Radiation exposure in dorsal instrumentation of the thoracolumbar spine using ultra-low radiation imaging with image enhancement software compared to conventional fluoroscopy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00037122

Enrollment

Registered

2025-06-05

Start date

2025-05-26

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

S22.0 S32.0

Interventions

Group 1: mFluoro = modified intraoperative fluoroscopy with ultra-low radiation imaging with image enhancement software Group 2: cFluoro = conventional intraoperative fluoroscopy

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with an indication for percutaneous dorsal instrumentation of the thoracic/ lumbar spine Written informed consent for the surgical procedure Written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: Patients with lack of capacity to give informed consent Intraoperative conversion from percutaneous to open surgical approach Patients for whom the following equipment is not fully available during the procedure: - Cios Spin C-arm with reference frame (Siemens) - PULSE platform with LessRay software (NuVasive) - Live dosimeter (Raysafe)

Design outcomes

Primary

Measure	Time frame
Radiation exposure for surgeon, assistant, OTA, determined by RaySafe live dosimeters (mGy) Radiation dose as dose area product (mGycm²) Fluoroscopy time (s)	—

Secondary

Measure	Time frame
Assessment of image quality in both groups by independet observers Accuracy of pedicle screw placement assessed by an independent observer in postoperative CT scans	—

Countries

Germany

Contacts

Public ContactSven Vetter

BG Klinik Ludwigshafen

sven.vetter@bgu-ludwigshafen.de+49621 6810 2000

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026