiness that integrates neurobiological mechanisms with practical clinical and policy levers.

Framework: Five synergistic domains-biological, psychological, social, spiritual, and existential-address discrete readiness deficits linked to dopaminergic tone, central sensitization, stress reactivity, connection, and meaning. Each domain is mapped to mechanisms, evidence-based interventions (eg, physical therapy, cognitive behavioral therapy/screening, social support linkage, chaplaincy, reflective practices), and relevant billing structures (Current Procedural Terminology Healthcare Common Procedure Coding System, International Classification of Diseases, 10th Revision Z codes).

Implementation: The model operationalizes a deliverables-based pathway-screen → triage → targeted interventions → outcome tracking-monitoring pain, function, opioid exposure (morphine milligram equivalents), length of stay/readmissions, depression and anxiety (Paitent Health Questionnaire-4), and pain catastrophizing (Pain Catastrophizing Scale). It aligns with risk-adjusted payment models and can be embedded within enhanced recovery after surgery programs.

Clinical significance: Reframing prehabilitation as neurobiologically informed whole-person readiness provides a low-risk, nonpharmacological strategy to reduce suffering, improve engagement, enhance postoperative pain control and recovery, and decrease opioid reliance.

Level of evidence: 5 (Expert Opinion). This perspective integrates neurobiological and behavioral theory with policy and billing frameworks to enable hypothesis-generating implementation and outcomes research.

背景:传统的外科康复强调生物力学调理。在由阿片类药物暴露、创伤史和心理社会困扰形成的疼痛环境中,这种还原主义方法是不够的。目的:提出一个多维的、全人的围手术期准备框架,将神经生物学机制与实际的临床和政策杠杆相结合。框架:五个协同领域——生物、心理、社会、精神和存在——解决与多巴胺能张力、中枢敏化、应激反应、连接和意义相关的离散准备缺陷。每个领域都映射到机制、基于证据的干预措施(例如,物理治疗、认知行为治疗/筛查、社会支持联系、牧师、反思实践)和相关的计费结构(当前程序术语卫生保健通用程序编码系统、国际疾病分类、第十版Z代码)。实施:该模型实现了一个基于可交付成果的途径-筛选→分诊→有针对性的干预→结果跟踪-监测疼痛、功能、阿片类药物暴露(吗啡毫克当量)、住院时间/再入院时间、抑郁和焦虑(患者健康问卷-4)和疼痛灾难(疼痛灾难量表)。它与风险调整支付模式相一致,可以嵌入到增强手术后恢复的项目中。临床意义:将康复作为神经生物学知情的全人准备提供了一种低风险的非药物策略,以减少痛苦,改善参与,增强术后疼痛控制和恢复,并减少阿片类药物依赖。证据等级:5(专家意见)。这种观点将神经生物学和行为理论与政策和计费框架相结合,以实现假设生成的实施和结果研究。
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引用次数: 0
Billions Spent, Few Saved: Rethinking National Institutes of Health HEAL Initiative in Light of Dopaminergic Alternatives to the Opioid Trap. 花费数十亿,很少节省:根据阿片类药物陷阱的多巴胺能替代品,重新思考国家卫生研究院的HEAL倡议。
IF 1.7 Q2 SURGERY Pub Date : 2025-12-11 DOI: 10.14444/8804
Kai-Uwe Lewandrowski, Kenneth Blum, Morgan P Lorio, Sergio Luis Schmidt, Rossano Kepler Alvim Fiorelli

Background: Despite >$3.2 billion invested across >1,800 projects by NIH's HEAL Initiative, scalable solutions for chronic pain and opioid use disorder remain limited. Continued reliance on opioid-replacement therapies often suppresses reward circuitry without restoring its neurobiology.

Objective: To articulate a neurobiologically grounded, whole-person strategy that reframes perioperative pain management as dopaminergic restoration, and to propose pragmatic clinical and policy steps for translation.

Approach conceptual model: We synthesize evidence that chronic pain and addiction share hypodopaminergic mechanisms (Reward Deficiency Syndrome). We highlight precision nutraceuticals (amino-acid precursors + enkephalinase inhibitors) aimed at restoring dopamine homeostasis-especially in genetically vulnerable patients identified by the Genetic Addiction Risk Severity (GARS) test-and position them within ERAS 2.0 as adjuncts to peripheral analgesia. KEY POINTS/RECOMMENDATIONS: (1) Initiate dopaminergic repletion ~2 weeks preoperative to 4 weeks postoperative, layered with local anesthetic strategies. (2) Incorporate GARS-guided risk stratification and track MMEs, pain, function, mood/craving, LOS, and 90-day opioid persistence. (3) Prioritize multicenter pragmatic RCTs and registries with mechanistic endpoints. (4) Improve funding transparency and link HEAL-like investments to clinical outcomes dashboards.

Clinical significance: We challenge the clinical status quo and call on spine surgeons and pain specialists to integrate dopaminergic repletion protocols within a precision-prehabilitation framework that offers a low-risk, non-opioid pathway to reduce suffering, enhance recovery, and decrease opioid dependence in spine surgery.

Level of evidence: 5 (Expert Opinion). The model integrates neurobiology, early translational signals, and policy levers to guide hypothesis-generating implementation.

背景:尽管NIH的HEAL计划在1800个项目中投资了32亿美元,但慢性疼痛和阿片类药物使用障碍的可扩展解决方案仍然有限。持续依赖阿片类药物替代疗法往往会抑制奖赏回路,而不会恢复其神经生物学。目的:阐明基于神经生物学的全人策略,将围手术期疼痛管理重新定义为多巴胺能恢复,并提出实用的临床和政策步骤。方法概念模型:我们综合证据,慢性疼痛和成瘾共享低多巴胺能机制(奖励缺乏综合征)。我们强调精确营养药物(氨基酸前体+脑啡肽酶抑制剂)旨在恢复多巴胺稳态-特别是在遗传成瘾风险严重程度(GARS)测试中确定的遗传易感患者中-并将其定位为ERAS 2.0作为外周镇痛的辅助药物。重点/建议:(1)术前2周至术后4周开始多巴胺能补充,分层局部麻醉策略。(2)结合gars引导的风险分层,跟踪MMEs、疼痛、功能、情绪/渴望、LOS和90天阿片类药物持续时间。(3)优先考虑多中心实用rct和具有机制终点的注册中心。(4)提高资金透明度,并将类似heald的投资与临床结果仪表板联系起来。临床意义:我们挑战临床现状,呼吁脊柱外科医生和疼痛专家在精准康复框架内整合多巴胺能补充方案,提供低风险,非阿片类药物途径,以减少脊柱手术中的痛苦,增强康复,减少阿片类药物依赖。证据等级:5(专家意见)。该模型整合了神经生物学、早期翻译信号和政策杠杆,以指导假设生成的实施。
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引用次数: 0
Differential Diagnosis of Posterior Buttock Pain: A Conceptual Review Based on Topographic Localization of Pain, Is It Really the Sacroiliac Joint? 后臀痛的鉴别诊断:基于疼痛的地形图定位的概念回顾,它真的是骶髂关节吗?
IF 1.7 Q2 SURGERY Pub Date : 2025-12-11 DOI: 10.14444/8821
W Carlton Reckling, David W Polly

Diagnosis and management of musculoskeletal pain in the lower back, buttock, and hip can be complex due to the multilayered muscular anatomy in this region. Each structure or functional group (ie, hip abductors) may present as a local pain syndrome. Pain may arise from osseous, intra-articular, ligamentous, musculotendinous, myofascial, neural, or vascular sources. Diagnosis is challenging due to overlapping innervation and referred pain patterns, particularly sclerotomal referral from osseous and ligamentous structures. Effective treatment requires accurate diagnosis. A regionalized approach categorizing pain syndromes into 6 anatomic zones-above the iliac crest, the iliac crest, the lateral hip, the gluteal region, sciatic nerve related, and the ischial tuberosity-may improve diagnostic clarity and guide treatment. A regionalized, 6-zone framework for posterior buttock pain may enhance diagnostic accuracy and guide individualized management.

下背部、臀部和髋关节肌肉骨骼疼痛的诊断和治疗是复杂的,因为该区域有多层肌肉解剖结构。每个结构或功能群(如髋外展肌)可能表现为局部疼痛综合征。疼痛可能来自骨性、关节内、韧带、肌肉肌腱、肌筋膜、神经或血管。诊断是具有挑战性的,由于重叠的神经支配和转诊疼痛模式,特别是骨性和韧带结构的硬化转诊。有效的治疗需要准确的诊断。区域性方法将疼痛综合征分为6个解剖区-髂嵴上方,髂嵴,髋外侧,臀区,坐骨神经相关区和坐骨结节-可以提高诊断清晰度和指导治疗。一个区域化的6区框架可以提高诊断的准确性并指导个体化治疗。
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引用次数: 0
Multifidus Dysfunction and Chronic Low Back Pain: Systematic Review and Meta-analysis of the Supporting Data for Accurate Diagnosis and Successful Treatment Outcomes Associated With Restorative Neurostimulation. 多裂肌功能障碍和慢性腰痛:与恢复性神经刺激相关的准确诊断和成功治疗结果的支持数据的系统回顾和荟萃分析。
IF 1.7 Q2 SURGERY Pub Date : 2025-12-11 DOI: 10.14444/8814
Shay Bess, Virginie Lafage, Morgan Lorio, Bassel G Diebo, Frank Schwab

Background: Chronic low back pain (CLBP) is a leading cause of disability worldwide. Multifidus muscle dysfunction is increasingly recognized as a distinct contributor to mechanical CLBP. Restorative neurostimulation has emerged as a targeted therapy for this phenotype.

Methods: A systematic review and meta-analysis was conducted according to PRISMA guidelines. Databases searched included PubMed, Cochrane, and Web of Science for studies published between January 2013 and September 2025. Eligible studies evaluated implantable restorative neurostimulation in adults with CLBP and multifidus dysfunction. Data extraction included patient demographics, study design, pain, disability, and quality of life outcomes. Risk of bias was assessed using Cochrane and National Institutes of Health tools. The meta-analysis reported pooled mean differences at 1- and 4-year follow-up.

Results: Six studies (N = 650; 546 treated, 104 controls) met inclusion criteria. Restorative neurostimulation resulted in significant improvements in pain (Numerical Rating Scale/visual analog scale), disability (Oswestry Disability Index [ODI]), and quality of life (EQ-5D) at 1 and 4 years. The meta-analysis showed a pooled mean reduction in pain scores of 3.2 (±0.8) at 1 year and 4.1 (±2.1) at 4 years. EQ-5D improved by 0.200 (±0.043) at 1 year and 0.251 (±0.072) at 4 years. Pooled mean ODI improvement was 17.1 at 1 year and 23.0 at 4 years, exceeding minimally clinically important differences at both 1 and 4 years. Mechanistic studies demonstrated reversal of multifidus fibrosis and normalization of muscle spindle structure.

Conclusions: Restorative neurostimulation targeting multifidus dysfunction provides sustained, clinically meaningful improvements in pain, disability, and quality of life for patients with mechanical CLBP. Accurate phenotyping and use of International Classification of Diseases, 10th revision, code M62.85 enable targeted intervention. Further research should focus on comparative effectiveness, cost-effectiveness, and predictive biomarkers to optimize patient selection.

背景:慢性腰痛(CLBP)是世界范围内致残的主要原因。多裂肌功能障碍越来越被认为是机械性CLBP的一个独特因素。恢复性神经刺激已成为这种表型的靶向治疗方法。方法:根据PRISMA指南进行系统评价和荟萃分析。检索的数据库包括PubMed、Cochrane和Web of Science,检索2013年1月至2025年9月间发表的研究。符合条件的研究评估了CLBP和多裂肌功能障碍的成人植入式恢复性神经刺激。数据提取包括患者人口统计、研究设计、疼痛、残疾和生活质量结果。使用Cochrane和美国国立卫生研究院的工具评估偏倚风险。荟萃分析报告了1年和4年随访期间的平均差异。结果:6项研究(N = 650;治疗组546,对照组104)符合纳入标准。恢复性神经刺激导致1年和4年疼痛(数值评定量表/视觉模拟量表)、残疾(Oswestry残疾指数[ODI])和生活质量(EQ-5D)的显著改善。荟萃分析显示,1年疼痛评分平均降低3.2(±0.8),4年疼痛评分平均降低4.1(±2.1)。EQ-5D在1年改善0.200(±0.043),4年改善0.251(±0.072)。综合平均ODI改善在1年和4年分别为17.1和23.0,超过了1年和4年的最低临床重要差异。机制研究表明多裂肌纤维化逆转和肌纺锤体结构正常化。结论:针对多裂肌功能障碍的恢复性神经刺激为机械性CLBP患者的疼痛、残疾和生活质量提供了持续的、有临床意义的改善。准确的表型和使用国际疾病分类,第十版,代码M62.85,使有针对性的干预。进一步的研究应侧重于比较有效性、成本效益和预测性生物标志物,以优化患者选择。
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引用次数: 0
Safety Evaluation of Intradiscal Delivery of Nucleus Pulposus Allograft for Lumbar Discogenic Pain. 同种异体髓核椎间盘内植入治疗腰椎间盘源性疼痛的安全性评价。
IF 1.7 Q2 SURGERY Pub Date : 2025-12-11 DOI: 10.14444/8808
Meredith L Langhorst, Daniel R Kendall, Siddardth Umapathy, Amol Soin, Morgan P Lorio

Background: Persistent concerns remain about the deleterious pathological effects of minimally invasive transannular puncture, such as occurs during discography and therapeutic intradiscal procedures. The objective of this study was to estimate the safety profile associated with fluoroscopically guided intradiscal delivery of nucleus pulposus (NP) allograft under clinical trial and real-world conditions.

Methods: This was a retrospective pooled analysis of adverse events (AEs) and clinical complaints captured from 4 different treatment populations (n = 392) and a database of commercial cases (n = 19,392 discs treated) with lumbar discogenic pain who underwent minimally invasive intradiscal NP allograft supplementation. All AEs were graded for severity as mild, moderate, or severe, and relatedness was judged as possibly, probably, or definitely. All serious AEs were adjudicated for outcome.

Results: There were 51 total AEs reported across all 4 clinical cohorts, and 6 AEs (12%) were judged to be related to the NP allograft product and the intradiscal procedure, with an additional 4 AEs (8%) related solely to the intradiscal procedure. None of the AEs was associated with infection (ie, discitis), neurological compromise, or escalation to surgical treatment. The product-attributable serious AE incidence was 0.26% (1/392). Of the commercial cases (n = 19,392 discs treated), no clinical AEs were reported from this cohort, with only 101 device complaints (0.521%) related primarily to delivery interface or packaging integrity.

Conclusions: Intradiscal NP allograft supplementation for symptomatic degenerative disc disease demonstrates a favorable safety profile. These findings serve to temper concerns about the risk of disc complications and accelerated degeneration following transannular puncture.

Clinical relevance: These findings validate that the NP allograft product and procedure have an exemplary safety profile. As a microinvasive, motion-preserving intervention, this procedure has the potential to bridge the therapeutic gap between conservative care and invasive spine surgery for patients suffering from discogenic back pain.

Level of evidence: 4:

背景:持续关注微创经环穿刺的有害病理影响,如在椎间盘造影术和治疗性椎间盘内手术中发生。本研究的目的是评估在临床试验和现实世界条件下,透视引导下椎间盘内移植髓核(NP)的安全性。方法:回顾性汇总分析了4个不同治疗人群(n = 392)的不良事件(ae)和临床投诉,以及一个商业病例数据库(n = 19392个治疗的椎间盘),这些患者接受了微创椎间盘内NP异体移植物补充。所有ae的严重程度分为轻度、中度或严重,相关性分为可能、可能或肯定。所有严重的ae都被判定为结果。结果:在所有4个临床队列中共报告了51例ae,其中6例ae(12%)被认为与NP异体移植产物和椎间盘内手术有关,另外4例ae(8%)仅与椎间盘内手术有关。所有不良反应均与感染(如椎间盘炎)、神经损伤或升级到手术治疗无关。产品归因的严重AE发生率为0.26%(1/392)。在商业案例中(n = 19,392个接受治疗的椎间盘),该队列中没有报告临床不良事件,只有101例器械投诉(0.521%)主要与输送界面或包装完整性相关。结论:椎间盘内NP异体移植补充治疗症状性退行性椎间盘疾病具有良好的安全性。这些发现有助于缓和对经环穿刺后椎间盘并发症和加速退变风险的担忧。临床相关性:这些发现证实了NP同种异体移植产品和程序具有典型的安全性。作为一种微创的、保持运动的干预手段,这种手术有可能弥补椎间盘源性背痛患者保守治疗和有创脊柱手术之间的治疗差距。证据等级:4;
{"title":"Safety Evaluation of Intradiscal Delivery of Nucleus Pulposus Allograft for Lumbar Discogenic Pain.","authors":"Meredith L Langhorst, Daniel R Kendall, Siddardth Umapathy, Amol Soin, Morgan P Lorio","doi":"10.14444/8808","DOIUrl":"10.14444/8808","url":null,"abstract":"<p><strong>Background: </strong>Persistent concerns remain about the deleterious pathological effects of minimally invasive transannular puncture, such as occurs during discography and therapeutic intradiscal procedures. The objective of this study was to estimate the safety profile associated with fluoroscopically guided intradiscal delivery of nucleus pulposus (NP) allograft under clinical trial and real-world conditions.</p><p><strong>Methods: </strong>This was a retrospective pooled analysis of adverse events (AEs) and clinical complaints captured from 4 different treatment populations (n = 392) and a database of commercial cases (n = 19,392 discs treated) with lumbar discogenic pain who underwent minimally invasive intradiscal NP allograft supplementation. All AEs were graded for severity as mild, moderate, or severe, and relatedness was judged as possibly, probably, or definitely. All serious AEs were adjudicated for outcome.</p><p><strong>Results: </strong>There were 51 total AEs reported across all 4 clinical cohorts, and 6 AEs (12%) were judged to be related to the NP allograft product and the intradiscal procedure, with an additional 4 AEs (8%) related solely to the intradiscal procedure. None of the AEs was associated with infection (ie, discitis), neurological compromise, or escalation to surgical treatment. The product-attributable serious AE incidence was 0.26% (1/392). Of the commercial cases (<i>n</i> = 19,392 discs treated), no clinical AEs were reported from this cohort, with only 101 device complaints (0.521%) related primarily to delivery interface or packaging integrity.</p><p><strong>Conclusions: </strong>Intradiscal NP allograft supplementation for symptomatic degenerative disc disease demonstrates a favorable safety profile. These findings serve to temper concerns about the risk of disc complications and accelerated degeneration following transannular puncture.</p><p><strong>Clinical relevance: </strong>These findings validate that the NP allograft product and procedure have an exemplary safety profile. As a microinvasive, motion-preserving intervention, this procedure has the potential to bridge the therapeutic gap between conservative care and invasive spine surgery for patients suffering from discogenic back pain.</p><p><strong>Level of evidence: 4: </strong></p>","PeriodicalId":38486,"journal":{"name":"International Journal of Spine Surgery","volume":" ","pages":"S48-S53"},"PeriodicalIF":1.7,"publicationDate":"2025-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145393896","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Guest Editorial: Neurogenetics and the Future of Pain: Reclaiming Reward, Function, and Identity. 客座评论:神经遗传学和疼痛的未来:重新获得奖励,功能和身份。
IF 1.7 Q2 SURGERY Pub Date : 2025-12-11 DOI: 10.14444/8806
Kenneth Blum
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引用次数: 0
Beyond Pain Relief: Preventing Recurrence and Preserving Function After Lumbar Discectomy. 缓解疼痛之外:预防腰椎间盘切除术后复发和保留功能。
IF 1.7 Q2 SURGERY Pub Date : 2025-12-11 DOI: 10.14444/8803
Parker Babington, Jason Zook, K Brandon Strenge, Pierce Nunley, Juliette Beristain, Marcus Stone, Laura C Shum, Michael Musacchio

Lumbar discectomy remains the most common surgical treatment for lumbar disc herniation, potentially providing quick pain relief for patients. However, while pain resolution is a key measure of short-term success, it does not guarantee long-term recovery. In patients with large annular defects (≥6 mm), the structural vulnerability left by discectomy predisposes patients to recurrent herniation, which can trigger a return of severe pain, diminished function, and the need for additional surgery. Revision surgeries for recurrent herniations are costly and are associated with a lower chance of positive patient outcomes compared with primary procedures.Bone-anchored annular closure devices aim to address the root structural cause of recurrent herniation by sealing the annular defect during discectomy to preserve disc integrity. Adding a bone-anchored annular closure device to discectomy reduces symptomatic reherniation and reoperation rates by more than 50%, prolonging pain-free intervals and improving quality of life. Patients treated with bone-anchored annular closure devices report low pain scores over long-term follow-up, faster return to work, and reduced opioid requirements.Cost-effectiveness analyses demonstrate that in patients with a large annular defect, bone-anchored annular closure devices achieve cost neutrality, or savings, within 2 to 5 years, with incremental cost-effectiveness ratios below accepted thresholds. By preventing the recurrence of lumbar herniation and the need for reoperation, bone-anchored annular closure technologies offer a clinically validated, economically prudent solution aligned with value-based care principles and durable, patient-centered success.

腰椎间盘切除术仍然是最常见的手术治疗腰椎间盘突出症,可能为患者提供快速疼痛缓解。然而,尽管缓解疼痛是衡量短期成功的关键指标,但它并不能保证长期康复。对于较大的椎间盘环缺损(≥6mm)的患者,椎间盘切除术留下的结构脆弱性使患者容易复发性疝出,这可能引发严重疼痛、功能下降和需要额外的手术。复发性疝的翻修手术费用昂贵,与初次手术相比,患者阳性结果的机会较低。骨锚定环封闭装置旨在通过在椎间盘切除术中封闭环缺损来保护椎间盘的完整性,从而解决复发性椎间盘突出的根本结构原因。在椎间盘切除术中加入骨锚定环闭合装置可减少症状性再突出和再手术率50%以上,延长无痛间隔时间,提高生活质量。接受骨锚定环形闭合装置治疗的患者在长期随访中报告疼痛评分低,更快地恢复工作,阿片类药物需求减少。成本-效果分析表明,在有较大环空缺损的患者中,骨锚定环空闭合装置可在2至5年内实现成本中立或节省,增量成本-效果比低于可接受的阈值。通过防止腰椎间盘突出症的复发和再次手术的需要,骨锚定环闭合技术提供了一种临床验证的、经济谨慎的解决方案,与基于价值的护理原则和持久的、以患者为中心的成功相一致。
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引用次数: 0
Editor's Introduction-Rethinking Pain: What We Are Treating, What We Are Missing, and Why It Matters. 编者介绍-重新思考疼痛:我们在治疗什么,我们错过了什么,为什么它很重要。
IF 1.7 Q2 SURGERY Pub Date : 2025-12-11 DOI: 10.14444/8805
Morgan P Lorio
{"title":"Editor's Introduction-Rethinking Pain: What We Are Treating, What We Are Missing, and Why It Matters.","authors":"Morgan P Lorio","doi":"10.14444/8805","DOIUrl":"10.14444/8805","url":null,"abstract":"","PeriodicalId":38486,"journal":{"name":"International Journal of Spine Surgery","volume":" ","pages":"S1-S3"},"PeriodicalIF":1.7,"publicationDate":"2025-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145655702","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Total Joint Replacement of the Lumbar Spine: 12-Month Pain and Functional Outcomes From an Investigational Device Exemption Clinical Trial. 腰椎全关节置换术:一项试验性器械豁免临床试验的12个月疼痛和功能结果
IF 1.7 Q2 SURGERY Pub Date : 2025-12-11 DOI: 10.14444/8809
Pierce D Nunley, J Alex Sielatycki, S Craig Humphreys, Scott D Hodges, Jon E Block, Domagoj Coric, Jeffrey A Goldstein

Background: Lumbar fusion eliminates motion at the operative level and is associated with altered load transfer and adjacent segment degeneration. Total joint replacement (TJR) of the lumbar spine is a motion segment reconstruction procedure performed via a bilateral transforaminal approach that allows direct neural decompression and replacement of both disc and facet function. This prospective investigational device exemption clinical trial compared TJR with a concurrent, propensity-score-weighted real-world evidence cohort treated with either instrumented transforaminal lumbar interbody fusion (TLIF) or posterior lumbar interbody spine fusion (PLIF).

Methods: This multicenter investigational device exemption trial was conducted at 20 US sites. Patient-reported outcomes from 152 TJR subjects implanted with the MOTUS device were compared with 142 propensity score-weighted TLIF/PLIF controls. Lumbar-related disability was measured with the Oswestry Disability Index (ODI) and back and worst leg pain severity by a 100-mm visual analog scale (VAS). Minimal clinically important difference thresholds were ODI ≥ 15 points and VAS ≥ 20 mm; responder analyses were also conducted using ≥30% and substantial clinical benefit (≥50%) thresholds. Effect sizes were calculated using Cohen's d or h.

Results: Baseline characteristics were well balanced, and there were no statistically significant differences between study groups. At 12 months, mean ODI decreased by 45 points (71%) with TJR and 37 points (59%) with TLIF/PLIF. The adjusted between-group difference was 8.1 points (95% CI, 2.5-13.7; P = 0.005; Cohen's d = 0.39, small). VAS back and leg pain decreases were similar between groups, with no significant between-group differences. Minimal clinically important difference responder rates were high (>85%) for both procedures; the ≥30% ODI threshold favored TJR (90% vs 80%; P = 0.04).

Conclusions: Substantial decreases in back impairment and pain severity were realized in both study groups. However, longitudinal improvement in ODI significantly favored patients treated with TJR.

Clinical relevance: Lumbar TJR combines decompression with motion preservation in a single procedure, potentially offering an alternative to fusion in selected patients. The advantage of utilizing a standard posterior operative approach with TJR is that it allows for direct decompression of the neural elements prior to implant placement.

Level of evidence: 2b.

背景:腰椎融合术消除了手术水平的运动,并与负荷转移改变和邻近节段退变有关。腰椎全关节置换术(TJR)是一种通过双侧经椎间孔入路进行的运动节段重建手术,可以直接进行神经减压并置换椎间盘和关节突功能。这项前瞻性研究性免器械临床试验将TJR与同时进行的倾向评分加权真实证据队列进行了比较,这些队列接受了经椎间孔腰椎体间融合术(tliff)或后路腰椎体间脊柱融合术(PLIF)。方法:这项多中心研究性器械豁免试验在美国20个地点进行。将152例植入MOTUS装置的TJR患者报告的结果与142例倾向评分加权TLIF/PLIF对照组进行比较。采用Oswestry残疾指数(ODI)测量腰部相关残疾,采用100 mm视觉模拟量表(VAS)测量背部和腿部最严重疼痛程度。最小临床重要差异阈值为ODI≥15分,VAS≥20 mm;应答者分析也采用≥30%和实质性临床获益(≥50%)阈值进行。效应量采用Cohen’s d或h计算。结果:基线特征平衡良好,研究组之间无统计学显著差异。12个月时,TJR组平均ODI下降45分(71%),TLIF/PLIF组平均ODI下降37分(59%)。调整后的组间差异为8.1点(95% CI, 2.5-13.7; P = 0.005; Cohen’s d = 0.39,小)。两组间VAS背部和腿部疼痛的减少相似,组间无显著差异。两种治疗方法的最小临床重要差异反应率都很高(约85%);≥30% ODI阈值有利于TJR (90% vs 80%; P = 0.04)。结论:在两个研究组中,背部损伤和疼痛严重程度均显著降低。然而,ODI的纵向改善明显有利于接受TJR治疗的患者。临床意义:腰椎TJR在单一手术中结合减压和运动保持,可能为特定患者提供融合的替代方案。TJR采用标准后路手术入路的优点是可以在植入前对神经元件进行直接减压。证据等级:2b。
{"title":"Total Joint Replacement of the Lumbar Spine: 12-Month Pain and Functional Outcomes From an Investigational Device Exemption Clinical Trial.","authors":"Pierce D Nunley, J Alex Sielatycki, S Craig Humphreys, Scott D Hodges, Jon E Block, Domagoj Coric, Jeffrey A Goldstein","doi":"10.14444/8809","DOIUrl":"10.14444/8809","url":null,"abstract":"<p><strong>Background: </strong>Lumbar fusion eliminates motion at the operative level and is associated with altered load transfer and adjacent segment degeneration. Total joint replacement (TJR) of the lumbar spine is a motion segment reconstruction procedure performed via a bilateral transforaminal approach that allows direct neural decompression and replacement of both disc and facet function. This prospective investigational device exemption clinical trial compared TJR with a concurrent, propensity-score-weighted real-world evidence cohort treated with either instrumented transforaminal lumbar interbody fusion (TLIF) or posterior lumbar interbody spine fusion (PLIF).</p><p><strong>Methods: </strong>This multicenter investigational device exemption trial was conducted at 20 US sites. Patient-reported outcomes from 152 TJR subjects implanted with the MOTUS device were compared with 142 propensity score-weighted TLIF/PLIF controls. Lumbar-related disability was measured with the Oswestry Disability Index (ODI) and back and worst leg pain severity by a 100-mm visual analog scale (VAS). Minimal clinically important difference thresholds were ODI ≥ 15 points and VAS ≥ 20 mm; responder analyses were also conducted using ≥30% and substantial clinical benefit (≥50%) thresholds. Effect sizes were calculated using Cohen's <i>d</i> or <i>h</i>.</p><p><strong>Results: </strong>Baseline characteristics were well balanced, and there were no statistically significant differences between study groups. At 12 months, mean ODI decreased by 45 points (71%) with TJR and 37 points (59%) with TLIF/PLIF. The adjusted between-group difference was 8.1 points (95% CI, 2.5-13.7; <i>P</i> = 0.005; Cohen's <i>d</i> = 0.39, small). VAS back and leg pain decreases were similar between groups, with no significant between-group differences. Minimal clinically important difference responder rates were high (>85%) for both procedures; the ≥30% ODI threshold favored TJR (90% vs 80%; <i>P</i> = 0.04).</p><p><strong>Conclusions: </strong>Substantial decreases in back impairment and pain severity were realized in both study groups. However, longitudinal improvement in ODI significantly favored patients treated with TJR.</p><p><strong>Clinical relevance: </strong>Lumbar TJR combines decompression with motion preservation in a single procedure, potentially offering an alternative to fusion in selected patients. The advantage of utilizing a standard posterior operative approach with TJR is that it allows for direct decompression of the neural elements prior to implant placement.</p><p><strong>Level of evidence: </strong>2b.</p>","PeriodicalId":38486,"journal":{"name":"International Journal of Spine Surgery","volume":" ","pages":"S59-S66"},"PeriodicalIF":1.7,"publicationDate":"2025-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145348952","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Facilitating Earlier Discharge for Patients Undergoing Spine Surgery. 促进脊柱手术病人早日出院。
IF 1.7 Q2 SURGERY Pub Date : 2025-12-11 DOI: 10.14444/8811
G Damian Brusko, Michael Y Wang

As the population ages and the incidence of spine surgeries increases, better solutions are needed for the challenges of adequate pain control and lengthy hospital stays, which often result from difficulty with controlling pain, managing complications, or coordinating post-hospitalization care services. Thus, there is an inherent need for ways to improve pain and time to discharge. Minimally invasive techniques aim to minimize tissue disruption and can decrease pain and accelerate recovery. However, these techniques are not indicated for all spine patients, and not all spine surgeons are adequately trained in such techniques, thus limiting generalizability. In contrast, Enhanced Recovery After Surgery (ERAS) has recently been adopted within spine surgery as an alternative management strategy to optimize patient outcomes. Enhanced recovery principles mitigate the surgical stress response through a series of evidence-based, perioperative interventions that have demonstrated success with reducing postoperative pain and complications, increasing ambulation, and shortening length of stay. While still in its infancy within spine surgery, there is ample evidence for the successful implementation of ERAS programs for numerous spine procedures. However, further randomized trials will likely be needed to support the continued application of ERAS within spine surgery.

随着人口老龄化和脊柱手术发生率的增加,需要更好的解决方案来应对适当的疼痛控制和长期住院的挑战,这通常是由于难以控制疼痛、处理并发症或协调住院后护理服务。因此,有一个内在的需要的方法来改善疼痛和时间出院。微创技术旨在最大限度地减少组织破坏,减轻疼痛,加速恢复。然而,这些技术并不适用于所有脊柱患者,并不是所有的脊柱外科医生都接受过这些技术的充分培训,因此限制了这些技术的推广。相比之下,术后增强恢复(ERAS)最近在脊柱手术中被采用作为优化患者预后的替代管理策略。增强恢复原则通过一系列循证围手术期干预措施减轻了手术应激反应,这些干预措施已被证明在减少术后疼痛和并发症、增加活动和缩短住院时间方面取得了成功。虽然在脊柱外科中仍处于起步阶段,但有充分的证据表明,在许多脊柱手术中成功实施了ERAS计划。然而,可能需要进一步的随机试验来支持ERAS在脊柱外科中的持续应用。
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引用次数: 0
期刊
International Journal of Spine Surgery
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