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

University of Opole

Status: Active, not recruiting

Conditions: Sciatic Leg Pain; Disc Herniation; Lumbar Degenerative Disease; Discopathy; Sciatic Nerve Compression; Disc Herniation With Radiculopathy; Lumbar Radiculopathy

Treatments: Procedure: Interlaminar endoscopic lumbar discectomy; Procedure: transforaminal endoscopic lumbar discectomy; Procedure: Microdiscectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06615518

UO/0001/KB/2024

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 3 patient groups

TELD

Experimental group

Description:

Transforaminal endoscopic lumbar discectomy

Treatment:

Procedure: transforaminal endoscopic lumbar discectomy

IELD

Experimental group

Description:

Interlaminar endoscopic lumbar discectomy

Treatment:

Procedure: Interlaminar endoscopic lumbar discectomy

MD

Active Comparator group

Description:

microdiscectomy

Treatment:

Procedure: Microdiscectomy