Preliminary clinical evaluation of a remote controlled injection manipulator system in preventing radiation exposure to the operator during vertebroplasty

YAN Jun; YANG Zhi-ping; ZHENG Yan-ping; LI Xin; LI Zhen-feng; YANG Qiang; LI Jian-min

doi:10.3969/j.issn.2095-252X.2014.12.015

Abstract：Objective To preliminarily assess the clinical application value of a novel remote controlled injection manipulator ( RCIM ) system in preventing radiation exposure to the operator during vertebroplasty for the patients with spinal metastases. Methods From June 2012 to July 2013, 20 patients ( 30 vertebral bodies ) with spinal metastases underwent vertebroplasty, who were randomly assigned to 2 groups. In manual group 10 patients ( 16 vertebral bodies ) underwent conventional vertebroplasty, and in RCIM group 10 patients ( 14 vertebral bodies ) received vertebroplasty assisted by the RCIM system. During the bone cement delivery process that was monitored by the X-ray, the operator in RCIM group kept far away from the operating field, who completed the operation under the shield and avoided the radiation exposure. The preoperative and postoperative visual analogue scale ( VAS ) scores were recorded in all the patients, and the digital dosimeter was used to estimate the radiation dose to the patient and operator. Results The preoperative and postoperative VAS scores were 8.3±1.0 points and 4.6±0.9 points respectively in manual group, and there were statistically significant differences between them ( P=0.000 ). The preoperative and postoperative VAS scores were 7.6±1.1 points and 4.1±0.8 points respectively in RCIM group, and there were statistically signiifcant differences between them ( P=0.000 ). No statistically signiifcant differences existed in the preoperative and postoperative VAS scores between the 2 groups ( P>0.05 ). The radiation doses to the patient were ( 32.4±12.1 ) uSv and ( 35.1±11.7 ) uSv in manual group and RCIM group respectively, and there were not statistically signiifcant differences between them ( P>0.05 ). The radiation doses to the operator were ( 28.9±15.2 )uSv and ( 0.29±0.014 ) uSv in manual group and RCIM group respectively, and there were not statistically signiifcant differences between them ( P>0.05 ). The radiation dose in manual group was signiifcantly higher than that in RCIM group, and there were statistically signiifcant differences between them ( P<0.05 ). Conclusions This RCIM system offers a promising alternative to the traditional bone cement injection devices, in that it can keep the operator and patient out of the harmful radiation exposure during the procedure of bone cement injection in vertebroplasty. And meanwhile, the safety is increased because of the full intraoperative X-ray monitoring.