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临床试验/DRKS00024825
DRKS00024825招募中不适用

Comparison of pedicle screw palcement accuracy in image-guided lumbosacral pedicle screw insertion procedures performed with dose-reduced standard 3D-fluoroscopy scans versus such with high density 3D-fluoroscopy scans - HDvsSTDScanPSInser

eckar-Odenwald-Kliniken gGmbH0 个研究点目标入组 500 人开始时间: 2023年6月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500

研究概览

简要总结

retrospective clinical study encompassing 548 lumbosacral image-guided procedures with 2190 inserted pedicle screws - a total of 904 pedicle screws were inserted using dose-reduced navigation scans below a threshold of 100 mGycm - 1286 pedicle screws were placed using high-density scans above 300 mGycm - no significant difference in pedicle screw insertion accuracy was found in the two groups (96.5%, and 94.7%, respectively, p˜0.11) - significantly lower 3D-radiation doses per scanned vertebral level were found in procedures using dose-reduced scans (22.78 versus 98.76 mGycm, p<0.00001)

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 100 Years(—)
性别
All

入选标准

  • procedures with pedicle screw insertion in lumbar and/or sacral levels AND
  • - intraoperative 3D-fluoroscopy scan with the O-arm for navigational data acquisition AND
  • - 3D-image guided pedicle screw insertion using the S7 StealthStation navigation unit AND
  • - visual control of final pedicle screw positions by 3D-fluoroscopy with the O-arm AND
  • - initial 3D-scan dose-length-product (DLP) below 100 mGycm (assignment to low-dose navigation scan group) OR
  • - initial 3D-scan DLP above 300 mGycm (assignment to high-dose navigation scan group)

排除标准

  • - procedures with pedicle screw insertions in cervical or thoracic levels OR
  • - pedicle screws inserted without 3D-image guidance OR
  • - use of pre-surgical CT scans for image-guided pedicle screw insertions OR
  • - omitting a final 3D-fluoroscopy scan with the O-arm for pedicle screw position control OR
  • - initial 3D-scan DLP thresholds between 100 mGycm and 300 mGycm

研究者

发起方
eckar-Odenwald-Kliniken gGmbH

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