Bone Cement Augmented Transpedicular Screw Fixation Versus Cannulated Screws Fixation in Osteoporotic Spine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Incidence of wound infection
研究概览
简要总结
This study aims to compare the clinical and radiological outcomes of bone-cement-augmented transpedicular screw fixation versus cannulated pedicle screw fixation in patients with osteoporotic spines requiring posterior instrumentation, with respect to implant stability (loosening/pull-out), pain relief, functional recovery, and complication rates.
详细描述
Osteoporosis of the spine presents a significant challenge in spine surgery, particularly when instrumentation is needed for stabilization. With declining bone mineral density, conventional pedicle screw purchase becomes unreliable, leading to increased rates of screw loosening, pull-out, and fixation failure.
A relevant development in instrumentation has been the use of cannulated pedicle screws, sometimes in combination with cement-injectable systems, designed to allow cement to flow through the screw to reinforce fixation. Such systems have shown improved implant stability and lower failure rates in osteoporotic bone compared with solid screws.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old.
- •Both sexes.
- •Patients with confirmed osteoporosis on dual-energy X-ray absorptiometry (DEXA) scan (T-score ≤ -2.5),
- •Patients presented with painful osteoporotic vertebral fractures, degenerative instability, or traumatic compression fractures.
- •Patients are unresponsive to conservative management and require surgical stabilization.
排除标准
- •Patients with healed or stable fractures respond to medical treatment.
- •Patients with uncontrolled coagulopathy, active spinal infections such as discitis or osteomyelitis.
- •Patients with spinal deformity exceeding thirty degrees, or vertebral body collapse greater than seventy percent.
结局指标
主要结局
Incidence of wound infection
时间窗: 6 months post-procedure
Incidence of wound infection will be recorded.
次要结局
- Incidence of complication rates(6 months post-procedure)
研究者
Ahmed Anas Zahra
Lecturer of Neurosurgery, Faculty of Medicine, KafrElsheikh University, KafrElsheikh, Egypt.
Kafrelsheikh University