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

NCT ID: NCT03924700

Last Updated: 2022-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-28

Study Completion Date

2021-12-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lumbar Herniated Intervertebral Disc

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Biportal endoscopic discectomy

Biportal endoscopic discectomy for lumbar herniated intervertebral disc

Group Type EXPERIMENTAL

Biportal endoscopy

Intervention Type PROCEDURE

Biportal endoscopic spine surgery (BESS)

Microdiscectomy

Microdiscectomy for lumbar herniated intervertebral disc

Group Type ACTIVE_COMPARATOR

Microdiscectomy

Intervention Type PROCEDURE

Using microscope for discectomy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biportal endoscopy

Biportal endoscopic spine surgery (BESS)

Intervention Type PROCEDURE

Microdiscectomy

Using microscope for discectomy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jin S. Yeom

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul National University Bundang Hospital

Seongnam-si, Gyounggido, South Korea

Site Status

Chungnam National University Hospital

Daejeon, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BESS_002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Paraspinal Muscle Remodeling
NCT03753711 COMPLETED NA