CardioVascular and Interventional Radiology

, Volume 33, Issue 4, pp 677–680 | Cite as

Have Recent Vertebroplasty Trials Changed the Indications for Vertebroplasty?

Review Article/State of the Art

Abstract

Two different investigators in the New England Journal of Medicine recently published two randomized controlled trials (RCTs) regarding the efficacy of vertebroplasty for painful osteoporotic vertebral compression fractures. In their results, both investigators concluded that there was no significant difference in pain relief between the vertebroplasty group and control group 1 month after treatment. The trials described a different patient cohort from the one we treat with vertebroplasty. Both enrolled patients had back pain for ≤12 months. This duration of pain was far too long for a vertebroplasty trial, resulting in parallel trials of vertebroplasty on healed fractures. Where a study is needed, it should be comprised of patients with acute osteoporotic compression fractures, particularly those who are hospitalized or bedridden because of the pain of such fractures. Magnetic resonance imaging was not systematically performed before vertebroplasty, and inpatients were excluded. Inpatients with acute fracture pain are the group most likely to respond well to vertebroplasty. Enrolment was a problem in both trials. Randomization in both RCTs took >4 years for completion. We advise that vertebroplasty be offered to patients with recent fractures <8 weeks old who have uncontrolled pain as well as patients progressing to osteonecrosis and the intravertebral vacuum phenomenon (Kummels disease). The availability of recent MRI scanning is also critical to proper patient selection.

Keywords

Vertebroplasty Osteoporosis Vertebral compression fracture Vertebroplasty trials 

References

  1. 1.
    Melton LJ III, Thamer M, Ray NF, Chan JK, Chesnut CH III, Einhorn TA et al (1997) Fractures attributable to osteoporosis: report from the National Osteoporosis Foundation. J Bone Miner Res 12:16–23CrossRefPubMedGoogle Scholar
  2. 2.
    Kallmes DF, Comstock BA, Heagerty PJ, Turner JA, Wilson DJ, Diamond TH et al (2009) A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med 361:569–579CrossRefPubMedGoogle Scholar
  3. 3.
    Buchbinder R, Osborne RH, Ebeling PR, Wark JD, Mitchell P, Wriedt C et al (2009) A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med 361:557–568CrossRefPubMedGoogle Scholar
  4. 4.
    Weinstein JN (2009) Balancing science and informed choice in decisions about vertebroplasty. N Engl J Med 361:619–621CrossRefPubMedGoogle Scholar
  5. 5.
    Klazen CAH, Verhaar HJJ, Lampmann LEH et al (2007) VERTOS II: percutaneous vertebroplasty versus conservative therapy in patients with painful osteoporotic vertebral compression fractures: rationale, objectives and design of a multi centre randomised controlled trial. Trials 8:33CrossRefPubMedGoogle Scholar
  6. 6.
    Buchbinder R, Osborne RH, Ebeling PR et al (2008) Efficacy and safety of vertebroplasty for treatment of painful osteoporotic vertebral fractures: a randomised controlled trial. BMC Musculoskelet Disord 9:156CrossRefPubMedGoogle Scholar
  7. 7.
    Pham T, Azulay-Parrado J, Champsaur P, Chagnaud C, Legre V, Lafforgue P (2005) “Occult” osteoporotic vertebral fractures: vertebral body fractures without radiologic collapse. Spine (Phila Pa 1976) 30(21):2430–2435Google Scholar
  8. 8.
    Rico H, Merono E, Del Olmo J, Revilla M (1991) The value of bone scintigraphy in the follow-up of vertebral osteoporosis. Clin Rheumatol 10:298–301CrossRefPubMedGoogle Scholar
  9. 9.
    Clinical Protocol: Investigational Vertebroplasty Efficacy and Safety Trial (INVEST). A controlled trial of percutaneous vertebroplasty IDE #G030091/S2. Presented to the St George Hospital Ethics Committee, Sydney, AustraliaGoogle Scholar
  10. 10.
    Gray LA, Jarvik JG, Heagerty PJ et al (2007) Investigational Vertebroplasty Efficacy and Safety Trial (INVEST): a randomized controlled trial of percutaneous vertebroplasty. BMC Musculoskelet Disord 8:126CrossRefPubMedGoogle Scholar
  11. 11.
    Bono C, Heggeness M, Mick C, Resnick D, Watters WC (2009) North American Spine Society Newly Released Vertebroplasty RCTs: a tale of two trials. On behalf of the North American Spine Society NASS 2009. www.spine.org.
  12. 12.
    Rousing R, Andersen MO, Jespersen SM, Thomsen K, Lauritsen J (2009) Percutaneous vertebroplasty compared to conservative treatment in patients with painful acute or subacute osteoporotic vertebral fractures: three-month follow-up in a clinical randomized study. Spine (Phila Pa 1976) 34(13):1349–1354Google Scholar
  13. 13.
    Ploeg WT, Veldhuizen AG, The B, Sietsma MS (2006) Percutaneous vertebroplasty as a treatment for osteoporotic vertebral compression fractures: a systematic review. Eur Spine J 15(12):1749–1758CrossRefPubMedGoogle Scholar
  14. 14.
    McGirt MJ, Parker SL, Wolinsky JP, Witham TF, Bydon A, Gokaslan ZL (2009) Vertebroplasty and kyphoplasty for the treatment of vertebral compression fractures: an evidenced-based review of the literature. Spine J 9(6):501–508CrossRefPubMedGoogle Scholar
  15. 15.
    Bolster MB (2010) Consternation and questions about two vertebroplasty trials. Cleve Clin J Med 77:12–16CrossRefPubMedGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2010

Authors and Affiliations

  1. 1.Department of Nonvascular Interventional RadiologyUniversity Hospital of StrasbourgStrasbourgFrance
  2. 2.Department of Interventional RadiologySt George Private HospitalKogarahAustralia

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