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AAOS new guideline does not support vertebroplasty
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Although vertebroplasty — using bone cement to fill a fractured vertebrae — has been a popular surgical intervention to treat vertebral compression fractures for more than a decade, the procedure does not offer any advantage over placebo, according to new clinical practice guidelines from the American Academy of Orthopaedic Surgeons (AAOS), which recommend against the procedure for patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically intact.
The recommendation is primarily based on the results of two randomized, controlled clinical trials that were published in the New England Journal of Medicine (NEJM), which compared vertebroplasty with a sham procedure, for which there was no statistically significant difference in pain noted between the two.
“If one puts aside anecdotal information and clearly looks objectively at the data that has been published to date, there is no evidence that vertebroplasty provides significant benefit to patients who have osteoporotic vertebral compression fractures,” said Stephen I. Esses, MD, an orthopedic spine surgeon in private practice in Houston, Texas, who chaired the workshop that developed the guideline.
Not an indictment of cement
For both studies, all patients were brought into the operating room, but for those who did not undergo vertebroplasty, “there was the suggestion of an operation because of the noise in the background and the way the skin was prepped,” Esses told Orthopedics Today. “So patients did not know whether they had the procedure or not.”
Esses, who began performing vertebroplasty in the late 1990s, stopped about 2 years ago because of his concern over inadequate scientific evidence that the procedure was effective. “This is not an indictment of bone cement by any means,” he stated.
The guideline mentions viable alternatives to vertebroplasty, such as calcitonin or facet blocks. “There is moderate evidence that the use of calcitonin is useful for these patients,” Esses said. “In addition, there is some suggestion that certain nerve root blocks are useful for specific types of compression fractures, and that kyphoplasty is an option for certain patients who present with these fractures.”
For patients who have undergone vertebroplasty and are functioning well, “there is no need to become worried, one way or the other,” Esses said. “There are no long-term consequences.”
Even without the AAOS recommendation against vertebroplasty, “it has become clear to a lot of people that the science behind this procedure has been flawed,” Esses said. “For people who are still recommending it, the guideline will make them stop and think, and perhaps encourage them to go back to the literature and read what is actually in there.”
Vertos II
But not every orthopedic surgeon is ready to give up on the procedure. “Every surgeon has his or her own treatment preferences,” said Eric D. Nabors, MD, chief, Department of Orthopedic Surgery at St. Clair Hospital in Scott Township, Pa. He feels at least one of the two NEJM clinical trials “was a much less rigorous study than the Vertos II [Vertebroplasty vs. conservative treatment in acute osteoporotic vertebral compression fractures] study recently published in The Lancet. Unlike the NEJM trial, Vertos II reviewed more than twice as many patients and confirmed with an MRI the presence of acute vertebral fracture, which is the appropriate indication for vertebroplasty.”
Nabors, who has performed hundreds of vertebroplasty procedures to date and will continue, told Orthopedics Today that he believes it “is very safe and effective for the treatment of acute fractures of the vertebrate. The Vertos II study has shown that pain relief after percutaneous vertebroplasty is immediate, sustained for at least a year, and significantly greater than that achieved with conservative treatment, at an effective cost. My experience with the procedure confirms these findings. I’ve seen countless patients return to pain-free, active lives almost instantaneously.”
Nabors’ preferred substitute therapy is a balloon-assisted vertebral augmentation (Stryker).
As for the future of vertebroplasty, “I expect that it will continue to be a widely accepted, clinically effective treatment for osteoporotic vertebral compression fractures,” Nabors said. “As time passes, the Vertos II study will become accepted by the medical community as a validation of the efficacy of vertebroplasty. Moreover, while any treatment option is up to the individual surgeon, I believe that vertebroplasty, like kyphoplasty, can enhance patient outcomes and improve cost efficiency within the health care system.”
Putting differences aside, Esses noted that all too often patients with compression fractures are being treated for the pain of the compression fracture, while the physician “totally ignores the fact that the patient has osteoporosis, which may be otherwise untreated. We need to be more aware that many patients with osteoporosis are either not receiving treatment or are receiving inadequate treatment.” – by Bob Kronemyer
Reference:
- The full guideline along with all supporting documentation and workgroup disclosures is available on the AAOS website.
- Stephen I. Esses, MD, can be reached at Scurlock Tower, 6560 Fannin St., Suite 1016, Houston, TX 77030; 713-333-4410; e-mail: sesses@mysurgeon.com.
- Eric D. Nabors, MD, can be reached at 363 Vanadium Road, Scott Township, PA 15243; 412-429-0880; e-mail: ednabors@yahoo.com.
