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

NCT06615518 | Active Not Recruiting

• 1 other identifier: UO/0001/KB/2024
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Back and Leg Pain Intensity (measured by the Visual Analog Scale [VAS])

  Description: The primary outcome measure will assess changes in back and leg pain intensity reported by patients using the Visual Analog Scale (VAS) at each follow-up. The reduction in pain scores will be compared between the FELD and MD groups to evaluate which technique provides superior pain relief over time.

  Baseline, 1 month, 3 months, 6 months, 12 months post-surgery

Secondary Outcomes (4)

• Change in Functional Disability (measured by the Oswestry Disability Index [ODI])

  Baseline, 1 month, 3 months, 6 months, 12 months post-surgery

• Change in Overall Patient Well-Being (measured by the Core Outcome Measures Index [COMI])

  Baseline, 1 month, 3 months, 6 months, 12 months post-surgery

• Recurrence Rate of Disc Herniation (measured by MRI and clinical assessment)

  1 month, 3 months, 6 months, 12 months post-surgery

• Time to Return to Work

  Up to 12 months post-surgery

Study Arms (3)

TELD

EXPERIMENTAL

Transforaminal endoscopic lumbar discectomy

Procedure: transforaminal endoscopic lumbar discectomy

IELD

EXPERIMENTAL

Interlaminar endoscopic lumbar discectomy

Procedure: Interlaminar endoscopic lumbar discectomy

MD

ACTIVE COMPARATOR

microdiscectomy

Procedure: Microdiscectomy

Interventions

transforaminal endoscopic lumbar discectomy PROCEDURE

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.

TELD

Interlaminar endoscopic lumbar discectomy PROCEDURE

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.

IELD

Microdiscectomy PROCEDURE

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

MD

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-85 years with symptoms of sciatica lasting more than 6 weeks
• Shorter duration in cases where symptoms significantly impair normal functioning or in cases of muscle strength deficits
• Symptoms correlate with MRI findings of lumbar spine pathology, showing the presence of intervertebral disc herniation (protrusion, extrusion, or sequestration) causing nerve root compression in the lumbar spine.

You may not qualify if:

• Previous lumbar spine surgery in the lumbar-sacral region
• MRI findings showing degenerative or stenotic spinal canal changes
• Multi-level pathology where identification of the pain source is not possible
• Pregnancy

Sponsors & Collaborators

• University of Opole: lead

Study Sites (2)

Uniwesytecki Szpital Kliniczny

Opole, Opole Voivodeship, 45-001, Poland

Location

Wojewódzki Szpital Specjalistyczny im Św Jadwigi w Opolu

Opole, Opole Voivodeship, 45-221, Poland

Location

MeSH Terms

Conditions

Radiculopathy; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Kajetan Latka, PhD

  University of Opole

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Deputy-Head Neurosurgery Department WSS Opole

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 26, 2024
• Study Start: March 1, 2024
• Primary Completion: January 12, 2025
• Study Completion: December 1, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

PL (2)