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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
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
Queen Savang Nadhana Memorial Hospital
Chon Buri, Thailand
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
Time frame: 1 year; Preoperative and post-operative at 12 months
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
Time frame: 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
Time frame: 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
Time frame: 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
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
Total days that the patients had been admitted to discharge
Time frame: 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.
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
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: 1. Draw a line along the posterior border of the lower vertebral body 2. Draw a line perpendicular to the first line at the top of the lower vertebral body 3. Draw a line along the posterior border of the upper vertebral body 4. Calculate the percentage of the anterior translation of the upper vertebral body relative to the width of the lower vertebral body.
Time frame: 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: 1. Extend a line along the anterior border of the upper vertebral body spondylolisthesis level 2. Draw a line along the posterior border of the lower vertebra spondylolisthesis level 3. 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.
Time frame: 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: 1. Draw a line tangent to the superior endplate of the first lumbar vertebra (L1) 2. Draw a line tangent to the inferior endplate of the fifth lumbar vertebra (L5) 3. Draw a perpendicular line to each tangent 4. The angle formed by the intersection of the two perpendicular lines is the lumbar lordosis angle
Time frame: 1 year; Preoperative and post-operative at 0,6,12 months
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