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NCT Number: NCT06615518

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

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.

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Key information

Conditions

Lumbar Degenerative Disease Bone Diseases Disc Herniation Disc Herniation With Radiculopathy Discopathy Hernia Intervertebral Disc Displacement Lumbar Radiculopathy Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Sciatic Leg Pain Sciatic Nerve Compression Spinal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uniwesytecki Szpital Kliniczny, Opole, Opole Voivodeship, Poland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

FELD (Full-Endoscopic Lumbar Discectomy), comprising IELD and TELD as anatomical subgroups

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 (5-7mm) 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.

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

Primary outcomes

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

    Time frame: Baseline, 1 month, 3 months, 6 months, 12 months post-surgery

    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.

Secondary outcomes

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

    Time frame: Baseline, 1 month, 3 months, 6 months, 12 months post-surgery

    This measure will assess the improvement in functional disability using the ODI, comparing the degree of disability reduction between the FELD and MD groups at each follow-up point.

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

    Time frame: Baseline, 1 month, 3 months, 6 months, 12 months post-surgery

    The COMI questionnaire will be used to evaluate changes in the patient's overall perception of their condition, including pain, function, and quality of life. Comparisons will be made between FELD and MD groups to assess which method leads to a greater improvement in patient well-being.

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

    Time frame: 1 month, 3 months, 6 months, 12 months post-surgery

    The rate of recurrent disc herniation will be monitored through MRI scans and clinical evaluations. The rate of recurrence in both the FELD and MD groups will be compared to determine if one technique results in a higher recurrence rate.

  4. Time to Return to Work

    Time frame: Up to 12 months post-surgery

    This measure will assess the number of days taken for patients to return to their regular work activities post-surgery, comparing the recovery times between the FELD and MD groups.

Sponsors and collaborators

Lead sponsor

University of Opole

Other

Registry information

Official study title

"Radiological Analysis of MRI Images in Patients Treated With Minimally Invasive Microsurgical and Endoscopic Techniques: A Randomized Study Comparing the Clinical Effectiveness of Full Endoscopic Lumbar Discectomy (FELD) and Microdiscectomy (MD)"

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 26, 2024
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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