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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FELD | Experimental | FELD (Full-Endoscopic Lumbar Discectomy), comprising IELD and TELD as anatomical subgroups |
|
| MD | Active Comparator | microdiscectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1 month, 3 months, 6 months, 12 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1 month, 3 months, 6 months, 12 months post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kajetan Latka, PhD | University of Opole | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniwesytecki Szpital Kliniczny | Opole | Opole Voivodeship | 45-001 | Poland | ||
| Wojewódzki Szpital Specjalistyczny im Św Jadwigi w Opolu |
The following specific Individual Participant Data (IPD) will be shared:
The data will be made available upon reasonable request for research purposes to qualified researchers following the publication of the primary study results.
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| 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:
|
|
| 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. |
| Baseline, 1 month, 3 months, 6 months, 12 months post-surgery |
| 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. | 1 month, 3 months, 6 months, 12 months post-surgery |
| 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. | Up to 12 months post-surgery |
| Opole |
| Opole Voivodeship |
| 45-221 |
| Poland |
| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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