Impact of Sham-Controlled Vertebroplasty Trials on Referral Patterns at Two Academic Medical Centers

Abstract

Debate persists regarding the merit of vertebroplasty following publication of blinded vertebroplasty trials in 2009, one of which was the Investigational Vertebroplasty Efficacy and Safety Trial (INVEST). This study was performed to determine whether referring physicians at two academic medical centers were aware of the trial results and to assess if this awareness prompted a change in their treatment of osteoporotic fractures. E-mail surveys were distributed to physicians within the Mayo Clinic and Baylor Health Care System (BHCS). Of 1390 surveys sent, 194 (14%) were returned. Results showed that 92 of 158 respondents (58%) reported familiarity with INVEST; 66 of 92 (72%) agreed that INVEST changed their understanding of vertebroplasty efficacy; and 64 of 92 (70%) agreed that INVEST diminished their enthusiasm to refer patients for vertebroplasty. However, 105 of 159 respondents (66%) felt vertebroplasty was an effective procedure in appropriate patients. Mayo physicians were more likely than BHCS physicians to be aware of INVEST (73% vs 67%, P < .0001), respond that INVEST changed their understanding of the appropriate treatment for osteoporotic compression fractures (79% vs 57%, P = 0.026), view vertebroplasty less favorably (45% vs 21%, P = 0.005), and treat osteoporotic compression fractures with medical therapy/pain management alone (73% vs 48%, P = 0.003). INVEST changed referring physicians' understanding of the role of vertebroplasty and diminished their willingness to refer osteoporotic compression fracture patients; the impact varied by location.

Were VCF patients at higher risk of mortality following the 2009 publication of the vertebroplasty “sham” trials?

“…Vertebral augmentation in the Medicare population was noted to decline from 2009 onwards, although this impacted VP more dramatically. Researchers [23, 25] have attributed diminished VP volumes to the controversy sparked by the 2009 “sham” control publications [19, 20]. Others [30] have also pointed to insurance coverage changes or recommendations from professional societies, such as the American Academy of Orthopaedic Surgeons (AAOS) guidelines, which were impacted by the two aforementioned studies [31].…”

“…Yet periosteal local anesthetic infiltration can have a treatment effect, making it an active control [21]; this is one of the important differences in trial design between the 2009 trials and a more recent VP trial [8, 22]. A physician survey later showed that at least one of these two “sham” control studies was directly linked to reduced enthusiasm for VP referrals, even though most still felt that VP was an effective procedure in appropriate patients [23]. Nonetheless, the period following those publications exhibited diminished volumes of vertebral augmentation [23–26].…”

“…A physician survey later showed that at least one of these two “sham” control studies was directly linked to reduced enthusiasm for VP referrals, even though most still felt that VP was an effective procedure in appropriate patients [23]. Nonetheless, the period following those publications exhibited diminished volumes of vertebral augmentation [23–26]. When taken in context of the trends in utilization of percutaneous interventional procedures for managing spinal pain [27, 28], the decrease is almost certainly the direct or indirect result of the two “sham” control studies.…”