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

Seoul National University Hospital64 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Lumbar Herniated Intervertebral Disc

Interventions

Biportal endoscopyPROCEDURE

Biportal endoscopic spine surgery (BESS)

MicrodiscectomyPROCEDURE

Using microscope for discectomy

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

Seoul National University Bundang Hospital

Seongnam-si, Gyounggido, South Korea

Chungnam National University Hospital

Daejeon, South Korea

Outcomes

Primary Outcomes

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

Time frame: at 1 year after surgery

Secondary Outcomes

Change from baseline Oswestry disability index (ODI)

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

Change from baseline Visual Analog Pain Scale (VAS)

VAS is a measurement score that indicates pain severity status. VAS score comprised a 10-cm line with ''none'' (0) on one end of the scale and ''disabling pain'' (10) on the other.

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

Change from baseline EuroQoL-5 dimension (EQ-5D) value

EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Rated level can be coded as a number 1 to 5, which indicates having no problems for 1, and having extreme problems for 5. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 55555 (having extreme problems in all dimensions). EQ-5D health states may be converted into a single index value. The index values are a major feature of the EQ-5D instrument, facilitating the calculation of quality-adjusted life years (QALYs) that are used to inform economic evaluations of health care interventions. The value sets are anchored on 11111 = 1 and 55555 = 0 and can therefore be used in QALY calculations.

Data from ClinicalTrials.gov

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