Prospective and Multicenter Evaluation of Outcomes for Quality of Life and Activities of Daily Living for Balloon Kyphoplasty in the Treatment of Vertebral Compression Fractures: The EVOLVE Trial
Douglas P Beall, M R Chambers, Sam Thomas, John Amburgy, James R Webb Jr, Bradly S Goodman, Devin K Datta, Richard W Easton, Douglas Linville 2nd, Sanjay Talati, John B Tillman, Douglas P Beall, M R Chambers, Sam Thomas, John Amburgy, James R Webb Jr, Bradly S Goodman, Devin K Datta, Richard W Easton, Douglas Linville 2nd, Sanjay Talati, John B Tillman
Abstract
Background: Osteoporotic and neoplastic vertebral compression fractures (VCF) are common and painful, threatening quality of life and increasing risk of morbidity and mortality. Balloon kyphoplasty is a percutaneous option for treating painful cancer- and osteoporosis-related VCFs, supported by 2 randomized trials demonstrating efficacy benefits of BKP over nonsurgical care.
Objective: To investigate 12-mo disability, quality of life, and safety outcomes specifically in a Medicare-eligible population, representing characteristic patients seen in routine clinical practice.
Methods: A total of 354 patients with painful VCFs were enrolled at 24 US sites with 350 undergoing kyphoplasty. Four coprimary endpoints-Numerical Rating Scale (NRS) back pain, Oswestry Disability Index (ODI), Short Form-36 Questionnaire Physical Component Summary (SF-36v2 PCS), EuroQol-5-Domain (EQ-5D)-were evaluated for statistically significant improvement 3 mo after kyphoplasty. Data were collected at baseline, 7 d, and 1, 3, 6, and 12 mo (www.clinicaltrials.gov registration NCT01871519).
Results: At the 3-mo primary endpoint, NRS improved from 8.7 to 2.7 and ODI improved from 63.4 to 27.1; SF-36 PCS was 24.2 at baseline improving to 36.6, and EQ-5D improved from 0.383 to 0.746 (P < .001 for each). These outcomes were statistically significant at every follow-up time point. Five device-/procedure-related adverse events, intraoperative asymptomatic balloon rupture, rib pain, and aspiration pneumonia, and a new VCF 25 d postprocedure, and myocardial infarction 105 d postprocedure were reported and each resolved with proper treatment.
Conclusion: This large, prospective, clinical study demonstrates that kyphoplasty is a safe, effective, and durable procedure for treating patients with painful VCF due to osteoporosis or cancer.
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References
- Chen AT, Cohen DB, Skolasky RL. 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):1729-1736.
- Zampini JM, White AP, McGuire KJ. Comparison of 5766 vertebral compression fractures treated with or without kyphoplasty. Clin Orthop Relat Res. 2010;468(7):1773-1780.
- Edidin AA, Ong KL, Lau E, Kurtz SM. Morbidity and mortality after vertebral fractures. Spine. 2015;40(15):1228-1241.
- Lange A, Kasperk C, Alvares L, Sauermann S, Braun S. Survival and cost comparison of kyphoplasty and percutaneous vertebroplasty using German claims data. Spine. 2014;39(4):318-326.
- Silverman S. The clinical consequences of vertebral compression fracture. Bone. 1992;13Suppl 2:S27-S31.
- Ong KL, Beall DP, Frohbergh M, Lau E, Hirsch JA. Were VCF patients at higher risk of mortality following the 2009 publication of the vertebroplasty “sham” trials? Osteoporos Int. 2018;29(2):375-383.
- Baaj AA, Downes K, Vaccaro AR, Uribe JS, Vale FL. Trends in the treatment of lumbar spine fractures in the United States: a socioeconomics perspective. J Neurosurg Spine. 2011;15(4):367-370.
- Ballane G, Cauley JA, Luckey MM, El-Hajj Fuleihan G. Worldwide prevalence and incidence of osteoporotic vertebral fractures. Osteoporos Int. 2017;28(5):1531-1542.
- Lindsay R, Silverman SL, Cooper C et al. . Risk of new vertebral fracture in the year following a fracture. JAMA. 2001;285(3):320-323.
- Saad F, Lipton A, Cook R, Chen YM, Smith M, Coleman R. Pathologic fractures correlate with reduced survival in patients with malignant bone disease. Cancer. 2007;110(8):1860-1867.
- Boonen S, Van Meirhaeghe J, Bastian L 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):1627-1637.
- Van Meirhaeghe J, Bastian L, Boonen S, Ranstam J, Tillman JB, Wardlaw D. A randomized trial of balloon kyphoplasty and nonsurgical management for treating acute vertebral compression fractures. Spine. 2013;38(12):971-983.
- Wardlaw D, Cummings SR, Van Meirhaeghe J 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):1016-1024.
- Berenson J, Pflugmacher R, Jarzem P 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):225-235.
- Siris ES, Adler R, Bilezikian J et al. . The clinical diagnosis of osteoporosis: a position statement from the National Bone Health Alliance Working Group. Osteoporos Int. 2014;25(5):1439-1443.
- Dohm M, Black CM, Dacre A, Tillman JB, Fueredi G. A randomized trial comparing balloon kyphoplasty and vertebroplasty for vertebral compression fractures due to osteoporosis. Am J Neuroradiol. 2014;35(12):2227-2236.
- Borgstrom F, Zethraeus N, Johnell O et al. . Costs and quality of life associated with osteoporosis-related fractures in Sweden. Osteoporos Int. 2006;17(5):637-650.
- Bastian L, Schils F, Tillman JB, Fueredi G. 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. Am J Neuroradiol. 2013;34(3):666-675.
- Mahoney FI, Barthel DW. Functional Evaluation: The Barthel Index. Md State Med J. 1965;14(2):61-65.
- Copay AG, Glassman SD, Subach BR, Berven S, Schuler TC, Carreon LY. 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):968-974.
- Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine. 2000;25(22):2940-2953.
- Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94(2):149-158.
- Walters SJ, Brazier JE. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res. 2005;14(6):1523-1532.
- McDonough CM, Tosteson TD, Tosteson AN, Jette AM, Grove MR, Weinstein JN. A longitudinal comparison of 5 preference-weighted health state classification systems in persons with intervertebral disk herniation. Med Decis Making. 2011;31(2):270-280.
- Gold DT. The nonskeletal consequences of osteoporotic fractures. Rheum Dis Clin North Am. 2001;27(1):255-262.
- Silverman SL, Minshall ME, Shen W, Harper KD, Xie S. 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):2611-2619.
- Papanastassiou ID, Phillips FM, Van Meirhaeghe J 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(9):1826-1843.
- Lee MJ, Dumonski M, Cahill P, Stanley T, Park D, Singh K. Percutaneous treatment of vertebral compression fractures. Spine. 2009;34(11):1228-1232.
- Buchbinder R, Osborne RH, Ebeling PR et al. . A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009;361(6):557-568.
- Clark W, Bird P, Gonski P et al. . Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet. 2016;388(10052):1408-1416.
- Kallmes DF, Comstock BA, Heagerty PJ et al. . A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009;361(6):569-579.
- Klazen CA, Lohle PN, de Vries J et al. . Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet. 2010;376(9746):1085-1092.
Source: PubMed