Sacral pedicle screw insertion accuracy with a navigated compared to a non-navigated screwdriver.

Sacral pedicle screw insertion accuracy with a navigated compared to a non-navigated screwdriver. - Navi SD versus Conv SD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00022167

Enrollment

106

Registered

2020-06-15

Start date

2020-06-22

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

fracture

Interventions

Group 1: navigated posterior lumbosacral pedicle screw instrumentation using a navigated screwdriver Group 2: navigation-assisted posterior lumbosacral pedicle screw instrumentation using a non-naviga

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: - procedures with PS insertions in thoracic/lumbar/sacral levels including S1 AND - intraoperative 3D-fluoroscopy scan with the O-arm for navigational data acquisition AND - 3D-image guided PS insertion using the S7 StealthStation navigation unit AND - visual control of final PS positions by 3D-fluoroscopy with the O-arm

Exclusion criteria

Exclusion criteria: - procedures with pedicle screw insertions in thoracic/lumbar/sacral levels without S1 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

Design outcomes

Primary

Measure	Time frame
WHAT: Assessment of PS insertion accuracies in S1 obtained with a navigated versus non-navigated screwdriver, and distribution of screw misplacement types (according to screw starting point, screw direction, screw insertion depth, screw length) WHEN: intraoperatively after having completed pedicle screw placements HOW: Evaluation of pedicle screw positions by post-instrumentation 3D-fluoroscopy control scan	—

Measure

Time frame

WHAT: Assessment of PS insertion accuracies in S1 obtained with a navigated versus non-navigated screwdriver, and distribution of screw misplacement types (according to screw starting point, screw direction, screw insertion depth, screw length) WHEN: intraoperatively after having completed pedicle screw placements HOW: Evaluation of pedicle screw positions by post-instrumentation 3D-fluoroscopy control scan

—

Secondary

Measure	Time frame
(1) Comparison of total procedural 3D- and 2D-radiation dose, 2D-fluoroscopy time, and 3D-radiation dose values per instrumented vertebral level to discern, whether investigated techniques were associated with relevant safety issues caused by significantly different amounts of applied procedure-related radiation doses. (2) Comparison of level-adjusted 3D-radiation dose values of initial scans between study groups to clarify, whether respective PS accuracy rates in S1 were related to differences in navigational 3D-radiation doses, which have implications on image quality and could bias sacral accuracy results	—

Measure

Time frame

(1) Comparison of total procedural 3D- and 2D-radiation dose, 2D-fluoroscopy time, and 3D-radiation dose values per instrumented vertebral level to discern, whether investigated techniques were associated with relevant safety issues caused by significantly different amounts of applied procedure-related radiation doses. (2) Comparison of level-adjusted 3D-radiation dose values of initial scans between study groups to clarify, whether respective PS accuracy rates in S1 were related to differences in navigational 3D-radiation doses, which have implications on image quality and could bias sacral accuracy results

—

Countries

Germany

Contacts

Public ContactHorst Balling

Neckar-Odenwald-Kliniken gGmbH, Standort Buchen

horst.balling@neckar-odenwald-kliniken.de49 6281 29 5163

Outcome results

None listed

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