NCT06615518

Comparison of Clinical Effectiveness of Full Endoscopic Lumbar Discectomy (FELD) and Microdiscectomy (MD) in Patients With Lumbar Disc Herniation

Active, enrolled NA Last updated 20 November 2025

What this trial tests

NA trial testing transforaminal endoscopic lumbar discectomy in Lumbar Degenerative Disease in 220 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 March 2024

Primary endpoint
12 January 2025

1 December 2025

Quick facts

Lead sponsor	University of Opole
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	220
Start date	1 March 2024
Primary completion	12 January 2025
Estimated completion	1 December 2025
Sites	2 locations across Poland

Drugs / interventions tested

• transforaminal endoscopic lumbar discectomy
• Interlaminar endoscopic lumbar discectomy
• Microdiscectomy

Conditions studied

• Lumbar Degenerative Disease — all drugs for Lumbar Degenerative Disease →
• Lumbar Radiculopathy — all drugs for Lumbar Radiculopathy →
• Sciatic Leg Pain — all drugs for Sciatic Leg Pain →
• Sciatic Nerve Compression — all drugs for Sciatic Nerve Compression →

Sponsor

University of Opole

Who can join

Adults 18 to 85, any sex, with Lumbar Degenerative Disease or Lumbar Radiculopathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to compare the clinical effectiveness of Full Endoscopic Lumbar Discectomy (FELD) and Microdiscectomy (MD) in patients aged 18-85 with single-level lumbar disc herniation who have not undergone prior lumbar surgery. This study also aims to perform a radiological analysis of MRI scans before and after treatment to optimize patient selection and surgical strategies. The main questions it aims to answer are:

* Does FELD provide superior early postoperative pain relief (measured by VAS) compared to MD?
* Does FELD offer better functional recovery (measured by COMI and ODI scores) postoperatively compared to MD?
* Can radiological analysis of pre- and post-operative MRI images help optimize patient qualification and guide surgical strategies?

Researchers will compare patients undergoing FELD to those undergoing MD to see if endoscopic techniques result in faster recovery and lower early postoperative pain while maintaining similar long-term outcomes. The study will also analyze how MRI findings correlate with clinical outcomes to refine operative decision-making.

Participants will:

* Undergo either FELD or MD surgery
* Complete VAS, COMI, and ODI questionnaires at pre-specified follow-up intervals (1, 3, 6, and 12 months post-surgery)
* Have MRI scans 24 hours before surgery, 24 hours after surgery, and at each follow-up to assess disc recurrence, residual pathology, and to optimize surgical strategies.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Tissue engineering strategies for treating intervertebral disc degeneration.
   Nie G, Liu W, Zeng F, Hu J, et al · · 2025 · cited 2× · PMID 40727644 · DOI 10.3389/fbioe.2025.1582189