Sacral pedicle screw insertion accuracy with a navigated compared to a non-navigated screwdriver.

Not Applicable

Conditions: fracture
Spondylarthritis
spondylolisthesis
degenerative disc disease
spinal stenosis with instability
recurrent disc herniation requiring posterior stabilization
M80.08
M51.3
M48.09
M53.29

Registration Number: DRKS00022167

Lead Sponsor: eckar-Odenwald-Kliniken gGmbH, Standort Buchen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 106

Inclusion Criteria

procedures with PS insertions in thoracic/lumbar/sacral levels including S1 AND
-intraoperative 3D-fluoroscopy scan with the O-arm for navigational data acquisition AND
-3D-image guided PS insertion using the S7 StealthStation navigation unit AND
-visual control of final PS positions by 3D-fluoroscopy with the O-arm

Exclusion Criteria

-procedures with pedicle screw insertions in thoracic/lumbar/sacral levels without S1 OR
-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
WHAT: Assessment of PS insertion accuracies in S1 obtained with a navigated versus non-navigated screwdriver, and distribution of screw misplacement types (according to screw starting point, screw direction, screw insertion depth, screw length)<br>WHEN: intraoperatively after having completed pedicle screw placements <br>HOW: Evaluation of pedicle screw positions by post-instrumentation 3D-fluoroscopy control scan

Secondary Outcome Measures

Name	Time	Method
(1) Comparison of total procedural 3D- and 2D-radiation dose, 2D-fluoroscopy time, and 3D-radiation dose values per instrumented vertebral level to discern, whether investigated techniques were associated with relevant safety issues caused by significantly different amounts of applied procedure-related radiation doses.<br>(2) Comparison of level-adjusted 3D-radiation dose values of initial scans between study groups to clarify, whether respective PS accuracy rates in S1 were related to differences in navigational 3D-radiation doses, which have implications on image quality and could bias sacral accuracy results