By Pat Anson, PNN Editor
There is little evidence that two surgical procedures commonly used to treat spinal fractures caused by osteoporosis reduce pain for patients better than pharmaceutical drugs, according to a new report by an international task force of bone health experts published in the Journal of Bone and Mineral Research..
More than 10 million Americans suffer from osteoporosis, a loss of calcium and bone density that worsens over time and significantly raises the risk of bone fractures, especially among the elderly. About 750,000 spinal fractures occur each year in the United States alone.
The task force looked at two types of spinal fusions: vertebroplasty, where medical grade cement is injected into the broken vertebrae to fuse bone fragments together; and balloon kyphoplasty, where a balloon is inserted into the compressed area of the spine to lift it and allow the cement to be inserted. Metal plates, screws and rods can also be used in spinal fusions, but were not the focus of the study.
The researchers found little to no evidence that vertebroplasty or kyphoplasty relieve pain effectively. In five clinical studies, vertebroplasty provided no significant benefit in pain control over placebo or sham procedures. There were no placebo-controlled trials for balloon kyphoplasty, leaving doctors to rely on anecdotal, low-quality evidence.
"The message for doctors and their patients suffering from painful spinal fractures is that procedures to stabilize spinal fractures should not be a first choice for treatment," said lead author Peter Ebeling, MD, Head of the Department of Medicine in the School of Clinical Sciences at Monash University in Australia.
"While patients who had these surgeries may have had a short-term reduction in pain, we found that there was no significant benefit over the long-term in improving pain, back-related disability, and quality of life when compared with those who did not have the procedures."
The task force report comes as spine surgeons increasingly market vertebroplasty and kyphoplasty as “minimally invasive" procedures that offer immediate relief from back pain without the risks of opioid medication. But there are still risks of infection, cement leakage and complications associated with elderly patients undergoing anesthesia.
Some 300,000 Medicare patients underwent vertebral augmentation between 2006-2014, with most getting the more expensive balloon kyphoplasty. The procedures have become so common they are recognized as a standard of care. The video below calls them "the most effective pain relieving treatments for elderly patients.”
"These procedures are not a magic bullet," says Bart Clarke, MD, President of the American Society for Bone and Mineral Health and a Professor of Medicine at the Mayo Clinic. “Until now, doctors have been left to sift through the data on their own to determine whether these procedures can benefit their patients. This report coalesces all that information concisely and provides recommendations to guide them."
Clarke said Mayo Clinic doctors do not typically perform vertebral augmentation procedures unless a patient's pain is unmanageable for more than 4-6 weeks. "We've seen that with analgesics and other pain relief, our patients often get better within about 6 weeks," he said.
The task force also focused on the need for osteoporosis prevention. About 25% of older men and women who have a hip fracture will have a second fracture within one year, as will around 20% of older patients who have a spinal fracture. Breaking a bone in your spine or hip may be so traumatic – especially for the elderly -- that it often leads to disability and chronic widespread body pain.
Recent studies have shown that many patients at high risk of fractures are not being diagnosed or treated for osteoporosis, even though hormones and bisphosphonate drugs can help strengthen their bones. Bisphosphonates such as Fosamax have been found to be effective at slowing the loss of bone mass and reducing fractures, but concerns about side effects made some patients reluctant to take bisphosphonates and doctors less likely to prescribe them.
"Overall, prevention is critical. and we need to get these high-risk patients on anti-osteoporosis drugs that have proven to reduce future fractures by as much as 70 percent," Clarke said.