Efficacy of a Novel Vertebral Body Augmentation System in the Treatment of Patients with Symptomatic Vertebral Body Fractures

Abstract

Purpose To evaluate the safety and efficacy of a novel augmentation implant in the treatment of patients with symptomatic vertebral body fractures. Materials and Methods Thirty consecutive patients (seven males and 23 females), mean age of 70 years (range 56 to 89) with osteoporotic fractures and/or low-energy trauma fractures (osteoporosis confirmed by CT), were enrolled in an IRB-approved prospective study. The type of fracture was classified according to the Magerl classification. The patients were treated with the Tektona® dedicated vertebral body augmentation system. Visual analogue scale (VAS) and Oswestry Disability Index (ODI) scores were obtained after 1, 6 and 12 months. Quality of life was assessed with the SF36 score. Results A total of 37 vertebral bodies, mostly from T6 to L5, were treated in the 30 enrolled patients. In 67.6% of the cases (n = 25), lumbar fractures were treated. Most of the fractures (43%; n = 16) were A1.1 according to the Magerl classification. A significant pain reduction evaluated by VAS scores (p < 0.0001) was observed on average 7.6 (before the procedure) to 2.8 (immediately post-treatment), 2.1 and 2.7 (after 6 and 12 months later, respectively). The mean ODI score was 55.5% before treatment, and this was statistically significant reduced to 22.3% and 26.9%, respectively, at 6 and 12 months after treatment (p < 0.0001). The SF36 scores, both physical and mental components, showed statistically significant variations (p < 0.0001) whose direction was subpopulation dependent. Conclusion Patients with confirmed osteoporosis, suffering from symptomatic vertebral body fractures (osteoporotic and/or low-energy traumatic), were treated safely and effectively using this novel implant.

Bioactive graphene oxide-functionalized self-expandable hydrophilic and osteogenic nanocomposite for orthopaedic applications

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Schatzker 3 tibial plateau reduction and osteoplasty using Tektona® flexible lamella: a case report.

“…A new type of spinal kyphoplasty has been described using the Tektona® device and compared to the balloon, for the moment only in spine and cadavers [9,10]. The advantage of the Tektona® system lies in its unidirectional exible lamella which can be oriented several times to obtain a better control of the plateau uplifting (Fig.…”

Efficiency of a Novel Vertebral Body Augmentation System (Tektona™) in Non-osteoporotic Spinal Fractures

“…The rst one, by Krüger et al was a cadaveric study, comparing the Tektona® to a standard balloon kyphoplasty concluded to promising results [14]. Secondly, Marcia et al described a cohort of 30 patients, with encouraging results in terms of clinical scores and vertebral body height (VBH) restoration but only on a osteoporotic population [15]. Is the Tektona reliable in terms of sagittal correction on acute vertebral fractures?…”