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Similar outcomes between biportal endoscopic and microscopic lumbar decompressive laminectomy
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April 2020
Similar outcomes between biportal endoscopic and microscopic lumbar decompressive laminectomy
Study Type:Therapy
OE Level Evidence:1
Journal Level of Evidence:1
Biportal endoscopic versus microscopic lumbar decompressive laminectomy in patients with spinal stenosis: a randomized controlled trial.
Spine J. 2020 Feb;20(2):156-165.Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
Sixty-four patients with degenerative lumbar spinal stenosis were randomized to receive a biportal endoscopic or microscopic lumbar decompressive laminectomy. The primary outcome of interest was Oswestry Disability Index (ODI) scores at 12 months post-operation. Secondary outcomes of interest included back and leg pain on a Visual Analog Scale (VAS), EQ-5D quality of life scores, painDETECT scores, and ODI scores up to 12 months post-operation. Results revealed no significant differences in all outcomes at all time-points between the two groups with exception of drainage volume, which was significantly lower in the microscopic lumbar group.
Publication Funding Details
Funding
Private for profit
Funding Details
Supported by grants from the Daewon Pharmaceutical Corporation in Seoul.
Disclosures
None disclosed
Why was this study needed now?
Lumbar stenosis leads to significant pain and functional deficit, in many cases requiring surgical treatment via decompressive laminectomy. Microscopic lumbar decompressive laminectomy has been reported to improve clinical outcomes compared to conventional surgical intervention in patients with lumbar spinal stenosis, however recently biportal endoscopic decompressive laminectomy has been introduced as an alternative surgical method. The aim of this study was to compare the two methods of decompressive laminectomy in patients with degenerative lumbar spinal stenosis.
What was the principal research question?
In patients with degenerative lumbar spinal stenosis, how does a biportal endoscopic decompressive laminectomy compare to microscopic lumbar decompressive laminectomy with regards to patient-reported function, 12 months post-operation?
What were the important study characteristics?
Population
64
Total Sample Size
Patients aged 30-80 years old with degenerative lumbar spinal stenosis, resulting in radiating pain to the lower extremities.
Intervention
32
Decompressive Laminectomy (Biportal Endoscopy)
Mean age 66.2. Mean BMI 25.4. 40.6% male. Patients received a biportal endoscopic decompressive laminectomy procedure for the treatment of lumbar spinal stenosis.
Comparison
32
Decompressive Laminectomy (Microscopic Lumbar)
Mean age 67.1. Mean BMI 24.8. 56.3% male. Patients received a microscopic lumbar decompressive laminectomy procedure for the treatment of lumbar spinal stenosis.
Outcomes
Visual analog scale (VAS) - back pain
Pain
Lower = Better
Scale: 0.0 to 10.0
Visual analog scale (VAS) - leg pain
Pain
Lower = Better
Scale: 0.0 to 10.0
Oswestry Disability Index (ODI)
Disease-specific Index
Lower = Better
Scale: 0.0 to 100.0
EuroQol 5D (EQ-5D)
Quality of Life (QoL)
Higher = Better
PainDetect-Questionnaire (PD-O)
Pain
Lower = Better
Scale: -1.0 to 38.0
Operative time
Resource consumption
Lower = Better
Length of stay
Resource consumption
Lower = Better
Drainage Volume
Blood Loss
Lower = Better
Levels of creatine phosphokinase
Biochemical
Incidence of incidental durotomy
Adverse events
Lower = Better
Incidence of recurrent lower back pain
Adverse events
Lower = Better
Incidence of recurrent lower extremity pain
Adverse events
Lower = Better
Incidence of symptomatic hematoma with revision surgery
Adverse events
Lower = Better
Incidence of revision surgery due to recurrent pain
Adverse events
Lower = Better
Methods
RCT
Randomized Controlled Trial
Single-Centered
Locations: South Korea
Blinding
Blinded
Who was blinded? Outcome Assessors
Paradigm
Superiority
Time
Baseline
Outcomes: Disease-specific Index, Pain, Quality of Life (QoL)
3 Months
Outcomes: Disease-specific Index, Pain, Quality of Life (QoL)
6 Months
Outcomes: Disease-specific Index, Pain, Quality of Life (QoL)
12 Months
Outcomes: Adverse events, Disease-specific Index, Pain, Quality of Life (QoL)
48 Hours
Outcomes: Biochemical
Perioperative
Outcomes: Blood Loss, Resource consumption
What were the important findings?
No significant differences were observed between the two groups in all outcomes, with exception of drainage volume, which was significantly lower in the microscopic lumbar group.
Significantly Better
No Difference
Significantly Better
Decompressive Laminectomy (Biportal Endoscopy)
Decompressive Laminectomy (Microscopic Lumbar)
Pain
Risk of Bias
Mean (0-10, Lower = Better)
Visual analog scale (VAS) - back pain
12 Months
Risk of Bias
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Blinding Healthcare Professionals: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Overall risk of bias
Mean (0-10, Lower = Better)
Visual analog scale (VAS) - leg pain
12 Months
Risk of Bias
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Blinding Healthcare Professionals: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Overall risk of bias
Disease-specific Index
Risk of Bias
Mean (0-100, Lower = Better)
Oswestry Disability Index (ODI)
12 Months
Risk of Bias
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Blinding Healthcare Professionals: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Overall risk of bias
Blood Loss
Risk of Bias
Median (Lower = Better)
Drainage Volume
Perioperative
Risk of Bias
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Blinding Healthcare Professionals: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Overall risk of bias
High Risk of Bias
Some Concern
Low Risk of Bias
Risk of Bias
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Blinding Healthcare Professionals: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Overall risk of bias
What should I remember most and how will this affect the care of my patients?
Study results suggest no significant difference in pain, functional or surgical outcomes between microscopic lumbar and biportal endoscopic decompressive laminectomy for the treatment of lumbar spinal stenosis. This study was limited by the lack of long-term follow up and small sample size.
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