Introduction: Osteoporotic and neoplastic vertebral compression fractures (VCF) are common and painful. In the U.S., there are more than 1.5 million vertebral fractures annually and 40% of those over the age of 80 will experience this pathology, threatening quality of life and increasing morbidity and mortality. Kyphoplasty is a minimally invasive surgery to stabilize the fracture and recent EVOLVE analysis demonstrated minimal improvement in kypohotic angulation or vertebral body height, however, patients demonstrated significant improvements in pain, disability, quality of life and overall health.

Methods: Prospective, multicenter 12-month clinical study of outcomes pertaining to activities of daily living, pain, quality of life, and safety parameters in a Medicare-eligible population treated with kyphoplasty for painful acute or subacute VCFs associated with osteoporosis or cancer.

Results: NRS back pain improved from 8.7 (scale 0-10) by 5.2, 5.4, 6.0, 6.2 and 6.3 points, at the 7-day, and the 1, 3, 6 and 12-month time points, respectively. ODI improved from 63.4 (scale 0-100) by 30.5, 35.3, 36.3 and 36.2 points, at the 1, 3, 6 and 12-month time points, respectively. The SF-36 PCS was 24.2 at baseline (scale 0-100) and improved 10.7, 12.4, 13.4 and 13.8 points, at 1, 3, 6 and 12 months. The EQ-5D was 0.383 points (scale 0-1) and improved 0.316, 0.351, 0.356 and 0.358 points, at 1, 3, 6 and 12 months. All measures were statistically significant with p< 0.001 at every time point. Despite these significant improvements in pain, disability, qulity of life and overall health, there were only modest, but significant improvements in kyphotic angulation (1.1° improvement) and vertebral body height (4% improvement).

Conclusions: This large, prospective, multicenter study trial demonstrates that utilization of kyphoplasty for vertebral compression fractures provides significant improvements in pain, disability, quality of life, and overall health despite modest improvements in kyphotic angulation and vertebral body height in Medicare-eligible patients.

Patient Care: This is the largest prospective outcomes trial to date utilizing balloon kyphoplasty in vertebral compression fractures. This is also an older patient population that is more likely to be seen in clinics than previous trials. Sustained improvements in quality of life, disability, pain, and overall health were noted despite minimal improvements in kyphotic angulation and vertebral body height restoration. This is important information for patients and those who perform this procedure.

Learning Objectives: By the conclusion of this session, participants should be able to: 1)Describe the results of the largest outcomes trial for balloon kyphoplasty in medicare-eligible patients with vertebral fractures, 2) Put this data in context of minimal improvements in kyphotic angulation and vertebral body height restoration, 3) Discuss how many benefits of balloon kyphoplasty may not be due to kyphotic angulation correction or vertebral height restoration.

References: 1. Lindsay, R., et al., Risk of new vertebral fracture in the year following a fracture. Jama, 2001. 285(3): p. 320-3. 2. Dawson-Hughes, B., et al., Implications of absolute fracture risk assessment for osteoporosis practice guidelines in the USA. Osteoporos Int, 2008. 19(4): p. 449-58. 3. Baaj, A.A., et al., Trends in the treatment of lumbar spine fractures in the United States: a socioeconomics perspective: clinical article. J Neurosurg Spine, 2011. 15(4): p. 367-70. 4. Barr, J.D., et al., Percutaneous vertebroplasty for pain relief and spinal stabilization. Spine (Phila Pa 1976), 2000. 25(8): p. 923-8. 5. Black, D.M., et al., Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet, 1996. 348(9041): p. 1535-41. 6. Babayev, M., E. Lachmann, and W. Nagler, The controversy surrounding sacral insufficiency fractures: to ambulate or not to ambulate? Am J Phys Med Rehabil, 2000. 79(4): p. 404-9. 7. Berenson, J., et al., Balloon kyphoplasty versus non-surgical fracture management for treatment of painful vertebral body compression fractures in patients with cancer: a multicentre, randomised controlled trial. Lancet Oncol, 2011. 12(3): p. 225-35. 8. Edidin, A.A., et al., Morbidity and Mortality After Vertebral Fractures: Comparison of Vertebral Augmentation and Nonoperative Management in the Medicare Population. Spine (Phila Pa 1976), 2015. 40(15): p. 1228-41. 9. Lau, E., et al., Mortality following the diagnosis of a vertebral compression fracture in the Medicare population. J Bone Joint Surg Am, 2008. 90(7): p. 1479-86. 10. Cauley, J.A., et al., Risk of mortality following clinical fractures. Osteoporos Int, 2000. 11(7): p. 556-61. 11. Chen, A.T., D.B. Cohen, and R.L. Skolasky, Impact of nonoperative treatment, vertebroplasty, and kyphoplasty on survival and morbidity after vertebral compression fracture in the medicare population. J Bone Joint Surg Am, 2013. 95(19): p. 1729-36. 12. Edidin, A.A., et al., Mortality risk for operated and nonoperated vertebral fracture patients in the medicare population. J Bone Miner Res, 2011. 26(7): p. 1617-26. 13. Lange, A., et al., Survival and Cost Comparison of Kyphoplasty and Percutaneous Vertebroplasty Using German Claims Data. Spine, 2013. 14. Zampini, J.M., A.P. White, and K.J. McGuire, Comparison of 5766 vertebral compression fractures treated with or without kyphoplasty. Clin Orthop Relat Res, 2010. 468(7): p. 1773-80. 15. Boonen, S., et al., Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial. J Bone Miner Res, 2011. 26(7): p. 1627-37. 16. Van Meirhaeghe, J., et al., A randomized trial of balloon kyphoplasty and non-surgical management for treating acute vertebral compression fractures: vertebral body kyphosis correction and surgical parameters. Spine, 2013. 38(12): p. 971-983. 17. Wardlaw, D., et al., Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet, 2009. 373(9668): p. 1016-24. 18. Nevitt, M.C., et al., Effect of alendronate on limited-activity days and bed-disability days caused by back pain in postmenopausal women with existing vertebral fractures. Fracture Intervention Trial Research Group. Arch Intern Med, 2000. 160(1): p. 77-85. 19. Mahoney, F.I. and D.W. Barthel, Functional Evaluation: The Barthel Index. Md State Med J, 1965. 14: p. 61-5. 20. Yates, J.W., B. Chalmer, and F.P. McKegney, Evaluation of patients with advanced cancer using the Karnofsky performance status. Cancer, 1980. 45(8): p. 2220-4. 21. Eastell, R., et al., Classification of vertebral fractures. J Bone Miner Res, 1991. 6(3): p. 207-215. 22. Genant, H.K., et al., Vertebral fracture assessment using a semiquantitative technique. J Bone Miner Res, 1993. 8(9): p. 1137-48. 23. MedDRA term selection: Points to consider. ICH endorsed guide for MedDRA users. Release 4.2, Based on MedDRA Version 14.1, October 2011. [cited 2014 September 16]; Available from: http://www.meddra.org/sites/default/files/guidance/file/9491-1410_termselptc_r4_2_sep2011.pdf. 24. Burge, R., et al., Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. J Bone Miner Res, 2007. 22(3): p. 465-75. 25. Copay, A.G., et al., The minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and Pain Scales. Spine J, 2008. 8(6): p. 968-974. 26. Farrar, J.T., et al., Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain, 2001. 94(2): p. 149-58. 27. Fairbank, J.C. and P.B. Pynsent, The Oswestry Disability Index. Spine, 2000. 25(22): p. 2940-52. 28. Walters, S.J. and J.E. Brazier, Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res, 2005. 14(6): p. 1523-32. 29. Pfeifer, M., B. Begerow, and H.W. Minne, Effects of a new spinal orthosis on posture, trunk strength, and quality of life in women with postmenopausal osteoporosis: a randomized trial. Am J Phys Med Rehabil, 2004. 83(3): p. 177-86. 30. Tseng, Y.Y., et al., Prospective comparison of the therapeutic effect of teriparatide with that of combined vertebroplasty with antiresorptive agents for the treatment of new-onset adjacent vertebral compression fracture after percutaneous vertebroplasty. Osteoporos Int, 2012. 23(5): p. 1613-22. 31. Bolland, M.J., et al., Effect of osteoporosis treatment on mortality: a meta-analysis. J Clin Endocrinol Metab, 2010. 95(3): p. 1174-81. 32. Stein, C.M. and W.A. Ray, The ethics of placebo in studies with fracture end points in osteoporosis. N Engl J Med, 2010. 363(14): p. 1367-70; discussion e21. 33. Dickman, C.A., et al., Transpedicular screw-rod fixation of the lumbar spine: operative technique and outcome in 104 cases. J Neurosurg, 1992. 77(6): p. 860-70. 34. Fitzpatrick, S.K., et al., The effect of osteoporosis on outcomes of operatively treated distal radius fractures. J Hand Surg Am, 2012. 37(10): p. 2027-34. 35. Shapiro, S., T. Abel, and S. Purvines, Surgical removal of epidural and intradural polymethylmethacrylate extravasation complicating percutaneous vertebroplasty for an osteoporotic lumbar compression fracture. Case report. J Neurosurg, 2003. 98(1 Suppl): p. 90-2. 36. Bernhard, J., P.F. Heini, and P.M. Villiger, Asymptomatic diffuse pulmonary embolism caused by acrylic cement: an unusual complication of percutaneous vertebroplasty. Ann Rheum Dis, 2003. 62(1): p. 85-6. 37. Choe, D.H., et al., Pulmonary embolism of polymethyl methacrylate during percutaneous vertebroplasty and kyphoplasty. AJR Am J Roentgenol, 2004. 183(4): p. 1097-102. 38. Duran, C., et al., Pulmonary cement embolism: a complication of percutaneous vertebroplasty. Acta Radiol, 2007. 48(8): p. 854-9. 39. Papanastassiou, I.D., et al., Comparing effects of kyphoplasty, vertebroplasty, and non-surgical management in a systematic review of randomized and non-randomized controlled studies. Eur Spine J, 2012. 21: p. 1826-43. 40. Yi, X., et al., Recompression in new levels after percutaneous vertebroplasty and kyphoplasty compared with conservative treatment. Arch Orthop Trauma Surg, 2014. 134(1): p. 21-30. 41. Uppin, A.A., et al., Occurrence of new vertebral body fracture after percutaneous vertebroplasty in patients with osteoporosis. Radiology, 2003. 226(1): p. 119-24. 42. Silverman, S.L., et al., The relationship of health-related quality of life to prevalent and incident vertebral fractures in postmenopausal women with osteoporosis: results from the Multiple Outcomes of Raloxifene Evaluation Study. Arthritis Rheum., 2001. 44(11): p. 2611-2619. 43. Van Meirhaeghe, J., et al., A randomized trial of balloon kyphoplasty and nonsurgical management for treating acute vertebral compression fractures: vertebral body kyphosis correction and surgical parameters. Spine (Phila Pa 1976), 2013. 38(12): p. 971-83. 44. Bastian, L., et al., A randomized trial comparing 2 techniques of balloon kyphoplasty and curette use for obtaining vertebral body height restoration and angular-deformity correction in vertebral compression fractures due to osteoporosis. AJNR Am J Neuroradiol, 2013. 34(3): p. 666-75. 45. Dohm, M., et al., A randomized trial comparing balloon kyphoplasty and vertebroplasty for vertebral compression fractures due to osteoporosis. AJNR Am J Neuroradiol, 2014. 35(12): p. 2227-36.