Clinical Evaluation of Orion Lamina Cover in Patients Undergoing Lumbar Laminectomy With Instrumented Fusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
Laminectomy with internal fixation and osseofusion is a common surgery for treating degenerative spinal diseases. It removes excessive bone spurs and removes the lamina for decompression to relieve nerve compression, and then utilizes a spinal fixation system to stabilize the structure to relieve lower limb pain, paralysis, and other symptoms. However, the spinal cord that lacks lamina coverage after surgery is often compressed by scar tissue formation and hematoma, leading to postoperative back and lower limb pain. Therefore, this trial is divided into two groups, comparing the use of the cross connector of the ORION spinal system - the spinal lamina cover and the general spinal fixation system (without lamina cover). For participants undergoing laminectomy with internal fixation and osseofusion, after utilizing the spinal lamina cover of the ORION spinal system, whether the nerve compression caused by postoperative scar tissue formation and hematoma can be effectively reduced, and the pain in the back and lower limbs can be improved.
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 (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender and age: females and males are at least 20 years old
- •Who with degenerative lumbar spondylolisthesis in one or two consecutive segments from lumbar vertebra L1 to sacral vertebra S1, and have objective evidence of back pain and numbness radiating to the lower limbs.
- •Clinical symptoms of degenerative lumbar spondylolisthesis, accompanied by objective symptoms of neurological deficit; spinal stenosis, neurogenic claudication or bilateral radiating pain.
- •Have received at least 3 months of non-surgical treatment without effectiveness.
- •Radiographic examination was consistent with clinical symptoms of degenerative spondylolisthesis or spinal stenosis.
- •After diagnosis who needs laminectomy with internal fixation and osseofusion
- •Able and willing to sign the consent form and answer the questionnaire.
排除标准
- •Already had lumbar surgery at the same lumbar vertebra
- •Physically health not well
- •Probably pregnant
- •Who suffering from malignant tumors or infections
- •below 20 years old
- •Unable and unwilling to answer the questionnaire and return to the hospital for treatment
- •Unable to undergo MRI examination due to any reason, such as having a cardiac rhythm regulator, ferromagnetic implants, or claustrophobia.
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: Pre-surgery; one month after surgery; three months after surgery; six months after surgery
To measure the pain and numb of the participants' back and limbs
Magnetic Resonance Imaging (MRI)
时间窗: Six months after surgery
To observe the recovery of the participants' spine
次要结局
- Oswestry Disability Index (ODI)(Pre-surgery; one month after surgery; three months after surgery; six months after surgery)
- Sort Form-12 Health Survey (SF-12)(Pre-surgery; one month after surgery; three months after surgery; six months after surgery)