Lumbar Degenerative DiseaseNCT06615518
Comparison of Clinical Effectiveness of Full Endoscopic Lumbar Discectomy (FELD) and Microdiscectomy (MD) in Patients With Lumbar Disc Herniation
A study testing FELD (Full-Endoscopic Lumbar Discectomy), comprising IELD and TELD as anatomical subgroups and Microdiscectomy in people with Lumbar Degenerative Disease and Lumbar Radiculopathy, run by University of Opole at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lumbar Degenerative Disease, Lumbar Radiculopathy, Sciatic Leg Pain
- What is being tested?
- FELD (Full-Endoscopic Lumbar Discectomy), comprising IELD and TELD as anatomical subgroups and Microdiscectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Mar 2024to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Poland2 sites
Uniwesytecki Szpital Kliniczny
Opole, Opole Voivodeship, 45-001
Wojewódzki Szpital Specjalistyczny im Św Jadwigi w Opolu
Opole, Opole Voivodeship, 45-221
About this study
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)"
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?
Read more
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.
- Conditions
- Lumbar Degenerative Disease, Lumbar Radiculopathy, Sciatic Leg Pain, Sciatic Nerve Compression, Discopathy, Disc Herniation
- Being tested
- FELD (Full-Endoscopic Lumbar Discectomy), comprising IELD and TELD as anatomical subgroups, Microdiscectomy
- Medical subject headings
- Radiculopathy, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FELD (Full-Endoscopic Lumbar Discectomy), comprising IELD and TELD as anatomical subgroupsProcedure or surgery
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.
MicrodiscectomyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| FELD | Experimental | FELD (Full-Endoscopic Lumbar Discectomy), comprising IELD and TELD as anatomical subgroups Receives: Procedure: FELD (Full-Endoscopic Lumbar Discectomy), comprising IELD and TELD as anatomical subgroups |
| MD | Active comparator | microdiscectomy Receives: Procedure: Microdiscectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, 3 months, 6 months, 12 months post-surgery
Secondary outcomes (4)
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.
Measured: Baseline, 1 month, 3 months, 6 months, 12 months post-surgery
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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Mar 2024
- Primary completion12 Jan 2025
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Degenerative DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Opole
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kajetan Latka, University of Opole
- Investigators
- Kajetan Latka, PhD, Principal investigator, University of Opole
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615518
- Sponsor's protocol ID
- UO/0001/KB/2024
- Status last verified
- Jun 2026
- First submitted
- 24 Sep 2024
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)"
- ClinicalTrials.gov ID
- NCT06615518
- Acronym / sponsor ID
- UO/0001/KB/2024
- Conditions
- Lumbar Degenerative Disease, Lumbar Radiculopathy, Sciatic Leg Pain, Sciatic Nerve Compression, Discopathy, Disc Herniation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of OpoleUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 12 Jan 2025 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FELD | Experimental | Procedure: FELD (Full-Endoscopic Lumbar Discectomy), comprising IELD and TELD as anatomical subgroupsFELD (Full-Endoscopic Lumbar Discectomy), comprising IELD and TELD as anatomical subgroups |
| MD | Active comparator | Procedure: Microdiscectomymicrodiscectomy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FELD (Full-Endoscopic Lumbar Discectomy), comprising IELD and TELD as anatomical subgroupsFELD 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. | Procedure or surgery | FELD |
| MicrodiscectomyMicrodiscectomy 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 | Procedure or surgery | MD |
Primary outcome
Change in Back and Leg Pain Intensity (measured by the Visual Analog Scale [VAS])
Time frame: 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.
4 secondary outcomes
Change in Functional Disability (measured by the Oswestry Disability Index [ODI])
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months post-surgery
Change in Overall Patient Well-Being (measured by the Core Outcome Measures Index [COMI])
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months post-surgery
Recurrence Rate of Disc Herniation (measured by MRI and clinical assessment)
Time frame: 1 month, 3 months, 6 months, 12 months post-surgery
Time to Return to Work
Time frame: Up to 12 months post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kajetan Latka, PhD principal investigator
University of Opole
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FELD (Full-Endoscopic Lumbar Discectomy), comprising IELD and TELD as anatomical subgroups and Microdiscectomy in people with Lumbar Degenerative Disease and Lumbar Radiculopathy, run by University of Opole at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Back and Leg Pain Intensity (measured by the Visual Analog Scale [VAS]) (time frame: Baseline, 1 month, 3 months, 6 months, 12 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.