Comparison of Endoscopic Lumbar Decompression and Minimal Invasive Surgery Transforaminal Lumbar Interbody Fusion (MIS-TLIF) for Degenerative Lumbar Spondylolisthesis: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Oswestry Disability Index score
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Oswestry Disability Index score
时间窗: 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
次要结局
- Visual analog scale of leg pain(1 year; Preoperative and post-operative at 1,3,6 and 12 months)
- Visual analog scale of back pain(1 year; Preoperative and post-operative at 1,3,6 and 12 months)
- Modified Macnab criteria(1 year; Preoperative and post-operative at 1,3,6 and 12 months)
- Operative time(1 day; From patient's skin is cut, through each intervention surgery completion (minute) when the skin is closed)
- Length of hospital stay(1 year; The date from the patients had been admitted to discharge)
- Amount of blood loss(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(1 year; Preoperative and post-operative at 0,6 and 12 months)
- Radiographic outcomes: Slip angle(1 year; Preoperative and post-operative at 0,6,12 months)
- Radiographic outcomes: lumbar lordosis degree(1 year; Preoperative and post-operative at 0,6,12 months)