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)
Investigators
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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