gms | German Medical Science

Objective: The kyphoplasty is an established method for the treatment of osteoporotic vertebral body fractures. Recently lots of new devices were presented for optimizing such procedure. In our prospective study we compare three different devices – the Rapid Intro Osteointroducer^©, the Speed Track Osteointroducer^© and the Standard Vertebra Access^©.

Method: The first prospective randomized 40 patients were compared regarding the device, the operation time, the cement application, the intraoperative cement dislocation, the X-ray time, the X-ray irradiation, the follow-up and the complications.

Results: At this point 13 patients were included in the Rapid Intro^© group, 10 in the Speed Track^© group and 17 in the Standard Vertebra^© group. The median operation time was 29 minutes, without any significant differences between the devices. 57% of the surgeons, who operated with at least 2 of 3 devices, reached the shortest operation time with the Rapid Intro Osteointroducer^©. On average there was an application of 5 ml bone cement per vertebra body. In 4 cases there was an intraoperative cement dislocation. The X-ray irradiation was minimal with the Standard Vertebra Access^© Device (765.1 mGy). The follow-up was in median 12.6 weeks (range 1–53 weeks).

Conclusions: 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 Vertebra Access^©. Reasons could be a high number of different surgeons and different experiences with the new devices.