Biportal Endoscopy Spine Surgery (BESS )Versus Unilateral Laminotomy Bilateral Decompression (ULBD ): RCT, Non-inferiority Trial

Seoul National University

Status

Completed

Conditions

Degenerative Lumbar Spinal Stenosis

Treatments

Procedure: BESS

Procedure: ULBD

Study type

Interventional

Funder types

Other

Identifiers

NCT03302507

BESS_001

Details and patient eligibility

About

This study is to compare the clinical outcome between the biportal endoscopic decompression and the unilateral approach bilateral decompression in spinal stenosis

Enrollment

64 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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