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Evaluation of the efficacy and safety of endoscopic decompressive laminectomy to treat lumbar spinal stenosis.

Evaluation of the efficacy and safety of conventional and interlaminar full-endoscopic decompressive laminectomy to treat lumbar spinal stenosis (ENDO-F Trial): A prospective, randomized, Assessor blind, multicenter trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0006198
Enrollment
120
Registered
2021-05-27
Start date
2021-08-16
Completion date
Unknown
Last updated
2025-07-21

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, Others : 1) Interlaminar percutaneous uniportal endoscopic laminotomy Under general anesthesia, the patient was placed in a prone position on the radiolucent frame after aseptic an

Sponsors

The Catholic University of Korea, Seoul St. Mary's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: A. 20 to 80 years old B. Those who have a grade of B or higher for lumbar central canal stenosis and who choose to perform 1-2 segment posterior decompression C. Those who can follow up for more than 1 year D. Research subject who signed the consent form after fully understanding the contents of the clinical trial by the principal (if signature is possible)

Exclusion criteria

Exclusion criteria: A. Meyer Gr II or higher spondylolisthesis B. Those who have previously performed the same segmental surgery C. Lumbar degenerative scoliosis (Cobb angle> 20 degrees) D. If the cause of the stenosis is not degenerative or due to an intervertebral disc herniation E. If there is another spinal disease in the affected area of lumbar stenosis (ankylosing spondylitis, tumor, compression fracture, etc.) F. Psychiatric diseases (dementia, mental retardation, severe drug addiction, etc.) G. Those who refused to participate in the study H. Other patients who are in charge of clinical trials as unsuitable for clinical trials

Design outcomes

Primary

MeasureTime frame
Difference in ODI value after 52 weeks after surgery

Secondary

MeasureTime frame
Oswestry disability index(ODI) score changes;Visual Analogue Scale(VAS) score changes;Walking time;Satisfaction after surgery;Period to return to daily life;POSAS questionnaire;Radiological evaluation

Countries

Korea, Republic of

Contacts

Public ContactChorong Lee

The Catholic University of Korea, Seoul St. Mary's Hospital

chorong84@nate.com+82-2-2258-6844

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 9, 2026