S32.0 S22.0
Conditions
Interventions
Group 1: Intraoperative fluoroscopy is performed using modified intraoperative fluoroscopy using ultra-low radiation imaging with image enhancement (LessRay) (mFluoro). The total duration of the inter
Sponsors
BG Klinik Ludwigshafen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with an indication for cement-augmented dorsal instrumentation of the thoracic and lumbar spine Written informed consent for the surgery has been obtained Written informed consent for participation in this study has been obtained
Exclusion criteria
Exclusion criteria: Patients who lack the capacity to provide informed consent or to understand the nature of the study Surgeries in which the following devices are not available: - Cios Spin C-arm equipped with a reference array (Siemens) - PULSE platform with LessRay software (NuVasive) - Live dosimeter (RaySafe)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the individual radiation exposure of the operator during a single surgical procedure, measured in milligray (mGy). The measurement is performed continuously throughout each procedure and documented after its completion. Data are collected using a real-time dosimeter (RaySafe Live dosimeter), which is worn above the lead apron. | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiation exposure of assistent and scrub nurse measured in mGy using real-time dosimetry Dose area product (mGycm²) Fluoroscopy time (s) Assessment of image quality in the two groups by independent observers Assessment of the position of the pedicle screws in postoperative CT by an independent observer | — |
Countries
Germany
Contacts
Public ContactSven Vetter
BG Klinik Ludwigshafen
Outcome results
None listed