Cure of choice for broken vertebrae: Cement
Published: August 28, 2005
It used to be that a patient with osteoporosis who broke a vertebra was pretty much out of luck. The only recourse was wearing a back brace and waiting to heal. If the searing pain was unbearable, it could be blunted with powerful narcotics.
But in the past few years, doctors have been offering and patients demanding what some call a miraculous treatment: vertebroplasty, in which a form of cement is injected into the broken spinal bone.
No one is sure why it helps, or even if it does. The hot acrylic bone cement may be shoring up the spine or merely destroying the nerve endings that transmit pain. Or the procedure may simply have a placebo effect.
And some research hints that the procedure may be harmful in the long run, because when one vertebra is shored up, adjacent ones may be more likely to break.
But vertebroplasty and a similar procedure, kyphoplasty, are fast becoming the treatments of choice for patients with bones so weak their vertebrae break. Kyphoplasty involves pumping the vertebra with a balloon to restore its shape before injecting cement.
The two procedures are so common, said Dr. Ethel Siris, an osteoporosis researcher at Columbia University, that “if you have osteoporosis and come into an emergency room with back pain from a fractured vertebra, you are unlikely to leave without it.” She said she was concerned about the procedures’ widespread and largely uncritical acceptance.
Even proponents would like to know whether cement injections really help in the long run, but medical scientists fear they may never know.
In 2002, a group of U.S. researchers received a federal grant for a clinical trial that would be the first to rigorously assess vertebroplasty. But their study is faltering.
Patients in severe pain have proved unwilling to enter such a trial, in which they might be randomly assigned to get a placebo, and their doctors have been reluctant to suggest it. In 18 months, the investigators have been able to persuade just three medical centers to recruit patients, and only three people have enrolled.
Now the investigators are looking for centers in other countries, but they agree that the study’s prospects are dim and that its failure would leave critical questions unanswered.
“Whose responsibility is it to decide that something should be part of medical practice without adequate evidence that it works?” asked Dr. Jeffrey Jarvik, an investigator with the study and a neuroradiologist at the University of Washington.
But for many doctors, the time to ask is long past. Whatever the evidence, they say, too many people are convinced that the procedures work.
“I struggle with this,” said Dr. Joshua Hirsch, director of interventional neuroradiology at Massachusetts General Hospital in Boston. He believes in clinical trials, he said, but when it comes to vertebroplasty and kyphoplasty, “I truly believe these procedures work.”
Vertebroplasty came to the United States in 1993 when Dr. Mary Jensen and Dr. Jacques Dion, interventional neuroradiologists at the University of Virginia Health System, were confronted with a woman with breast cancer that had spread to her spine. Conventional medicine had nothing to offer for her excruciating, unrelenting pain.
But they remembered a lecture by a French doctor who said she had injected a form of cement into the vertebrae of cancer patients and said it relieved their pain. She did not, however, explain how to do it.
So Jensen and Dion began mixing up various concoctions of polymethylmethacrylate, a cement approved by the Food and Drug Administration for attaching bone to implants. (Surgeons can try new procedures without FDA approval and can use approved substances in new ways at their discretion.)
“We’ve never tried this before,” Jensen said they told the cancer patient. “But it’s all we have to offer.” With trepidation, they injected the cement.
“The next day,” Jensen said, “her pain was gone.”
Then they saw two men with severe compression fractures of the spine caused by osteoporosis. After practicing on spines from cadavers, the two doctors treated the men with cement. Again, their pain went away.
“We said, ‘O.K., now we may actually be on to something,”‘ Jensen recalled. In November 1997, she and her colleagues reported on 29 patients. Twenty-six, they said, “reported significant pain relief immediately after treatment.”
Jensen was won over.
“Anyone who goes from a pain scale of nine to a pain scale of two within 48 hours, I’m sorry, but I just do not believe it is a placebo or natural history,” she says. “These were people who had been in unremitting, relentless pain for weeks.”
Patients tell a variety of stories, not all with happy endings.
Jacqueline Gosselin, 76, of Winslow, Maine, was consumed with pain after two of her vertebrae collapsed. She spent weeks in the hospital and was unable to walk for months. Seven months after her injury, she had kyphoplasty.
At first she thought she had improved, she said, but “I’ve gone downhill ever since.” The pain is now about the same as before the procedure, she said, adding, “I’m still looking for help.”
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