T12 COMPRESSION FRACTURE TRIAL
A randomized placebo-controlled trial under the auspices of the Mayo Clinic (the Investigational Vertebroplasty Efficacy and Safety Trial ) is currently enrolling patients however, it will be some time before results are available. It is almost impossible to find patients in severe pain who are willing to risk being randomly assigned to the placebo arm of such a study. However, this reflects less the effectiveness or safety of the procedure than it does the difficulty involved in conducting randomized controlled trials of any treatment for a pain disorder. No double-blind, randomized controlled studies of the effectiveness of vertebroplasty have been performed.
Or, pain may be relieved by a combination of these 2 mechanisms of action.ĮFFECTIVENESS OF VERTEBROPLASTY: WHAT THE EVIDENCE SHOWS Some experts have postulated that pain relief results from the cement's stabilization of the fracture, others that the procedure destroys the endings of nerves that transmit pain. What has proved less simple is determining how the procedure relieves pain. The patient remains prone until the cement has hardened (about 2 hours) he or she is then usually discharged. Cement is then injected through each needle into the vertebra, where it fills in the spaces in the bone. With the patient consciously sedated and in the prone position, 2 needles are inserted into the fractured vertebra under fluoroscopic guidance. The mechanics of the procedure are simple and straightforward. This relatively new, minimally invasive procedure has been touted as providing dramatic pain relief in patients with vertebral compression fractures.īut is the procedure really as easy, effective, and safe as is claimed? And are the claims backed by solid evidence? Which patients stand to benefit most from the procedure? Are there any hidden risks? I will attempt here to answer these and other questions. With increasing frequency, however, physicians are recommending vertebroplasty for such patients. Too frail to be candidates for surgical fixation, they were prescribed narcotics and bed rest, were perhaps fitted for a back brace, and were told that their pain would gradually resolve-if they were lucky, within a few weeks, but possibly not for several months.
Not long ago, there were few options for elderly patients such as this woman. The films confirm your suspicion they reveal a compression fracture at T12. Because your patient has a history of osteoporosis, you strongly suspect a vertebral compression fracture, and you arrange for radiographs to investigate.
The pain prevents her from walking and is exacerbated by even slight movement. The son of an elderly patient calls you to say that his mother has severe back pain that began suddenly just a few days earlier.
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