Biportal Endoscopic Discectomy Versus Microdiscectomy: RCT, Non-inferiority Trial (BESS)

Seoul National University

Status

Completed

Conditions

Lumbar Herniated Intervertebral Disc

Treatments

Procedure: Microdiscectomy

Procedure: Biportal endoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT03924700

BESS_002

Details and patient eligibility

About

This study is to compare the clinical outcome between the biportal endoscopic discectomy and microdiscectomy in herniated intervertebral disc of lumbar spine

Enrollment

64 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

patients aged between 20 and 80
patients who has radiating pain (VAS >=40) on lower extremities with HIVD
patients who required one-level discectomy 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)
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