Pathologies requiring anterior spinal fusion with disc replacement at L1–L5.
Conditions
Interventions
Group 1: Ventral spondylodesis using a fully motorized C-arm
Group 2: Ventral spondylodesis using a non-motorized C-arm
Sponsors
BG Klinik Ludwigshafen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients with an indication for anterior spinal fusion with disc replacement in the lumbar spine (L1–L5) - Written informed consent for the surgical procedure - Written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: - Patients with impaired or questionable capacity to provide informed consent - Patients in whom, during the surgical procedure, the availability of the following devices is limited: non-motorized C-arm Cios Spin / motorized C-arm Ciartic Move (Siemens) / live dosimeter (Raysafe)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the radiation exposure of the operating room personnel (surgeon, assistant, scrub nurse, circulating nurse) in microsieverts (µSv), measured during each procedure over the entire duration of the surgery using personalized live dosimeters worn at sternal level above the lead apron. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Radiation exposure for the patient based on the dose-area product (DAP) of the C-arm in mGy*cm² - Surgery duration based on intraoperative documentation in minutes - Workload of the surgical team assessed using the validated SURG-Task Load Index questionnaire | — |
Countries
Germany
Contacts
Public ContactSven Y. Vetter
BG Klinik Ludwigshafen
Outcome results
None listed