Outcomes Following Lumbar Discectomy Surgery in Lumbar Herniated Intervertebral Disc With Biportal Endoscopy Versus Open Microdiscectomy Technique: A Prospective, Multicenter, Single-blinded, Randomized Controlled Non-inferiority Trial

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

Sponsors

Lead sponsor: Seoul National University Hospital

Source Seoul National University Hospital
Brief Summary

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

Overall Status Recruiting
Start Date May 1, 2019
Completion Date December 31, 2021
Primary Completion Date December 31, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Oswestry disability index (ODI) at 1 year after surgery
Secondary Outcome
Measure Time Frame
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
Operation duration time (minutes) Immediate after operation
Volume of postoperative drainage (ml) Within 3 days after operation
Number of participants with complete discectomy Within 3 days after operation
Concentration of creatine phosphokinase level in blood At 2 day after surgery
Volume of postoperative Fentanyl consumption At 3 days after operation
Times of hospital stay (hours) Within 7 days after operation
Number of radiographic complications every year, up to 5 year after operation
Enrollment 64
Condition
Intervention

Intervention type: Procedure

Intervention name: Biportal endoscopy

Description: Biportal endoscopic spine surgery (BESS)

Arm group label: Biportal endoscopic discectomy

Intervention type: Procedure

Intervention name: Microdiscectomy

Description: Using microscope for discectomy

Arm group label: Microdiscectomy

Eligibility

Criteria:

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

Gender: All

Minimum age: 20 Years

Maximum age: 80 Years

Healthy volunteers: No

Overall Contact

Last name: Sang-Min Park, M.D.

Phone: 82-31-787-7810

Email: [email protected]

Location
facility status contact investigator
Seoul National University Bundang Hospital | Seongnam-si, Gyounggido, Korea, Republic of Recruiting Sang-Min Park, M.D. [email protected] Jin S. Yeom, M.D. Sub-Investigator Sang-Min Park, M.D. Principal Investigator
Chungnam National University Hospital | Daejeon, 35015, Korea, Republic of Recruiting Ho-Jin Lee, M.D. 82-42-280-7345 [email protected] Ho-Jin Lee, M.D Principal Investigator
Location Countries

Korea, Republic of

Verification Date

July 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Seoul National University Hospital

Investigator full name: Jin S. Yeom

Investigator title: Professor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: Biportal endoscopic discectomy

Arm group type: Experimental

Description: Biportal endoscopic discectomy for lumbar herniated intervertebral disc

Arm group label: Microdiscectomy

Arm group type: Active Comparator

Description: Microdiscectomy for lumbar herniated intervertebral disc

Acronym BESS
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov