Microendoscopic Discectomy Vs Transforaminal Endoscopic Lumbar Discectomy Vs Open Discectomy for the Treatment of Lumbar Disc Herniation
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 240
- 主要终点
- Oswestry Disability Index(ODI)
研究概览
简要总结
In our study, a multicenter randomized controlled，single blind trial will be performed to evaluate the effectiveness and safety of these three procedures for the treatment of symptomatic lumbar disc herniation.
详细描述
Lumbar disc herniation (LDH) is one of the most common diseases in the department of orthopedics, which produced medical and economic burdens to families and society. In spite, the majority of the patients with disc herniation can be relieved or even cured via conservative treatment; there are still a considerable number of invalid patients who eventually still need to be undergoing a surgical operation treatment. Three main methods for intervertebral disc surgery are adopted in our routine work. One procedure is Open Discectomy (OD), which has been always a gold standard for treatment of LDH. And the other two procedures are Microendoscopic Discectomy (MED) and Transforaminal Endoscopic Lumbar Discectomy (TELD) respectively. MED and TELD have been developed as alternatives to OD. OD can compress the nerve root or spinal cord through removal of the protrusion. However, it destroys the rear structure of spine, causing segmental instability and long-term distress. Compared with OD, MED and TELD procedures are smaller incisions or less dissection (or both), lower blood loss, less postoperative pain, shorter hospitalisation and earlier return to work. However, the steep learning curves of MID inhibit the development of surgery specialists; for example, optimal surgical management requires many years of experience. These deficiencies need more educational effort at a higher priority than accorded so far. There are inconsistent outcomes about the efficacy and safety in the previous studies; all of the recent researches do not yield conclusive results.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All forms of disc herniation were included in the study
- •History of concordant radicular leg pain refractory to conservative treatment for longer than 6 months
- •Leg pain must be greater than back pain
排除标准
- •cauda equine syndrome,
- •progressive neurologic deficit,
- •bilateral lower extremity symptoms,
- •low back pain more than leg pain
- •Systemic infection or localized infection at the anticipated entry needle site
- •combined with lumbar infection, fracture of lumbar vertebra, tumor, Ⅱ°and above spondylolisthesis, lumbar spinal stenosis, lumbar scoliosis is larger than 15 degree
- •with severe heart, brain, lungs, and other organs disease or mental illness
- •History of opioid abuse or patients currently on long acting opioid
- •History of the operation on lumbar
结局指标
主要结局
Oswestry Disability Index(ODI)
时间窗: up to 104 weeks
Oswestry Disability Index (ODI) -\> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5. 0 is the best outcome and 50 is the worst The ODI is the most commonly outcome measures in patients with low back pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5. 0 is the best outcome and 50 is the worst outcome
次要结局
- visual analogue scale(VAS)(up to 104 weeks)
- The generic health survey on the Short Form-36(SF-36)(up to 104 weeks)
- Complications survey(up to 104 weeks)
研究者
Kun Wang
Kun Wang
Southeast University, China