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Vertebroplasty Strikes Out

This procedure yielded no improvements in two randomized placebo-controlled trials.

Two procedures have become routine for treating patients with painful osteoporotic vertebral fractures: vertebroplasty (percutaneous injection of polymethylmethacrylate "cement" into the affected vertebral body) and kyphoplasty (a similar procedure, but preceded by inflation of a balloon to restore vertebral height). However, randomized double-blind placebo-controlled trials to prove the effectiveness of either procedure have been lacking — until now.

In one study, conducted mainly in the U.S. and U.K., researchers randomized 131 patients with painful osteoporotic vertebral fractures to undergo vertebroplasty or a simulated procedure (without injection of cement). In an intent-to-treat analysis, pain and disability scores in the two groups were not significantly different at 3 days, 2 weeks, and 1 month. Patients were permitted to cross over and receive the opposite treatment at 1 month, but controls who crossed over did not experience substantial benefits after vertebroplasty.

In a similar Australian trial, 78 patients were randomized to vertebroplasty or a sham procedure; crossovers were not permitted. At 1 week and at 1, 3, and 6 months, outcomes in the two groups were similar. Participation in both trials was limited to patients whose fractures had occurred as long as 1 year before enrollment, but response to vertebroplasty was not associated with duration of symptoms in either trial.

Comment: When compared with a sham intervention, vertebroplasty was ineffective in two randomized trials. The benefits noted in previous observational studies likely were attributable to placebo effects and the underlying tendency for vertebral pain to improve with time. Unless well-designed controlled studies can identify a subgroup that benefits from vertebroplasty, it should be viewed skeptically. A final note: Randomized trials are in progress to compare vertebroplasty and kyphoplasty.

— Allan S. Brett, MD

Published in Journal Watch General Medicine August 5, 2009

Citation(s):

Kallmes DF et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med 2009 Aug 6; 361:569.

• Medline abstract (Free)

Buchbinder R et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med 2009 Aug 6; 361:557.

• Medline abstract (Free)

Reader Remarks:

Review and add to remarks on this article

• Vertebroplasty
  Darol Joseff, Santa Barbara, 7 Aug 2009 12:26 PM EST
  I've seen a number of very miserable, severely pained (to the point of being morbund) elders be functional and without... [more]
• Vertebroplasty
  Roman. B. Ruther, family office, 10 Aug 2009 4:06 PM EST
  I agree with colleague Darol Joseff. I'm a general practitioner and have seen several older patients with spine fractures due... [more]
• Vertebroplasty
  j harper, NHS Hospital, 27 Aug 2009 8:57 AM EST
  Re. previous remarks - consider the power of placebo (especially powerful in "hospital-based, high tech" interventions)
• Placebo
  R. Luz Coelho, Family Physician, Curitiba - Brasil, 19 Jan 2010 12:29 PM EST
  Placebo is a very powerfull entity in medicine, one wich many very good physicians and surgeons sometimes underestimate.
  
  A procedure... [more]

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