Spine tuning

Last November, as she went about her daily routines, Florence Hayes suddenly felt intense back pain. The active 79-year-old soon learned she had suffered two compression fractures in her spine.

About one-quarter of all post-menopausal women suffer these breaks, typically caused by osteoporosis and simple movements such as bending or sneezing.

Hayes's doctor prescribed standard medical treatment - rest, pain pills, and physical therapy. But weeks passed and debilitating pain kept Hayes bedridden.

In January, the Cohasset resident had a minimally invasive surgery called vertebroplasty, in which doctors inject cement into broken back bones to strengthen them and relieve pain.

"The next day, the pain was gone," she said. "This man enabled me to walk again," she said of Dr. Joshua Hirsch, the Massachusetts General Hospital interventional radiologist who did the surgery.

Glowing reports from patients and doctors have fueled rapid growth of vertebroplasty and a related procedure called kyphoplasty - from about 14,000 in 2001 to more than 73,000 last year in the United States. A majority of the patients are women, because they are more prone to osteoporotic fractures, but older men and people of all ages with compression fractures triggered by cancer are also getting these procedures.

Looking ahead, the aging of the population is expected to boost spinal compression fractures well above the current 700,000 annually, so observers expect even more demand for the surgeries, despite the fact that most of these fractures heal on their own in six to 12 weeks.

The growth is sparking concern among some doctors that the procedures are becoming the first line of treatment, even though their effectiveness remains unproven and they carry significant, if uncommon, risks, including paralysis or even death. It's possible the procedure also increases the likelihood of additional broken bones.

"It's clearly spread like wildfire," said Dr. David Kallmes, a radiology professor at the Mayo Clinic, who does the surgeries. "Vertebroplasty appears to be an extremely promising procedure, but we shouldn't just extend it to every woman with a fractured back. We don't know if it's as good as a placebo and we don't know if it causes fractures."

"The medical literature is filled with horror stories of things that seem like a good idea and when tested against a placebo were no better or sometimes worse," he added.

Although Medicare pays for the procedures in most of the country, Blue Cross Blue Shield, Massachusetts' largest private insurer, does not. The Blue Cross decision is based on a 2005 analysis that found there was not enough evidence to show that vertebroplasty was effective and beneficial.

An expert committee convened by Medicare the same year also found evidence lacking, but committee members were convinced that both procedures would eventually be determined to work better than basic treatment for reducing pain and improving mobility. Last year, Medicare spent more than $600 million on the procedures.

"If we stopped paying for everything that had no evidence of benefit, we would be a very unpopular organization," said Dr. Steve Phurrough, director of Medicare's coverage and analysis group. "Back pain is an increasing problem in our country and people . . . want something done."

Hayes's case shows both the benefits and the possible problems with the procedures. She has suffered six more compression fractures since the first surgery, and had all of them cemented. In mid-August, a few hours after the last surgery, she smiled as she sat up in bed at Mass. General.

"I will be dancing at the next family wedding," she said.

Hirsch, who was the first to perform the procedures in New England, said treating Hayes has been challenging because of her tendency to develop new fractures. He believes Hayes's advanced osteoporosis caused the new breaks, but he can't be sure.

Patients with osteoporosis who suffer one fracture are highly prone to others, even without treatment. But some doctors fear that cementing one part of the spine takes away natural flexibility and puts more stress on nearby bones.

Overall, about 1 percent to 3 percent of the patients suffer complications. Problems include cement leaks that cause blood clots, paralysis, or death; slips with the needle that damage nerves; allergic reactions to the cement; infections; and broken ribs from lying on the operating table.

Hirsch, who is director of interventional neuroradiology at Mass. General, believes the benefits outweigh the risks for most patients.

"It's unbelievable to take people who've become incapacitated because of pain and make them feel better and go about their lives," he said. "While I still believe in trying medical treatment first, I do believe this [procedure] is what we should be doing."

Hirsch says he thinks the procedures will prove so effective that they will spur minimally invasive techniques for other bone surgeries. Already, he is using the methods in new ways - injecting cement, for instance, into a cancer patient's hip that was so eaten away it was about to shatter.

But he also supports more research to show scientifically whether the procedures work.

A definitive study is underway in which willing patients are being randomly assigned to either vertebroplasty or a sham procedure and then followed for a year. The federally funded study initially had trouble finding participants, in part because of hype about vertebroplasty, according to the Mayo Clinic's Kallmes, who is leading the research. But it has now enrolled 85 patients, about half the goal. Kallmes expects to publish results in 2009.

Hirsch said he urged Mass. General to join the study, but the hospital's review committee declined. They were concerned, he said, that patients undergoing the sham procedure would be put at risk - from sedation to mimic vertebroplasty - without any benefit.

Kallmes and the National Institutes of Health believe the study is ethical and essential to provide patients and doctors with solid evidence.

Many small studies have tracked patients without comparisons to placebos and reported positive results. A few have compared vertebroplasty to medical treatment and found that the procedure provides faster and greater reduction in pain and return to normal activities. But, in most studies, that advantage faded over time and by six months or a year, there was little or no difference.

In a consensus statement published in January, associations of radiologists and neurological surgeons call the procedures "safe, efficacious, and durable" when performed by experienced doctors on appropriate patients. They say the procedures should be offered only after medical care has failed to relieve pain and get the patient back to normal activity. But Kallmes and some other doctors say it is often being done without that waiting period.

Dr. James Weinstein, an orthopedist, said the rapid growth in the procedures, coupled with the lack of hard evidence, points to the need to spell out all the risks and benefits for patients and let them choose.

"As in most of medicine, there isn't as much evidence as we would like," said Weinstein, director of the Dartmouth Institute for Health Policy and Clinical Practice. "We need to be clear that there is a choice" of treatments, he said, and "that one isn't necessarily better than the other."

To prevent compression fractures:

Younger people can help prevent osteoporosis and the risk of compression fractures by avoiding smoking, moderating alcohol consumption, eating enough calcium and vitamin D, and doing exercise that strengthens core muscles, including weight training, Pilates, walking, or rowing.

Older people, whose spine may be weakened by osteoporosis, should ask their doctor for a bone density test and about medicines that help build bone and prevent fractures, according to Dr. Douglas Kiel, director of medical research at Hebrew SeniorLife's Institute for Aging Research.

They can do mild exercises, such as walking, Pilates, and back extensions, but should avoid activities that load the spine while bending. Risky motions include bending into a crib and lifting a baby, reaching into a shopping cart for a heavy bag, or trying to open an old window sash.

Alice Dembner can be reached at dembner@globe.com.