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

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.

PROPHYLACTIC OF STRESS FRACTURES OF VERTEBRAE ADJACENT TO TRANSPEDICULAR SCREW FIXATION FOR OSTEOPOROSIS

ABSTRACT Objective: To assess the efficacy and use of vertebroplasty as a prophylactic measure to prevent stress fractures of vertebrae adjacent to transpedicular screw fixation with augmentation for osteoporosis. Methods: An experimental cadaveric study was performed to assess the overall strength of 10 cadaveric blocks of T10-L4 vertebral segments with simulation of L1 fracture and T12-L2 transpedicular 4-screw system with augmentation. T11 and L2 vertebroplasty cranial and caudal to the transpedicular system was performed in 5 blocks in the main group. Stress testing of the blocks was performed by placing them under a vertically directed load until destruction. Results: Vertically directed load on the blocks in the main group (0.84 ± 0.39831 kN) resulted in T11 vertebrae fractures. Vertebrae with augmentation were resistant to the load in the main group. T10 vertebrae fractures in the blocks of the main group occurred at a load of 1.91 ± 0.40566 kN. Conclusion: 1. The adjacent T11 vertebra is the weakest vertebra in the anatomical blocks of T10-L4 vertebral segments with simulation of L1 fracture (type A according to the AO/Magerl classification) and the T12-L2 4-screw transpedicular system with augmentation. 2. Bone cement injection into the T11 cranial vertebra adjacent to the level of fixation increases the overall strength of the blocks 3. Vertebroplasty of the overlying vertebra is an effective way to prevent its fracture and in case of osteoporosis. 4. Prophylactic vertebroplasty of the vertebra caudal to the level of fixation is unnecessary due to the insignificant risk of a fracture. Level of Evidence III; Experimental – Quasi experiments

COMPARATIVE ANALYSIS OF TWO CLASSIFICATION SYSTEMS OF THORACOLUMBAR SPINE FRACTURES

ABSTRACT Objective: To evaluate the reproducibility and the interobserver coefficient of concordance between the AO/Magerl and AOSpine classifications for thoracolumbar spine fractures. Methods: Retrospective study of radiographic data analysis. Data were collected from 31 radiographic studies of patients with thoracolumbar spine fracture and distributed to a team involving spinal surgeons and residents. The fractures were classified according to the AO/Magerl and AOSpine classifications. Statistical analysis was performed using the Cohen Kappa test to assess the coefficient of concordance. Results: The Kappa value for interobserver concordance of AO/Magerl classification was κ = 0.70 and standard deviation was 0.16. For the AOSpine classification, we observed κ = 0.76, both with significance level α = 0.05 and P<0.001. Conclusions: We conclude that the interobserver concordance of the new AOSpine classification is similar to the AO/Magerl classification. This conclusion reinforces the reproducibility of the new AOSpine classification. Level of evidence: IV,Type of Study: Case series.