Results of Vertebral Augmentation Treatment for Patients of Painful Osteoporotic Vertebral Compression Fractures: A Meta-Analysis of Eight Randomized Controlled Trials

Lianhua Li, Jixin Ren, Jia Liu, Hao Wang, Xiaowei Wang, Zhi Liu, Tiansheng Sun, Lianhua Li, Jixin Ren, Jia Liu, Hao Wang, Xiaowei Wang, Zhi Liu, Tiansheng Sun

Abstract

Background: In 2009 two RCTs were publicated to question the efficacy of vertebroplasty comparing with sham treatment (ST) in the New England Journal of Medicine (NEJM), which provoked an academic debate on the efficacy of PVA. The purposes of our study were to compare clinical differences in pain relief, spinal functional outcomes, and overall quality of life between PVA and CT for painful osteoporotic VCFs.

Methods: We searched PubMed, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials and Web of Knowledge from January 1980 to June 2013 with Medical Subject Headings terms and keywords. Risk of bias in the included studies was assessed in accordance with the Cochrane risk of bias tool. In this Meta-analysis dichotomous and continuous variables were calculated using the risk ratio (RR) and standardized mean difference (SMD), respectively.

Results: Eight studies involving 987 patients met the criteria for inclusion. The VAS SMD was favoring the experimental group significantly (p < 0.001). Subgroup analysis suggested that the patients performed PVA with mean fracture age less than 3 months would got pain relief earlier and more durable than the control group (P <0.05). The SMD of spinal function assessed with RDQ and Oswestry LBP data was in favor of the experimental groups. QOL outcome improvement was demonstrated statistically significant at early, middle and late-term follow-up for PVA than the control group (P <0.05).

Conclusions: In conclusion, this meta-analysis, which evaluated PVA for osteoporotic VCFs, demonstrated significant improvement regarding VAS, spinal function and QOL outcomes. The optimal fracture age was less than 12 weeks.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

References

    1. Lad SP, Patil CG, Lad EM, Hayden MG, Boakye M. National trends in vertebral augmentation procedures for the treatment of vertebral compression fractures. Surgical neurology. 2009;71(5):580–4; discussion 4–5. Epub 2008/06/03. 10.1016/j.surneu.2008.02.043 .
    1. Jensen ME, McGraw JK, Cardella JF, Hirsch JA. Position statement on percutaneous vertebral augmentation: a consensus statement developed by the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, American Association of Neurological Surgeons/Congress of Neurological Surgeons, and American Society of Spine Radiology. Journal of neurointerventional surgery. 2009;1(2):181–5. Epub 2009/12/01. 10.1016/j.jvir.2009.04.022 .
    1. Buchbinder R, Osborne RH, Ebeling PR, Wark JD, Mitchell P, Wriedt C, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. The New England journal of medicine. 2009;361(6):557–68. Epub 2009/08/07. 10.1056/NEJMoa0900429 .
    1. Kallmes DF, Comstock BA, Heagerty PJ, Turner JA, Wilson DJ, Diamond TH, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. The New England journal of medicine. 2009;361(6):569–79. Epub 2009/08/07. 10.1056/NEJMoa0900563
    1. Luetmer MT, Kallmes DF. Have referral patterns for vertebroplasty changed since publication of the placebo-controlled trials? AJNR American journal of neuroradiology. 2011;32(4):647–8. Epub 2011/02/26. 10.3174/ajnr.A2371 .
    1. Esses SI, McGuire R, Jenkins J, Finkelstein J, Woodard E, Watters WC 3rd, et al. American Academy of Orthopaedic Surgeons clinical practice guideline on: the treatment of osteoporotic spinal compression fractures. The Journal of bone and joint surgery American volume. 2011;93(20):1934–6. Epub 2011/10/21. 10.2106/JBJS.9320ebo .
    1. Boszczyk B. Volume matters: a review of procedural details of two randomised controlled vertebroplasty trials of 2009. European Spine Journal. 2010;19(11):1837–40. 10.1007/s00586.010.1525.4 .
    1. Baerlocher MO, Munk PL, Radvany MG, Murphy TP, Murphy KJ. Vertebroplasty, Research Design, and Critical Analysis. Journal of Vascular and Interventional Radiology. 2009;20(10):1277–8. 10.1016/j.jvir.2009.08.017 .
    1. Bolster MB. Consternation and questions about two vertebroplasty trials. Cleveland Clinic Journal of Medicine. 2010;77(1):12–+. 10.3949/ccjm.77a.09161 .
    1. Bono CM, Heggeness M, Mick C, Resnick D, Watters WC III. North American Spine Society Newly released vertebroplasty randomized controlled trials: a tale of two trials. Spine Journal. 2010;10(3):238–40. 10.1016/j.spinee.2009.09.007 .
    1. Brodano GB, Amendola L, Martikos K, Bettuzzi C, Boriani L, Gasbarrini A, et al. Vertebroplasty: benefits are more than risks in selected and evidence-based informed patients. A retrospective study of 59 cases. European Spine Journal. 2011;20(8):1265–71. 10.1007/s00586-011-1705-x .
    1. Clark W, Goh AC. Vertebroplasty for Acute Osteoporotic Spinal Fractures-Best Evidence? Journal of Vascular and Interventional Radiology. 2010;21(9):1330–3. 10.1016/j.jvir.2010.06.008 .
    1. Blasco J, Martinez-Ferrer A, Macho J, San Roman L, Pomes J, Carrasco J, et al. Effect of vertebroplasty on pain relief, quality of life, and the incidence of new vertebral fractures: a 12-month randomized follow-up, controlled trial. Journal of bone and mineral research: the official journal of the American Society for Bone and Mineral Research. 2012;27(5):1159–66. Epub 2012/04/20. 10.1002/jbmr.1564 .
    1. Boonen S, Van Meirhaeghe J, Bastian L, Cummings SR, Ranstam J, Tillman JB, et al. Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial. Journal of bone and mineral research: the official journal of the American Society for Bone and Mineral Research. 2011;26(7):1627–37. Epub 2011/02/22. 10.1002/jbmr.364 .
    1. Farrokhi MR, Alibai E, Maghami Z. Randomized controlled trial of percutaneous vertebroplasty versus optimal medical management for the relief of pain and disability in acute osteoporotic vertebral compression fractures. Journal of neurosurgery Spine. 2011;14(5):561–9. Epub 2011/03/08. 10.3171/2010.12.spine10286 .
    1. Klazen CA, Lohle PN, de Vries J, Jansen FH, Tielbeek AV, Blonk MC, et al. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet. 2010;376(9746):1085–92. Epub 2010/08/13. 10.1016/s0140-6736(10)60954-3 .
    1. Rousing R, Andersen MO, Jespersen SM, Thomsen K, Lauritsen J. Percutaneous vertebroplasty compared to conservative treatment in patients with painful acute or subacute osteoporotic vertebral fractures: three-months follow-up in a clinical randomized study. Spine. 2009;34(13):1349–54. Epub 2009/05/30. 10.1097/BRS.0b013e3181a4e628 .
    1. Rousing R, Hansen KL, Andersen MO, Jespersen SM, Thomsen K, Lauritsen JM. Twelve-months follow-up in forty-nine patients with acute/semiacute osteoporotic vertebral fractures treated conservatively or with percutaneous vertebroplasty: a clinical randomized study. Spine. 2010;35(5):478–82. Epub 2010/03/02. 10.1097/BRS.0b013e3181b71bd1 .
    1. Moher D LA, Tetzlaff J, PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6:e1000097 10.1371/journal.pmed.1000097
    1. Higgins JPT GS, eds. Cochrane hand book for systematic reviews of interventions version 5.1.0 [updated March2011]2011.
    1. Fritzell P, Ohlin A, Borgstrom F. Cost-effectiveness of balloon kyphoplasty versus standard medical treatment in patients with osteoporotic vertebral compression fracture: a Swedish multicenter randomized controlled trial with 2-year follow-up. Spine. 2011;36(26):2243–51. Epub 2011/09/14. 10.1097/BRS.0b013e3182322d0f .
    1. Van Meirhaeghe J, Bastian L, Boonen S, Ranstam J, Tillman JB, Wardlaw D. 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. Epub 2013/03/01. 10.1097/BRS.0b013e31828e8e22
    1. Voormolen MH, Mali WP, Lohle PN, Fransen H, Lampmann LE, van der Graaf Y, et al. Percutaneous vertebroplasty compared with optimal pain medication treatment: short-term clinical outcome of patients with subacute or chronic painful osteoporotic vertebral compression fractures. The VERTOS study. AJNR American journal of neuroradiology. 2007;28(3):555–60. Epub 2007/03/14. .
    1. Wardlaw D, Cummings SR, Van Meirhaeghe J, Bastian L, Tillman JB, Ranstam 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):1016–24. Epub 2009/02/28. 10.1016/s0140-6736(09)60010-6 .
    1. Thiessen Philbrook H, Barrowman N, Garg AX. Imputing variance estimates do not alter the conclusions of a meta-analysis with continuous outcomes: a case study of changes in renal function after living kidney donation. Journal of clinical epidemiology. 2007;60(3):228–40. Epub 2007/02/13. 10.1016/j.jclinepi.2006.06.018 .
    1. Furukawa TA, Barbui C, Cipriani A, Brambilla P, Watanabe N. Imputing missing standard deviations in meta-analyses can provide accurate results. Journal of clinical epidemiology. 2006;59(1):7–10. Epub 2005/12/20. 10.1016/j.jclinepi.2005.06.006 .
    1. Belkoff SM, Mathis JM, Jasper LE, Deramond H. The biomechanics of vertebroplasty. The effect of cement volume on mechanical behavior. Spine. 2001;26(14):1537–41. Epub 2001/07/20. .
    1. Belkoff SM, Mathis JM, Jasper LE, Deramond H. An ex vivo biomechanical evaluation of a hydroxyapatite cement for use with vertebroplasty. Spine. 2001;26(14):1542–6. Epub 2001/07/20. .
    1. Togawa D, Bauer TW, Lieberman IH, Takikawa S. Histologic evaluation of human vertebral bodies after vertebral augmentation with polymethyl methacrylate. Spine. 2003;28(14):1521–7. Epub 2003/07/17. .
    1. Tanigawa N, Kariya S, Komemushi A, Nakatani M, Yagi R, Kohzai M, et al. Percutaneous Vertebroplasty for Osteoporotic Compression Fractures: Long-Term Evaluation of the Technical and Clinical Outcomes. American Journal of Roentgenology. 2011;196(6):1415–8. 10.2214/ajr.10.5586 .
    1. Anselmetti GC, Manca A, Hirsch J, Montemurro F, Isaia G, Osella G, et al. Percutaneous Vertebroplasty in Osteoporotic Patients: An Institutional Experience of 1,634 Patients with Long-Term Follow-Up. Journal of Vascular and Interventional Radiology. 2011;22(12):1714–20. 10.1016/j.jvir.2011.09.001 .
    1. Tsai Y-W, Hsiao F-Y, Wen Y-W, Kao Y-H, Chang L-C, Huang W-F, et al. Clinical Outcomes of Vertebroplasty or Kyphoplasty for Patients With Vertebral Compression Fractures: A Nationwide Cohort Study. Journal of the American Medical Directors Association. 2013;14(1):41–7. 10.1016/j.jamda.2012.09.007 .
    1. Farahmand BY, Michaelsson K, Ahlbom A, Ljunghall S, Baron JA. Survival after hip fracture. Osteoporosis international: a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA. 2005;16(12):1583–90. Epub 2005/10/12. 10.1007/s00198-005-2024-z .
    1. Gerling MC, Eubanks JD, Patel R, Whang PG, Bohlman HH, Ahn NU. Cement augmentation of refractory osteoporotic vertebral compression fractures: survivorship analysis. Spine. 2011;36(19):E1266–9. Epub 2011/03/02. 10.1097/BRS.0b013e31820a0b3f .
    1. Taylor RS, Fritzell P, Taylor RJ. Balloon kyphoplasty in the management of vertebral compression fractures: an updated systematic review and meta-analysis. European spine journal: official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2007;16(8):1085–100. Epub 2007/02/06. 10.1007/s00586-007-0308-z ; PubMed Central PMCID: PMCPmc2200787.
    1. Anderson PA, Froyshteter AB, Tontz WL Jr. Meta-analysis of vertebral augmentation compared with conservative treatment for osteoporotic spinal fractures. Journal of bone and mineral research: the official journal of the American Society for Bone and Mineral Research. 2013;28(2):372–82. Epub 2012/09/20. 10.1002/jbmr.1762 .
    1. Abrams KR, Gillies CL, Lambert PC. Meta-analysis of heterogeneously reported trials assessing change from baseline. Statistics in medicine. 2005;24(24):3823–44. Epub 2005/12/02. 10.1002/sim.2423 .

Source: PubMed

スポンサーと協力者

医学的状態

薬物療法

3
購読する