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Efficacy of Epidural Steroid in Controlling Pain After Unilateral Biportal Endoscopic Discectomy for Single-Level Lumbar Disc Herniation: A Randomized, Double-Blind, Placebo-Controlled Trial. 硬膜外类固醇对单侧双侧内窥镜椎间盘切除术治疗单水平腰椎间盘突出症后疼痛的控制效果:随机、双盲、安慰剂对照试验。
IF 1.7 Q2 SURGERY Pub Date : 2024-10-23 DOI: 10.14444/8655
Rattalerk Arunakul, Thanapat Boonraksa, Punnawit Pinitchanon, Koopong Siribumrungwong, Thongchai Suntharapa, Waroot Pholsawatchai

Background: The effects of epidural steroid (ES) administration following open or minimally invasive surgery lumbar discectomy have been extensively studied. However, no research has investigated the impact of steroids following the unilateral biportal technique endoscopic lumbar discectomy (UBE-D) for lumbar disc herniation. This study aims to evaluate the efficacy of ES administration in controlling postoperative pain and disability scores following UBE-D for single-level lumbar disc herniation.

Methods: This double-blind, randomized, placebo-controlled trial was conducted between June 2021 and June 2023. Eighty-two patients were assessed, and 60 were eligible and randomized to receive either ES (n = 30) or saline (placebo; n = 30) after UBE-D. The Outcome measures included visual analog scale scores for pain, Oswestry Disability Index scores, morphine consumption over 24 hours, serum C-reactive protein levels, and the occurrence of complications over a 6-month follow-up period.

Results: The baseline characteristics were comparable between the 2 groups, with no significant differences observed. Analysis of visual analog scale scores for back and leg pain, as well as Oswestry Disability Index scores, at various postoperative time points (6 hours, 12 hours, 24 hours, 2 weeks, 6 weeks, 3 months, and 6 months), showed no statistically significant differences between the ES and placebo groups (P values ranged from 0.47-0.94). Additionally, no significant differences were found in morphine consumption within the first 24 hours postoperatively (P = 0.85), length of hospital stay (P = 0.36), or C-reactive protein levels at 24 hours and 3 weeks postoperatively (P values ranged from 0.54-0.79) between the 2 groups. Importantly, no postoperative or steroid-related complications were reported in either group within the 6-month follow-up period.

Conclusions: ES administration after UBE-D did not significantly reduce postoperative pain, disability scores, or morphine consumption compared with placebo. The findings suggest that routine use of ESs in this context may not provide additional benefits.

Clinical relevance: Clinicians should reconsider the use of epidural steroids as part of standard postoperative management after UBE-D, as the lack of significant improvement in patient outcomes indicates that alternative pain management strategies may be more effective.

Level of evidence: 1:

背景:对开放或微创手术腰椎间盘切除术后硬膜外类固醇(ES)用药的影响进行了广泛的研究。然而,还没有研究调查过单侧双侧技术内窥镜腰椎间盘切除术(UBE-D)治疗腰椎间盘突出症后使用类固醇的影响。本研究旨在评估服用 ES 对单侧腰椎间盘突出症 UBE-D 术后疼痛和残疾评分的控制效果:这项双盲、随机、安慰剂对照试验于 2021 年 6 月至 2023 年 6 月期间进行。82名患者接受了评估,其中60人符合条件,并在UBE-D后随机接受ES(30人)或生理盐水(安慰剂;30人)治疗。结果测量包括疼痛视觉模拟量表评分、Oswestry残疾指数评分、24小时吗啡消耗量、血清C反应蛋白水平以及6个月随访期间并发症的发生情况:结果:两组患者的基线特征相当,无明显差异。对术后不同时间点(6 小时、12 小时、24 小时、2 周、6 周、3 个月和 6 个月)的腰腿痛视觉模拟量表评分和 Oswestry 残疾指数评分进行分析后发现,ES 组和安慰剂组在统计学上没有显著差异(P 值在 0.47-0.94 之间)。此外,两组患者在术后 24 小时内的吗啡用量(P = 0.85)、住院时间(P = 0.36)或术后 24 小时和 3 周时的 C 反应蛋白水平(P 值范围为 0.54-0.79)方面也无明显差异。重要的是,在 6 个月的随访期内,两组患者均未出现术后或类固醇相关并发症:结论:与安慰剂相比,在 UBE-D 术后使用 ES 并不能明显减轻术后疼痛、残疾评分或吗啡用量。研究结果表明,在这种情况下常规使用 ES 可能不会带来额外的益处:临床医生应重新考虑将硬膜外类固醇作为 UBE-D 术后标准治疗的一部分,因为患者的预后没有明显改善,这表明其他疼痛治疗策略可能更有效:1:
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引用次数: 0
Baseline Neck Disability Index and Patient-Reported Outcomes Measurement Information System Physical Function Predict Postoperative Return to Normal in Cervical Spine Surgery. 颈椎手术术后恢复正常的基线颈部残疾指数和 "患者报告结果测量信息系统 "物理功能预测。
IF 1.7 Q2 SURGERY Pub Date : 2024-10-09 DOI: 10.14444/8653
Gregory S Kazarian, Michael E Steinhaus, Sravisht Iyer, Drake LeBrun, Robert Cecere, Takashi Hirase, Francis Lovecchio, Todd J Albert, Darren Lebl, Darren Huang, Harvinder Sandhu, Bernard Rawlins, Frank Schwab, Virginie Lafage, Han Jo Kim

Background: Recent studies assessing the importance of various preoperative factors on postoperative outcomes following spine surgery have uncovered several important variables that influence subjective and objective outcomes following cervical spine surgery, but it is still unclear which patients are most likely to benefit from operative management.

Purpose: The objective of this study was to assess whether preoperative patient-reported outcome measures (PROMs) can be used to predict which patients achieve "normal" levels of pain and function after surgery.

Study design: This was a prospective cohort study.

Patient sample: This study included all adult patients undergoing cervical spine surgery by 1 of 7 senior spine surgeons at our institution between 2016 and 2018. Of the 164 patients who were eligible for 6-month follow-up at the time that study data were collected, 139 had available follow-up data and were included in our analysis.

Outcomes measures: Patients completed the Neck Disability Index (NDI) as well as the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference computer adaptive tests preoperatively and at 6 months postoperatively.

Methods: Patients who achieved postoperative patient-acceptable symptom state (PASS) for NDI (≤17) and the normative mean (50) for PROMIS were identified. The relationship between preoperative PROMs and the probability of achieving PASS and the normative mean was assessed.

Results: One hundred thirty-nine patients met inclusion criteria with diagnoses of myelopathy (n = 36), radiculopathy (n = 48), and myeloradiculopathy (n = 49). For NDI, a 1-point worsening in the preoperative score resulted in an OR of achieving PASS of 0.96 (P < 0.001) in the overall population. This association held true for patients with radiculopathy (OR 0.96; P = 0.022) but not myelopathy (OR 0.98; P = 0.35). For PROMIS PF, a 1-point improvement in the preoperative score resulted in an OR of achieving the normative mean of 1.10 (P < 0.001). This association held true for patients with radiculopathy (OR 1.14; P = 0.033) but did not reach statistical significance for patients with myelopathy (OR 1.03; P = 0.515).

Conclusions: Preoperative PROMs can predict postoperative benefit for patients undergoing cervical spine surgery, with worse baseline function associated with a lower likelihood of attaining PASS for NDI and the normative mean for PROMIS PF, especially for patients with radiculopathy.

Clinical relevance: Baseline symptoms and function, including myelopathy or radiculopathy-dominant symptoms and preoperative PROMs, may predict postoperative outcomes.

Level of evidence: 3:

背景:目的:本研究的目的是评估术前患者报告的结果测量(PROMs)是否可用于预测哪些患者术后疼痛和功能达到 "正常 "水平:研究设计:这是一项前瞻性队列研究:本研究纳入了我院 7 位高级脊柱外科医生中的 1 位在 2016 年至 2018 年期间接受颈椎手术的所有成年患者。在收集研究数据时符合6个月随访条件的164名患者中,139名患者有可用的随访数据,并纳入了我们的分析:患者在术前和术后6个月完成颈部残疾指数(NDI)以及患者报告结果测量信息系统(PROMIS)身体功能(PF)和疼痛干扰计算机适应性测试:方法:确定术后NDI(≤17)达到患者可接受症状状态(PASS)和PROMIS常模平均值(50)的患者。评估了术前 PROMs 与达到 PASS 的概率和常模平均值之间的关系:139 名患者符合纳入标准,诊断为脊髓病(36 人)、根病(48 人)和脊髓脊膜病(49 人)。就 NDI 而言,术前评分每恶化 1 分,总体人群中达到 PASS 的 OR 值为 0.96(P < 0.001)。这种关联对根性脊髓病(OR 0.96; P = 0.022)患者有效,但对脊髓病(OR 0.98; P = 0.35)患者无效。就 PROMIS PF 而言,术前评分每提高 1 分,达到常模平均值的 OR 为 1.10(P < 0.001)。这种关联在根性脊髓病患者身上成立(OR 1.14; P = 0.033),但在脊髓病患者身上没有达到统计学意义(OR 1.03; P = 0.515):结论:术前PROMs可预测颈椎手术患者的术后获益,基线功能较差的患者达到NDI PASS和PROMIS PF常模平均值的可能性较低,尤其是根神经病患者:基线症状和功能,包括脊髓病或根性病变为主的症状和术前 PROMs,可预测术后结果:3:
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引用次数: 0
Redefining Surgical Boundaries for Obese Patients? Full Endoscopic Lumbar Discectomy Proves Equally Effective With Shorter Hospital Stay in Obese Patients. 重新定义肥胖患者的手术界限?全内窥镜腰椎间盘切除术对肥胖患者同样有效,住院时间更短。
IF 1.7 Q2 SURGERY Pub Date : 2024-10-02 DOI: 10.14444/8654
Xavier Castel, Henri d'Astorg, Mohammad Allaji, Vincent Fiere, Marc Szadkowski

Objective: This cohort study aims to evaluate the impact of obesity on the outcomes of full endoscopic lumbar discectomy (FELD) in patients with lumbar disc herniation.

Methods: We conducted a retrospective analysis of 156 adult patients who underwent FELD for lumbar disc herniation from January 2015 to February 2023. Patients were divided into 3 groups: obese endoscopic (n = 71), obese open surgery (n = 31), and nonobese endoscopic (n = 54). Clinical outcomes were assessed using the visual analog scale for leg and back pain, the Oswestry Disability Index, and patient satisfaction rates. Operative time, hospital stay duration, and complication rates were also analyzed.

Results: No significant differences were observed in patient-reported outcome measures, operative time, or complication rates between obese and nonobese patients undergoing FELD. The mean operative time was longer in the endoscopic group compared with the open surgery group (70.2 vs 59.8 minutes), but the hospital stay was significantly shorter for endoscopic patients (1.7 vs 2.4 nights, P = 0.0006). Both obese and nonobese groups showed significant improvements in visual analog scale and Oswestry Disability Index scores at the final follow-up, with satisfaction rates of 85.7% in the endoscopic group reporting good to excellent outcomes.

Conclusions: FELD is a viable and effective alternative to traditional open surgery for obese patients, offering comparable clinical outcomes and the added benefit of a shorter hospital stay. These findings suggest that obesity does not inherently affect surgical outcomes, underscoring the need for further research with larger sample sizes and longer follow-up periods.

Clinical relevance: FELD offers a viable and effective surgical option for obese patients, with outcomes comparable to traditional surgery but with the added benefit of shorter hospital stays.

Level of evidence: 3:

目的这项队列研究旨在评估肥胖对腰椎间盘突出症患者接受全内窥镜腰椎间盘切除术(FELD)治疗效果的影响:我们对2015年1月至2023年2月期间因腰椎间盘突出症接受全内镜下腰椎间盘切除术的156名成年患者进行了回顾性分析。患者分为3组:肥胖内镜组(n = 71)、肥胖开放手术组(n = 31)和非肥胖内镜组(n = 54)。临床结果采用腿部和背部疼痛视觉模拟量表、Oswestry 残疾指数和患者满意度进行评估。此外,还对手术时间、住院时间和并发症发生率进行了分析:结果:在患者报告的结果指标、手术时间或并发症发生率方面,接受 FELD 的肥胖患者和非肥胖患者之间没有明显差异。与开放手术组相比,内窥镜组的平均手术时间更长(70.2 分钟对 59.8 分钟),但内窥镜组患者的住院时间明显更短(1.7 晚对 2.4 晚,P = 0.0006)。肥胖组和非肥胖组在最终随访时的视觉模拟量表和Oswestry残疾指数评分均有显著改善,内镜组的满意率为85.7%,结果为良好至优秀:对于肥胖症患者来说,内镜手术是传统开放手术的一种可行且有效的替代方案,不仅能提供相当的临床效果,还能缩短住院时间。这些研究结果表明,肥胖并不会从根本上影响手术效果,因此有必要进行样本量更大、随访时间更长的进一步研究:临床相关性:FELD为肥胖患者提供了一种可行且有效的手术选择,其效果与传统手术相当,但住院时间更短:3:
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引用次数: 0
Analysis of 1027 Adverse Events Reports for Interspinous Process Devices From the US Food and Drug Administration Manufacturer and User Facility Device Experience Database. 对美国食品药品管理局制造商和用户机构设备经验数据库中有关椎间孔镜设备的 1027 份不良事件报告的分析。
IF 1.7 Q2 SURGERY Pub Date : 2024-09-26 DOI: 10.14444/8652
Gregory S Kazarian, Yusef J Jordan, Mitchell Johnson, Satyaj Bhargava, Robert Cecere, Takashi Hirase, Sheeraz Qureshi, James Dowdell, Evan Sheha, Francis Lovecchio, Sravisht Iyer

Background: Interspinous process devices (IPDs) introduce a new class of complications to surgical decompression without fusion: hardware-related complications. The purpose of this study was to describe the adverse events associated with IPDs.

Study design: This was a retrospective review of the Food and Drug Administration Manufacturer and User Facility Device Experience database.

Methods: The database was queried from its inception to November 2022 for reports associated with "Prosthesis, Spinous Process Spacer/Plate." Entries were categorized by event type, patient impact, and interventions.

Results: A total of 943 surgery-related adverse events were identified. The most common intraoperative events were implant malfunctions (39.7%, n = 374) and fractures (2.2%, n = 21). The most common postoperative events were persistent pain (26.6%, n = 251), implant migration (19.1%, n = 180), and fracture (6.8%, n = 64). The most common resultant outcome of an adverse event was the need for revision surgery (48.8%, n = 460). The need for revision surgery was common in patients who experienced fracture (47.1%), implant migration (84.5%), infection (76.7%), and neurological complications (76.9%). Implant migration, fracture, and implant malfunction, 3 complications that are unique to decompression with an IPD as compared with traditional laminectomy, accounted for 45.9% of revisions (211/460), and revision was required in 33.0% of cases where 1 of these complications was reported (211/640). Implant malfunction made up 21.2% of Coflex complications, 47.3% of Superion complications, and 5.2% of X-Stop complications.

Conclusions: The most common adverse events were implant malfunction, inadequate efficacy, implant migration, and fracture. Concerningly, these complications require revision surgery in one-third of cases when they occur. Implant-specific assessments demonstrate a high prevalence of implant malfunctions for the Coflex and Superion implants.

Clinical relevance: Interspinous process devices introduce a new class of complications to isolated spinal decompression surgery: implant-related complications. These complications occur both intraoperatively and postoperatively, and they frequently necessitate revision surgery.

Level of evidence: 4:

背景:棘突间装置(IPD)为无融合手术减压带来了一类新的并发症:硬件相关并发症。本研究旨在描述与 IPD 相关的不良事件:研究设计:这是对食品药品管理局制造商和用户机构设备经验数据库的回顾性审查:从数据库建立之初到 2022 年 11 月,对与 "假体、棘突垫片/板 "相关的报告进行了查询。条目按事件类型、对患者的影响和干预措施进行分类:结果:共发现 943 例手术相关不良事件。最常见的术中事件是植入物故障(39.7%,n = 374)和骨折(2.2%,n = 21)。最常见的术后事件是持续疼痛(26.6%,n = 251)、植入物移位(19.1%,n = 180)和骨折(6.8%,n = 64)。最常见的不良事件结果是需要进行翻修手术(48.8%,n = 460)。骨折(47.1%)、植入物移位(84.5%)、感染(76.7%)和神经系统并发症(76.9%)是需要进行翻修手术的常见原因。与传统的椎板切除术相比,植入体移位、骨折和植入体故障是IPD减压术特有的3种并发症,这3种并发症占到翻修手术的45.9%(211/460),在报告了其中1种并发症的病例中,33.0%需要进行翻修(211/640)。在Coflex并发症中,21.2%的病例出现植入物故障;在Superion并发症中,47.3%的病例出现植入物故障;在X-Stop并发症中,5.2%的病例出现植入物故障:结论:最常见的不良事件是植入物故障、疗效不佳、植入物移位和骨折。令人担忧的是,在出现这些并发症时,有三分之一的病例需要进行翻修手术。针对植入物的评估显示,Coflex 和 Superion 植入物的植入物故障率较高:棘突间装置为孤立脊柱减压手术带来了一类新的并发症:植入物相关并发症。这些并发症在术中和术后都会发生,而且经常需要进行翻修手术:4:
{"title":"Analysis of 1027 Adverse Events Reports for Interspinous Process Devices From the US Food and Drug Administration Manufacturer and User Facility Device Experience Database.","authors":"Gregory S Kazarian, Yusef J Jordan, Mitchell Johnson, Satyaj Bhargava, Robert Cecere, Takashi Hirase, Sheeraz Qureshi, James Dowdell, Evan Sheha, Francis Lovecchio, Sravisht Iyer","doi":"10.14444/8652","DOIUrl":"https://doi.org/10.14444/8652","url":null,"abstract":"<p><strong>Background: </strong>Interspinous process devices (IPDs) introduce a new class of complications to surgical decompression without fusion: hardware-related complications. The purpose of this study was to describe the adverse events associated with IPDs.</p><p><strong>Study design: </strong>This was a retrospective review of the Food and Drug Administration Manufacturer and User Facility Device Experience database.</p><p><strong>Methods: </strong>The database was queried from its inception to November 2022 for reports associated with \"Prosthesis, Spinous Process Spacer/Plate.\" Entries were categorized by event type, patient impact, and interventions.</p><p><strong>Results: </strong>A total of 943 surgery-related adverse events were identified. The most common intraoperative events were implant malfunctions (39.7%, <i>n</i> = 374) and fractures (2.2%, <i>n</i> = 21). The most common postoperative events were persistent pain (26.6%, <i>n</i> = 251), implant migration (19.1%, <i>n</i> = 180), and fracture (6.8%, <i>n</i> = 64). The most common resultant outcome of an adverse event was the need for revision surgery (48.8%, <i>n</i> = 460). The need for revision surgery was common in patients who experienced fracture (47.1%), implant migration (84.5%), infection (76.7%), and neurological complications (76.9%). Implant migration, fracture, and implant malfunction, 3 complications that are unique to decompression with an IPD as compared with traditional laminectomy, accounted for 45.9% of revisions (211/460), and revision was required in 33.0% of cases where 1 of these complications was reported (211/640). Implant malfunction made up 21.2% of Coflex complications, 47.3% of Superion complications, and 5.2% of X-Stop complications.</p><p><strong>Conclusions: </strong>The most common adverse events were implant malfunction, inadequate efficacy, implant migration, and fracture. Concerningly, these complications require revision surgery in one-third of cases when they occur. Implant-specific assessments demonstrate a high prevalence of implant malfunctions for the Coflex and Superion implants.</p><p><strong>Clinical relevance: </strong>Interspinous process devices introduce a new class of complications to isolated spinal decompression surgery: implant-related complications. These complications occur both intraoperatively and postoperatively, and they frequently necessitate revision surgery.</p><p><strong>Level of evidence: 4: </strong></p>","PeriodicalId":38486,"journal":{"name":"International Journal of Spine Surgery","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142355881","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
Are the Umbilicus and Iliac Crests Truly at the Level of L4 to L5? A Computed Tomography-Based Study of Surface Anatomy of the Anterior Lumbar Spine. 脐带和髂嵴是否真正位于 L4 至 L5 水平?基于计算机断层扫描的腰椎前部表面解剖学研究。
IF 1.7 Q2 SURGERY Pub Date : 2024-09-26 DOI: 10.14444/8651
David Shin, Kai Nguyen, Easton Small, Trevor Case, Mikayla Kricfalusi, Alexander Bouterse, Andrew Cabrera, Ethan Purnell, Wheddy Laguerre, Jacob Razzouk, Omar Ramos, Olumide Danisa, Wayne Cheng

Background: This study aimed to determine whether the iliac crests are truly at the level of L4 to L5, accounting for patient demographic and anthropometric characteristics.

Methods: We measured the umbilicus and iliac crests relative to the lumbar spine using computed tomography of patients without spinal pathology, accounting for the influences of patient height, weight, body mass index (BMI), sex, race, and ethnicity.

Results: A total of 834 patients (391 men and 443 women) were reviewed. The location of the umbilicus relative to the lumbar spine demonstrated a unimodal distribution pattern clustered at L4, while the iliac crests were most frequently located from L4 to L5. Iliac crests were located above the L4 to L5 disc space 26.5% of the time. Iliac crests were located at the L4 to L5 disc space 29.8% of the time. No correlations were observed between the umbilicus and iliac crests with patient height, weight, or BMI. There was no difference in the location of the umbilicus with respect to patient sex, race, and ethnicity. The locations of the iliac crests were cephalad in women compared with men and in Hispanics compared with African American, Caucasian, and Asian patients.

Conclusions: The iliac crests were located above the level of the L4 to L5 disc space approximately 26% of the time. The umbilicus is most frequently at the level of the L4 vertebral body. Patient height, weight, and BMI do not influence the location of the umbilicus or the iliac crests relative to the lumbar spine. Patient sex and ethnicity influence the location of the iliac crests but not the umbilicus relative to the lumbar spine.

Clinical relevance: Modern neurosurgical techniques require clearance of the iliac crests during anterior and anterolateral approaches. Understanding the level of the iliac crests is crucial in planning for transpsoas fusion approaches.

Level of evidence: 2:

背景:本研究旨在确定髂嵴是否真正位于 L4 至 L5 水平:本研究旨在确定髂嵴是否真正位于L4至L5水平,同时考虑到患者的人口统计学和人体测量学特征:我们使用计算机断层扫描测量了无脊柱病变患者的脐部和髂嵴相对于腰椎的位置,并考虑了患者身高、体重、体重指数(BMI)、性别、种族和民族的影响:共对 834 名患者(391 名男性和 443 名女性)进行了复查。脐部相对于腰椎的位置呈现单峰分布模式,集中在L4,而髂嵴最常位于L4至L5。髂嵴位于L4至L5椎间盘间隙上方的比例为26.5%。髂嵴位于 L4 至 L5 椎间盘间隙的比例为 29.8%。脐嵴和髂嵴与患者的身高、体重或体重指数之间没有相关性。脐的位置与患者的性别、种族和民族没有差异。与男性患者相比,女性患者的髂嵴位置在头侧;与非裔美国人、高加索人和亚裔患者相比,西班牙裔患者的髂嵴位置在头侧:结论:髂嵴位于 L4 至 L5 椎间盘间隙水平以上的比例约为 26%。脐部最常位于 L4 椎体水平。患者的身高、体重和体重指数不会影响脐部或髂嵴相对于腰椎的位置。患者的性别和种族会影响髂嵴的位置,但不会影响脐部相对于腰椎的位置:现代神经外科技术要求在前方和前外侧入路时清除髂嵴。了解髂嵴的水平对于规划经腰椎融合术至关重要:
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引用次数: 0
Predictive Factors for Outcomes Following Surgical Treatment of Lumbar Disc Herniation. 腰椎间盘突出症手术治疗后疗效的预测因素。
IF 1.7 Q2 SURGERY Pub Date : 2024-09-20 DOI: 10.14444/8650
Gregory I Sacks, Vincent Destefano, Susan M Fiore, Raphael P Davis, Samuel Ahknoukh, Harry M Mushlin

Background: Lumbar disc herniation (LDH) is a common cause of radicular pain with an annual incidence between 5 and 20 cases per 1000 adults. LDH is typically treated by microdiscectomy, of which more than 300,000 are performed in the United States each year. Despite this frequency, 25% to 33% of patients report poor surgical outcomes. This study sought to present a retrospective analysis of patients who underwent microdiscectomy surgery for the treatment of LDH with the aim of identifying demographic, historical, and surgical factors that may contribute to inadequate surgical results.

Methods: A retrospective study of 241 patients at Stony Brook Medicine from 2017 to 2022 was performed, 123 of whom had follow-up of 90 days or more and were included for final analysis. Data collection included demographics, medical/surgical history, and surgical methodology. Good outcomes were defined as meeting the absolute point change threshold (ACT)-3.5pt reduction in pain reported by the Numerical Rating System (NRS) or the resolution of either radicular pain or neurological symptoms.

Results: Univariate analysis revealed that 100% of patients with prior fusion surgery (P = 0.039) and 73.2% who underwent preoperative physical therapy (PT; P = 0.032) failed to meet the ACT. Additionally, 79.1% (P = 0.021) and 82.8% (P = 0.026) of patients who had PT had residual radicular pain and neurological symptoms, respectively. Multivariate logistic regression confirmed correlations between preoperative PT and failure to meet the ACT (P = 0.030, OR = 0.252) and resolution of radicular (P = 0.006, OR = 0.196) and neurological (P = 0.030, OR = 0.177) complaints. ACT directly correlated with higher preoperative NRS scores in univariate (P = 0.0002) and multivariate (P = 0.002, OR = 1.554) analyses.

Conclusion: Our results show that higher preoperative NRS scores, PT, and prior fusion surgery are associated with poorer outcomes. While PT is considered a viable nonoperative treatment for LDH, our findings suggest detrimental effects when preceding surgery, indicating the need for additional research into the effects of PT on patients with high grade LDH.

背景:腰椎间盘突出症(LDH)是引起根性疼痛的常见原因,每年的发病率在每 1000 名成年人中有 5 到 20 例。腰椎间盘突出症通常采用显微椎间盘切除术进行治疗,美国每年进行的手术超过 30 万例。尽管如此,仍有 25% 至 33% 的患者报告手术效果不佳。本研究试图对接受显微椎间盘切除手术治疗 LDH 的患者进行回顾性分析,旨在找出可能导致手术效果不佳的人口、历史和手术因素:对石溪医学中心 2017 年至 2022 年的 241 名患者进行了回顾性研究,其中 123 名患者随访 90 天或以上,并纳入最终分析。数据收集包括人口统计学、病史/手术史和手术方法。良好结果的定义是达到数字评分系统(NRS)报告的疼痛绝对点变化阈值(ACT)-3.5点,或根性疼痛或神经症状得到缓解:单变量分析显示,100%曾接受过融合手术的患者(P = 0.039)和73.2%曾接受术前物理治疗(PT;P = 0.032)的患者未能达到ACT标准。此外,79.1%(P = 0.021)和 82.8%(P = 0.026)接受过物理治疗的患者分别有残余根性疼痛和神经症状。多变量逻辑回归证实了术前 PT 与未达到 ACT(P = 0.030,OR = 0.252)、根性疼痛(P = 0.006,OR = 0.196)和神经症状(P = 0.030,OR = 0.177)缓解之间的相关性。在单变量(P = 0.0002)和多变量(P = 0.002,OR = 1.554)分析中,ACT 与术前较高的 NRS 评分直接相关:我们的研究结果表明,术前较高的 NRS 评分、PT 和既往融合手术与较差的预后有关。虽然PT被认为是治疗LDH的一种可行的非手术疗法,但我们的研究结果表明,在手术前进行PT会产生不利影响,这表明有必要对PT对高级别LDH患者的影响进行更多研究。
{"title":"Predictive Factors for Outcomes Following Surgical Treatment of Lumbar Disc Herniation.","authors":"Gregory I Sacks, Vincent Destefano, Susan M Fiore, Raphael P Davis, Samuel Ahknoukh, Harry M Mushlin","doi":"10.14444/8650","DOIUrl":"https://doi.org/10.14444/8650","url":null,"abstract":"<p><strong>Background: </strong>Lumbar disc herniation (LDH) is a common cause of radicular pain with an annual incidence between 5 and 20 cases per 1000 adults. LDH is typically treated by microdiscectomy, of which more than 300,000 are performed in the United States each year. Despite this frequency, 25% to 33% of patients report poor surgical outcomes. This study sought to present a retrospective analysis of patients who underwent microdiscectomy surgery for the treatment of LDH with the aim of identifying demographic, historical, and surgical factors that may contribute to inadequate surgical results.</p><p><strong>Methods: </strong>A retrospective study of 241 patients at Stony Brook Medicine from 2017 to 2022 was performed, 123 of whom had follow-up of 90 days or more and were included for final analysis. Data collection included demographics, medical/surgical history, and surgical methodology. Good outcomes were defined as meeting the absolute point change threshold (ACT)-3.5pt reduction in pain reported by the Numerical Rating System (NRS) or the resolution of either radicular pain or neurological symptoms.</p><p><strong>Results: </strong>Univariate analysis revealed that 100% of patients with prior fusion surgery (<i>P</i> = 0.039) and 73.2% who underwent preoperative physical therapy (PT; <i>P</i> = 0.032) failed to meet the ACT. Additionally, 79.1% (<i>P</i> = 0.021) and 82.8% (<i>P</i> = 0.026) of patients who had PT had residual radicular pain and neurological symptoms, respectively. Multivariate logistic regression confirmed correlations between preoperative PT and failure to meet the ACT (<i>P</i> = 0.030, OR = 0.252) and resolution of radicular (<i>P</i> = 0.006, OR = 0.196) and neurological (<i>P</i> = 0.030, OR = 0.177) complaints. ACT directly correlated with higher preoperative NRS scores in univariate (<i>P</i> = 0.0002) and multivariate (<i>P</i> = 0.002, OR = 1.554) analyses.</p><p><strong>Conclusion: </strong>Our results show that higher preoperative NRS scores, PT, and prior fusion surgery are associated with poorer outcomes. While PT is considered a viable nonoperative treatment for LDH, our findings suggest detrimental effects when preceding surgery, indicating the need for additional research into the effects of PT on patients with high grade LDH.</p>","PeriodicalId":38486,"journal":{"name":"International Journal of Spine Surgery","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142297560","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
Efficacy and Safety of Transforaminal Percutaneous Endoscopic Discectomy in Treatment of Patients Suffering From Discogenic Low Back Pain in Kenya. 肯尼亚经椎间孔经皮内窥镜椎间盘切除术治疗椎间盘源性腰痛患者的有效性和安全性。
IF 1.7 Q2 SURGERY Pub Date : 2024-09-12 DOI: 10.14444/8628
Shirazahmed Munshi, Abdullah Kaki, Osama AlAhdal, Seema Yadav

Background: Low back pain (LBP) is a globally prevalent condition, often attributed to lumbar disc herniation (LDH). Transforaminal percutaneous endoscopic discectomy (TPED) is a minimally invasive surgical approach for LDH, offering distinct advantages. This study aimed to assess the progression of pain in patients who underwent TPED in Kenya, with a focus on the impact of pre-existing factors.

Methods: This retrospective study included 610 patients from the Mediheal Group of Hospitals who underwent TPED between January 2018 and December 2022. Data were collected from medical records, direct patient interactions, and telephone interviews. Statistical analyses, including repeated measures analysis of variance, correlation coefficients, and t tests, were used to examine pain progression and factors influencing outcomes.

Results: Among the 610 included patients, all reported LBP and 87.9% reported leg pain. TPED resulted in significant pain reduction (P < 0.001) for both LBP and leg pain, with sustained improvement over 1 year. Factors such as age, body mass index, and duration of pain correlated with pain outcomes. No significant impact of comorbidities on pre- or postoperative pain was observed. Its retrospective design and the absence of a control group limit the strength of causal inferences.

Conclusions: TPED is an effective treatment for LBP and leg pain in Kenyan patients with LDH. Pain improvement was sustained over 1 year after performing TPED, and pre-existing factors influenced outcomes. This study provides valuable insights into TPED outcomes, contributing to the understanding of LDH management in diverse populations.

背景:腰背痛(LBP)是一种全球流行的疾病,通常由腰椎间盘突出症(LDH)引起。经椎间孔经皮内窥镜椎间盘切除术(TPED)是一种治疗腰椎间盘突出症的微创手术方法,具有独特的优势。本研究旨在评估在肯尼亚接受经皮内镜椎间盘切除术的患者的疼痛进展情况,重点关注术前因素的影响:这项回顾性研究纳入了 Mediheal 医院集团在 2018 年 1 月至 2022 年 12 月期间接受 TPED 的 610 名患者。数据通过病历、患者直接交流和电话访谈收集。统计分析包括重复测量方差分析、相关系数和t检验,用于研究疼痛进展和影响结果的因素:在纳入的 610 名患者中,所有患者都报告了腰腿痛,87.9% 的患者报告了腿痛。TPED 可显著减轻腰痛和腿痛的疼痛(P < 0.001),并在 1 年内持续改善。年龄、体重指数和疼痛持续时间等因素与疼痛结果相关。没有观察到合并症对术前或术后疼痛有明显影响。该研究的回顾性设计和对照组的缺失限制了因果推论的力度:结论:TPED 是治疗肯尼亚 LDH 患者 LBP 和腿部疼痛的有效方法。进行 TPED 治疗后,疼痛的改善可持续 1 年以上,而治疗前存在的因素会影响治疗效果。这项研究为 TPED 的疗效提供了宝贵的见解,有助于了解不同人群的 LDH 管理情况。
{"title":"Efficacy and Safety of Transforaminal Percutaneous Endoscopic Discectomy in Treatment of Patients Suffering From Discogenic Low Back Pain in Kenya.","authors":"Shirazahmed Munshi, Abdullah Kaki, Osama AlAhdal, Seema Yadav","doi":"10.14444/8628","DOIUrl":"10.14444/8628","url":null,"abstract":"<p><strong>Background: </strong>Low back pain (LBP) is a globally prevalent condition, often attributed to lumbar disc herniation (LDH). Transforaminal percutaneous endoscopic discectomy (TPED) is a minimally invasive surgical approach for LDH, offering distinct advantages. This study aimed to assess the progression of pain in patients who underwent TPED in Kenya, with a focus on the impact of pre-existing factors.</p><p><strong>Methods: </strong>This retrospective study included 610 patients from the Mediheal Group of Hospitals who underwent TPED between January 2018 and December 2022. Data were collected from medical records, direct patient interactions, and telephone interviews. Statistical analyses, including repeated measures analysis of variance, correlation coefficients, and <i>t</i> tests, were used to examine pain progression and factors influencing outcomes.</p><p><strong>Results: </strong>Among the 610 included patients, all reported LBP and 87.9% reported leg pain. TPED resulted in significant pain reduction (<i>P</i> < 0.001) for both LBP and leg pain, with sustained improvement over 1 year. Factors such as age, body mass index, and duration of pain correlated with pain outcomes. No significant impact of comorbidities on pre- or postoperative pain was observed. Its retrospective design and the absence of a control group limit the strength of causal inferences.</p><p><strong>Conclusions: </strong>TPED is an effective treatment for LBP and leg pain in Kenyan patients with LDH. Pain improvement was sustained over 1 year after performing TPED, and pre-existing factors influenced outcomes. This study provides valuable insights into TPED outcomes, contributing to the understanding of LDH management in diverse populations.</p>","PeriodicalId":38486,"journal":{"name":"International Journal of Spine Surgery","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11483631/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142141320","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Nonoperative Management of Isolated Thoracolumbar Flexion Distraction Injuries: A Single-Center Study. 孤立性胸腰椎屈曲牵引损伤的非手术治疗:单中心研究
IF 1.7 Q2 SURGERY Pub Date : 2024-09-12 DOI: 10.14444/8619
Reed Butler, Connor Donley, Zuhair Mohammed, Jacob Lepard, Eric Vess, Nicholas Andrews, Gerald McGwin, Sakthivel Rajaram, Steven M Theiss

Background: Nonoperative management is an appealing option for purely transosseous thoracolumbar flexion-distraction injuries given the prospects of osseous healing and restoration of the posterior tension band complex. This study seeks to examine differences in outcomes following flexion-distraction injuries after operative and nonoperative management.

Methods: This study reviews all patients at a single Level 1 trauma center from 2004 to 2022 with AO Spine B1 thoracolumbar injuries treated operatively vs nonoperatively. Inclusion criteria were age greater than 16 years, computed tomography-confirmed transosseous flexion-distraction injuries, and at least 3 months of follow-up with available imaging. The primary outcome assessed was a change in local Cobb angles, with secondary outcomes consisting of complications, time to return to work, and need for subsequent operative fixation.

Results: Initial Cobb angles in the operative (n = 14) vs nonoperative group (n = 13) were -5° and -13°, respectively (P = 0.225), indicating kyphotic alignment in both cohorts. We noted a significant difference in Cobb angles between cohorts at first follow-up (2.6° and -13.9°, P = 0.015) and within the operative cohort from presentation to first follow-up (P = 0.029). At the second follow-up, there was no significant difference in Cobb angles between cohorts (3.6° and -12.6°, P = 0.07). No significant differences were noted in complication rates (P = 1), time to return to work (P = 0.193), or resolution of subjective back pain (P = 0.193). No crossover was noted.

Conclusions: Nonoperative management of minimally displaced transosseous flexion-distraction injuries is a safe alternative to surgery. Patient factors, such as compliance with follow-up, and location of the injury should be factored into the surgeon's management recommendation.

Clinical relevance: Overall, no significant differences in outcomes and complications were noted following nonoperative management of AO Spine B1 injuries, indicating the potential for these injuries to be managed conservatively.

Level of evidence: 3:

背景:鉴于骨性愈合和后拉力带复合体恢复的前景,非手术治疗是纯经骨性胸腰椎屈曲牵引损伤的一种吸引人的选择。本研究旨在探讨屈曲牵引损伤后手术治疗和非手术治疗在疗效上的差异:本研究回顾了 2004 年至 2022 年在一家一级创伤中心接受 AO 脊柱 B1 胸腰椎损伤手术治疗与非手术治疗的所有患者。纳入标准为年龄大于 16 岁、经计算机断层扫描确认为经骨屈曲牵引损伤、至少随访 3 个月并获得可用影像学资料。评估的主要结果是局部 Cobb 角的变化,次要结果包括并发症、恢复工作时间和后续手术固定的需要:结果:手术组(n = 14)与非手术组(n = 13)的初始 Cobb 角分别为-5°和-13°(P = 0.225),这表明两组患者都存在畸形排列。我们注意到,在首次随访(2.6° 和 -13.9°,P = 0.015)和手术组内从发病到首次随访(P = 0.029)期间,各组间的 Cobb 角存在明显差异。第二次随访时,各组间的 Cobb 角无明显差异(3.6° 和 -12.6°,P = 0.07)。并发症发生率(P = 1)、恢复工作时间(P = 0.193)或主观背痛缓解程度(P = 0.193)均无明显差异。没有发现交叉现象:结论:非手术治疗微小移位的经骨屈伸损伤是一种安全的手术替代方案。外科医生在提出治疗建议时应考虑患者的因素,如随访的依从性和损伤的位置:总体而言,AO脊柱B1损伤的非手术治疗在疗效和并发症方面没有明显差异,这表明这些损伤有可能通过保守治疗得到控制:3:
{"title":"Nonoperative Management of Isolated Thoracolumbar Flexion Distraction Injuries: A Single-Center Study.","authors":"Reed Butler, Connor Donley, Zuhair Mohammed, Jacob Lepard, Eric Vess, Nicholas Andrews, Gerald McGwin, Sakthivel Rajaram, Steven M Theiss","doi":"10.14444/8619","DOIUrl":"10.14444/8619","url":null,"abstract":"<p><strong>Background: </strong>Nonoperative management is an appealing option for purely transosseous thoracolumbar flexion-distraction injuries given the prospects of osseous healing and restoration of the posterior tension band complex. This study seeks to examine differences in outcomes following flexion-distraction injuries after operative and nonoperative management.</p><p><strong>Methods: </strong>This study reviews all patients at a single Level 1 trauma center from 2004 to 2022 with AO Spine B1 thoracolumbar injuries treated operatively vs nonoperatively. Inclusion criteria were age greater than 16 years, computed tomography-confirmed transosseous flexion-distraction injuries, and at least 3 months of follow-up with available imaging. The primary outcome assessed was a change in local Cobb angles, with secondary outcomes consisting of complications, time to return to work, and need for subsequent operative fixation.</p><p><strong>Results: </strong>Initial Cobb angles in the operative (<i>n</i> = 14) vs nonoperative group (<i>n</i> = 13) were -5° and -13°, respectively (<i>P</i> = 0.225), indicating kyphotic alignment in both cohorts. We noted a significant difference in Cobb angles between cohorts at first follow-up (2.6° and -13.9°, <i>P</i> = 0.015) and within the operative cohort from presentation to first follow-up (<i>P</i> = 0.029). At the second follow-up, there was no significant difference in Cobb angles between cohorts (3.6° and -12.6°, <i>P</i> = 0.07). No significant differences were noted in complication rates (<i>P</i> = 1), time to return to work (<i>P</i> = 0.193), or resolution of subjective back pain (<i>P</i> = 0.193). No crossover was noted.</p><p><strong>Conclusions: </strong>Nonoperative management of minimally displaced transosseous flexion-distraction injuries is a safe alternative to surgery. Patient factors, such as compliance with follow-up, and location of the injury should be factored into the surgeon's management recommendation.</p><p><strong>Clinical relevance: </strong>Overall, no significant differences in outcomes and complications were noted following nonoperative management of AO Spine B1 injuries, indicating the potential for these injuries to be managed conservatively.</p><p><strong>Level of evidence: 3: </strong></p>","PeriodicalId":38486,"journal":{"name":"International Journal of Spine Surgery","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11483580/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141724655","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Outcomes and Spinopelvic Changes After Anterior Lumbar Interbody Fusion With a Novel Interbody Fusion Device: A Retrospective Study. 使用新型椎体间融合器进行腰椎前路椎体间融合术后的效果和脊柱骨变化:回顾性研究
IF 1.7 Q2 SURGERY Pub Date : 2024-09-12 DOI: 10.14444/8621
Ankit Hirpara, Christina Koshak, Eric Marty, Christopher Gallus, Christopher Kleck

Background: Interbody devices in anterior lumbar interbody fusion (ALIF) are currently a focus of innovation due to their potential to improve clinical outcomes. The purpose of the present study was to analyze complications and changes in spinopelvic parameters after ALIF with the novel Medacta MectaLIF interbody fusion device.

Methods: Patients aged 18 to 80 years who underwent multilevel ALIF using this novel implant were identified. Demographic and surgical data were collected. Patients were divided into short- and long-fusion cohorts. A comparison of outcomes between the short- and long-fusion groups was performed using the Student t test for continuous variables and Fisher's exact test and the χ2 test for categorical variables. Analysis of the pre- vs postoperative radiographic data for the entire cohort was performed using the 2-tailed Student t test.

Results: One hundred and eight patients met the inclusion criteria. No significant postoperative change was observed in L1-4 lumbar lordosis (LL). L1-S1 LL increased to a mean of 55.1 ± 12.8 (a mean change of 10.7 ± 14.5), and L4-S1 LL increased to a mean of 38.4 ± 8.7 (a mean increase of 7.5 ± 8.2), with pelvic incidence LL mismatch changing from 8.9 ± 15.1 to 1.1 ± 13.5 (n = 102). Related changes in sacral slope and pelvic tilt were also observed (33.0 ± 11.0 to 37.6 ± 10.9 and 19.6 ± 9.5 to 18.2 ± 9.1 [n = 103], respectively). Five patients (4.6%) experienced implant subsidence, 1 (0.9%) had implant migration, and 6 (5.6%) experienced a nonunion. There was no difference in the rates of complications associated with the novel implant in the short- and long-fusion cohorts.

Conclusion: This novel implant achieves correction of spinopelvic parameters with minimal complications. The ability to modify the implant intraoperatively based on the patient's anatomy can help achieve maximal contact area and therefore help reduce the risk of subsidence.

Clinical relevance: This modular implant can achieve correction of spinopelvic parameters with minimal medical and surgical complications.

Level of evidence: 4:

背景:腰椎前路椎体间融合术(ALIF)中的椎体间融合器因其改善临床疗效的潜力而成为当前创新的焦点。本研究旨在分析使用新型 Medacta MectaLIF 椎间融合器进行 ALIF 后的并发症和脊柱骨参数变化:方法:对使用这种新型植入物进行多层次 ALIF 的 18 至 80 岁患者进行鉴定。收集了人口统计学和手术数据。将患者分为短期融合组和长期融合组。对连续变量采用Student t检验,对分类变量采用Fisher's exact检验和χ2检验,比较短融合组和长融合组的结果。使用双尾学生 t 检验对整个组群的术前与术后放射学数据进行分析:结果:有 118 名患者符合纳入标准。术后L1-4腰椎前凸(LL)无明显变化。L1-S1 LL平均增加到55.1 ± 12.8(平均变化为10.7 ± 14.5),L4-S1 LL平均增加到38.4 ± 8.7(平均增加为7.5 ± 8.2),骨盆发生率LL不匹配从8.9 ± 15.1变为1.1 ± 13.5(n = 102)。骶骨斜度和骨盆倾斜度也出现了相关变化(分别从 33.0 ± 11.0 到 37.6 ± 10.9 和 19.6 ± 9.5 到 18.2 ± 9.1 [n = 103])。5名患者(4.6%)出现种植体下沉,1名患者(0.9%)出现种植体移位,6名患者(5.6%)出现不愈合。新型植入体的并发症发生率在短融合组和长融合组中没有差异:结论:这种新型植入体能矫正脊柱骨盆参数,并发症极少。根据患者的解剖结构在术中修改植入体的能力有助于实现最大的接触面积,从而有助于降低下沉的风险:临床相关性:这种模块化植入物可在医疗和手术并发症最小的情况下实现脊柱骨盆参数的矫正:4:
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引用次数: 0
High Lumbar Spinal Fusion Rates Using Cellular Bone Allograft Irrespective of Surgical Approach. 使用细胞骨异体移植的腰椎融合率高,与手术方法无关
IF 1.7 Q2 SURGERY Pub Date : 2024-09-12 DOI: 10.14444/8612
Todd Lansford, Daniel K Park, Joshua J Wind, Pierce Nunley, Timothy A Peppers, Anthony Russo, Hamid Hassanzadeh, Jonathan Sembrano, Jung Yoo, Jonathan Sales

Background: Mounting evidence demonstrates a promising safety and efficacy profile for spinal fusion procedures using cellular bone allograft (CBA). However, limited data exists on fusion outcomes stratified by surgical approach. The current study investigates the effectiveness of CBA in lumbar spinal fusion by surgical approach (ie, anterior, lateral, and posterior approaches).

Methods: Patients undergoing lumbar spinal fusion with CBA (Trinity Elite) were enrolled into a prospective, multi-center, open-label clinical study (NCT02969616). Fusion status was assessed by an independent review of dynamic radiographs and computed tomography images. Clinical outcome measures included quality of life (QoL; EQ5D), disability (Oswestry Disability Index [ODI]), and pain (visual analog scale [VAS]) for back pain and leg pain). Patient data extending to 24 months were analyzed in a post-hoc analysis.

Results: A total of 252 patients underwent interbody fusion (159 women; 93 men). Patients had a mean age of 58.3 years (SD 12.5), height of 168.3 cm (SD 10.2), and weight of 87.3 kg (SD 20.0) with a body mass index of 30.8 kg/m2 (SD 6.5). At 12 months, the overall fusion success rate for bridging bone was 98.5%; fusion success was 98.1%, 100.0%, and 97.9% for anterior, lateral, and posterior approaches, respectively. At 24 months, the overall fusion success rate for bridging bone was 98.9%; fusion success was 97.9%, 100.0%, and 98.8% for anterior, lateral, and posterior approaches, respectively. The surgical approach did not significantly impact fusion success. A significant (P < 0.0001) improvement in QoL, pain, and disability scores was also observed. Significant differences in the ODI, VAS, and EQ5D were observed between the treatment groups (P < 0.05).

Conclusions: CBA represents an attractive alternative to autograft alone, reporting a high rate of successful fusion and clinical outcomes across various surgical approaches.

Clinical relevance: The use of CBA for spinal fusion procedures, regardless of surgical approach, provides high rates of fusion with a favorable safety profile and improved patient outcomes.

Level of evidence: 4:

Trial registration: NCT02969616.

背景:越来越多的证据表明,使用细胞骨异体移植(CBA)进行脊柱融合手术具有良好的安全性和有效性。然而,按手术方法分层的融合效果数据有限。本研究按手术方式(即前路、侧路和后路)调查了细胞骨异体移植在腰椎融合术中的有效性:一项前瞻性、多中心、开放标签临床研究(NCT02969616)招募了接受CBA(Trinity Elite)腰椎融合术的患者。融合状态由动态X光片和计算机断层扫描图像的独立审查进行评估。临床结果指标包括生活质量(QoL;EQ5D)、残疾(Oswestry残疾指数[ODI])和疼痛(腰痛和腿痛的视觉模拟量表[VAS])。在一项事后分析中,对患者长达 24 个月的数据进行了分析:共有 252 名患者接受了椎间融合术(女性 159 人;男性 93 人)。患者的平均年龄为 58.3 岁(SD 12.5),身高为 168.3 厘米(SD 10.2),体重为 87.3 千克(SD 20.0),体重指数为 30.8 千克/平方米(SD 6.5)。12个月时,桥接骨的总体融合成功率为98.5%;前路、侧路和后路的融合成功率分别为98.1%、100.0%和97.9%。24 个月时,桥接骨的总体融合成功率为 98.9%;前路、侧路和后路的融合成功率分别为 97.9%、100.0% 和 98.8%。手术方式对融合成功率没有明显影响。患者的生活质量、疼痛和残疾评分也有明显改善(P < 0.0001)。治疗组之间在ODI、VAS和EQ5D方面存在显著差异(P < 0.05):结论:CBA是一种有吸引力的替代自体移植物的方法,在各种手术方法中都有较高的融合成功率和临床疗效:临床相关性:在脊柱融合术中使用CBA,无论采用哪种手术方法,都能获得较高的融合成功率,同时具有良好的安全性,并能改善患者预后:4:试验注册:NCT02969616。
{"title":"High Lumbar Spinal Fusion Rates Using Cellular Bone Allograft Irrespective of Surgical Approach.","authors":"Todd Lansford, Daniel K Park, Joshua J Wind, Pierce Nunley, Timothy A Peppers, Anthony Russo, Hamid Hassanzadeh, Jonathan Sembrano, Jung Yoo, Jonathan Sales","doi":"10.14444/8612","DOIUrl":"10.14444/8612","url":null,"abstract":"<p><strong>Background: </strong>Mounting evidence demonstrates a promising safety and efficacy profile for spinal fusion procedures using cellular bone allograft (CBA). However, limited data exists on fusion outcomes stratified by surgical approach. The current study investigates the effectiveness of CBA in lumbar spinal fusion by surgical approach (ie, anterior, lateral, and posterior approaches).</p><p><strong>Methods: </strong>Patients undergoing lumbar spinal fusion with CBA (Trinity Elite) were enrolled into a prospective, multi-center, open-label clinical study (NCT02969616). Fusion status was assessed by an independent review of dynamic radiographs and computed tomography images. Clinical outcome measures included quality of life (QoL; EQ5D), disability (Oswestry Disability Index [ODI]), and pain (visual analog scale [VAS]) for back pain and leg pain). Patient data extending to 24 months were analyzed in a post-hoc analysis.</p><p><strong>Results: </strong>A total of 252 patients underwent interbody fusion (159 women; 93 men). Patients had a mean age of 58.3 years (SD 12.5), height of 168.3 cm (SD 10.2), and weight of 87.3 kg (SD 20.0) with a body mass index of 30.8 kg/m<sup>2</sup> (SD 6.5). At 12 months, the overall fusion success rate for bridging bone was 98.5%; fusion success was 98.1%, 100.0%, and 97.9% for anterior, lateral, and posterior approaches, respectively. At 24 months, the overall fusion success rate for bridging bone was 98.9%; fusion success was 97.9%, 100.0%, and 98.8% for anterior, lateral, and posterior approaches, respectively. The surgical approach did not significantly impact fusion success. A significant (<i>P</i> < 0.0001) improvement in QoL, pain, and disability scores was also observed. Significant differences in the ODI, VAS, and EQ5D were observed between the treatment groups (<i>P</i> < 0.05).</p><p><strong>Conclusions: </strong>CBA represents an attractive alternative to autograft alone, reporting a high rate of successful fusion and clinical outcomes across various surgical approaches.</p><p><strong>Clinical relevance: </strong>The use of CBA for spinal fusion procedures, regardless of surgical approach, provides high rates of fusion with a favorable safety profile and improved patient outcomes.</p><p><strong>Level of evidence: 4: </strong></p><p><strong>Trial registration: </strong>NCT02969616.</p>","PeriodicalId":38486,"journal":{"name":"International Journal of Spine Surgery","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11483417/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141761494","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
International Journal of Spine Surgery
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