Efficacy of Crenel Lateral Interbody Fusion Combined With Lateral Plate Fixation Versus Transforaminal Lumber Interbody Fusion for Lumbar Spinal Stenosis Combined With Lumbar Instability
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 98
- 主要终点
- Oswestry Disability index (ODI)
研究概览
简要总结
At present, interbody fusion is the mainstream treatment for patients with lumbar spinal stenosis (LSS) and lumbar instability. However, the choice of interbody fusion for LSS patients with lumbar instability remains controversial. Recently, we developed crenel lateral interbody fusion combined with lateral plate fixation(CLIF - LP) for patients with LSS and lumbar instability. This surgical method has many advantages and showed good results for patients with LSS and lumbar instability. Therefore, we propose the following hypothesis: The clinical and imaging efficacy of CLIF-LP in the treatment of LSS patients with lumbar instability is not inferior to that of traditional transforaminal lumber interbody fusion (TLIF).
详细描述
At present, interbody fusion is the mainstream treatment for patients with lumbar spinal stenosis (LSS) and lumbar instability. However, the choice of interbody fusion for LSS patients with lumbar instability remains controversial. Recently, we developed crenel lateral interbody fusion combined with lateral plate fixation(CLIF - LP) for patients with LSS and lumbar instability. This surgical method has the advantages of direct view operation, "safe" psoas major approach, application of modified retractor, and lateral plate reinforcement, which not only significantly improves the postoperative lumbar function and nerve function of patients with LSS and lumbar instability, but also significantly reduces related complications, accelerates rehabilitation, and reduces the medical cost of patients.
Therefore, we propose the following hypothesis: The clinical and imaging efficacy of CLIF-LP in the treatment of LSS patients with lumbar instability is not inferior to that of traditional transforaminal lumber interbody fusion (TLIF).
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50-80 years old
- •Patients diagnosed with clinical symptoms of lumbar spinal stenosis, neurogenic intermittent claudication, the patient's walking ability is highly limited, and the quality of life is severely reduced
- •Imaging diagnosis of 1-2 LSS patients, consistent with clinical symptoms
- •Lumbar spine instability can be considered if one of the following three criteria is met: ① mechanical back pain with severe (VAS > 7) (pain aggravates with weight bearing). Radiographs of lumbar hyperextension and flexion show a slip of at least 3mm between the two vertebrae, or a rotation Angle of 11°. ③ Degenerative slip
- •Formal conservative treatment is ineffective for more than 3 months
- •No history of lumbar surgery
- •American College of Physicians ASA Grade I or II
- •Subjects voluntarily sign informed consent as subjects
排除标准
- •In patients with significant symptoms of lumbar radiculopathy, the pain from postural changes cannot be relieved
- •Bone stenosis, including developmental lumbar spinal stenosis
- •Free nucleus pulposus tissue into the spinal canal or cause spinal canal compression of the small joint cyst
- •Patients with hypertrophy of the yellow ligament or small joint cyst as the main pressure
- •Intervertebral space or posterior facet joints have fused
- •Infectious, traumatic and neoplastic diseases of the lumbar spine
- •Patients who are unable to undergo MRI
- •Some medical conditions, such as metabolic bone disease, autoimmune disease, poliomyelitis sequelae, osteoporosis, history of poor bone healing, and long-term oral steroids, were determined by the investigators to be unsuitable for inclusion in the study
- •Patients with evidence of neurological disorders (such as peripheral neuropathy), neuromuscular disorders (such as multiple sclerosis, Parkinson's disease, etc.), or systemic diseases (such as inflammatory arthritis) that affect bodily function
- •The patient has participated in other clinical trials in the past 3 months
- •Patients with poor adherence, judged by the researchers to be unable to complete the trial according to the study plan, such as schizophrenia and dementia, did not provide consent to volunteer to participate in the clinical study
结局指标
主要结局
Oswestry Disability index (ODI)
时间窗: 24 months after surgery
Lumbar function was assessed by the Oswestry Disability index (ODI) at 24 months after surgery. ODI includes 10 items, including waist and leg pain, personal life care, lifting heavy objects, walking, sitting, standing, sleeping, sexual life, social life, and whether you can travel freely. The total score is 50 points, and the lower the score, the better the function of the lumbar spine.
次要结局
- Visual analogue scale（VAS）(1 month, 3 months, 6 months, 12 months and 24 months after surgery)
- Japanese Orthopaedic Association (JOA)(1 month, 3 months, 6 months, 12 months and 24 months after surgery)
- EuroQoL-5D-5L(1 month, 3 months, 6 months, 12 months and 24 months after surgery)