Biportal Endoscopy Spine Surgery (BESS )Versus Unilateral Laminotomy Bilateral Decompression (ULBD ): RCT, Non-inferiority Trial
NCT ID: NCT03302507
Last Updated: 2019-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2017-11-01
2019-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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BESS, biportal endoscopic spine surgery
Biportal endoscopic decompression surgery for lumbar spinal stenosis
BESS
Biportal endoscopic surgery
ULBD, unilateral laminotomy bilateral decompression
Minimally invasive ULBD for lumbar spinal stenosis
ULBD
Unilateral laminotomy bilateral decompression
Interventions
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BESS
Biportal endoscopic surgery
ULBD
Unilateral laminotomy bilateral decompression
Eligibility Criteria
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Inclusion Criteria
* patients who has radiating pain (VAS \>=40) on lower extremities with spinal stenosis over Gr B
* patients who required one-level decompression between L1 and S1
* those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form
Exclusion Criteria
* Over spondylolisthesis Gr II
* Degenerative lumbar scoliosis (Cobb angle \>20)
* herniated disc
* patients with a history of other spinal diseases (compression fracture, spondylitis, tumor)
* women with positive pregnancy tests before the trial or who planned to become pregnant within the following 3 years
* patients with a history of malignant tumor or malignant diseases (but the cases of cured disease with no relapse for the past 5 years were included in the present study)
* patients with mental retardation or whose parents or legal guardians were older or had mental disabilities
* other patients viewed as inappropriate by the staff
30 Years
80 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Jin S. Yeom
Professor
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyounggido, South Korea
Countries
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Other Identifiers
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BESS_001
Identifier Type: -
Identifier Source: org_study_id
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