gms | German Medical Science

Objective: Since 1998 the kyphoplasty has been an established method to treat osteoporotic vertebral body fractures. Recently, lots of new devices have been presented to optimize this procedure. In our study we compare one device (ST - standard), which is most common in clinical use, with two new kyphoplasty devices (N1 – new one; N2 – new two). The advantage of both new devices is a reduction of intraoperative working steps.

Methods: Ninety patients were prospectively randomized and compared regarding the device, operation time, cement application, intraoperative cement dislocation, X-ray time, radiation dose, follow-up and complications.

Results: In every device group 30 patients were included. 57 patients (63.3%) were female. Median time of operation was 30 minutes with a minimal radiation dose in the standard device (853 mGy). Regarding the operation time (ST = 32 min; N1 = 29 min; N2 = 30 min) and the radiation dose (ST = 853 mGy; N1 = 907 mGy; N2 = 920 mGy) significant differences were not detected between the three different groups. On average 5 ml bone cement were applied per fractured vertebra body. In 8 cases an intraoperative cement dislocation was determined without any clinically relevance. At this moment the median follow-up is 10 months.

Conclusion: Despite a reduction of working steps and a subjective shorter operation time, there is no objective advantage for the new devices in comparison to the standard device. Reasons could be a high number of different surgeons in our study and different experiences with the new devices. Also the bone density and the level of kyphoplasty seem to influence the operation time.