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Clinical Trials/DRKS00024825
DRKS00024825
Recruiting
Not Applicable

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 sites500 target enrollmentJune 13, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
M93.9
Sponsor
eckar-Odenwald-Kliniken gGmbH
Enrollment
500
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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)

Registry
who.int
Start Date
June 13, 2023
End Date
TBD
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
eckar-Odenwald-Kliniken gGmbH

Eligibility Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

  • \- 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

Outcomes

Primary Outcomes

Not specified

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