跳至主要内容
临床试验/NCT04559399
NCT04559399Unknown不适用

Smiley Face Shaped Rod Technique Versus Instrumented Posteriolateral Fusion in Treatment of Isthmic Lumbar Spondylolisthesis

Assiut University0 个研究点目标入组 30 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
change pain

研究概览

简要总结

Aim of research is to investigates clinical, surgical and radiological outcome of vertebral pars intetarticularis repair by used smile face shape rod technique and bone grafting and comparing that with posteriolateral fusion with used traditional transpedical screw and rod fixation in management of isthmic spondylistheisis

详细描述

Isthmic spondylolisthesis is considered to represent a fatigue fracture of the pars interarticularis of the neural arch, The clinical symptom is activity-related back pain in young and athletic patients . The cause of Isthmic spondylolisthesis in these patients is repetitive stress of the pars interarticularis with subsequent microfracture, which in turn may lead to a bony defect and cause progressive spondylolisthesis in up to 25% of cases. Surgical intervention is indicated for patients who are not responsive despite adequate period of conservative management such as activity modification , physical therapy, and occasionally bracing .

Techniques for repair of a pars defect include Scott wiring , a Buck screw , a pedicle screw and hook , multiple segment fixations or a U-rod . After repair, radiographic healing rates range from 67 percent to 90 percent; asymptomatic and return to sports rates range from 80 percent to 90 percent.

These methods have achieved variable success .In Buck screw fusion surgery,it is not effect on flexion and axial rotation of the spine but bone healing is compromised.

Stabilization with wiring and titanium cable had less success rate than other methods and requires the use of lumbar brace or prolonged immobilization.

The pedicle screw-vertebral plate hook system may complicated by injury to the dural sac or nerves ensues.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age above 18 years old
  • failure of conservative treatment for 3months
  • fit for surgery

排除标准

  • age less than 18
  • Not fit for surgery
  • pathological fracture of pars
  • assosciated pathology like disc degeneration, spinal canal stenosis, spondylolisthesis grad 2,3and 4

结局指标

主要结局

change pain

时间窗: pain assess one week postoperation

assessment of pain change one week postoperation by using visual analog scale (AVS) and MacNabs chart to assess degree of change

radiological fusion of pars defect

时间窗: 6 month postoperative

using CT scan for fusion percentage assess at 6 month of postoperation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Najib Mohammed AL-shaea

Principal Investigator,assistant lecturer

Assiut University

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