Clinical StudyBiportal endoscopic versus microscopic lumbar decompressive laminectomy in patients with spinal stenosis: a randomized controlled trial
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.
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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.
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Sang-Min Park and Jiwon Park equally contributed to this work.