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

Not Applicable

• Conditions: M93.9; T08.0; Osteochondropathy, unspecified

• Registration Number: DRKS00024827
• Lead Sponsor: eckar-Odenwald-Kliniken gGmbH, Standort Buchen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-01-31
• Study Start: 2021-03-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 668

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

- 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
identification of modes of pedicle screw misplacements in 3D-image-guided thoracic, lumbar, and sacral PS instrumentation procedures

Secondary Outcome Measures

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