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临床试验/NCT04196153
NCT04196153Unknown不适用

A Comparison of Pedicle Screws Placement Accuracy in Thoracolumbar Spine Using Two Guidance Techniques: O-arm Navigation and Cervical Distractor Screws

King Abdullah International Medical Research Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年10月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Screw insertion time

研究概览

简要总结

Pedicle screw instrumentation is used nowadays mostly in spine fusion which is a surgical option for treating variety of conditions such as vertebral fractures, degenerative spine diseases, spine tumors and spine deformities. However, pedicle screws misplacement and breach may occur and be a great cause of morbidity. The breach rate can be as high as 20-39.8% but most of the time only small number is associated with complications. Surgeons use assistive technique to avoid screw breached and improve screw placement accuracy. Investigators aim in this study to compare accuracy of pedicle screws placement using two guidance techniques are O-arm navigation the latest assistive imaging technique that uses three-dimensional (3-D) real time images to allow the surgeons follow the screw's trajectory, and standard cervical distractor screws to mark the entry point and trajectory.

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 (Outcomes Assessor)

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

  • •Patients who need a thoracolumbar spine surgery that require pedicle screw insertion.

排除标准

  • •Patients whose surgeries in cervical spine
  • •Patients whose surgeries are for correction of deformities such as scoliosis and kyphosis, patients with infections or tumors.

研究组 & 干预措施

Neuronavigation / O-arm group

Active Comparator

Under neural navigation with the use of intraoperative three dimensional imaging quality O-arm , pedicle screws inserted at the thoraolumbar/lumbar spine after insertion of the reference frame at the spinous process above or below the level of instrumentation followed by O-Arm imaging and uploading the images to the stelth navigation system and pedicle tract identification using instrumented tools guided by the Navigation polyaxial screws is inserted.

干预措施: Pedicle screws instrumentation (Procedure)

Cervical distractor screws group

Active Comparator

pedicle screws inserted using marker screws after posterior exposure of thoracolumbar /lumbar spine by either open midline posterior exposure or minimal invasive posterior wiltse style exposure with expandable tubular retractor, anatomical landmark for insertion of pedical screws identified and followed by inserting of a cervical distraction screw size 3 / 12 mm as a stable marker using high speed drill. C-arm floro is used to take antroposterior and lateral view to confirm the position of the marker screws at this stage.free hand technique supported by the images provided to cannulate the pedicle with the use of information on the images taken for all the marker screws simultaneously.

干预措施: Pedicle screws instrumentation (Procedure)

结局指标

主要结局

Screw insertion time

时间窗: 5 hours

screw insertion time in each technique which will be assessed by calculating the total time from puncture at the entry point by awl to complete all screw insertions into pedicles divided by the number of pedicle screws

screws revision times

时间窗: 6 months

investigators will determine which group needs more screws revision

degree of screws breach

时间窗: 6 months

Investigators will determine degree of screws breach in the two comparison groups

Rate screws breach

时间窗: 6 months

Investigators will determine the rate of screws breach in the two comparison groups

次要结局

  • complications(Up to 24 weeks)
  • Direction of the breach(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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