A Prospective Randomized Trails for Primary Disc Herniation With Radiculopathy:Conservative Versus Aggressive Discectomy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- patients satisfaction
研究概览
简要总结
Summary: This is a prospective randomize study to compare conservative and aggressive discectomy for treatment of disc herniation with radiculopathy.
Study hypothesis: The investigators believe that conservative discectomy could preserve a higher disc space and has a better long-term outcomes.
详细描述
objectives:to compare the effect of two type surgery(conservative discectomy and aggressive discectomy)on disc herniation with radiculopathy after long-term follow-up.
methods:the patients who were confirmed suffer from disc herniation with radiculopathy and failed to nonsurgical treatment will be divided into two groups, and will be follow up 3~6 years for seeking the effect on disc space preservation and recurrent.
outcome measures:the rate of pain release and patients satisfaction were measured by SF-36,ODI,VAS,score post-OP. the height of disc was measured on X-ray film by the end point.
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Duration of symptoms: 6 or more weeks.
- •Treatments tried: Non-steroidal anti-inflammatory medical therapy and physical therapy.
- •Surgical screening: Persistent radicular pain provoked by moderate exercise, sitting, increased abdominal pressure, decreased mobility, list (scoliosis), straight leg raising.
- •Tests: MRI to confirm diagnosis and level(s).
排除标准
- •Previous lumbar spine surgery.
- •Not a surgical candidate for any of these reasons: Overall health which makes spinal surgery too life-threatening to be an appropriate alternative, dramatic improvement with conservative care, or inability (for any reason) to undergo surgery within 6 months.
- •Possible pregnancy.
- •Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer) is ineligible unless he or she has been treated with a curative intent AND there has been no clinical signs or symptoms of the malignancy for at least 5 years.
- •Current fracture, infection, and/or deformity (greater than 15 degrees of lumbar scoliosis, using Cobb measure technique) of the spine.
- •Age less than 18 years.
- •Cauda Equina syndrome or progressive neurological deficit (usually requiring urgent surgery).
- •Unavailability for follow-up (planning to move, no telephone, etc.) or inability to complete data surveys.
- •Symptoms less than 6 weeks.
- •Patient currently enrolled in any experimental "spine related" study.
结局指标
主要结局
patients satisfaction
时间窗: 5th year after intervention
次要结局
- recurrence rate of disc herniation(5th year after operation)
- height of disc space(5th year after operation)
- height of disc operation(1st year after operation)