The Spine Journal
Volume 10, Issue 3 , Pages 241-243 , March 2010

Vertebroplasty: when randomized placebo-controlled trial results clash with common belief

  • Rachelle Buchbinder, MBBS(Hons), MSc, PhD, FRACP

      Affiliations

    • Monash Department of Clinical Epidemiology, Cabrini Hospital, and Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria 3144, Australia
    • Corresponding Author InformationCorresponding author. Monash Department of Clinical Epidemiology, Suite 41, Cabrini Medical Centre, 183 Wattletree Road, Malvern, Victoria 3144, Australia. Tel: (61) 3-95094445; Fax: (61) 3-395081653.
    • ,
  • David F. Kallmes, MD

      Affiliations

    • Department of Radiology, Mayo Clinic, Rochester, MN, 55905, USA

Received 22 December 2009 ,Accepted 5 January 2010.

References 

  1. Bono L, Heggeness M, Mick C, et al. Newly released vertebroplasty RCTs: a tale of two trials. Spine J. 2010;10:238–240
  2. Álvarez L, Alcarez M, Pérez-Higueras A, et al. Percutaneous vertebroplasty: functional improvement in patients with osteoporotic compression fractures. Spine. 2006;31:1113–1118
  3. Diamond TH, Champion B, Clark WA. Management of acute osteoporotic vertebral fractures: a nonrandomized trial comparing percutaneous vertebroplasty with conservative therapy. [comment] Am J Med. 2003;114:257–265
  4. Buchbinder R, Osborne R, Ebeling P, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009;361:557–568
  5. Kallmes D, Comstock B, Heagerty P, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009;361:569–579
  6. Hancock M, Herbert R, Maher C. A guide to interpretation of studies investigating subgroups of responders to physical therapy interventions. Phys Ther. 2009;89:698–704
  7. Buchbinder R, Osborne R, Staples M. Response to letters to the editor. N Engl J Med. 2009;361:2099
  8. Rousing R, Andersen M, Jespersen S, et al. 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;34:1349–1354
  9. Voormolen M, Mali W, Lohle P, 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 Am J Neuroradiol. 2007;28:555–560
  10. Wardlaw D, Cummings S, 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;373:1016–1024
  11. Kallmes D, Comstock B, Gray L, et al. Baseline pain and disability in the Investigational Vertebroplasty Efficacy and Safety Trial. AJNR Am J Neuroradiol. 2009;30:1203–1205
  12. Staal J, de Bie R, de Vet H, et al. Injection therapy for subacute and chronic low-back pain. Cochrane Database Syst Rev. 2008;Issue 3. Art. No.: CD001824. 10.1002/14651858.CD001824.pub3
  13. Trout AT, Kallmes DF, Gray LA, et al. Evaluation of vertebroplasty with a validated outcome measure: the Roland-Morris Disability Questionnaire. AJNR Am J Neuroradiol. 2005;26:2652–2657
  14. Carey T. Vertebroplasty was not effective for painful osteoporotic vertebral fractures. ACP Journal Club. 2009;151:8–9

 FDA device/drug status: not applicable.

 Author disclosures: RB (other relationships, Cook Australia Pty Ltd); DFK (consulting, Skeltex, Inc., Bone Support, Inc., research support, Stryker, Cook, Parallax, Cardinal Health).

PII: S1529-9430(10)00012-4

doi: 10.1016/j.spinee.2010.01.001

The Spine Journal
Volume 10, Issue 3 , Pages 241-243 , March 2010

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