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

NCT03302507 | Completed

• 1 other identifier: BESS_001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Degenerative Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• Oswestry disability index (ODI)

  The ODI is based on a self-administered questionnaire measuring ''back-specific function.'' The questionnaire comprises 10 items, each with 6 levels of response. Each item is scored from 0 to 5, and the total summation is converted to a 0-100 scale. The ODI scores ranges from 0 to 100, with higher scores indicating severe symptoms. This is assessed by ODI survey at 1 year after surgery

  3, 6, and 12, months, and every year, up to 5 year after operation

Secondary Outcomes (13)

• Visual Analog Pain Scale (VAS)

  4, 8, 12, 24, 48 hours, 2 weeks, 3, 6, and 12, months, and every year, up to 5 year after operation

• EQ-5D

  3, 6, and 12, months, and every year, up to 5 year after operation

• PainDETECT

  3, 6, and 12, months, and every year, up to 5 year after operation

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  up to 1 month after operation

• Operation duration

  Immediate after operation

Study Arms (2)

BESS, biportal endoscopic spine surgery

EXPERIMENTAL

Biportal endoscopic decompression surgery for lumbar spinal stenosis

Procedure: BESS

ULBD, unilateral laminotomy bilateral decompression

ACTIVE COMPARATOR

Minimally invasive ULBD for lumbar spinal stenosis

Procedure: ULBD

Interventions

BESS PROCEDURE

Biportal endoscopic surgery

BESS, biportal endoscopic spine surgery

ULBD PROCEDURE

Unilateral laminotomy bilateral decompression

ULBD, unilateral laminotomy bilateral decompression

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyounggido, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: October 5, 2017
• Study Start: November 1, 2017
• Primary Completion: June 30, 2019
• Study Completion: October 1, 2019
• Last Updated: October 14, 2019

Record last verified: 2019-10

Locations

KR (1)