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

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• Radiculopathy 483
• Intervertebral Disc Displacement 474

Radiculopathy

483 studies on the registry are indexed under Radiculopathy; 144 are open to participants now.

This study's enrollment of 200 is above the median of 60 across 373 interventional studies indexed under Radiculopathy.

Lead sponsor

University of Opole is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Study arms

• Experimental
  FELD

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

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

• Active comparator
  MD

  microdiscectomy

  Procedure: Microdiscectomy

Interventions

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

  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.

• ProcedureMicrodiscectomy

  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])

   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.

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

Secondary outcomes

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

   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.

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

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

   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.

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

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

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

4. Time to Return to Work

   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.

   Time frame: Up to 12 months post-surgery

Individual participant data

Plan to share: Yes — The following specific Individual Participant Data (IPD) will be shared: De-identified individual clinical data: This includes data from questionnaires such as Visual Analog Scale (VAS), Core Outcome Measures Index (COMI), and Oswestry Disability Index (ODI), collected at baseline and during follow-up visits (1, 3, 6, and 12 months post-surgery). De-identified radiological data: MRI images taken 24 hours before surgery, 24 hours after surgery, and at each follow-up visit will be shared for the purpose of comparing radiological outcomes. De-identified recurrence and complication data: This includes any clinical or radiological evidence of recurrent disc herniation or complications (e.g., infection, reoperation). The data will be made available upon reasonable request for research purposes to qualified researchers following the publication of the primary study results.