Unilateral Versus Bilateral Pedicle Screw Fixation for Lumbar Degenerative Diseases
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- fusion rate of the operated spine segment
研究概览
简要总结
Determining the treatment strategy for patients with degenerative diseases of the spine is extremely difficult, without an accurate understanding of the nature of stress distribution in the vertebral-motor segments of the spine, as well as biomechanical changes that are associated with degenerative diseases of the spine. In this clinical study, we want to compare the use of unilateral and bilateral transpedicular fixation for treating the patients with degenerative diseases of the lumbar spine.
详细描述
It is planned to use posterior stabilization without interbody fusion. In the postoperative period, all the patients receive antibacterial and analgesic therapy. The early postoperative period is spent in a hospital. Repeated appearances for control examinations (3, 6, 12 months) are provided for physical examination (EQ-5D, Oswestry Disability Index) and performing radiographs or computed tomography (CT) of the spine. All patients undergo a standard rehabilitation course.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent of the patient to participate in the study;
- •Patients with degenerative diseases of the lumbar spine.
- •The opportunity for observation during the entire study period (12 months);
- •Mental adequacy, ability, willingness to cooperate and follow the doctor's recommendations.
排除标准
- •The refusal of a patient from surgery
- •The presence of contraindications to surgery
- •Severe forms of diabetes (glycosylated hemoglobin >9%);
- •Blood diseases (thrombopenia, thrombocytopenia, anemia with Hb< 90g\l);
- •The unwillingness of the patient to conscious cooperation.
结局指标
主要结局
fusion rate of the operated spine segment
时间窗: in 12 months after surgery
Control CT/Radiography examination
次要结局
未报告次要终点