Status:
COMPLETED
Biportal Endoscopy Spine Surgery (BESS )Versus Unilateral Laminotomy Bilateral Decompression (ULBD ): RCT, Non-inferiority Trial
Lead Sponsor:
Seoul National University Hospital
Conditions:
Degenerative Lumbar Spinal Stenosis
Eligibility:
All Genders
30-80 years
Phase:
NA
Brief Summary
This study is to compare the clinical outcome between the biportal endoscopic decompression and the unilateral approach bilateral decompression in spinal stenosis
Eligibility Criteria
Inclusion
- patients aged between 30 and 80
- 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
- Revision surgery
- 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
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03302507
Start Date
November 1 2017
End Date
October 1 2019
Last Update
October 14 2019
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam-si, Gyounggido, South Korea