Study design: Prospective cohort study.
Objectives: The purpose of this prospective study was to evaluate a protocol for radiation-sparing kyphoplasty by assessing dosemetrically recorded radiation exposures to both patient and surgeon.
Methods: This prospective clinical study examines the radiation exposure to patient and surgeon during single-level kyphoplasty in 32 thoracolumbar osteoporotic vertebral body fractures (12 OF 2, 9 OF 3, 11 OF 4 types) using a radiation aware surgical protocol between May 2017 and November 2019. The radiation exposure was measured at different locations using film, eye lens and ring dosemeters. Dose values are reported under consideration of lower detection limits of each dosemeter type.
Results: A high proportion of dosemeter readings was below the lower detection limits, especially for the surgeon (>90%). Radiation exposure to the surgeon was highest at the unprotected thyroid gland (0.053 ± 0.047 mSv), however only slightly above the lower detection limit of dosemeters (0.044 mSv). Radiation exposure to the patient was highest at the chest (0.349 ± 0.414 mSv) and the gonad (0.186 ± 0.262 mSv). Fluoroscopy time, dose area product and number of fluoroscopic images were 46.0 ± 17.9 sec, 124 ± 109 cGy×cm2, and 35 ± 13 per kyphoplasty, respectively. Back pain significantly improved from 6.8 ± 1.6 to 2.5 ± 1.7 on the numeric rating scale on the first postoperative day (P < 0.0001).
Conclusions: The implementation of a strict intraoperative radiation protection protocol allows for safely performed kyphoplasty with ultra-low radiation exposure for the patient and surgeon without exceeding the annual occupational dose limits.
Trial registration: The study was registered in the German Clinical Trials Register (DRKS00011908, registration date 16/05/2017).
Keywords: X-ray; cement augmentation; dosemetric; dosimetry; fluoroscopy; kyphoplasty; minimally invasive; occupational limit; radiation exposure; vertebroplasty.