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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression | Experimental | using endoscopic decompression for treatment |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression | Procedure | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sirawit Wachirasakulchai, M.D. | Contact | +660859721082 | sirawit.wac@gmail.com | |
| Khanatip Jitpakdee, M.D. | Contact | +660812582050 | pooh_maru116@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Savang Nadhana Memorial Hospital | Chon Buri | 20110 | Thailand |
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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.
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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:
| 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:
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:
| 1 year; Preoperative and post-operative at 0,6,12 months |
| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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