Full-Endoscopic vs Open Discectomy for the Treatment of Symptomatic Lumbar Herniated Disc: A Prospective Multi-Center Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Leg pain as assessed by VAS score
研究概览
简要总结
The purpose of this study is to compare the clinical and radiographic outcomes of full endoscopic lumbar discectomy versus open lumbar decompression for the treatment of lumbar herniated discs in which the patient's leg pain is greater than back pain.
详细描述
The study will be performed utilizing a prospective multi-center randomized model. Approximately 7 centers will be included in the study as listed above. Patients will be informed of clinical trial and asked if they would like to participate. Patients are informed that participation is optional. Patients may withdraw from study any time prior to or after surgery. Patients will be randomized 2:1 ratio endoscopic:open surgery. Both the endoscopic and open surgical techniques are utilized in standard of care. If a subject requires an open surgery approach (based on the surgeons assessment at the time of surgery pre or post incision) after they are randomized to the endoscopic arm, they will be switched to the open arm and included in the open crossover arm of the study.
Study procedures will occur at the following time points; Pre-op, 6 wk, 3 mon, 6 mon, 1 yr and 2 yr follow-up.Subjects will complete questionnaires that assess pain level and location, functional capacity, work and health status, medication usage and duration of symptoms.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient equal to or greater than 18 years old.
- •Patients with single level para-central herniated discs from L1-S
- •VAS (Visual Analog Scale) leg > 40 mm.
- •Leg pain must be greater than back pain.
- •Minimum 6 weeks conservative treatment unless motor strength U< U4/5 and or deteriorating neurologic function.
排除标准
- •Lateral/subarticular, far lateral disc herniations
- •Multi-focal (multi modal) disc herniations
- •Symptomatic multiple level disc herniations
- •Active infection either spinal or otherwise
- •Prior history of lumbar spinal infection at any level
- •Spinal tumor in lumbar region
- •Dynamic (any grade) or fixed spondylolisthesis more than 3mm
- •Disc extrusion that is more superior than most inferior aspect of superior pedicle above index disc level
- •Disc extrusion that is more inferior than the middle aspect of inferior pedicle below the index disc level
- •Presence of unilateral or bilateral pars inter articularis defects (spondylolysis)
- •Disc herniation which is significantly calcified
- •Contra-lateral leg pain U>40 mm
- •History of peripheral diabetic neuropathy
- •Significant central stenosis with history of neurogenic claudication
- •Facet cyst on symptomatic side
- •Cauda Equina syndrome past or present
- •Patients cannot have had prior lumbar surgery including IDET (Intradiscal Electrothermal Therapy) or other percutaneous surgical procedures.
- •Significant vascular claudication
- •History of radiation to the spinal column
- •History of malignancy of any type within 2 years of consideration of enrollment
结局指标
主要结局
Leg pain as assessed by VAS score
时间窗: 2 years
次要结局
未报告次要终点