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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00024855
Enrollment
55
Registered
2021-03-22
Start date
2011-08-01
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

S32.1

Interventions

Group 1: screw insertion accuracy, mean preparation time, mean surgical time per screw inserted, and mean procedural 3D-radiation dose during the first 5 navigated iliosacral/transsacral screw inserti

Sponsors

Neckar-Odenwald-Kliniken gGmbH, Standort Buchen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
(1) reduction of pre-operative time from patient positioning to skin incision (2) reduction of surgical time per screw insertion (3) reduction of total procedural (intraoperative) 3D-radiation dose

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