跳至主要内容
临床试验/NCT04353895
NCT04353895Unknown不适用

Fluoro-registered Mazor X Stealth Edition Versus O-arm Navigation: a State of the Art Technology Comparison for Pedicle Screw Insertion

P. D. Dr. med. Duccio BOSCHERINI2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
36
试验地点
2
主要终点
Pedicle screw accuracy

研究概览

简要总结

The investigators would like to investigate the fluoro-registered Mazor X Stealth in terms of pedicle screw accuracy and radiation exposure in comparison with the O-arm and navigation as the institutional gold standard.

详细描述

Pedicle screw insertion for spinal fusion is a surgical procedure regularly performed around the world. Surgeons use free-hand, navigation or robotic techniques. The navigation began in 1995 in spine surgery. Surgical navigation systems provide pedicle screw insertion by projecting screw trajectories on a three-dimensional (3D) image acquisition, preoperatively or during the surgical procedure. Laine et al reported better accuracy and safety in pedicle screw insertion using the navigation system. Other authors reported less irradiation with the use of computer-assisted navigation. Robotic guidance was introduced in 2006 and assists the surgeon through a mechanical guidance according to a planning of screw trajectories on 3D imaging. This technique allows stable guidance for pedicle drilling and screw insertion, leading to greater screw positioning in lumbar fusion.

Medtronic (Medtronic, Minneapolis, MN, USA) introduced the Mazor X Stealth in Europa in 2019, including the Mazor robotic device with the navigation technology within the same system. The hypothesis would be a combination of the stability of the robot during screw insertion and the accuracy of the navigation with cumulative benefit from the two techniques.

The goal of this study is to compare radiological and clinical results of the use of the new Mazor Stealth with the surgical O-arm navigation during pedicle screw insertion for posterior lumbar fusion.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

single-blind, only for the patient, after randomization

入排标准

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

入选标准

  • adult patients
  • who require pedicle screw insertion for vertebral posterior stabilization

排除标准

  • participants incapable of judgment
  • participants under tutelage
  • vertebral fusion indication without pedicle screw implantation
  • refusal to participate
  • data missing for radiation exposure calculation
  • unstable vertebral fracture requiring urgent fixation
  • pregnancy
  • refusal to participate

结局指标

主要结局

Pedicle screw accuracy

时间窗: Intraoperative

Usinge the Heary classification for thoracic screws and the Gertzbein classification for lumbar screws

次要结局

  • Radiation exposure(Intraoperative)

研究者

发起方
P. D. Dr. med. Duccio BOSCHERINI
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

P. D. Dr. med. Duccio BOSCHERINI

Director of the Neuro Orthopedic Center

Neuro Orthopedic Center

研究点 (2)

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