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Vertebroplasty Controversy

Vertebroplasty Controversy. Christopher Guest MD, FRCPC. “Teach the Controversy”. Controversy? What Controversy?. “A Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral Fractures” -Rachelle Buchbinder, Ph.D. et al. NEJM 2009; 361:557-568. Controversy? What Controversy?.

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Vertebroplasty Controversy

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  1. Vertebroplasty Controversy Christopher Guest MD, FRCPC

  2. “Teach the Controversy”

  3. Controversy? What Controversy? “A Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral Fractures” -Rachelle Buchbinder, Ph.D. et al. NEJM 2009; 361:557-568

  4. Controversy? What Controversy? “A Randomized Trial of Vertebroplasty for Osteoporotic Spinal Fractures” -David F. Kallmes, M.D. et al. NEJM 2009; 361:569-579

  5. Media Coverage • “Studies Find No Benefit to Popular Spine Procedure” • Wall Street Journal • “Trial FindsNew, Expensive Back Procedure Ineffective” • -Reuters • “Percutaneous Vertebroplasty Exposed as Ineffective” • -The Medical News

  6. Study Enrollment NEJM 2009; 361:557-568

  7. Vertebroplasty Technique NEJM 2009; 361:557-568

  8. Sham Procedure Technique

  9. Australian Results NEJM 2009; 361:557-568

  10. Mayo Clinic Results NEJM 2009; 361:569-579

  11. Mayo Clinic Results NEJM 2009; 361:569-579

  12. Criticism of Trials • Was there selection bias? • Australian study: 30% declined • Mayo Clinic study: 17% declined • patients who declined → ?% had vertebroplasty • inpatients excluded

  13. Criticism of Trials • What about preprocedural pain scores? • sham studies → VAS 6.9 • other studies → VAS 8.2 to 9.4

  14. Criticism of Trials • Was there enough statistical power? • n=78 • p=80% to detect Δ 1.5 on VAS • vertebroplasty superiority VAS (3.9 vs 4.6) • questionnaire follow-up

  15. Criticism of Trials • Was the vertebroplasty technique sound? • IR’s experience: 50-800 • study cases/site: 2-26 • PMMA volume: 2.8cc • cement leakage: 37%

  16. Criticism of Trials • Had the window of opportunity closed? • Australian study → 70% patients pain > 6wks • Mayo Clinic → included VCFs up to 1 year old • → 51% VCFs > 6 months old

  17. Criticism of Trials • Was the sham procedure a good control? • 0.25% bupivacaine → pedicle • VAS placebo: 6-7% vs. 40% • “reset button” hypothesis? J Bone Joint Surg Am 2000; 82:1589-1593

  18. Criticism of Trials • What about the crossover rates? • 43% sham → vertebroplasty • 12% vertebroplasty → sham

  19. Criticism of Trials What about anatomical deformity?

  20. Criticism of Trials • What does the balance of evidence suggest? 116clinical trials 478publications 2sham studies

  21. SIR Position Statement “ The SIR recognizes the value of randomized controlled trials and evidence-based medicine; however, the weakness in the studies and the degree of discordance between the outcomes of these studies and prior studies as well as more than 15 years of accumulated medical literature espousing the benefits of vertebroplasty, suggest that it is premature – and possibly incorrect – to conclude that vertebroplasty is no better than a sham procedure. These studies demonstrate the importance of scientific debate and rigorous analysis of all data prior to rushing to conclusions. Hundreds of thousands of patients have greatly benefited from vertebroplasty and the SIR supports the use of vertebral body augmentation (vertebroplasty and kyphoplasty) for patients with painful compression fractures.” - Brian F. Stainken M.D., President SIR, November 2009

  22. Now What?

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