Clinical trial NCT06615518: Comparison of Clinical Effectiveness of Full Endoscopic Lumbar Discectomy (FELD) and Microdiscectomy (MD) in Patients with Lumbar Disc Herniation
Official 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)"
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lumbar Degenerative Disease
Lumbar Radiculopathy
Sciatic Leg Pain
Sciatic Nerve Compression
Discopathy
Disc Herniation
Disc Herniation with Radiculopathy
Lead sponsor: University of Opole
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Back and Leg Pain Intensity (measured by the Visual Analog Scale [VAS])
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 months post-surgery
Secondary outcomes:
measure: Change in Functional Disability (measured by the Oswestry Disability Index [ODI])
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 months post-surgery
measure: Change in Overall Patient Well-Being (measured by the Core Outcome Measures Index [COMI])
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 months post-surgery
measure: Recurrence Rate of Disc Herniation (measured by MRI and clinical assessment)
timeFrame: 1 month, 3 months, 6 months, 12 months post-surgery
measure: Time to Return to Work
timeFrame: Up to 12 months post-surgery
Other outcomes:
Locations:
city: Opole
country: Poland
facility: Uniwesytecki Szpital Kliniczny
state: Opolskie
city: Opole
country: Poland
facility: Wojewódzki Szpital Specjalistyczny im Św Jadwigi w Opolu
state: Opolskie
Study officials:
affiliation: University of Opole
name: Kajetan Latka, PhD
role: PRINCIPAL_INVESTIGATOR
References: