NCT03924700

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 23, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

April 28, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2021

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

2.6 years

First QC Date

April 17, 2019

Last Update Submit

March 21, 2022

Conditions

Lumbar Herniated Intervertebral Disc

Keywords

Herniated intervertebral discDiscectomyMicroscopeBiportal endoscopy

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

    at 1 year after surgery

Secondary Outcomes (12)

  • Change from baseline Oswestry disability index (ODI)

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

  • Change from baseline 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

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

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

  • Change from baseline PainDETECT score

    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

  • +7 more secondary outcomes

Study Arms (2)

Biportal endoscopic discectomy

EXPERIMENTAL

Biportal endoscopic discectomy for lumbar herniated intervertebral disc

Procedure: Biportal endoscopy

Microdiscectomy

ACTIVE COMPARATOR

Microdiscectomy for lumbar herniated intervertebral disc

Procedure: Microdiscectomy

Interventions

Biportal endoscopyPROCEDURE

Biportal endoscopic spine surgery (BESS)

Biportal endoscopic discectomy
MicrodiscectomyPROCEDURE

Using microscope for discectomy

Microdiscectomy

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam-si, Gyounggido, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

April 17, 2019

First Posted

April 23, 2019

Study Start

April 28, 2019

Primary Completion

November 30, 2021

Study Completion

December 28, 2021

Last Updated

March 23, 2022

Record last verified: 2022-03

Locations

KR(2)