Elsevier

The Spine Journal

Volume 20, Issue 2, February 2020, Pages 156-165
The Spine Journal

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

https://doi.org/10.1016/j.spinee.2019.09.015Get rights and content

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.

Introduction

Lumbar spinal stenosis is characterized by a narrowed spinal canal, which leads to nerve compression. Patients with spinal stenosis complain of low back and lower extremity pain and present with decreased function, walking ability, and quality of life. Thus, patients who present with low back and leg pain due to lumbar spinal stenosis are commonly treated surgically rather than nonoperatively [1], [2], [3], [4]. However, conventional open decompressive laminectomy can damage spinal structures such as paraspinal muscles, bone, and ligaments [2], [3], [4], [5]. Decompression through laminectomy also has a potential risk of future instability and deformity [6]. Minimally invasive laminectomy was introduced as a tissue-sparing alternative and applied to lumbar central stenosis. Minimally invasive laminectomy revealed good clinical outcomes comparable to those of conventional surgery [[3], [4], [5],[7], [8], [9], [10], [11], [12]]. It also showed a reasonable operative time, shorter hospital stay, and reduced blood loss, time to mobilization, postoperative pain, and narcotic use when compared to that seen with conventional surgery [[3], [4], [5],[7], [8], [9], [10], [11], [12]]. However, it presents some disadvantages, including poor visualization, difficulty of instrument manipulation, potential to induce inadequate decompression, and longer operative time than other minimally invasive surgeries [3,5,[7], [8], [9], [10], [11], [12]].

Recently, endoscopic decompressive laminectomy for lumbar stenosis has been used to treat lumbar stenosis [13,14]. However, endoscopic surgery needs specialized instruments and extensive training to reach surgical competency [15,16]. Due to the easier use of instruments and cost reduction, biportal endoscopy has been introduced and used in lumbar surgeries, such as discectomy, laminectomy, and foraminotomy [17], [18], [19], [20], [21], [22], [23], [24], [25], [26], [27], [28], [29], [30], [31], [32], [33], [34], [35]. Biportal endoscopic decompressive laminectomy has demonstrated satisfactory clinical outcomes, but evidence suggesting the advantages of biportal endoscopic surgery compared to other minimally invasive laminectomy techniques is weak; therefore, a randomized controlled trial is warranted. Thus, the purpose of this study was to assess the clinical efficacy of biportal endoscopic decompressive laminectomy compared to that of microscopic lumbar decompressive laminectomy in patients with lumbar spinal stenosis.

Section snippets

Study design and participant population

The design and protocol of this prospective, randomized, noninferiority clinical trial was approved by the institutional review board of our hospital (B-1708/417-003) and registered on ClinicalTrials.gov (NCT03302507). All participants gave written informed consent before enrollment. In this trial, all participants were randomly assigned in a 1:1 ratio to undergo biportal endoscopic or microscopic lumbar decompressive laminectomy. We recruited participants from November 2017 to July 2018.

We

Participants

A total of 70 participants were screened for eligibility; 1 participant declined to participate in this trial and 5 participants did not meet our inclusion criteria. The remaining 64 participants consented to undergo randomization into one of the treatment groups. All participants were randomly assigned to the microscopic (32 participants) or biportal endoscopic (32 participants) lumbar decompressive laminectomy groups. There was no crossover from each randomized treatment strategy. A total of

Discussion

This randomized controlled trial, which included 64 participants with lumbar central stenosis, was designed to compare the clinical outcomes between microscopic and biportal endoscopic laminectomy at 12 months after surgery and confirmed the noninferiority of biportal endoscopy compared to microscopy. The more technically advanced procedure of biportal endoscopy showed similar clinical improvements and complication rates during the 12-month follow-up after surgery in our study.

Recently, to save

Conclusions

In this randomized controlled trial of patients with lumbar central stenosis, the results confirmed the noninferiority of biportal endoscopy to microscopic decompressive laminectomy. Our findings revealed no differences in clinical outcomes between the two interventions at 12 months after surgery. Therefore, for patients with lumbar central stenosis who are considered for lumbar decompressive laminectomy, biportal endoscopic decompressive laminectomy is a feasible surgical procedure option.

Acknowledgments

This study was partially supported by research grants from Daewon Pharmaceutical Corporation in Seoul, Republic of Korea. The funder had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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    Author disclosures: S-MP: Nothing to disclose. JP: Nothing to disclose. HSJ: Nothing to disclose. YWH: Nothing to disclose. HH: Nothing to disclose. H-JK: Nothing to disclose. B-SC: Nothing to disclose. C-KL: Nothing to disclose. JSY: Nothing to disclose.

    1

    Sang-Min Park and Jiwon Park equally contributed to this work.

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