earning Curve in 3D-Fluoroscopy Image-Guided Iliosacral/Transsacral Screw Insertion Procedures

Not Applicable

• Conditions: S32.1; Fracture of sacrum

• Registration Number: DRKS00024855
• Lead Sponsor: eckar-Odenwald-Kliniken gGmbH, Standort Buchen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-05-31
• Study Start: 2021-03-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

procedures with iliosacral and/or transsacral screw insertions AND
- intraoperative 3D-fluoroscopy scan with the O-arm for navigational data acquisition AND
- 3D-image guided screw insertion using the S7 StealthStation navigation unit AND
- visual control of final screw positions by 3D-fluoroscopy with the O-arm

Exclusion Criteria

- iliosacral/transsacral screw insertion without the use of 3D-image guidance OR
- use of pre-surgical CT scans for image-guided iliosacral/transsacral screw insertions OR
- omitting a final 3D-fluoroscopy scan with the O-arm for screw position control

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in screw insertion accuracy during learning curve (frequency of correctly placed screws inside the osseous corridor between neural foramina and spinal canal)

Secondary Outcome Measures

Name	Time	Method
(1) reduction of pre-operative time from patient positioning to skin incision<br>(2) reduction of surgical time per screw insertion<br>(3) reduction of total procedural (intraoperative) 3D-radiation dose