跳至主要内容
临床试验/NCT04784923
NCT04784923Unknown不适用

Detecting Malposition of Trans-pedicle Screw From AP and LAT Plain Radiographs

Taipei Medical University0 个研究点目标入组 20 人开始时间: 2021年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
主要终点
Verify the position of pedicle screw on X-ray compared to that on CT's

研究概览

简要总结

Our study focuses on reducing the use of CT (Computer Tomography) for pedicle screw instrumentation, replacing CT with X-ray. We are writing a program to measure the position on X-ray seeing whether the position meets that on CT after operation. In the future,our method can be used in fluoroscopy, helping us detecting screw malposition efficiently during the surgeries, and hoping reduce complications.

详细描述

Most of the spine surgeries are decompression, fusion, with instrumentation.Instrumentation needs screws. Pedicle screws are often used. If the pedicle screws are mal-located, that is breaking the pedicle wall; the consequence may be injury of the spinal cord, or nerve root. Some lucky patients may have no symptom; however, broken pedicle will reduce the fixation strength which may reduce fusion rate.

Detecting malposition screws, currently we use CT (computer tomography) method. The surgeon carefully read the CT slice by slice, looking for clues of screws malposition. However, CT is costly both price and radiation dose.We invented a plain radiograph method which has been pilot tested in one patient with good correction rate. The purpose of this study is to solve the following two clinical problems:

  1. What are the inter-observer and intra-observer reliabilities of CT method?
  2. The radiation dose for CT method is too high. Does our plain radiograph method has the same correction rate? Materials and methods We planned to collect about 100 patients received spinal fusion and instrumentation who has preoperative CT(or MRI) and postoperative plain radiographs and CT. We will firstly verify CT method's reproducibility by interobserver and intra-observer reliability test. With the same databank, we will use our plain radiograph method again, and test if the two methods' results are the same by Chi-square test.

Conclusion:

We hope our study can reduce some unnecessary CT examination. In the future,our method can be used in fluoroscopy, helping us detecting screw malposition efficiently during the surgeries, and hoping reduce complications.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • s/p pedicle screw insertion surgery
  • good quality postoperative plain radiograph
  • good quality postoperative CT

排除标准

  • poor quality postoperative plain radiograph
  • poor quality postoperative CT

结局指标

主要结局

Verify the position of pedicle screw on X-ray compared to that on CT's

时间窗: 30 days

Investigators will verify CT method's reproducibility by interobserver and intra-observer reliability test. With the same databank, investigators will use the plain radiograph method again, and test if the two methods' results are the same by Chi-square test.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

相似试验