Stefano Marcia1, Emanuele Piras1, Joshua A Hirsch2, Alessio Mereu3, Mariangela Marras4, Alessio Spinelli1, Luca Saba5. 1. UOC of Radiology, Ospedale SS Trinità, ATS, Cagliari, Italy. 2. Neuroendovascular Program, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. 3. Department of Radiology, Azienda Ospedaliero Universitaria (A.O.U.), Di Cagliari, Polo di Monserrato s.s. 554 Monserrato, 09045, Cagliari, Italy. 4. UOC of Radiology, Ospedale Brotzu, AOB, Cagliari, Italy. 5. Department of Radiology, Azienda Ospedaliero Universitaria (A.O.U.), Di Cagliari, Polo di Monserrato s.s. 554 Monserrato, 09045, Cagliari, Italy. lucasaba@tiscali.it.
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.
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.
Entities:
Keywords:
Osteoporosis; Vertebral body augmentation; Vertebral body fractures
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