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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00024825

Enrollment

500

Registered

2023-06-13

Start date

2011-02-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M93.9 S32.00

Interventions

Group 1: image-guided lumbosacral pedicle screw insertion procedures with a total procedural 3D-scan dose below 100 mGycm Group 2: image-guided lumbosacral pedicle screw insertion procedures with a to

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
pedicle screw insertion accuracy rates	—

Secondary

Measure	Time frame
- initial 3D-scan dose - procedural total 3D-scan dose - 3D-fluoroscopy dose per instrumented vertebral level	—

Countries

Germany

Contacts

Public ContactHorst Balling

Neckar-Odenwald-Kliniken gGmbH

horst.balling@neckar-odenwald-kliniken.de49 6281 29 0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026