Comparison of Endoscopic Lumbar Decompression and Minimally Invasive Transforaminal Lumbar Interbody Fusion(MIS-TLIF) for Degenerative Lumbar Spondylolisthesis (MIS-TLIF)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lumbar Spinal Stenosis; Degenerative Lumbar Spondylolisthesis; Lumbar Degenerative Disease
• Intervention / Treatment: Procedure: Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression

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 Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sirawit Wachirasakulchai, M.D.; Phone Number: +660859721082; Email: sirawit.wac@gmail.com
• Study Contact Backup: Name: Khanatip Jitpakdee, M.D.; Phone Number: +660812582050; Email: pooh_maru116@hotmail.com

Study Locations

• Thailand
  • Chon Buri, Thailand, 20110
    • Queen Savang Nadhana Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression; using endoscopic decompression for treatment	Procedure: Lumbar Endoscopic - Unilateral Laminotomy for Bilateral 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; Other Names: LE-ULBD; endoscopic decompression
No Intervention: MIS-TLIF: Minimal Invasive Surgery - Transforaminal Lumbar interbody Fusion; Using conventional treatment, minimal invasive decompression with interbody fusion surgery for treatment in control groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year; Preoperative and post-operative at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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.	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.	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 3. 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.	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	1 year; Preoperative and post-operative at 0,6,12 months

Collaborators and Investigators

• Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spondylolysis; Spondylosis; Spinal Stenosis; Spondylolisthesis
• Other Study ID Numbers: 024/2567

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No