Ultrasound-guided Jamshidi needle puncture to reduce radiation exposure during percutaneous pedicle screw placement: study protocol for a randomised controlled trial

INTRODUCTION: Percutaneous pedicle screw placement (PPSP) is a minimally invasive procedure highly dependent on fluoroscopic guidance, which results in increased radiation exposure and prolonged operative time. Ultrasound can image the lumbar paravertebral anatomy and the needle trajectory in real time, which may help reduce the use of fluoroscopy and radiation dose in PPSP. We will conduct a parallel randomised controlled trial to mainly investigate the effect of ultrasound guidance in radiation reduction during PPSP. METHODS AND ANALYSIS: A total of 42 patients will be recruited and randomly assigned to the intervention group and the control group at a 1:1 ratio. In the intervention group, we will use ultrasound in combination with fluoroscopy to guide the insertion of the Jamshidi needles. In the control group, PPSP will be performed under conventional fluoroscopic guidance. The primary outcomes are the cumulative fluoroscopy time (s), radiation dose (mGy) and exposure times of screw placement. The secondary outcomes are insertion time of guidewire, rate of pedicle perforation, rate of facet joint violation, visual analogue scale for back pain, Oswestry Disability Index and complications. The participants, outcome assessors and data analysts will be blinded to allocation. ETHICS AND DISSEMINATION: The trial was approved by the research ethics committee of Shengjing Hospital, China Medical University. The results will be presented at academic seminars and submitted for publication in peer-reviewed journals. This study involves human participants and was approved by Research Ethics Committee of Shengjing Hospital, China Medical University reference number：2022PS704K. Participants gave informed consent to participate in the study before taking part. TRIAL REGISTRATION NUMBER: ChiCTR2200057131.