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

Summary

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.

Conditions

• Lumbar Degenerative Disease
• Lumbar Radiculopathy
• Sciatic Leg Pain
• Sciatic Nerve Compression
• Discopathy
• Disc Herniation
• Disc Herniation With Radiculopathy

Interventions

PROCEDURE

transforaminal endoscopic lumbar discectomy

FELD is a minimally invasive spine surgery technique performed through small incisions using an endoscope. The procedure involves accessing the herniated disc through either the transforaminal (TELD) or interlaminar (IELD) approach, depending on the location of the disc herniation. The endoscopic approach allows for direct visualization of the affected area using a camera, and specialized instruments are used to remove the herniated portion of the disc. What distinguishes this intervention: * Small incisions (typically \<1 cm) result in less soft tissue damage compared to traditional open surgery. * Real-time endoscopic visualization allows for precise disc removal and reduced trauma to surrounding structures such as muscles and ligaments. * Minimized postoperative pain and faster recovery times due to the less invasive nature of the procedure. * Outpatient or short hospital stay is often possible, contributing to faster patient discharge.

PROCEDURE

Interlaminar endoscopic lumbar discectomy

FELD is a minimally invasive spine surgery technique performed through small incisions using an endoscope. The procedure involves accessing the herniated disc through either the transforaminal (TELD) or interlaminar (IELD) approach, depending on the location of the disc herniation. The endoscopic approach allows for direct visualization of the affected area using a camera, and specialized instruments are used to remove the herniated portion of the disc. What distinguishes this intervention: * Small incisions (typically \<1 cm) result in less soft tissue damage compared to traditional open surgery. * Real-time endoscopic visualization allows for precise disc removal and reduced trauma to surrounding structures such as muscles and ligaments. * Minimized postoperative pain and faster recovery times due to the less invasive nature of the procedure. * Outpatient or short hospital stay is often possible, contributing to faster patient discharge.

PROCEDURE

Microdiscectomy

Microdiscectomy is a conventional surgical technique for treating lumbar disc herniation, involving a small open incision. In this procedure, the surgeon makes an incision typically between 2-3 cm in length, then uses an operating microscope to gain magnified visualization of the herniated disc. The surgeon removes part of the lamina (laminotomy) to access the disc and nerves. Special instruments are used to remove the herniated portion of the disc that is compressing the spinal nerves, relieving symptoms such as pain, numbness, and weakness. What distinguishes this intervention: * Larger incision (2-3 cm) compared to FELD, but still smaller than traditional open discectomy, allowing better visualization. * Microscopic magnification allows precise removal of disc material while minimizing trauma to surrounding neural structures. * Direct access to the affected area via the removal of part of the lamina (laminotomy), offering a well-established and highly effective approach to reli

Sponsors & Collaborators

• University of Opole

  lead OTHER

Principal Investigators

• Kajetan Latka, PhD · University of Opole

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-01

Primary Completion

2025-01-12

Completion

2025-12-01

Countries

• Poland

Study Locations