Specificity of 3D-image guided pedicle screw insertion inaccuracies for different surgeons (surgical fingerprint) and their effect on overall pedicle screw insertion accuracy rates

Specificity of 3D-image guided pedicle screw insertion inaccuracies for different surgeons (surgical fingerprint) and their effect on overall pedicle screw insertion accuracy rates - NavPSInsertionSurFinPri

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00024827

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

Interventions

Group 1: investigate modes of PS misplacements of surgeon #1 in 3D-image-guided thoracic, lumbar, and sacral PS instrumentation procedures Group 2: investigate modes of PS misplacements of surgeon #2

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: - procedures with pedicle screw insertion in thoracic, 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

Exclusion criteria

Exclusion criteria: - 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
identification of modes of pedicle screw misplacements in 3D-image-guided thoracic, lumbar, and sacral PS instrumentation procedures	—

Secondary

Measure	Time frame
characterization of preferred modes of pedicle screw misplacements (=surgical fingerprint) from participating surgeons in 3D-image-guided thoracic, lumbar, and sacral PS 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