Simplicity of Randomized, Controlled Trials of Percutaneous Vertebroplasty

The readers of Pain Physician have been very fortunate to have the opportunity to read a very thorough review article on percutaneous procedures for the treatment of painful compression fractures.By and large, the authors have effectively discussed advantages and disadvantages of both percutaneous vertebroplasty and percutaneous kyphoplasty.The purpose of this invited commentary is to discuss one aspect of the paper; the ability to perform a randomized, controlled study of percutaneous vertebroplasty.There is little doubt that percutaneous kyphoplasty could be approached in the same fashion and equally little doubt that it will in the relatively near future.Vertebroplasty is a well-established procedure that has been "seemed" efficacious in clinical practice extending over 10 years.Published case series examining thousands of patient cases attest to its "anecdotal" safety and efficacy.However, the procedure is done as an off-label use of products approved by the FDA for other procedures.The call for randomized, clinical trials to prove the efficacy and safety of specific products for use in vertebroplasty has been the topic of much debate over the past few years.For example, Jarvik and Deyo wrote a letter to the editor in the American Journal of Neuroradiology calling for such a trial to clear the final, formal, scientific hurdle for a procedure that had become a standard of care for pain caused by vertebral compression fractures (1).In their current article, Burton and Mendel reference several of the key papers calling for carefully monitored clinical trials; however, they assert that difficulty in enrolling patients and maintaining blindness to the control group will make randomized controlled trials for short and long-term outcomes of vertebroplasty problematic (2).The authors of this commentary respectfully disagree with several aspects of this assertion, and offer the following references in the spirit of advancing the procedure for the benefit of the patient population now and in the future.