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双通道内窥镜与显微镜下腰椎减压椎板切除术治疗腰椎管狭窄症患者的随机对照试验。

Biportal endoscopic versus microscopic lumbar decompressive laminectomy in patients with spinal stenosis: a randomized controlled trial.

机构信息

Spine Center and Department of Orthopaedic Surgery, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam, Republic of Korea.

Department of Orthopaedic Surgery, Seoul National University College of Medicine and Seoul National University Hospital, Seoul, Republic of Korea.

出版信息

Spine J. 2020 Feb;20(2):156-165. doi: 10.1016/j.spinee.2019.09.015. Epub 2019 Sep 19.

Abstract

BACKGROUND CONTEXT

Biportal endoscopic decompressive laminectomy is a widely performed procedure and shows acceptable clinical outcomes. However, the evidence regarding the advantages of biportal endoscopic surgery is weak, a randomized controlled trial is therefore warranted.

PURPOSE

To compare the clinical efficacies of biportal endoscopic and microscopic decompressive laminectomy in patients with lumbar spinal stenosis.

STUDY DESIGN

Randomized controlled trial.

PATIENT SAMPLE

Sixty-four participants suffering from low back and leg pain with single-level lumbar spinal stenosis who required decompressive laminectomy.

OUTCOME MEASURES

Outcomes were assessed with the use of patient-reported outcome measures, visual analog scale (VAS) score for low back and lower extremity radiating pain, Oswestry disability index (ODI), European Quality of Life-5 Dimensions (EQ-5D) score, and painDETECT for neuropathic pain. Surgery-related outcomes including operation time, length of hospital stay, postoperative drainage, and serum creatine phosphokinase were evaluated. Perioperative (<30 days) and late (1-12 months) complications were also noted.

METHODS

All participants were randomly assigned in a 1:1 ratio to undergo biportal endoscopic or microscopic decompressive laminectomy. The primary outcome was the ODI score at 12 months after surgery based on a modified intention-to-treat strategy. The secondary outcomes included VAS score for low back and lower extremity radiating pain, ODI scores, EQ-5D score, and painDETECT score. There were no sources of funding and no conflicts of interest associated with this study.

RESULTS

There was no significant difference between groups in the mean ODI score at 12 months after surgery (30 in the microscopy vs. 29 in the biportal endoscopy group, p=.635). There were also no significant differences in low back and lower extremity pain VAS scores, ODI, EQ-5D scores, and painDETECT scores at the 3-, 6-, or 12-month follow-up. Operation time, length of hospital stay, serum creatine phosphokinase, and perioperative complications, such as durotomies and symptomatic hematoma, showed no significant differences between the groups; however, one participant underwent additional revision surgery 9 months after the index surgery in the microscopy group.

CONCLUSIONS

Despite the study design limitation of relatively short duration of follow-up, this trial suggests that biportal endoscopic decompressive laminectomy is an alternative to and offers similar clinical outcomes as microscopic open surgery in patients with symptomatic lumbar spinal stenosis.

摘要

背景

经皮双侧内窥镜下减压性椎板切除术是一种广泛应用的手术方法,其临床效果也得到了认可。然而,目前关于经皮双侧内窥镜下减压性椎板切除术优势的证据还比较薄弱,因此有必要开展一项随机对照试验。

目的

比较经皮双侧内窥镜下减压性椎板切除术与显微镜下减压性椎板切除术治疗腰椎管狭窄症的临床疗效。

研究设计

随机对照试验。

患者样本

64 例患有单节段腰椎管狭窄症并伴有腰痛和下肢放射痛的患者,需要进行减压性椎板切除术。

疗效评估指标

采用患者报告的结局测量指标、视觉模拟评分(VAS)评估腰痛和下肢放射痛、Oswestry 功能障碍指数(ODI)、欧洲五维健康量表(EQ-5D)评分、疼痛 DETECT 量表评估神经性疼痛。还评估了手术相关的结局,包括手术时间、住院时间、术后引流和血清肌酸磷酸激酶。记录了围手术期(<30 天)和晚期(1-12 个月)并发症。

方法

所有患者按 1:1 的比例随机分配至经皮双侧内窥镜下减压性椎板切除术组或显微镜下减压性椎板切除术组。主要结局是基于改良意向治疗策略的术后 12 个月 ODI 评分。次要结局包括腰痛和下肢放射痛的 VAS 评分、ODI 评分、EQ-5D 评分和疼痛 DETECT 评分。本研究无资金来源,也不存在与研究相关的利益冲突。

结果

术后 12 个月时,两组患者的 ODI 评分平均值无显著差异(显微镜组 30 分,经皮双侧内窥镜下减压性椎板切除术组 29 分,p=0.635)。术后 3、6 和 12 个月时,两组患者的腰痛和下肢疼痛 VAS 评分、ODI、EQ-5D 评分和疼痛 DETECT 评分也无显著差异。手术时间、住院时间、血清肌酸磷酸激酶以及围手术期并发症(如硬脊膜撕裂和症状性血肿)在两组之间也无显著差异;然而,显微镜组有 1 例患者在索引手术后 9 个月时需要再次接受翻修手术。

结论

尽管本试验的研究设计存在随访时间相对较短的局限性,但该研究表明,对于有症状的腰椎管狭窄症患者,经皮双侧内窥镜下减压性椎板切除术是显微镜下开放性手术的一种替代方法,可提供相似的临床效果。

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