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

Not Applicable

Active, not recruiting

• 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; Procedure: Interlaminar endoscopic lumbar discectomy; Procedure: Microdiscectomy

• Registration Number: NCT06615518
• Lead Sponsor: University of Opole

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Study First Submitted: 2024-09-24
• Study First Submitted QC: 2024-09-24
• Study First Posted: 2024-09-26
• Status Verified: 2025-01
• Primary Completion: 2025-01-12
• Last Update Submitted: 2025-01-12
• Last Update Posted: 2025-01-14
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TELD	transforaminal endoscopic lumbar discectomy	Transforaminal endoscopic lumbar discectomy
IELD	Interlaminar endoscopic lumbar discectomy	Interlaminar endoscopic lumbar discectomy
MD	Microdiscectomy	microdiscectomy

Primary Outcome Measures

Name	Time	Method
Change in Back and Leg Pain Intensity (measured by the Visual Analog Scale [VAS])	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 Outcome Measures

Name	Time	Method
Change in Functional Disability (measured by the Oswestry Disability Index [ODI])	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.
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	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.
Recurrence Rate of Disc Herniation (measured by MRI and clinical assessment)	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.
Time to Return to Work	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.

Trial Locations

Locations (2)

Uniwesytecki Szpital Kliniczny; 🇵🇱 Opole, Opolskie, Poland

Wojewódzki Szpital Specjalistyczny im Św Jadwigi w Opolu; 🇵🇱 Opole, Opolskie, Poland