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

Not Applicable

• Conditions: M93.9; T08.0; M51.3; Osteochondropathy, unspecified; Other specified intervertebral disc degeneration

• Registration Number: DRKS00024831
• Lead Sponsor: eckar-Odenwald-Kliniken gGmbH, Standort Buchen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-12-31
• Study Start: 2021-03-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 669

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

- 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detecting differences in screw misplacement rates related to thoracic, lumbar, and sacral sections

Secondary Outcome Measures

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