Vertebroplasty Controversy Final

Document Sample
Vertebroplasty Controversy Final Powered By Docstoc
					Vertebroplasty Controversy




  Christopher Guest MD, FRCPC
                                16000728
“Teach the Controversy”




                          16000728
16000728
Controversy? What Controversy?


“A Randomized Trial of Vertebroplasty for
Painful Osteoporotic Vertebral Fractures”
       -Rachelle Buchbinder, Ph.D. et al.




   NEJM 2009; 361:557-568               16000728
Controversy? What Controversy?


“A Randomized Trial of Vertebroplasty for
    Osteoporotic Spinal Fractures”
         -David F. Kallmes, M.D. et al.




   NEJM 2009; 361:569-579               16000728
                       Media Coverage


“Studies Find No Benefit to Popular Spine Procedure”
-Wall Street Journal

“Trial Finds New, Expensive Back Procedure Ineffective”
-Reuters

“Percutaneous Vertebroplasty Exposed as Ineffective”
-The Medical News




                                                       16000728
        Study Enrollment




NEJM 2009; 361:557-568     16000728
Vertebroplasty Technique




NEJM 2009; 361:557-568     16000728
Sham Procedure Technique




                           16000728
16000728
       Australian Results




NEJM 2009; 361:557-568      16000728
      Mayo Clinic Results




NEJM 2009; 361:569-579      16000728
      Mayo Clinic Results




NEJM 2009; 361:569-579      16000728
16000728
          Criticism of Trials


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




                                                  16000728
          Criticism of Trials


What about preprocedural pain scores?
• sham studies → VAS 6.9
• other studies → VAS 8.2 to 9.4




                                        16000728
           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




                                                16000728
           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%




                                          16000728
          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




                                                16000728
16000728
            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   16000728
        Criticism of Trials


What about the crossover rates?
• 43% sham → vertebroplasty
• 12% vertebroplasty → sham




                                  16000728
         Criticism of Trials

What about anatomical deformity?




                                   16000728
           Criticism of Trials

What does the balance of evidence suggest?




   116 clinical trials
   478 publications      2 sham studies



                                             16000728
16000728
           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


                                                                        16000728
Now What?




            16000728

				
DOCUMENT INFO
Categories:
Tags:
Stats:
views:11
posted:9/16/2011
language:English
pages:27