The Vertect Jack Device: A new method for augmentation of vertebral fractures. Clinical study with comparisons to kyphoplasty.

Background: Kyphoplasty is a proven minimally invasive procedure for the treatment of patients with osteoporotic fractures. By augmentation of fractured vertebral body, however, a very large portion of the intervertebral structures will be destroyed. With the help of a new device (Vertect Jack Device), the erection of the vertebral body will be carried out more gentle.

Objective: In the present study, the new method should be clinically tested for efficacy and safety for the first time. As a comparison results of previous treatments with kyphoplasty were used.

Methods: For Vertect Jack Device study patients with painful vertebral fractures were selected in which conservative treatment had not yielded sufficient results. For comparison random data from the records of patients who had been treated with kyphoplasty were selected. The Vertect Jack Device was placed under the central fractures and then erected. After having restorted the vertebral height the device was removed and cement injected. Clinical and radiological examinations were carried out before and after 1,3, and 6 months.

Results: In the Vertect Jack Device Group the data of 40 patients were evaluated. For group 2 (kyphoplasty) 50 patients were selected. There was a significant difference in the duration of the surgery (Group 1: 27.4, Group 2: 45.9 minutes). A significant difference of 20 mm with regard to the reduction of VAS scores (0-100 mm pain intensity) was detected. Under the application of the Vertect Jack Device an average increase of 3.1 mm of vertebral height was achieved. In group 2, the erection averaged 0.4 mm. A correlation between the postoperative change of vertebral body height and VAS scores could not be detected in both groups.

Conclusions: The comparative analysis of this study shows that promising results can be achieved with the augmentation of vertebral fractures with the Vertect Jack Device. When compared with kyphoplasty, advantages show in terms of targeted and thus more gentle application possibility and better pain relief over a period of 6 months after surgery. Further study results should help to demonstrate the efficacy and tolerability of the new method.