Comparison of Percutaneous Diskectomy SpineJet x Open Microdiscectomy for Treatment of Lumbar Radiculopathy in Contained Disc Herniation: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- VAS for Lumbar Pain in 3 Months
研究概览
简要总结
Approximately 300,000 patients undergo open surgical procedures to treat symptoms caused by disc herniation.
Among the various surgical techniques practiced the percutaneous discectomy occupies its space since the first description of the technique by Hijikata, 1975. Throughout, many techniques have been described. Studies indicate that the treatment was successful for pain and disability resulting from herniated disc associated with radiculopathy small.
However, some methods remove very small amounts of tissue with little change in volume of the disc. Thus, studies on the cadaver with Percutaneous Diskectomy by SpineJet ® showed more macroscopic changes of the disc with a predictable amount of removal and significant disc material.
The Percutaneous Diskectomy by SpineJet ® is a new technique of percutaneous diskectomy which creates a suction effect in tissues adjacent to the exit point of the fluid and the opening point of the collector. However, no studies have examined the effect of the Percutaneous Diskectomy by SpineJet ® in humans about the disk size after treatment or measures of disc degeneration by imaging methods or how these characteristics might correlate with clinical outcomes.
Thus, the study will compare outcomes of patients with contained or extruded disc herniation, with complaints of radiculopathy, concordant with the imaging findings. With treatment by surgical technique or the traditional by SpineJet ®, in order to determine whether percutaneous discectomy with SpineJet ® will produce results comparable to open microdiskectomy.
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 76 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •single disc herniation, posterolateral, at any lumbar level, with a size of up to 1 / 3 of the spinal canal sagittal diameter, with radicular pain correlated with findings at MRI
- •Failure of nonoperative treatment with at least one anti-inflammatory medication and at least two weeks of physical therapy within a period of 6 months
- •acceptance of completion of informed consent
排除标准
- •Force <4 / 5 in a muscle group in the lower limb
- •Herniated Disc extrusa large (> 1 / 3 of the sagittal canal diameter) or sequestered herniation
- •moderate to grade stenosis of the central canal, lateral recess or foramen
- •Surgery in the previous level involved
- •Herniated disc at another level in the affected side
- •Loss of disc height significantly (> 60%) compared with the adjacent higher level
- •Infection at the insertion of the device
- •Pregnancy
- •Any illness or medications that contraindicate surgical treatment
研究组 & 干预措施
OMicro
This group will be formed by randomization, which gets out surgery to open microdiscectomy
干预措施: Open microdiscectomy (Procedure)
SJet
This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet
干预措施: Percutaneous Diskectomy SpineJet (Procedure)
结局指标
主要结局
VAS for Lumbar Pain in 3 Months
时间窗: VAS for Lumbar Pain at 3 Months
Pain Score - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.
Oswestry Disability Index (ODI) - 3th Month
时间窗: 3th month
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 outcome.
次要结局
- VAS for Lumbar 1st Month(1st month from surgery)
- VAS for Leg Pain - 1st Month(1st month from surgery)
- VAS for Leg Pain - 12th Month(12th month from surgery)
- Clinical Evaluation(6th month)
- VAS for Leg Pain - 1st Week(1st week from surgery)
- VAS for Lumbar - 1st Week(1st week from surgery)
- VAS for Lumbar Pain - 6th Month(6th month from surgery)
- VAS for Lumbar Pain - 12th Month(12th month from surgery)
- Oswestry Disability Index (ODI) - 1st Month(1st month from baseline)
- Oswestry Disability Index (ODI) - 6th Month(6th month from surgery)
- VAS for Leg Pain - 3rd Month(3rd month from surgery)
- VAS for Leg Pain - 6rd Month(6th month from surgery)
- VAS for Lumbar Pain - 3rd Month(3rd month from surgery)
- Oswestry Disability Index (ODI) - 1st Week(1st week minus baseline)
- Oswestry Disability Index (ODI) - 12th Month(12th month from surgery)
研究者
Alexandre F. Cristante
PhD.
University of Sao Paulo
