Comparative Study Between Microdecompression and Open Decompression With Posterior Stabilization for Symptomatic Lumbar Spine Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Visual analoge score
研究概览
简要总结
This study compare the results of 2 methods in surgical treatment of Lumbar spine stenosis.These are microdecompresssion and open decompression with posterior stabilization. 100 patients are involved in this study who divided in 2 groups.Each group was treated with one method and follow up done which showed both method are effective with better results in those patients treated with microdecomppression.
详细描述
This randomized controlled study was conducted between January 2016 and October 2018. One hundred patients were involved in this study. All these patients were suffered from radicular leg pain with MRI features of multilevel lumbar spinal stenosis and were treated by conservative treatment of medical treatment and physiotherapy without benefit for (6) months. Those patients were divided into two groups; Group A, (50) Microdecompression, and Group B, (50) patients who were treated by open wide laminectomy and posterior stabilization. Both groups of patients were followed up with ODI (Oswestry disability index) and VAS (Visual analogue score) for the back and leg pain for one year.
Results: The results showed that both groups got significant improvement regarding Oswestry disability index. Regarding back pain, there was a significant improvement in both groups with better results in-group A due minimal tissues injury as the advantage of minimal invasive technique. In both groups, there were marked improvement of radicular leg pain postoperatively.
Conclusions: Both Microdecompression and wide open laminectomy with posterior stabilization were effective in treatment of multilevel lumbar spinal stenosis with superior results of Microdecompression regarding less back pain postoperatively with less blood loss and soft tissue dissection.
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
- 41 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients were suffered from back pain of different degrees with spinal claudication
排除标准
- •Diabetic patients,
- •Previous spinal surgery,
- •any neuromuscular disorder like poliomyelitis, and
- •vertebral instability proved by Dynamic plain radiographs
研究组 & 干预措施
Open
Open laminectomy and posterior stabilization with pedicle screws for symptomatic lumbar spine stenosis
干预措施: Microdecompression (Procedure)
Microscope
Microscopically done decompression of lumbar spine stenosis who are symptomatic
干预措施: Microdecompression (Procedure)
结局指标
主要结局
Visual analoge score
时间窗: It was measured at 12 months after operation
This is in pain measurement ranging from 0 when no pain to 10 when there is severe pain
Oswestry disability index
时间窗: It was measured at 12 months after operation
For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. If all 10 sections are completed the score is calculated as follows: Example: 16 (total scored) 50 (total possible score) x 100 = 32% If one section is missed or not applicable the score is calculated: 16 (total scored) 45 (total possible score) x 100 = 35.5% Minimum detectable change (90% confidence): 10% points (change of less than this may be attributable to error in the measurement)
次要结局
未报告次要终点
研究者
Sherwan Ahmed Ali Hamawandi
Assistant professor of orthopedic surgery
Hawler Medical University