NEJM Studies Continue to Haunt Vertebroplasty Companies

For the past year, proponents of vertebral compression fracture procedures, particularly vertebroplasty (the injection of cement in a fractured vertebral body), have had to defend the efficacy of the procedure against the two critical clinical trials published last summer in The New England Journal of Medicine ( NEJM) . Immediately after the studies were published, spinal specialists and companies worked to refute the conclusions that vertebroplasty isn't any more effective than a so-called sham procedure (although the sham label may be misapplied because the control patients in those trials did receive a spinal injection of pain killers). Defenders of vertebroplasty conceded the trial had a worthy design, but they felt the execution was poor given that many of the trial participants had injuries that were so old that they weren't likely to benefit from vertebroplasty. ( See " Critical Vertebroplasty Studies Raise Questions," IN VIVO, September 2009 Also see "Critical Vertebroplasty Studies Raise Questions " - In Vivo, 1 September, 2009..)

Now, vertebroplasty advocates look to be losing on a very significant front. A growing number of third-party payors – including at least one Medicare contractor – are reconsidering their coverage...