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.
Keywords: Osteoporosis; Vertebral body augmentation; Vertebral body fractures.