NCT03924700已完成不适用
Outcomes Following Lumbar Discectomy Surgery in Lumbar Herniated Intervertebral Disc With Biportal Endoscopy Versus Open Microdiscectomy Technique: A Prospective, Multicenter, Single-blinded, Randomized Controlled Non-inferiority Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Oswestry disability index (ODI)
研究概览
简要总结
This study is to compare the clinical outcome between the biportal endoscopic discectomy and microdiscectomy in herniated intervertebral disc of lumbar spine
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged between 20 and 80
- •patients who has radiating pain (VAS >=40) on lower extremities with HIVD
- •patients who required one-level discectomy between L1 and S1
- •those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form
排除标准
- •Revision surgery
- •Over spondylolisthesis Gr II
- •Degenerative lumbar scoliosis (Cobb angle >20)
- •patients with a history of other spinal diseases (compression fracture, spondylitis, tumor)
- •women with positive pregnancy tests before the trial or who planned to become pregnant within the following 3 years
- •patients with a history of malignant tumor or malignant diseases (but the cases of cured disease with no relapse for the past 5 years were included in the present study)
- •patients with mental retardation or whose parents or legal guardians were older or had mental disabilities
- •other patients viewed as inappropriate by the staff
研究组 & 干预措施
Biportal endoscopic discectomy
Experimental
Biportal endoscopic discectomy for lumbar herniated intervertebral disc
干预措施: Biportal endoscopy (Procedure)
Microdiscectomy
Active Comparator
Microdiscectomy for lumbar herniated intervertebral disc
干预措施: Microdiscectomy (Procedure)
结局指标
主要结局
Oswestry disability index (ODI)
时间窗: at 1 year after surgery
The ODI is based on a self-administered questionnaire measuring ''back-specific function.'' The questionnaire comprises 10 items, each with 6 levels of response. Each item is scored from 0 to 5, and the total summation is converted to a 0-100 scale. The ODI scores ranges from 0 to 100, with higher scores indicating severe symptoms. This is assessed by ODI survey at 1 year after surgery
次要结局
- Change from baseline Oswestry disability index (ODI)(3, 6, and 12, months, and every year, up to 5 year after operation)
- Operation duration time (minutes)(Immediate after operation)
- Change from baseline EuroQoL-5 dimension (EQ-5D) value(3, 6, and 12, months, and every year, up to 5 year after operation)
- Change from baseline PainDETECT score(3, 6, and 12, months, and every year, up to 5 year after operation)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(up to 1 month after operation)
- Volume of postoperative drainage (ml)(Within 3 days after operation)
- Number of participants with complete discectomy(Within 3 days after operation)
- Concentration of creatine phosphokinase level in blood(At 2 day after surgery)
- Times of hospital stay (hours)(Within 7 days after operation)
- Volume of postoperative Fentanyl consumption(At 3 days after operation)
- Number of radiographic complications(every year, up to 5 year after operation)
- Change from baseline Visual Analog Pain Scale (VAS)(4, 8, 12, 24, 48 hours, 2 weeks, 3, 6, and 12, months, and every year, up to 5 year after operation)
研究者
Jin S. Yeom
Professor
Seoul National University Hospital
研究点 (2)
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