Outcomes Following Bilateral Decompression Surgery in Lumbar Spinal Stenosis With Biportal Endoscopy Versus Unilateral Laminotomy Technique: A Prospective, Single-blinded, Randomized Controlled Non-inferiority Trial

Seoul National University Hospital1 site in 1 country64 target enrollmentNovember 1, 2017

ConditionsDegenerative Lumbar Spinal Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Degenerative Lumbar Spinal Stenosis
Sponsor: Seoul National University Hospital
Enrollment: 64
Locations: 1
Primary Endpoint: Oswestry disability index (ODI)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

November 1, 2017

End Date

October 1, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Jin S. Yeom

Professor

Seoul National University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Oswestry disability index (ODI)

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

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

Secondary Outcomes

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)
Postoperative drainage(Within 3 days after operation)
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)
Completeness of decompression(Within 3 days after operation)
Creatine phosphokinase level in blood(At 2 day after surgery)
Postoperative Fentanyl consumption(At 3 days after operation)
Satisfaction scale(At 1 year after operation)
Amount of transfusion(Within 7 days after operation)
Hospital stay(Within 7 days after operation)
Radiographic complications(every year, up to 5 year after operation,)