Safety and feasibility of a smart assistive bone-cement injection system: a cadaveric study.

BACKGROUND

Percutaneous vertebral augmentation is an effective and commonly surgical treatment for osteoporotic vertebral compression fractures, but the problem of bone cement leakage still cannot be prevented. It has been reported that cement leakage occurs in approximately 20% of vertebroplasty procedures, with symptomatic manifestations reported in 1.6% of cases. Leakage of bone cement into the spinal canal increases the risk for spinal cord compression and nerve injury. The objective of this study was to introduce a smart assistive device specifically designed to facilitate both cement injection control and operator protection.

METHODS

Two freshly frozen human cadaver specimens were used. The 2 cadaver specimens were divided according to injection method: manual (10 vertebrae, T8-L5); and motorized (10 vertebrae, T8-L5). Fluoroscopy time, cement time, volume injected, and cement distribution were recorded. Postoperative radiography and CT images were used to assess cement distribution in this cadaveric study.

RESULTS

The number of times intraoperative X-ray fluoroscopy was used for the manual injection group (6.7 ± 1.5) was significantly greater (P < 0.001) than that for the motorized injection group (4.1 ± 0.9). Mean cement time for the manual injection group (164.3 ± 18.7 s) was significantly greater (P < 0.001) than that for the motorized injection group (72.0 ± 7.2 s). There were no significant differences in the amount of cement injected in the manual vs. motorized injection group (5.2 ± 1.3 mL vs. 5.3 ± 1.0 mL; P = 0.878). Moreover, we found that leakage of cement outside the vertebral body was noted in 4 of 10 injected vertebrae (40%) in the manual injection group, whereas there was no bone cement leakage in the motorized injection group.

CONCLUSIONS

The system exhibited more precise control of the bone cement injection dosage and better cement distribution compared with traditional manual injection. In addition, the device provided remote activation, reducing the X-ray intake of the surgeon.