Degenerative Lumbar SpondylolisthesisMIS-TLIFNCT06749314
Comparison of Endoscopic Lumbar Decompression and Minimally Invasive Transforaminal Lumbar Interbody Fusion(MIS-TLIF) for Degenerative Lumbar Spondylolisthesis
A study testing Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression in people with Degenerative Lumbar Spondylolisthesis and Lumbar Degenerative Disease, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
Trial summary
Comparing the functional and radiographic outcomes in surgical treatment in failed conservative treatment, single-level low grade degenerative lumbar spondylolisthesis between Minimal Invasive Surgery Transforaminal Lumbar Interbody Fusion, which is conventional treatment recently, and Endoscopic Lumbar Decompression… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Degenerative Lumbar Spondylolisthesis, Lumbar Degenerative Disease, Lumbar Spinal Stenosis
- What is being tested?
- Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2025to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single level lumbar degenerative spondylolisthesis (Meyerding Grading Grade I or II).
- Failed conservative treatment for at least 3 months.
- No instability evidence of levels of lesion (Consideration from translation more than 5 mm or angulation change more than 10 degree in flexion and extension L-S plain films ).
- Able to follow up for at least 12 months.
- Patient who vorantarily agree to participate in research.
Who cannot join
- Patients with severe foraminal stenosis diagnosed by MRI.
- Patients who have previously undergone lumbar spine surgery (revision surgery).
- Patients with other abnormalities in the lumbar spine, such as infection, tumors, or fractures.
- Patients who cannot undergo surgery due to underlying conditions or who cannot maintain the prone position for extended periods.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Endoscopic Lumbar Decompression and Minimal Invasive Surgery Transforaminal Lumbar Interbody Fusion (MIS-TLIF) for Degenerative Lumbar Spondylolisthesis: A Randomized Controlled Study
Comparing the functional and radiographic outcomes in surgical treatment in failed conservative treatment, single-level low grade degenerative lumbar spondylolisthesis between Minimal Invasive Surgery Transforaminal Lumbar Interbody Fusion, which is conventional treatment recently, and Endoscopic Lumbar Decompression, which is minimal invasive in symptomatic treatment.
Read the detailed description
This was a randomized controlled trial in patient with single-level low grade degenerative lumbar spondylolisthesis with failed conservatives treatment, by comparing two group of surgical intervention between Minimally Invasive Transforaminal Lumbar Interbody Fusion (MIS TLIF) and Endoscopic lumbar decompression using functional outcomes.
The participants were randomized into two groups with 33 cases each group (Total = 66) by using computer generated program with block of four randomization with allocation ratio 1:1. The control group received conventional treatment which is Minimal Invasive Surgery Transforaminal Lumbar Interbody Fusion while the experimental group received endoscopic lumbar decompression. Using ODI score as primary outcome. Data were analyzed using chi-square test for categorical data (eg, sex, symptoms of weakness and numbness, level of spondylolisthesis) and unpaired T-test for continuous data (eg. VAS score, ODI, slippage percentage, lumbar lordosis degree, slip angle, op time) which considered significant difference of the outcomes when p < 0.05 with a power of 80%. Consider endoscopic decompression is non-inferiority to MIS-TLIF when upper limit of the one-sided 95%CI for the differences in ODI means is less than margin (12.8 points) If the results show that endoscopic decompression is non-inferiority to MIS TLIF, endoscopic lumbar decompression may be a choice of treatments giving benefit of minimal invasive surgery and avoid interbody fusion complication such as pseudoarthrosis, adjacent problems and operative blood loss
- Conditions
- Degenerative Lumbar Spondylolisthesis, Lumbar Degenerative Disease, Lumbar Spinal Stenosis
- Being tested
- Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Endoscopic - Unilateral Laminotomy for Bilateral DecompressionProcedure or surgery
Also called LE-ULBD, endoscopic decompression
The LE-ULBD: Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression is a single portal through lamina with instrument to decompression both side of the spinal canal, giving strength of preserve facet joint, preserve spinal musculature, mitigate the risk of adjacent fusion and lesser bleeding
| Study group | Role | What they receive |
|---|---|---|
| Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression | Experimental | using endoscopic decompression for treatment Receives: Procedure: Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression |
| MIS-TLIF: Minimal Invasive Surgery - Transforaminal Lumbar interbody Fusion | No intervention | Using conventional treatment, minimal invasive decompression with interbody fusion surgery for treatment in control groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index score
The Oswestry Disability Index (ODI) is a patient-completed questionnaire made up of 10 questions, each with six statements that are scored from 0 to 5. The questions cover a range of activities, including pain intensity, personal care, walking, sleeping, social life, and travel. The ODI score ranges from 0% to 100%, with higher scores indicating more severe disability:
0-20%: Mild disability 20-40%: Moderate disability 40-60%: Severe disability 60-80%: Disabling 80-100%: Bedridden or functional impairment
Measured: 1 year; Preoperative and post-operative at 12 months
Secondary outcomes (9)
Visual analog scale of leg pain
Pain score of leg pain from 1-10 determined by measuring in millimeters from the left hand end of the line to the point that the patient marks
Measured: 1 year; Preoperative and post-operative at 1,3,6 and 12 months
Visual analog scale of back pain
Pain score of back pain from 1-10 determined by measuring in millimeters from the left hand end of the line to the point that the patient marks
Measured: 1 year; Preoperative and post-operative at 1,3,6 and 12 months
Modified Macnab criteria
The Modified MacNab criteria are a set of guidelines used to assess the outcomes of spinal surgery, particularly in evaluating the effectiveness of procedures like discectomy or spinal fusion
Measured: 1 year; Preoperative and post-operative at 1,3,6 and 12 months
Operative time
Operative time that using in each intervention start from when patient's skin is cut and stop when it is closed. Measure in minute
Measured: 1 day; From patient's skin is cut, through each intervention surgery completion (minute) when the skin is closed
Length of hospital stay
Total days that the patients had been admitted to discharge
Measured: 1 year; The date from the patients had been admitted to discharge
Amount of blood loss
Total blood loss during surgery and postoperative measuring from visual estimation, gravimetric method, suction bottle and drainage bottle after surgery.
Measured: 1 day; Start from the skin's is cut through surgery period and postoperative until the drain bottle was removed.
Radiographic outcomes: lumbar slip percentage
Comparing lumbar slip percentage which calculated by measuring the displacement of the upper vertebral body relative to the lower vertebral body on a lateral radiograph preoperative and postoperative at each time point by:
- Draw a line along the posterior border of the lower vertebral body
- Draw a line perpendicular to the first line at the top of the lower vertebral body
- Draw a line along the posterior border of the upper vertebral body
- Calculate the percentage of the anterior translation of the upper vertebral body relative to the width of the lower vertebral body.
Measured: 1 year; Preoperative and post-operative at 0,6 and 12 months
Radiographic outcomes: Slip angle
The lumbar slip angle in spondylolisthesis is measured by drawing lines on a lateral X-ray and measuring the angle between them:
- Extend a line along the anterior border of the upper vertebral body spondylolisthesis level
- Draw a line along the posterior border of the lower vertebra spondylolisthesis level
- Draw a line perpendicular to the posterior aspect of the first lower vertebra
- Measure the angle between the line perpendicular to the first lower vertebra and a line parallel to the inferior end plate of upper vertebra A slip angle greater than 45 degrees is associated with a higher risk of instability, slip progression, and post-op pseudo-arthrosis.
Measured: 1 year; Preoperative and post-operative at 0,6,12 months
Radiographic outcomes: lumbar lordosis degree
The lumbar lordosis angle in spondylolisthesis is measured in degree by drawing lines on an X-ray film and calculating the angle formed by their intersection:
- Draw a line tangent to the superior endplate of the first lumbar vertebra (L1)
- Draw a line tangent to the inferior endplate of the fifth lumbar vertebra (L5)
- Draw a perpendicular line to each tangent
- The angle formed by the intersection of the two perpendicular lines is the lumbar lordosis angle
Measured: 1 year; Preoperative and post-operative at 0,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 May 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Lumbar SpondylolisthesisStudies 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
- Model description
- The participants were randomized into two group with computer generated block-of-four randomization with allocation 1:1 into two groups. The control group recieved MIS TLIF while the experimental group recieved endoscopic decompression.
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749314
- Sponsor's protocol ID
- 024/2567
- Acronym
- MIS-TLIF
- Status last verified
- Apr 2025
- First submitted
- 4 Nov 2024
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Endoscopic Lumbar Decompression and Minimal Invasive Surgery Transforaminal Lumbar Interbody Fusion (MIS-TLIF) for Degenerative Lumbar Spondylolisthesis: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06749314
- Acronym / sponsor ID
- MIS-TLIF / 024/2567
- Conditions
- Degenerative Lumbar Spondylolisthesis, Lumbar Degenerative Disease, Lumbar Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, ThailandUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 27 Dec 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.
Comparing the functional and radiographic outcomes in surgical treatment in failed conservative treatment, single-level low grade degenerative lumbar spondylolisthesis between Minimal Invasive Surgery Transforaminal Lumbar Interbody Fusion, which is conventional treatment recently, and Endoscopic Lumbar Decompression, which is minimal invasive in symptomatic treatment.
Detailed description
This was a randomized controlled trial in patient with single-level low grade degenerative lumbar spondylolisthesis with failed conservatives treatment, by comparing two group of surgical intervention between Minimally Invasive Transforaminal Lumbar Interbody Fusion (MIS TLIF) and Endoscopic lumbar decompression using functional outcomes.
The participants were randomized into two groups with 33 cases each group (Total = 66) by using computer generated program with block of four randomization with allocation ratio 1:1. The control group received conventional treatment which is Minimal Invasive Surgery Transforaminal Lumbar Interbody Fusion while the experimental group received endoscopic lumbar decompression. Using ODI score as primary outcome. Data were analyzed using chi-square test for categorical data (eg, sex, symptoms of weakness and numbness, level of spondylolisthesis) and unpaired T-test for continuous data (eg. VAS score, ODI, slippage percentage, lumbar lordosis degree, slip angle, op time) which considered significant difference of the outcomes when p < 0.05 with a power of 80%. Consider endoscopic decompression is non-inferiority to MIS-TLIF when upper limit of the one-sided 95%CI for the differences in ODI means is less than margin (12.8 points) If the results show that endoscopic decompression is non-inferiority to MIS TLIF, endoscopic lumbar decompression may be a choice of treatments giving benefit of minimal invasive surgery and avoid interbody fusion complication such as pseudoarthrosis, adjacent problems and operative blood loss
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants were randomized into two group with computer generated block-of-four randomization with allocation 1:1 into two groups. The control group recieved MIS TLIF while the experimental group recieved endoscopic decompression.
| Arm | Type | Receives |
|---|---|---|
| Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression | Experimental | Procedure: Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompressionusing endoscopic decompression for treatment |
| MIS-TLIF: Minimal Invasive Surgery - Transforaminal Lumbar interbody Fusion | No intervention | –Using conventional treatment, minimal invasive decompression with interbody fusion surgery for treatment in control groups |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Single level lumbar degenerative spondylolisthesis (Meyerding Grading Grade I or II).
- Failed conservative treatment for at least 3 months.
- No instability evidence of levels of lesion (Consideration from translation more than 5 mm or angulation change more than 10 degree in flexion and extension L-S plain films ).
- Able to follow up for at least 12 months.
- Patient who vorantarily agree to participate in research.
Key exclusion criteria (4 listed)
- Patients with severe foraminal stenosis diagnosed by MRI.
- Patients who have previously undergone lumbar spine surgery (revision surgery).
- Patients with other abnormalities in the lumbar spine, such as infection, tumors, or fractures.
- Patients who cannot undergo surgery due to underlying conditions or who cannot maintain the prone position for extended periods.
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 |
|---|---|---|
| Lumbar Endoscopic - Unilateral Laminotomy for Bilateral DecompressionAlso: LE-ULBD, endoscopic decompressionThe LE-ULBD: Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression is a single portal through lamina with instrument to decompression both side of the spinal canal, giving strength of preserve facet joint, preserve spinal musculature, mitigate the risk of adjacent fusion and lesser bleeding | Procedure or surgery | Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression |
Primary outcome
Oswestry Disability Index score
Time frame: 1 year; Preoperative and post-operative at 12 months
The Oswestry Disability Index (ODI) is a patient-completed questionnaire made up of 10 questions, each with six statements that are scored from 0 to 5. The questions cover a range of activities, including pain intensity, personal care, walking, sleeping, social life, and travel. The ODI score ranges from 0% to 100%, with higher scores indicating more severe disability: 0-20%: Mild disability 20-40%: Moderate disability 40-60%: Severe disability 60-80%: Disabling 80-100%: Bedridden or functional impairment
9 secondary outcomes
Visual analog scale of leg pain
Time frame: 1 year; Preoperative and post-operative at 1,3,6 and 12 months
Visual analog scale of back pain
Time frame: 1 year; Preoperative and post-operative at 1,3,6 and 12 months
Modified Macnab criteria
Time frame: 1 year; Preoperative and post-operative at 1,3,6 and 12 months
Operative time
Time frame: 1 day; From patient's skin is cut, through each intervention surgery completion (minute) when the skin is closed
Length of hospital stay
Time frame: 1 year; The date from the patients had been admitted to discharge
Amount of blood loss
Time frame: 1 day; Start from the skin's is cut through surgery period and postoperative until the drain bottle was removed.
Radiographic outcomes: lumbar slip percentage
Time frame: 1 year; Preoperative and post-operative at 0,6 and 12 months
Radiographic outcomes: Slip angle
Time frame: 1 year; Preoperative and post-operative at 0,6,12 months
Radiographic outcomes: lumbar lordosis degree
Time frame: 1 year; Preoperative and post-operative at 0,6,12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression in people with Degenerative Lumbar Spondylolisthesis and Lumbar Degenerative Disease, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
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 5 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: opening soon, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sirawit Wachirasakulchai, M.D. (+660859721082, sirawit.wac@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index score (time frame: 1 year; Preoperative and post-operative at 12 months). 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 22 Apr 2025.