A Prospective, Randomized, Assessor-Blind Study on Biportal and Transforaminal Endoscopic Lumbar Fusion for Spinal Stenosis

Evaluation of the efficacy and safety of minimally invasive transforaminal and biportal endoscopic lumbar interbody fusion to treat lumbar spinal stenosis (BELIFS Trial): A prospective, Randomized, Assessor blind, Multicenter trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0010533

Enrollment

Registered

2025-05-26

Start date

2025-06-30

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : 1. Intervention Overview This study is a prospective, randomized, assessor-blind, multicenter trial comparing the clinical efficacy and safety of Biportal Endoscopic Lumbar Interbo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A. Age between 20 and 85 years B. Patients diagnosed with lumbar central canal stenosis, foraminal stenosis, or spondylolisthesis, requiring single-level lumbar interbody fusion surgery (between L2 and S1) C. Patients (or legally authorized representatives) who fully understand the clinical trial and have signed the informed consent form

Exclusion criteria

Exclusion criteria: A. Patients who have previously undergone fusion surgery at the same spinal level B. Patients with other spinal disorders at the surgical site (e.g., ankylosing spondylitis, tumors, compression fractures) C. Patients with psychiatric disorders (e.g., dementia, intellectual disability, severe substance abuse) D. Patients with severe osteoporosis (T-score < -3.0) E. Patients with infectious diseases that may interfere with fusion surgery F. Patients who refuse to participate in the study G. Patients deemed ineligible for the study at the discretion of the clinical investigator

Design outcomes

Primary

Measure	Time frame
Proportion of patients with a =30% reduction in Oswestry Disability Index (ODI) at 12 months postoperatively	—

Secondary

Measure	Time frame
VAS (Visual Analog Scale);EQ5D (European quality of life-5 dimension);Oswestry Disability Index (ODI) ;Postoperative satisfaction;POSAS (Patient and Observer Scar Assessment Scale);Degree of decompression;Fusion rate;Complications;Operative time;Blood loss;Length of hospital stay;CK(Creatine Kinase) level;Reoperation rate	—

Countries

Korea, Republic of

Contacts

Public ContactSang-Min Park

Seoul National University Bundang Hospital

psmini@naver.com+82-31-787-7208

Outcome results