Impact of practical experience in navigated spinal procedures on improved thoracic, lumbar, and sacral image-guided pedicle screw insertion accuracy rates

Impact of practical experience in navigated spinal procedures on improved thoracic, lumbar, and sacral image-guided pedicle screw insertion accuracy rates - PrExNavPedScrI

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00024831

Enrollment

500

Registered

2021-03-19

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 T08.0 M51.3

Interventions

Group 1: 3D-image guided accuracy rates/pedicle screw misplacement rates/pedicle screw misplacement types during the first 400 thoracic, lumbar, and sacral pedicle screw insertions Group 2: 3D-image g

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: - pedicle screw insertions in thoracic, lumbar and/or sacral levels AND - performance of an initial intraoperative 3D-fluoroscopy scan with the O-arm AND - PS insertion using 3D-navigation with the S7 StealthStation navigation unit AND - performance of a final 3D-fluoroscopy scan with the O-arm for controlling PS positions

Exclusion criteria

Exclusion criteria: - non-navigated pedicle screw insertion OR - use of pre-operative CT scans for navigated pedicle screw insertion OR - no final 3D-fluoroscopy scan with the O-arm for controlling PS positions

Design outcomes

Primary

Measure	Time frame
Detecting differences in screw misplacement rates related to thoracic, lumbar, and sacral sections	—

Secondary

Measure	Time frame
Improvement of pedicle screw insertion accuracy after development of a pre-defined status of experience in performing navigated pedicle screw instrumentation procedures?	—

Countries

Germany

Contacts

Public ContactHorst Balling

Neckar-Odenwald-Kliniken gGmbH, Standort Buchen

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

Outcome results

None listed

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